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

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Other: General exercise recommendations; Other: Adapted exercise

• Registration Number: NCT02448888
• Lead Sponsor: Universidad San Jorge

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-03-20
• Study First Submitted QC: 2015-05-15
• Study First Posted: 2015-05-20
• Primary Completion: 2015-11
• Study Completion: 2016-05
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-08
• Last Update Posted: 2016-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General exercise recommendations	General exercise recommendations	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.
Adapted exercise	Adapted exercise	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.

Primary Outcome Measures

Name	Time	Method
Change in disability caused by lumbar pain	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 the functional assessment of the lumbar spine	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 lumbar pain intensity	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 Outcome Measures

Name	Time	Method
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.	Weekly physical activity performed by the patient assessed by the IPAQ
Incidence of sick-leave caused by lumbar pain	1 year

Trial Locations

Locations (2)

BSH electrodomesticos España S.A; 🇪🇸 Zaragoza, Spain

San Jorge University; 🇪🇸 Villanueva de Gallego, Zaragoza, Spain