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

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02448888
• Other study ID #: PTDLEF1
• Status: Completed
• Phase: N/A
• First received: March 20, 2015
• Last updated: November 8, 2016
• Start date: January 2015
• Est. completion date: May 2016

Study information

• Verified date: November 2016
• Source: Universidad San Jorge
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics commitee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Adapted exercise
2 months, 3 times/week
• General exercise recommendations
2 months, 3 times/week

Locations

Country	Name	City	State
Spain	San Jorge University	Villanueva de Gallego	Zaragoza
Spain	BSH electrodomesticos España S.A	Zaragoza

Sponsors (3)

Lead Sponsor	Collaborator
Universidad San Jorge	BSH electrodomésticos España S.A., Mutua MAZ

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in lumbar pain intensity	The assessment is performed with Brief Pain Index short form Self-administered questionnaire with 9 questions.	Baseline, at the end of the two weeks training period and three months after the end of the training period.	No
Primary	Change in disability caused by lumbar pain	The assessment is performed with Oswestry Low Back Pain Disability Questionnaire,	Baseline, at the end of the two weeks training period and three months after the end of the training period.	No
Primary	Change in the functional assessment of the lumbar spine	Functional assessment of the lumbar spine with EMG Flexion-relaxation test:	Baseline, at the end of the two weeks training period and three months after the end of the train	No
Secondary	Change in weekly physical activity amount	Weekly physical activity performed by the patient assessed by the IPAQ	Baseline, at the end of the two weeks training period and three months after the end of the training period.	No
Secondary	Incidence of sick-leave caused by lumbar pain		1 year	No