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

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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Adapted exercise; Other: General exercise recommendations

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Zaragoza, Spain, 50059
    • BSH electrodomesticos España S.A
  • Zaragoza
    • Villanueva de Gallego, Zaragoza, Spain, 50830
      • San Jorge University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Adapted exercise; 2 months, 3 times/week
Experimental: 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.	Other: General exercise recommendations; 2 months, 3 times/week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Incidence of sick-leave caused by lumbar pain		1 year

Collaborators and Investigators

• Sponsor: Universidad San Jorge
• Collaborators: Mutua MAZ; BSH electrodomésticos España S.A.
• Investigators: Study Director: Vanessa Bataller, San Jorge University; Principal Investigator: Cristina Cimarras, San Jorge University

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: March 20, 2015
• First Submitted That Met QC Criteria: May 15, 2015
• First Posted (Estimate): May 20, 2015

Study Record Updates

• Last Update Posted (Estimate): November 9, 2016
• Last Update Submitted That Met QC Criteria: November 8, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: PTDLEF1