Return to Work Interventions for Patients With Low Back Pain

Low Back Pain Clinical Trial

Official title:

Return to Work Interventions for Patients With Low Back Pain During Inpatient Rehabilitation: a Quasi-Experimental Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00329342
• Other study ID #: RTW-LBP-1
• Status: Completed
• Phase: N/A
• First received: May 23, 2006
• Last updated: November 26, 2007
• Start date: April 2006
• Est. completion date: June 2007

Study information

• Verified date: November 2007
• Source: Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Description:

In recent years most industrialized nations have been confronted with a dramatic increase in cases dealing with back pain; in Germany, back pain belongs to the major individual and societal health problems with associated costs that have put a strain not only on health care systems. Besides frequent demand for medical services, loss of production (due to temporal sick leave) and disability allowances are important economic factors. In total, the estimated annual costs caused by back pain range between 16 and 22 billion Euros. Population based studies revealed high life-time prevalence with 80% report having ever experienced back pain. The point prevalence lies between 30 and 40%. Approximately one-fourth to one-third of those affected suffer from clinically significant back pain. Epidemiological evidence for the prevalence of back pain, its severity, course and associated risk factors is extensive; however, little systematic knowledge is available about treatment of back pain especially about return-to-work interventions.

This study is designed as a quasi-experimental study to evaluate benefits of return-to-work interventions during medical rehabilitation. Positive effects are expected for low back pain related functional limitations and subsequently job performance. The intervention tested is based on the biomechanical model of chronic pain that assumes a relationship between external strain, body posture, muscle activity, and intravertebral pressure. According to this model, chronic low back pain is partially caused by overexertion and poor postural habits. The intervention aims at lowering the impact of biomechanical stress by training an adequate body posture while performing activities of daily living or job-related activities. Additionally, performing job-related activities target fear-avoidance beliefs especially assumptions about the connection between pain and work activities. The experimental group training good postural habits while performing activities of daily living or job-related activities (additionally to standard rehabilitation activities such as physiotherapy or education and counselling) will be compared with participants receiving a standard rehabilitation only.

Outcome measures are assessed at baseline, post-intervention, and 6 month post-intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Chronic low back pain

• Undergoing inpatient rehabilitation

• Working age

Exclusion Criteria:

• Receiving or applying for retirement pension

• Diagnostic findings that require surgery

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Behavioral:
• Occupational ergonomic training
Adequate postural habits in activities of daily living

Locations

Country	Name	City	State
Germany	Vogtlandklinik Bad Elster	Bad Elster

Sponsors (3)

Lead Sponsor	Collaborator
Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster	European Union, Federal ministry of labour and social affairs

Country where clinical trial is conducted

Germany, 

References & Publications (6)

Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980 Aug;66(8):271-3. — View Citation

Hüppe 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. Review. German. Erratum in: Rehabilitation (Stuttg). 2003 Oct;42(5):322. — View Citation

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. — View Citation

Pfingsten M, Kröner-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. — View Citation

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. German. — View Citation

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):157-68. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low Back Pain Disability: Oswestry Disability Index (ODI)		6 months
Secondary	Return-to-work (RTW) outcomes: Duration of time out of work, RTW-status		6 months
Secondary	Fear avoidance: Fear-Avoidance Beliefs Questionnaire (FABQ) for Patients with Back Pain		6 months
Secondary	Vitality: SF-36 vitality		6 months
Secondary	Ergonomic competence: Rating of posture and movement.		3 weeks