A comparative effectiveness trial of postoperative management for lumbar spine surgery: changing behavior through physical therapy (CBPT) study protocol

BMC Musculoskeletal Disorders

Stephen T Wegener⁶  Lee H Riley¹  Richard L Skolasky¹  Joseph S Cheng⁴  Oran S Aaronson⁴  Christopher J Fonnesbeck⁵  Clinton J Devin²  Susan W Vanston²  Christine M Haug²  Rogelio A Coronado²  Kristin R Archer³ 

[1] Department of Orthopaedic Surgery, Johns Hopkins Medicine, Baltimore, MD, USA;Department of Orthopaedic Surgery and Rehabilitation, Vanderbilt University Medical Center, Nashville, TN, USA;Department of Orthopaedic Surgery and Rehabilitation, Vanderbilt University, School of Medicine, Medical Center East – South Tower, Suite 4200, Nashville, TN 37232, USA;Department of Neurological Surgery, Vanderbilt University Medical Center, Nashville, TN, USA;Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA;Department of Physical Medicine and Rehabilitation, Johns Hopkins Medicine, Baltimore, MD, USA

关键词: Spine surgery;    Postoperative pain;    Rehabilitation;    Self-management;    Cognitive-behavioral therapy;    Comparative effectiveness research;   

Others  :  1122015
DOI  :  10.1186/1471-2474-15-325

 received in 2014-09-09, accepted in 2014-09-25,  发布年份 2014

【 摘 要 】

Background

The United States has the highest rate of lumbar spine surgery in the world, with rates increasing over 200% since 1990. Medicare spends over $1 billion annually on lumbar spine surgery. Despite surgical advances, up to 40% of patients report chronic pain and disability following surgery. Our work has demonstrated that fear of movement is a risk factor for increased pain and disability and decreased physical function in patients following lumbar spine surgery for degenerative conditions. Cognitive-behavioral therapy and self-management treatments have the potential to address psychosocial risk factors and improve outcomes after spine surgery, but are unavailable or insufficiently adapted for postoperative care. Our research team developed a cognitive-behavioral based self-management approach to postoperative rehabilitation (Changing Behavior through Physical Therapy (CBPT)). Pilot testing of the CBPT program demonstrated greater improvement in pain, disability, physical and mental health, and physical performance compared to education. The current study compares which of two treatments provided by telephone – a CBPT Program or an Education Program about postoperative recovery - are more effective for improving patient-centered outcomes in adults following lumbar spine surgery for degenerative conditions.

Methods/design

A multi-center, comparative effectiveness trial will be conducted. Two hundred and sixty patients undergoing lumbar spine surgery for degenerative conditions will be recruited from two medical centers and community surgical practices. Participants will be randomly assigned to CBPT or Education at 6 weeks following surgery. Treatments consist of six weekly telephone sessions with a trained physical therapist. The primary outcome will be disability and secondary outcomes include pain, general health, and physical activity. Outcomes will be assessed preoperatively and at 6 weeks, 6 months and 12 months after surgery by an assessor masked to group allocation.

Discussion

Effective rehabilitation treatments that can guide clinicians in their recommendations, and patients in their actions will have the potential to effect change in current clinical practice.

Trial registration

NCT02184143.

【 授权许可】

   
2014 Archer et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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