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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02448888
Enrollment
18
Registered
2015-05-20
Start date
2015-01-31
Completion date
2016-05-31
Last updated
2016-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

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.

Interventions

OTHERAdapted exercise

2 months, 3 times/week

OTHERGeneral exercise recommendations

2 months, 3 times/week

Sponsors

Mutua MAZ
CollaboratorUNKNOWN
BSH electrodomésticos España S.A.
CollaboratorUNKNOWN
Universidad San Jorge
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in lumbar pain intensityBaseline, 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.
Change in disability caused by lumbar painBaseline, 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,
Change in the functional assessment of the lumbar spineBaseline, at the end of the two weeks training period and three months after the end of the trainFunctional assessment of the lumbar spine with EMG Flexion-relaxation test:

Secondary

MeasureTime frameDescription
Change in weekly physical activity amountBaseline, 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
Incidence of sick-leave caused by lumbar pain1 year

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026