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

NCT ID: NCT02448888

Last Updated: 2016-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-05-31

Brief Summary

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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

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Adapted exercise

Intervention Type OTHER

2 months, 3 times/week

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.

Group Type EXPERIMENTAL

General exercise recommendations

Intervention Type OTHER

2 months, 3 times/week

Interventions

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Adapted exercise

2 months, 3 times/week

Intervention Type OTHER

General exercise recommendations

2 months, 3 times/week

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mutua MAZ

UNKNOWN

Sponsor Role collaborator

BSH electrodomésticos España S.A.

UNKNOWN

Sponsor Role collaborator

Universidad San Jorge

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vanessa Bataller

Role: STUDY_DIRECTOR

San Jorge University

Cristina Cimarras

Role: PRINCIPAL_INVESTIGATOR

San Jorge University

Locations

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San Jorge University

Villanueva de Gállego, Zaragoza, Spain

Site Status

BSH electrodomesticos España S.A

Zaragoza, Zaragoza, Spain

Site Status

Countries

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Spain

Other Identifiers

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PTDLEF1

Identifier Type: -

Identifier Source: org_study_id