Behavioral Exercise Therapy and Multidisciplinary Rehabilitation for Chronic Non-specific Low Back Pain

NCT01666639 | Completed

• 1 other identifier: 0421-FSCP-Z256
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 3

Brief Summary

Multidisciplinary behavioral-orthopedic rehabilitation in the treatment of chronic back pain has proven its short-term effectiveness. Exercise therapy plays a major role in such a combination of treatments. There is a considerable need to develop theory-based exercise interventions which foster a long-term adherence to physical activity. Furthermore, an integration of behavioral elements such as coping competencies regarding back pain is needed. It is not yet clear, which specific part of multidisciplinary rehabilitation causes its effects. The role of exercise therapy has yet to be investigated. Aim of this study is the implementation of a standardized behavioral exercise therapy into an existing behavioral-medical rehabilitation for patients with chronic back pain. The main hypothesis is that the participation in the behavioral exercise therapy leads to greater short- and long-term improvements in functional capacity compared to the usual care.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Hannover Functional Ability Questionnaire (HFAQ) (Kohlmann, Raspe, 1996)

  The Hannover Functional Ability Questionnaire surveys the subjective estimate of a person of his or her functional ability in the context of physical activities of daily living. The Questionnaire has 12 Items. The participant is asked whether he or she is able to perform activities (e.g. to put on and pull off one's socks) and rates each on a 3-point scale (1=yes, 2=yes, but with trouble), 3=no, or only with help).

  one year

Secondary Outcomes (12)

• Freiburger Questionnaire on Physical Activity (FQPA) (Frey et al., 1999)

  one year

• Numeric Rating Scale (NRS) to assess pain intensity (Farrar et al., 2001)

  one year

• Graded Chronic Pain Status (GCPS)(von Korff et al., 1992)(adapted for 6 months)

  one year

• Generalized Anxiety Disorder (GAD-7) (Löwe et al., 2008)

  one year

• HAPA variables (Fleig et al., 2011; Sniehotta et al., 2005; Schwarzer et al., 2011)

  one year

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Behavioral: Usual Behavioral Medical Rehabilitation

Intervention Group

EXPERIMENTAL

Behavioral: Behavioral Medical Rehabilitation plus behavioral exercise therapy

Interventions

Behavioral Medical Rehabilitation plus behavioral exercise therapy BEHAVIORAL

The Intervention Group is characterized by the same treatment as in the control group, plus a modification of the exercise therapy. An "Behavioral Exercise Therapy" (BET) is implemented in the usual care. The Behavioral Exercise Therapy is based on a goal-oriented and systematic combination of knowledge-, behavior-, and exercise-related elements. It had been developed prior as part of a multidisciplinary treatment and was adapted for this study. The Aims of BET are gradual improvements of individual coping competencies and self-management regarding back pain as well as long-term adherence to physical activity.

Intervention Group

Usual Behavioral Medical Rehabilitation BEHAVIORAL

The Behavioral Medical Rehabilitation (BMR), which is in this case the control group (usual care), consists of usual orthopedic medical care, exercise therapy, individual physiotherapy, psychological treatment elements (e.g. a pain management group), occupational therapy and back school. Pain medication is given if necessary. For the most part, the psychological elements draw a distinction between more "traditional" concepts or orthopedic rehabilitation and the BMR. The pain management group with its cognitive-behavioral principles comprises 9 sessions of 90 minutes each.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• F45.4 Persistent somatoform pain disorder
• F45.41 Chronic pain disorder with somatic and psychological factors
• F54 Psychological and behavioural factors associated with disorders or diseases classified elsewhere
• M51.2 Other specified intervertebral disc displacement
• M51.3 Other specified intervertebral disc degeneration
• M51.4 Schmorl's nodes
• M51.8 Other specified intervertebral disc disorders
• M51.9 Intervertebral disc disorder, unspecified
• M53.8 Other specified dorsopathies
• M53.9 dorsophathy, unspecified
• M54.4 Lumbago with sciatica
• M54.5 Low back pain
• M54.6 Pain in thoracic spine
• M54.8 Other dorsalgia
• M54.9 Dorsalgia, unspecified

You may not qualify if:

• distinct specific diagnosis for back pain (e.g. radicular symptoms, myelopathy)
• severely limited health status (comorbidity)
• serious impairment of vision and hearing (not corrected)
• inability to speak german
• pension claim (§51 SGB V - german law)

Sponsors & Collaborators

• University of Erlangen-Nürnberg: lead
• Deutsche Rentenversicherung: collaborator

Study Sites (3)

Institute of Sport Science and Sport

Erlangen, Bavaria, 91058, Germany

Location

Paracelsus-Klinik an der Gande

Bad Gandersheim, Lower Saxony, 37581, Germany

Location

Klinik Weser

Bad Pyrmont, Lower Saxony, 31812, Germany

Location

Related Publications (2)

• Hofmann J, Peters S, Geidl W, Hentschke C, Pfeifer K. Effects of behavioural exercise therapy on the effectiveness of a multidisciplinary rehabilitation for chronic non-specific low back pain: study protocol for a randomised controlled trial. BMC Musculoskelet Disord. 2013 Mar 11;14:89. doi: 10.1186/1471-2474-14-89.

  PMID: 23496822 BACKGROUND

• Semrau J, Hentschke C, Peters S, Pfeifer K. Effects of behavioural exercise therapy on the effectiveness of multidisciplinary rehabilitation for chronic non-specific low back pain: a randomised controlled trial. BMC Musculoskelet Disord. 2021 May 29;22(1):500. doi: 10.1186/s12891-021-04353-y.

  PMID: 34051780 DERIVED

Related Links

• Homepage: Research funding for care-oriented research "Chronic diseases and patient orientation"

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: June 18, 2012
• First Posted: August 16, 2012
• Study Start: March 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 28, 2014

Record last verified: 2014-01

Locations

DE (3)