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Completed

NCT Number: NCT02448888

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Jorge University, Villanueva de Gállego, Zaragoza, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adapted exercise

Other

2 months, 3 times/week

General exercise recommendations

Other

2 months, 3 times/week

Primary outcomes

  1. Change in lumbar pain intensity

    Time frame: Baseline, at the end of the two weeks training period and three months after the end of the training period.

    The assessment is performed with Brief Pain Index short form Self-administered questionnaire with 9 questions.

  2. Change in disability caused by lumbar pain

    Time frame: Baseline, at the end of the two weeks training period and three months after the end of the training period.

    The assessment is performed with Oswestry Low Back Pain Disability Questionnaire,

  3. Change in the functional assessment of the lumbar spine

    Time frame: Baseline, at the end of the two weeks training period and three months after the end of the train

    Functional assessment of the lumbar spine with EMG Flexion-relaxation test:

Secondary outcomes

  1. Change in weekly physical activity amount

    Time frame: Baseline, at the end of the two weeks training period and three months after the end of the training period.

    Weekly physical activity performed by the patient assessed by the IPAQ

  2. Incidence of sick-leave caused by lumbar pain

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Universidad San Jorge

Other

Collaborators

  • BSH electrodomésticos España S.A.
  • Mutua MAZ

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
May 20, 2015
Registry last updated
Nov 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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