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Clinical Trials/NCT02448888
NCT02448888
Completed
N/A

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

Universidad San Jorge2 sites in 1 country18 target enrollmentJanuary 2015
ConditionsLow Back Pain

Overview

Phase
N/A
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
Universidad San Jorge
Enrollment
18
Locations
2
Primary Endpoint
Change in the functional assessment of the lumbar spine
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
May 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Universidad San Jorge
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change in the functional assessment of the lumbar spine

Time Frame: Baseline, at the end of the two weeks training period and three months after the end of the train

Functional assessment of the lumbar spine with EMG Flexion-relaxation test:

Change in disability caused by lumbar pain

Time Frame: Baseline, at the end of the two weeks training period and three months after the end of the training period.

The assessment is performed with Oswestry Low Back Pain Disability Questionnaire,

Change in lumbar pain intensity

Time Frame: Baseline, at the end of the two weeks training period and three months after the end of the training period.

The assessment is performed with Brief Pain Index short form Self-administered questionnaire with 9 questions.

Secondary Outcomes

  • Change in weekly physical activity amount(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)

Study Sites (2)

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