Return to Work Interventions for Patients With Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00329342
Recruitment Status : Completed
First Posted : May 24, 2006
Last Update Posted : November 27, 2007
European Union
Federal ministry of labour and social affairs
Information provided by:
Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Behavioral: Occupational ergonomic training Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Return to Work Interventions for Patients With Low Back Pain During Inpatient Rehabilitation: a Quasi-Experimental Study
Study Start Date : April 2006
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Behavioral: Occupational ergonomic training
Adequate postural habits in activities of daily living
No Intervention: 2

Primary Outcome Measures :
  1. Low Back Pain Disability: Oswestry Disability Index (ODI) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Return-to-work (RTW) outcomes: Duration of time out of work, RTW-status [ Time Frame: 6 months ]
  2. Fear avoidance: Fear-Avoidance Beliefs Questionnaire (FABQ) for Patients with Back Pain [ Time Frame: 6 months ]
  3. Vitality: SF-36 vitality [ Time Frame: 6 months ]
  4. Ergonomic competence: Rating of posture and movement. [ Time Frame: 3 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00329342

Vogtlandklinik Bad Elster
Bad Elster, Germany, 08645
Sponsors and Collaborators
Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
European Union
Federal ministry of labour and social affairs
Principal Investigator: Martina Markes Forschungsinstitut fuer Balneologie und Kurortwissenschaft

Publications: Identifier: NCT00329342     History of Changes
Other Study ID Numbers: RTW-LBP-1
First Posted: May 24, 2006    Key Record Dates
Last Update Posted: November 27, 2007
Last Verified: November 2007

Keywords provided by Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster:
Low back pain;
Return to work;

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms