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Effects of Aerobic Exercises in Patients With Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03668574
Recruitment Status : Enrolling by invitation
First Posted : September 12, 2018
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
Leonardo Oliveira Pena Costa
Information provided by (Responsible Party):
Irlei dos Santos, Universidade Cidade de Sao Paulo

Brief Summary:
The aim of this study is to test the feasibility of a clinical trial testing the effectiveness of aerobic exercises program in patients with chronic non-specific low back pain.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: Aerobic exercise Other: Placebo Group Not Applicable

Detailed Description:

A total of 30 patients with chronic non-specific low back pain (with a duration of at least 12 weeks) who are seeking for treatment will be recruited. These patients will be randomly allocated into two groups.

Patients allocated to the placebo group will be treated twice a week for a total of 12 weeks with detuned ultrasound and shortwave therapy

Patients allocated to the exercise group will be trained with aerobic exercises on a treadmill twice a week for a total of 12 weeks.

Primary outcomes will be pain and disability. Feasibility outcomes will be adherence, satisfaction and recruitment. Kinesiophobia, perceived global effect and physical capacity will also be analyzed as secondary outcomes. The outcome assessor of this trial will be blinded to the group allocation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Aerobic Exercise for Patients With Non-specific Chronic Low Back Pain: a Feasibility Randomized Controlled Trial
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : November 15, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aerobic exercise group
Patients will firstly warm up for 5 minutes and begin training on the treadmill. There will be two weekly sessions, lasting 40 minutes, for 6 weeks, reaching a total of 12 sessions. The exercise intensity will vary from 60 to 90% of the maximum heart rate (HRmax) predicted by the percentage formula HR = HR rep + percentage (HRmax - HR rep), where HRmax = 220-age (years) and HR rep = HR obtained for five minutes of rest. Heart rate and level of subjective perception of the effort will be monitored during all sessions. Patients from this group will also be educated about their back pain by receiving a copy of The back Book.
Other: Aerobic exercise
Aerobic exercise that is defined as a form of exercise lasting 15 to 60 minutes continuous and intensity of 60% to 90% of maximal heart rate.

Placebo Comparator: Placebo Group
Patients will received a detuned pulsed 5-minute ultrasound and pulsed short-wave diathermy for 25 minutes, twice weekly for 6 weeks. The devices will be used with disconnected internal cables to obtain the placebo effect; however, it will be possible to manipulate the devices and adjust the doses and alarms as if they were connected, in order to simulate the pragmatism of clinical practice as well as to increase the credibility of the use of these devices in patients. Patients from this group will also be educated about their back pain by receiving a copy of The back Book.
Other: Placebo Group
Will be treated with pulsed 5-minute ultrasound and pulsed short-wave diathermy for 25 minutes. The devices will be used with disconnected internal cables to obtain the placebo effect




Primary Outcome Measures :
  1. Pain intensity measured by a 0-10 Numerical Pain Rating Scale. [ Time Frame: Six weeks after randomization ]
    Pain intensity will be measured by a 0-10 Numerical Pain Rating Scale. Higher values represent higher pain intensity.


Secondary Outcome Measures :
  1. Disability measured with the 0-24 Rolland Morris Disability Questionnaire. [ Time Frame: Six weeks after randomization ]
    Disability will be measured with the 0-24 Rolland Morris Disability Questionnaire. Higher values represent higher disability.

  2. Kinesiophobia measured with Tampa Scale of Kinesiophobia [ Time Frame: Six weeks after randomization ]
    Kinesiophobia (i.e. fear of movement) will be measured with the 17-68 point Tampa Scale of kinesiophobia. The higher the score, the higher is the fear of movement.

  3. Global Impression of Recovery measured with the 11-point Global Perceived Effect Scale [ Time Frame: Six weeks after randomization ]
    Global impression of recovery will be measured with the 11-point (-5 to + 5) Global Perceived Effect Scale. A negative score means deterioration of symptoms and positive scores mean improvement. A score of +5 means that the patient is considered as fully recovered.

  4. Physical activity levels measured with an Accelerometer [ Time Frame: Six weeks after randomization ]
    Physical Activity will be measured with an accelerometer. Patients will wear an accelerometer for seven consecutive days. The higher the values, the higher the physical activity levels.

  5. Maximum exercise capacity measured with the modified Shuttle Walk Test [ Time Frame: Six weeks after randomization ]

    Maximum exercise capacity will be measured with the modified Shuttle Walk Test. The purpose of this test is to see how far and fast patients can walk by following a series of time signals.

    Patients will be asked to walk between two cones spaced 10 metres apart. Participants will begin by walking at a very slow pace; this pace is set by a beep. Patients will walk around the 10 metre course aiming to turn around a cone at the first beep, and around the second cone at the next beep.

    The beep's will very gradually get faster, which means that patients will begin to walk at a quicker pace, getting faster and faster until he/she cannot keep up with the set pace, or until the participant is too breathless or tired to continue.

    The test has 12 levels each lasting 1 minute with a minimum walking speed of 1.2 miles per hour, up to a maximum of 5.3 miles per hour.



Other Outcome Measures:
  1. Adherence [ Time Frame: Six weeks after randomization ]
    This is the first measure to test if a larger trial will be feasible: the investigators will count the number of treatment sessions that patients attended during the treatment phase of the trial. The higher the number, the higher the adherence.

  2. Recruitment measures [ Time Frame: Prior to randomisation ]
    The investigators will record the number of patients who will not agree to participate in the study and reasons for declining.

  3. Satisfaction with care measured with the 0-130 Medrisk Patient Satisfaction Questionnaire [ Time Frame: Six weeks after randomization ]
    The investigators will use the 0-130 Medrisk Patient Satisfaction Questionnaire for measuring satisfaction with care. The higher the score, the higher is the satisfaction with care.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with chronic non-specific low back pain with a pain intensity of at least 3 points at the baseline assessment measured by the Numerical Pain Scale, between 18 and 80 years of age and able to read Portuguese.

Exclusion Criteria:

  • Patients who have some contraindication to exercise, fractures, tumors, inflammatory and infectious diseases, severe cardiovascular and metabolic diseases, and the development of chronic inflammatory diseases (eg, dyspnoea, limiting diseases of the lower limbs, previous spinal surgery and pregnancy.

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): NCT03668574


Locations
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Brazil
Irlei dos Santos
São Paulo, SP, Brazil, 04313-210
Sponsors and Collaborators
Universidade Cidade de Sao Paulo
Leonardo Oliveira Pena Costa
Investigators
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Principal Investigator: Leonardo Costa, PhD Universidade Cidade de Sao Paulo
Publications:

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Responsible Party: Irlei dos Santos, Associate Professor, Universidade Cidade de Sao Paulo
ClinicalTrials.gov Identifier: NCT03668574    
Other Study ID Numbers: 2.661.658
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Irlei dos Santos, Universidade Cidade de Sao Paulo:
Back pain
Low back pain
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations