NCT00329342

Brief Summary

Low back pain has become a major concern to employees and employers because of its negative impact on employee health and productivity. The objective of this study is to investigate whether a return-to-work intervention conducted during inpatient rehabilitation improves functional limitations that are related with low back pain and interfere with job performance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Apr 2006

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

November 27, 2007

Status Verified

November 1, 2007

First QC Date

May 23, 2006

Last Update Submit

November 26, 2007

Conditions

Low Back Pain

Keywords

Low back pain;Return to work;Posture

Outcome Measures

Primary Outcomes (1)

  • Low Back Pain Disability: Oswestry Disability Index (ODI)

    6 months

Secondary Outcomes (4)

  • Return-to-work (RTW) outcomes: Duration of time out of work, RTW-status

    6 months

  • Fear avoidance: Fear-Avoidance Beliefs Questionnaire (FABQ) for Patients with Back Pain

    6 months

  • Vitality: SF-36 vitality

    6 months

  • Ergonomic competence: Rating of posture and movement.

    3 weeks

Study Arms (2)

1

EXPERIMENTAL
Behavioral: Occupational ergonomic training

2

NO INTERVENTION

Interventions

Occupational ergonomic trainingBEHAVIORAL

Adequate postural habits in activities of daily living

1

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Chronic low back pain
  • Undergoing inpatient rehabilitation
  • Working age

You may not qualify if:

  • Receiving or applying for retirement pension
  • Diagnostic findings that require surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vogtlandklinik Bad Elster

Bad Elster, 08645, Germany

Location

Related Publications (6)

  • Schmidt CO, Kohlmann T. [What do we know about the symptoms of back pain? Epidemiological results on prevalence, incidence, progression and risk factors]. Z Orthop Ihre Grenzgeb. 2005 May-Jun;143(3):292-8. doi: 10.1055/s-2005-836631. German.

    PMID: 15977117BACKGROUND

  • Keller S, Herda C, Ridder K, Basler HD. Readiness to adopt adequate postural habits: an application of the Transtheoretical Model in the context of back pain prevention. Patient Educ Couns. 2001 Feb;42(2):175-84. doi: 10.1016/s0738-3991(00)00103-8.

    PMID: 11118783BACKGROUND

  • Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993 Feb;52(2):157-168. doi: 10.1016/0304-3959(93)90127-B.

    PMID: 8455963BACKGROUND

  • Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980 Aug;66(8):271-3. No abstract available.

    PMID: 6450426BACKGROUND

  • Pfingsten M, Kroner-Herwig B, Leibing E, Kronshage U, Hildebrandt J. Validation of the German version of the Fear-Avoidance Beliefs Questionnaire (FABQ). Eur J Pain. 2000;4(3):259-66. doi: 10.1053/eujp.2000.0178.

    PMID: 10985869BACKGROUND

  • Huppe A, Raspe H. [Efficacy of inpatient rehabilitation for chronic back pain in Germany: a systematic review 1980-2001]. Rehabilitation (Stuttg). 2003 Jun;42(3):143-54. doi: 10.1055/s-2003-40099. German.

    PMID: 12813651BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Martina Markes

    Forschungsinstitut fuer Balneologie und Kurortwissenschaft

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 23, 2006

First Posted

May 24, 2006

Study Start

April 1, 2006

Study Completion

June 1, 2007

Last Updated

November 27, 2007

Record last verified: 2007-11

Locations

DE(1)