Prevention and Treatment of Chronic Low Back Pain Through an Adapted Exercise Program

Study Overview
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Brief Summary
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Objective: The purpose of this study is to investigate the effects of a adapted exercise program and general exercise recommendations compared with only general exercise recommendations for the management of chronic back pain among the workers of BSH (Bosch Siemens Hausgeräte), a manufacturing company.

Detailed Description
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Design: Randomized controlled trial. Participants: Subjects (N_40 volunteers) experimental group (n_20) control group (n_20). All of the participants needs to be diagnosed with chronic back pain by a physician. Participants are going to be randomly assigned to two groups: a control group (CG), and experimental group (EG). Intervention: The experimental group is going to follow a home-exercise program designed specifically to compensate the overloads and strength necessities of the workplace, the patient enter the description of the workplace in a mobile application (APP) and the APP shows specific exercises that the patient needs to practice. The exercise program includes muscle strengthening, flexibility, and endurance training, during 2 months, 3 times/week and generla recommendations. The control group is going to receive only general recommendation (ACSM recommendations) with the same kind of mobile application to control the amount of exercise that each patient performs during the week. Data on pain intensity (BPI short form, Brief Pain Inventory), disability (Oswestry Low Back Pain Disability Questionnaire), functional assessment of the lumbar spine (EMG Flexion-relaxation test), amount of weekly physical activity (IPAQ), and number of sick leaves are going to be measured immediately before and after intervention and 3 months after the end of the intervention period.

Official Title
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Prevention and Treatment of Chronic Low Back Pain Through an Adapted Exercise Program and General Exercise Recommendations Tailored to the Job on an Assembly Line Training Versus General Exercise Recommendations: Randomized Clinical Trial

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Adapted exercise
* Other: General exercise recommendations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BSH industry workers. Spine pain diagnosed by a doctor, that has caused a previously sick-leave. The pain does not incapacitate to the patient to perform his job. In possession of a next-generation mobile. Exclusion Criteria: Lumbar injury that does not let the patient performs his work or an exercise program.

Ages Eligible for Study
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Minimum Age: 18 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adapted exercise<br>The experimental group is going to follow a home-exercise program designed specifically to compensate the overloads and strength necessities of the workplace, the patient enter the description of the workplace in a mobile application and the APP shows the specific exercise that the patient needs to practice and general exercise recommendations. | Other: Adapted exercise<br>* 2 months, 3 times/week<br>|
| Experimental: General exercise recommendations<br>The control group is going to receive general exercise recommendations (ACSM recommendations) with the same kind of APP to control the amount of exercise that each patient performs during the week. | Other: General exercise recommendations<br>* 2 months, 3 times/week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lumbar pain intensity | The assessment is performed with Brief Pain Index short form Self-administered questionnaire with 9 questions. | Baseline, at the end of the two weeks training period and three months after the end of the training period. | 
| Change in disability caused by lumbar pain | The assessment is performed with Oswestry Low Back Pain Disability Questionnaire, | Baseline, at the end of the two weeks training period and three months after the end of the training period. | 
| Change in the functional assessment of the lumbar spine | Functional assessment of the lumbar spine with EMG Flexion-relaxation test: | Baseline, at the end of the two weeks training period and three months after the end of the train | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weekly physical activity amount | Weekly physical activity performed by the patient assessed by the IPAQ | Baseline, at the end of the two weeks training period and three months after the end of the training period. | 
| Incidence of sick-leave caused by lumbar pain |  | 1 year |