Clinical trial NCT02448888: Prevention and Treatment of Chronic Low Back Pain Through an Adapted Exercise Program
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Universidad San Jorge
Sponsor class: OTHER
Collaborators: name: Mutua MAZ
name: BSH electrodomésticos España S.A.
First posted: 2015-05-20
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in lumbar pain intensity
timeFrame: Baseline, at the end of the two weeks training period and three months after the end of the training period.
measure: Change in disability caused by lumbar pain
timeFrame: Baseline, at the end of the two weeks training period and three months after the end of the training period.
measure: Change in the functional assessment of the lumbar spine
timeFrame: 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
timeFrame: Baseline, at the end of the two weeks training period and three months after the end of the training period.
measure: Incidence of sick-leave caused by lumbar pain
timeFrame: 1 year
Other outcomes:
Locations:
city: Villanueva de Gallego
country: Spain
facility: San Jorge University
state: Zaragoza
city: Zaragoza
country: Spain
facility: BSH electrodomesticos España S.A
Study officials:
affiliation: San Jorge University
name: Vanessa Bataller
role: STUDY_DIRECTOR
affiliation: San Jorge University
name: Cristina Cimarras
role: PRINCIPAL_INVESTIGATOR
References: