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Completed

NCT Number: NCT00329342

Return to Work Interventions for Patients With Low Back Pain

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vogtlandklinik Bad Elster

Bad Elster, 08645, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Occupational ergonomic training

Behavioral

Adequate postural habits in activities of daily living

Primary outcomes

  1. Low Back Pain Disability: Oswestry Disability Index (ODI)

    Time frame: 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster

Other Gov

Collaborators

  • European Union
  • Federal ministry of labour and social affairs

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2007
First posted
May 24, 2006
Registry last updated
Nov 27, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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