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Effect of Strength Training for Chronic Low Back Pain Patients (IRMA20) (IRMA20)

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ClinicalTrials.gov Identifier: NCT03172962
Recruitment Status : Completed
First Posted : June 1, 2017
Last Update Posted : November 30, 2018
Sponsor:
Collaborator:
University of Valencia
Information provided by (Responsible Party):
National Research Centre for the Working Environment, Denmark

Brief Summary:
Low back pain (LBP) is common in the population and has great socioeconomic consequences for societies across Europe and the United States. About a third of working-age adults have frequent LBP, and for about 10% the pain becomes chronic with consequences for work and leisure activities. A Cochrane review from April 2017 concluded that physical exercise is an intervention with few adverse events and positive outcomes on pain and function in adults with chronic pain. However, when scrutinizing the specific studies of the review there are large differences in adherence to the exercise interventions and consequently in the results obtained. Thus, there is a need for simple exercises that the patients can easily adhere to.

Condition or disease Intervention/treatment Phase
Musculoskeletal Pain Low Back Pain Behavioral: Strength training Behavioral: Usual care (control) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Strength Training for Chronic Low Back Pain Patients: Randomized Clinical Trial
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Strength training
Specific strength training exercises for the lumbar and abdominal muscles for 8 weeks
Behavioral: Strength training
Specific strength training exercises for the lumbar and abdominal muscles for 8 weeks

Behavioral: Usual care (control)
Will receive the usual care at the hospital

Active Comparator: Usual care (control)
Will receive the usual care at the hospital
Behavioral: Usual care (control)
Will receive the usual care at the hospital




Primary Outcome Measures :
  1. Low back pain intensity [ Time Frame: change from baseline to 8-week follow-up ]
    Low back pain intensity (VAS 0-10)

  2. Back pain recurrence [ Time Frame: 1 to 100 days, beginning from the last day of termination of the 8-week intervention ]
    number of episodes with back pain recurrence after termination of the intervention


Secondary Outcome Measures :
  1. Roland-Morris disability [ Time Frame: change from baseline to 8-week follow-up ]
    The Roland-Morris disability questionnaire

  2. Muscle endurance [ Time Frame: change from baseline to 8-week follow-up ]
    The Biering-Sørensen test

  3. Use of analgesics [ Time Frame: change from baseline to 8-week follow-up ]
    Number of days using analgesic within the last week

  4. Handgrip strength [ Time Frame: change from baseline to 8-week follow-up ]
    Maximal force (kg) in handgrip

  5. Pain sites [ Time Frame: change from baseline to 8-week follow-up ]
    Number of pain sites



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Non-specific Chronic low back pain patient (more than 3 months) at the hospital Arnau de Vilanova

Exclusion Criteria:

  • Spine surgery
  • neurologic or psyquiatric disorders
  • Low back traumastism
  • Recent participation in a similar training program

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03172962


Locations
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Spain
Primary care center of Lliria
Lliria, Valencia, Spain, 46160
Sponsors and Collaborators
National Research Centre for the Working Environment, Denmark
University of Valencia
Investigators
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Principal Investigator: Joaquin Calatayud, PhD University of Valencia

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Responsible Party: National Research Centre for the Working Environment, Denmark
ClinicalTrials.gov Identifier: NCT03172962     History of Changes
Other Study ID Numbers: IRMA20
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Musculoskeletal Pain
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases