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

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Strength Training for Chronic Low Back Pain Patients: Randomized Clinical Trial

Conditions
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Low Back Pain, Musculoskeletal Pain

Intervention / Treatment
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* Behavioral: Strength training
* Behavioral: Usual care (control)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Strength training<br>Specific strength training exercises for the lumbar and abdominal muscles for 8 weeks | Behavioral: Strength training<br>* Specific strength training exercises for the lumbar and abdominal muscles for 8 weeks<br>Behavioral: Usual care (control)<br>* Will receive the usual care at the hospital<br>|
| Active Comparator: Usual care (control)<br>Will receive the usual care at the hospital | Behavioral: Usual care (control)<br>* Will receive the usual care at the hospital<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low back pain intensity | Low back pain intensity (VAS 0-10) | change from baseline to 8-week follow-up | 
| Back pain recurrence | number of episodes with back pain recurrence after termination of the intervention | 1 to 100 days, beginning from the last day of termination of the 8-week intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Roland-Morris disability | The Roland-Morris disability questionnaire | change from baseline to 8-week follow-up | 
| Muscle endurance | The Biering-Sørensen test | change from baseline to 8-week follow-up | 
| Use of analgesics | Number of days using analgesic within the last week | change from baseline to 8-week follow-up | 
| Handgrip strength | Maximal force (kg) in handgrip | change from baseline to 8-week follow-up | 
| Pain sites | Number of pain sites | change from baseline to 8-week follow-up |