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

Not Applicable

Completed

• Conditions: Chronic Low Back Pain
• Interventions: Behavioral: Behavioral Medical Rehabilitation plus behavioral exercise therapy; Behavioral: Usual Behavioral Medical Rehabilitation

• Registration Number: NCT01666639
• Lead Sponsor: University of Erlangen-Nürnberg

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2012-06-18
• Study First Submitted QC: 2012-08-10
• Study First Posted: 2012-08-16
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-26
• Last Update Posted: 2014-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 351

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Behavioral Medical Rehabilitation plus behavioral exercise therapy	-
Control Group	Usual Behavioral Medical Rehabilitation	-

Primary Outcome Measures

Name	Time	Method
Hannover Functional Ability Questionnaire (HFAQ) (Kohlmann, Raspe, 1996)	one year	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).

Secondary Outcome Measures

Name	Time	Method
Numeric Rating Scale (NRS) to assess pain intensity (Farrar et al., 2001)	one year	Three items to assess the pain intensity felt by participants at the moment, as well as during the last six months (mean and maximum pain).
Graded Chronic Pain Status (GCPS)(von Korff et al., 1992)(adapted for 6 months)	one year	Six items to assess the number of days with pain during the last six months, the history of pain and the functional disability due to pain.
Freiburger Questionnaire on Physical Activity (FQPA) (Frey et al., 1999)	one year	The FQPA measures the amount of physical activity in different contexts performed by the participants: occupational setting (rating: intensive movement, moderate movement, mostly sitting) as well as leisure time physical activity (e.g. gardening, stair-climbing, habitual walking and cycling, sports). It consists of eight items.
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	The HAPA variables include a stage assessment of behaviour change: Have you performed moderate physical for 30 minutes or longer on a minimum of 3 days per week? (rating: No, and I don't intend to do so - No, but I am currently thinking about that - No, but I strongly intend to do so - Yes, but it is difficult to me - Yes and it is easy to me) Further more, the HAPA variables include a validation item ("Since when are you regularly active as you are now?") and sets of items about the participants' intention, self-efficacy, action and coping planning, risk perception, expectations of consequences of physical activity behaviour and action control regarding physical activity. See Schwarzer et al., 2011 (Rehabilitation psychology 56(3), 161-170) for more details. Furthermore, experiences with physical activity are included (Fleig et al., 2011).
Health-related Quality of Life (SF-12) (Bullinger, Kirchberger, 1998)	one year
Depression (PHQ-D) (Löwe et al., 2002)	one year
Perceived Stress scale (Cohen, Williamson, 1988)	one year
Attitudes towards performing sports (Brand, 2006)	one year	Four items assess the attitudes towards performing physical activity which are based on cognitions (e.g. "When I think about it, I regard physical activity as: not healthy -- very healthy"). Four items assess the attitudes based on affective judgement (e.g. "When I think about bein physically active, I feel not satisfied -- very satisfied"). Each of the eight items is rated on a 7-point scale in between the two poles.
Questionnaire for the detection of pain coping strategies (FESV) (Geissner, 2001)	one year
Tampa Scale of Kinesiophobia (TSK) (Kori et al., 1990)	one year
Avoidance-Endurance Questionnaire (AEQ) (Hasenbring et al., 2009)	one year

Trial Locations

Locations (3)

Institute of Sport Science and Sport; 🇩🇪 Erlangen, Bavaria, Germany

Klinik Weser; 🇩🇪 Bad Pyrmont, Lower Saxony, Germany

Paracelsus-Klinik an der Gande; 🇩🇪 Bad Gandersheim, Lower Saxony, Germany