NCT02448888

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 20, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

November 9, 2016

Status Verified

November 1, 2016

Enrollment Period

10 months

First QC Date

March 20, 2015

Last Update Submit

November 8, 2016

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Change in weekly physical activity amount

    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

Study Arms (2)

Adapted exercise

EXPERIMENTAL

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

General exercise recommendations

EXPERIMENTAL

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

Interventions

Adapted exerciseOTHER

2 months, 3 times/week

Adapted exercise
General exercise recommendationsOTHER

2 months, 3 times/week

General exercise recommendations

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Lumbar injury that does not let the patient performs his work or an exercise program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

San Jorge University

Villanueva de Gállego, Zaragoza, 50830, Spain

Location

BSH electrodomesticos España S.A

Zaragoza, Zaragoza, 50059, Spain

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Vanessa Bataller

    San Jorge University

    STUDY DIRECTOR

  • Cristina Cimarras

    San Jorge University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2015

First Posted

May 20, 2015

Study Start

January 1, 2015

Primary Completion

November 1, 2015

Study Completion

May 1, 2016

Last Updated

November 9, 2016

Record last verified: 2016-11

Locations

ES(2)