An interventional study of Adapted exercise and General exercise recommendations in Low Back Pain, sponsored by Universidad San Jorge. Completed at 2 sites in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-11-09.
Sponsored by Universidad San Jorge · Not applicable, Interventional, and Treatment
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.
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 18 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.
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Exclusion Criteria:
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
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
2 months, 3 times/week
2 months, 3 times/week
Change in lumbar pain intensity
The assessment is performed with Brief Pain Index short form Self-administered questionnaire with 9 questions.
Time frame: 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,
Time frame: 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:
Time frame: Baseline, at the end of the two weeks training period and three months after the end of the train
Change in weekly physical activity amount
Weekly physical activity performed by the patient assessed by the IPAQ
Time frame: 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
Time frame: 1 year
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Universidad San Jorge