Overview

This trial has been completed.

Condition low back pain
Treatments adapted exercise, general exercise recommendations
Sponsor Universidad San Jorge
Collaborator Mutua MAZ
Start date January 2015
End date November 2015
Trial size 18 participants
Trial identifier NCT02448888, PTDLEF1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
adapted exercise
2 months, 3 times/week
(Experimental)
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.
general exercise recommendations
2 months, 3 times/week

Primary Outcomes

Measure
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.
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.
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

Secondary Outcomes

Measure
Change in weekly physical activity amount
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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title 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
Principal investigator Cristina Cimarras
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Universidad San Jorge.