Effects of Resistance Training on Pain, Function and Work Ability in Patients With Moderate to Severe Low Back Pain

Study Overview
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Brief Summary
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The purpose of this study is to investigate if high-intensity resistance training can induce additional beneficial effects, for patients with moderate to severe long term pain in the low back, when added to a multidisciplinary treatment program.

Official Title
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Effects of Resistance Training on Pain, Function and Work Ability in Patients With Moderate to Severe Low Back Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Behavioral: High-intensity resistance training
* Behavioral: General physical activity
* Behavioral: Multidisciplinary rehabilitation program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Referred to the multidisciplinary clinic for treatment of pain in low back Long term (≥ 3months) or recurrent (≥ 2 periods of ≥ 4 weeks the past year) non-specific low back pain Pain intensity ≥ 4 on numerical rating scale (0-10) Exclusion Criteria: Severe somatic condition (unstable injury, malignity, infectious disease, active rheumatic disease, severe osteoporosis) Psychiatric condition/disease that severely impairs group functioning Insufficient comprehension of Norwegian language to participate in group sessions and fill out questionnaires Awaiting surgery of back Alcohol or drug abuse Ongoing compensation case or applying for disability benefits due to pain in the back Engaged in high-intensity resistance training on a regular basis the last 6 months

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-intensity resistance training<br>Full body, progressive strength training with Theraband® Elastic bands. Three times per week for 12 weeks - 3 weeks with supervised sessions at the clinic, and 9 weeks of home training. Three guided sessions will be offered during the home training period. | Behavioral: High-intensity resistance training<br> <br> Behavioral: Multidisciplinary rehabilitation program<br> <br> |
| Active Comparator: General physical activity<br>12 weeks of general physical activity - 3 weeks with supervised sessions at the clinic, and 9 weeks of individually adjusted home training. This include circle-training, low-intensity resistance exercises, endurance exercises, ball playing, body awareness, stretching, and relaxation techniques, and similar activities. Neither moderate nor high-intensity resistance exercise is included for participants in this group.Three guided sessions will be offered during the home training period. | Behavioral: General physical activity<br> <br> Behavioral: Multidisciplinary rehabilitation program<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low back-related disability as assessed by the oswestry disability index | Oswestry disability index | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessed by the Numerical Pain Rating Scale |  | 3 and 12 weeks + 6 and 12 months | 
| Fear avoidance beliefs assessed by Fear Avoidance Beliefs Questionnaire |  | 3 and 12 weeks + 6 and 12 months | 
| Patients' perceived effect of the treatment assessed by the Patient specific functioning scale |  | 3 and 12 weeks + 6 and 12 months | 
| Anxiety and depression assessed by Hopkins symptom checklist |  | 3 and 12 weeks + 6 and 12 months | 
| Quality of life assessed by EQ-5D-5L |  | 3 and 12 weeks + 6 and 12 months | 
| Work ability assessed by Work ability index |  | 3 and 12 weeks + 6 and 12 months | 
| Use of analgesics assessed by a questionnaire from the HUNT study |  | 3 and 12 weeks + 6 and 12 months | 
| Physical activity level assessed by a questionnaire from the HUNT study |  | 3 and 12 weeks + 6 and 12 months | 
| Strength in the low back during maximal isometric contractions of the back extensors |  | 3 and 12 weeks + 6 and 12 months | 
| Grip strength using a handheld dynamometer |  | 3 and 12 weeks + 6 and 12 months | 
| Patients' perceived effect of the treatment assessed by the Global rating of change scale |  | 3 and 12 weeks + 6 and 12 months | 
| Low back-related disability as assessed by the oswestry disability index |  | 3 weeks + 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise therapy, Resistance training, Multidisciplinary treatment