Improvement in Pain,Function and HRQoL ( Health Related Quality of Life) in Subacute Low Back Pain: A Controlled Clinical Trial of Exercise vs NSAIDs (Nonsteroidal Antiinflammatory) (DLSEA)

This study has been completed.
Sponsor:
Collaborator:
Universidad de Antioquia
Information provided by (Responsible Party):
Fabio Alonso Salinas Duran, Grupo Rehabilitacion en Salud
ClinicalTrials.gov Identifier:
NCT01374269
First received: June 14, 2011
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

Our clinical trial has the purpose to evaluate the effectiveness in reducing pain and improving function and quality of life during a 6-months follow-up of a therapeutic exercise program compared to pharmacological treatment with NSAIDs in patients with subacute low back pain attending the physiatrist consultation of several ambulatory health centers in Medellín during the years 2009-2010.


Condition Intervention Phase
Back Pain Lower Back
Other: Exercise program
Drug: NSAID (Nonsteroidal anti-inflammatory drugs)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improvement in Pain, Function and Quality of Life With a Protocolized Exercise Program Compared With Non-steroidal Anti-inflammatory Analgesics in Patients With Subacute Low Back Pain in Medellín, Colombia, 2009-2010

Resource links provided by NLM:


Further study details as provided by Grupo Rehabilitacion en Salud:

Primary Outcome Measures:
  • Visual Analogue Scale of Pain [ Time Frame: At the beginning ] [ Designated as safety issue: No ]
    In the Visual Analogue Sacale the best result is 0 and the worst is 100, The primary outcome was pain the mesurement of the Visual Analog Scale (VAS) (0 [no pain] to 100 [maximum pain]) at the beginning.

  • Visual Analogue Scale of Pain [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    In the VAS the best result is 0 and the worst is 100. The primary outcome was pain improvement of ≥25 mm on the Visual Analog Scale (VAS) (0 [no pain] to 100 [maximum pain]) at 4 weeks.

  • Visual Analogue Scale of Pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    In the VAS the best result is 0 and the worst is 100. The primary outcome was pain improvement of ≥25 mm on the Visual Analog Scale (VAS) (0 [no pain] to 100 [maximum pain]) at 12 weeks.

  • Visual Analogue Scale of Pain [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The best result is 0 and the worst is 100, Pain relief more than 25 mm on the Visual Analogue Scale, assessed 24 weeks after intervention.


Secondary Outcome Measures:
  • Oswestry Disability Index [ Time Frame: At the beginning ] [ Designated as safety issue: No ]
    Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.

  • Oswestry Disability Index [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.

  • Oswestry Disability Index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.

  • Oswestry Disability Index [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.

  • Roland-Morris Questionnaire [ Time Frame: At the beginning ] [ Designated as safety issue: No ]
    Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. Being worst 24.

  • Roland-Morris Questionnaire [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. Being worst 24.

  • Roland-Morris Questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. Being worst 24.

  • Roland-Morris Questionnaire [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. Being worst 24.

  • Quality of Life, Change in Health [ Time Frame: At the beginning ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.

  • Quality of Life, Change in Health [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.

  • Quality of Life, Change in Health [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.

  • Quality of Life, Change in Health [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.

  • Quality of Life, Bodily Pain [ Time Frame: At the beginning ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.

  • Quality of Life, Bodily Pain [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.

  • Quality of Life, Bodily Pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.

  • Quality of Life, Bodily Pain [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.

  • Quality of Life, Emotional Performance. [ Time Frame: At the beginning ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.

  • Quality of Life, Emotional Performance. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.

  • Quality of Life, Emotional Performance. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.

  • Quality of Life, Emotional Performance. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.

  • Quality of Life, Physical Performance. [ Time Frame: At the beginning ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance

  • Quality of Life, Physical Performance. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance

  • Quality of Life, Physical Performance. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance

  • Quality of Life, Physical Performance. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance.

  • Quality of Life, Physical Function. [ Time Frame: At the beginning ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.

  • Quality of Life, Physical Function. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.

  • Quality of Life, Physical Function. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.

  • Quality of Life, Physical Function. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.

  • Quality of Life, Social Function. [ Time Frame: At the beginning ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.

  • Quality of Life, Social Function. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.

  • Quality of Life, Social Function. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.

  • Quality of Life, Social Function. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.

  • Quality of Life, General Health Perceptions. [ Time Frame: At the beginning ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.

  • Quality of Life, General Health Perceptions. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.

  • Quality of Life, General Health Perceptions. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.

  • Quality of Life, General Health Perceptions. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.

  • Quality of Life, Mental Health. [ Time Frame: At the beginning ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.

  • Quality of Life, Mental Health. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.

  • Quality of Life, Mental Health. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.

  • Quality of Life, Mental Health. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.

  • Quality of Life, Vitality. [ Time Frame: At the beginning ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.

  • Quality of Life, Vitality. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.

  • Quality of Life, Vitality. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.

  • Quality of Life, Vitality. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.

  • PHQ-9 Patient Health Questionnaire (PHQ-9) Depression [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).

  • PHQ-9 Patient Health Questionnaire (PHQ-9) Depression [ Time Frame: At the beginning ] [ Designated as safety issue: No ]
    Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).

  • PHQ-9 Patient Health Questionnaire (PHQ-9) Depression [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).

  • PHQ-9 Patient Health Questionnaire (PHQ-9) Depression [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).

  • Relapses of Lumbar Pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The percentage of patients with relapsed of low back pain was measured.

  • Relapses of Lumbar Pain [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The percentage of patients with relapsed of low back pain was measured.

  • Treatments Associated With Low Back Pain at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    we are showing in this result, the number of patients who had to receive any additional treatment in either group. The measure is the number of participants who received additional treatment throughout the duration of the study.

  • Missing Workdays [ Time Frame: 6 weeks before starting ] [ Designated as safety issue: No ]
    This result shows the average of the number of missed work days.

  • Missing Workdays [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    This result shows the average of the number of missed work days.

  • Missing Workdays [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    This result shows the average of the number of missed work days.

  • Missing Workdays [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    This result shows the average of the number of missed work days.

  • Medical Consultations. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    This result shows, the total number of participants received additional medical consultations.

  • Medical Consultations. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    This result shows, the total number of participants received additional medical consultations.

  • Medical Consultations. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    This result shows, the total number of participants received additional medical consultations.


Enrollment: 90
Study Start Date: June 2009
Study Completion Date: March 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Excercise
One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered
Other: Exercise program
Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.
Other Names:
  • Therapeutic exercise
  • Physiotherapy
Active Comparator: NSAID
Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue
Drug: NSAID (Nonsteroidal anti-inflammatory drugs)
The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.
Other Names:
  • Naproxen
  • Celecoxib
  • Acetaminophen

  Hide Detailed Description

Detailed Description:

General Purpose To evaluate the effectiveness in reducing pain and improving function and quality of life during a 6-months follow-up of a therapeutic exercise program compared to pharmacological treatment with NSAIDs in patients with subacute low back pain attending the physiatrist consultation of several ambulatory health centers in Medellín during the years 2009-2010.

Specific Objectives

  1. To evaluate the efficacy of a protocolized exercise program in reducing low back pain.
  2. To evaluate the efficacy of a protocolized exercise program in improving the function.
  3. To compare the effects of both interventions on quality of life and work absenteeism in the two groups of patients.
  4. To compare the safety of both interventions.
  5. To estimate adherence and causes of non-adherence of patients to different treatments proposed.
  6. To compare in both groups the number of relapses, general and specialized medical consultations, screening studies, images and other treatments associated with low back pain.

    Null Hypothesis Management of subacute low back pain patients with a protocolized exercise program is not more effective than treatment with NSAIDs to reduce pain at least in 25 mm, measured with a Visual Analog Scale 0-100 mm.

    Alternative hypothesis Management of subacute low back pain patients with a protocolized exercise program is not more effective than treatment with NSAIDs to reduce pain at least in 25 mm, measured with a Visual Analog Scale 0-100 mm.

    Methodology:

    Type of study: randomized controlled clinical trial, single-blinded with independent evaluators.

    Reference population: Patients consulting physiatrists in different physical medicine and rehabilitation departments in Medellin, Colombia.

    Study population: patients with subacute low back pain -evolution time more than 6 weeks and less than 3 months-, with or without radiculopathy, and that fulfill inclusion criteria. In addition patients must sign an informed consent to participate in research.

    Inclusion criteria:

    • Patients aged between 18 and 60 years with subacute low back pain.
    • Evolution time more than 6 weeks and less than 3 months.
    • That were included in the social security system and live in the metropolitan area.

    Exclusion criteria:

    • Antecedents of spinal, pelvis or abdominal trauma.
    • Cancer.
    • Diabetes mellitus.
    • Steroid use.
    • Women over 60 years.
    • Cauda equine syndrome.
    • Men with osteoporosis or compression fractures.
    • Suspicion of infection
    • Insidious onset
    • Constitutional symptoms
    • Intravenous drugs abuse
    • HIV
    • Immunosuppression
    • Previous surgery
    • Rheumatic diseases
    • Urinary tract infections
    • Neurological symptoms in lower limbs
    • Mental illness (schizophrenia, bipolar or somatomorphic disorder, major depression)
    • Deformities in the spine (scoliosis greater than 15º)
    • History of peptic acid disease
    • Renal failure
    • Intake of anticoagulants or antiplatelet drugs
    • Allergy to NSAIDs.

    Primary outcome Pain relief more than 25 mm on the Visual Analogue Scale, ranging from 0 to 100, assessed 4 weeks after intervention.

    Secondary outcomes:

    Improvement in function assessed by the Oswestry Disability Index and Roland-Morris questionnaire comparing baseline to first, three and six months follow-up.

    Improvement in quality of life assessed by SF-36 (The Short Form Health Survey) questionnaire at baseline and at first, third and sixth months.

    Work absenteeism decrease. Decrease in the number of relapses, general and specialized medical consultations, screening studies, images and other treatments associated with low back pain at 6 months.

    Safety of both treatments evaluated in the exercise group by tolerance to training and presence or not of side effects, and in the NSAIDs group by the presence or absence of adverse reactions.

    Sample:

    Sampling type: simple random. Sample size calculation was based on software "Sample size Javeriana University" Type I error: 0.05 Type II Error: 0.2 Assessments number prior to randomization: 1 Assessments number after randomization: 3 Correlation between evaluations: 0.8 Clinically important difference: 0.33 Number of patients per group: 33 Experimental group control group ratio : 1 to 1 10% of loss: 7 Total: 73

    Randomization Randomization was done by means of permuted blocks of size 2, 4 and 6, generated by computer (Ralloc program, co Stata 8.2, College Station, TX, USA). Allocation will be confidential and will not be opened until the investigation is completed, this will be monitored by the Committee of Data Security.

    Enrollment Patients with subacute low back pain consulting Physical Medicine and Rehabilitation Departments of hospitals in Medellín, Colombia. There will be an initial assessment, and if patient is considered eligible will be invited to participate and asked to sign an informed consent (Appendix 1). Treatment assignment will be given in an opaque envelope.

    Masking Medical researchers who evaluate the patients, research assistants who perform the application of different measure instruments and statistical will be blinded to treatment allocation.

    Initial assessment Clinical evaluation will be performed by one of the research physiatrists. Evaluation will include: epidemiological and clinical, Visual Analog Scale (VAS), Oswestry scale, Rolland Morris Scale, and SF-36 quality of life scale.

    Intervention One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered. The second group will receive NSAID for 10 days, there will be two different options (naproxen or celecoxib) according to indications and contraindications. In case of increase in pain intensity in either of the two groups, acetaminophen in doses of 1.5 to 2.0 g / day will be used as a rescue.

    Adherence to different treatments. To ensure adherence to different treatments each patient will receive a phone call weekly to inquire about assistance, difficulties, tolerance, use of medications, and adverse effects. Patients will be given a questionnaire to verify drugs intake, dosage, time and side effects. They should also register any other drug ingestion.

    Telephone calls will be made every 15 days to ask about the health status and ensuring assistance to new assessments.

    Assessment will be scheduled at 1, 3, and 6 months Clinical evaluation will be performed by one of the researcher physiatrists or a postgraduate student.

    Committee of safety and quality of data. This committee will consist of two researchers and one professional information management responsible for the database. This will be done in Access and SPSS 15 (Statistical Product and Service Solutions) before starting information recollection.

    Analysis Plan Categorical univariate variables will be analyzed by frequency distributions and quantitative variables by measures of central tendency (mean, standard deviation, median or range). Both groups will be compared after randomization and before intervention for all variables.

    Initially, it will be established for each group if the quantitative variables are of normal distribution, by using the Kolmogorov-Smirnov test.

    Pain (primary outcome) will be evaluated in each patient at 1, 3 and 6 months and will be compared with initial pain (mean and confidence intervals) by using Student t test or Mann Whitney for each time period. The same procedure would be for the other outcomes measured quantitatively.

    An analysis of variance with repeated measures for the variability between groups and intragroup will be made.

    Comparison of categorical variables at each assessment will be done using the Chi2 test.

    The level of statistical significance to be used in all cases is 0.05. An analysis by intention to treat and per protocol will be made.

    Ethics This research and informed consent is according to "Scientific, technical and administrative standards for health research" of the Ministry of Health and the Decree 309 of 2000 of the Ministry of Environment. This is considered a minimal risk research, because therapeutic interventions are widely used to treat patients with these conditions.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged between 18 and 60 years old
  • Subacute low back pain -evolution time more than 4 weeks and less than 3 months.
  • That have social security system
  • Live in the metropolitan area

Exclusion Criteria:

  • Antecedents of spinal, pelvis or abdominal trauma
  • Cancer
  • Diabetes mellitus
  • Steroids use
  • Men and Women over 60 years
  • Cauda equine syndrome
  • Women and men with osteoporosis or compression fractures
  • Suspicion of infection.
  • Insidious onset, constitutional symptoms
  • Intravenous drugs abuse
  • HIV
  • Immunosuppression or previous surgery
  • Rheumatic diseases
  • Urinary tract infections
  • Neurological symptoms in lower limbs
  • Mental illness (schizophrenia, bipolar or somatomorphic disorder, major depression)
  • Deformities in the spine (scoliosis greater than 15º)
  • History of peptic acid disease
  • Renal failure
  • Intake of anticoagulants or antiplatelet drugs
  • Allergy to NSAIDs.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01374269

Locations
Colombia
Clínica de Las Américas
Medellin, Antioquia, Colombia
Ips Universitaria
Medellin, Antioquia, Colombia
Sponsors and Collaborators
Grupo Rehabilitacion en Salud
Universidad de Antioquia
Investigators
Study Director: Luz H Lugo, Professor Universidad de Antioquia
  More Information

No publications provided

Responsible Party: Fabio Alonso Salinas Duran, Associate Professor, Grupo Rehabilitacion en Salud
ClinicalTrials.gov Identifier: NCT01374269     History of Changes
Other Study ID Numbers: DLSejervsaine, DLSEjercicioyAINES
Study First Received: June 14, 2011
Results First Received: September 20, 2013
Last Updated: March 18, 2014
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Grupo Rehabilitacion en Salud:
NSAIDS (Nonsteroidal anti-inflammatory drugs)
Exercise
Physiotherapy
Subacute Low Back Pain
Pain
Visual Analogue Scale
oswesrty
Roland Morris
SF-36
Quality of life

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Acetaminophen
Naproxen
Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014