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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Adapted exercise
General exercise recommendations
Sponsored by
Universidad San Jorge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • San Jorge University
  • BSH electrodomesticos España S.A

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Adapted exercise

General exercise recommendations

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in lumbar pain intensity
The assessment is performed with Brief Pain Index short form Self-administered questionnaire with 9 questions.
Change in disability caused by lumbar pain
The assessment is performed with Oswestry Low Back Pain Disability Questionnaire,
Change in the functional assessment of the lumbar spine
Functional assessment of the lumbar spine with EMG Flexion-relaxation test:

Secondary Outcome Measures

Change in weekly physical activity amount
Weekly physical activity performed by the patient assessed by the IPAQ
Incidence of sick-leave caused by lumbar pain

Full Information

First Posted
March 20, 2015
Last Updated
November 8, 2016
Sponsor
Universidad San Jorge
Collaborators
Mutua MAZ, BSH electrodomésticos España S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT02448888
Brief Title
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

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad San Jorge
Collaborators
Mutua MAZ, BSH electrodomésticos España S.A.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adapted exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
General exercise recommendations
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Adapted exercise
Intervention Description
2 months, 3 times/week
Intervention Type
Other
Intervention Name(s)
General exercise recommendations
Intervention Description
2 months, 3 times/week
Primary Outcome Measure Information:
Title
Change in lumbar pain intensity
Description
The assessment is performed with Brief Pain Index short form Self-administered questionnaire with 9 questions.
Time Frame
Baseline, at the end of the two weeks training period and three months after the end of the training period.
Title
Change in disability caused by lumbar pain
Description
The assessment is performed with Oswestry Low Back Pain Disability Questionnaire,
Time Frame
Baseline, at the end of the two weeks training period and three months after the end of the training period.
Title
Change in the functional assessment of the lumbar spine
Description
Functional assessment of the lumbar spine with EMG Flexion-relaxation test:
Time Frame
Baseline, at the end of the two weeks training period and three months after the end of the train
Secondary Outcome Measure Information:
Title
Change in weekly physical activity amount
Description
Weekly physical activity performed by the patient assessed by the IPAQ
Time Frame
Baseline, at the end of the two weeks training period and three months after the end of the training period.
Title
Incidence of sick-leave caused by lumbar pain
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanessa Bataller
Organizational Affiliation
San Jorge University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Cristina Cimarras
Organizational Affiliation
San Jorge University
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Jorge University
City
Villanueva de Gallego
State/Province
Zaragoza
ZIP/Postal Code
50830
Country
Spain
Facility Name
BSH electrodomesticos España S.A
City
Zaragoza
ZIP/Postal Code
50059
Country
Spain

12. IPD Sharing Statement

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

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