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Cognitive-Behavioral Physical Therapy (CBPT)

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ClinicalTrials.gov Identifier: NCT01131611
Recruitment Status : Completed
First Posted : May 27, 2010
Last Update Posted : July 4, 2014
Sponsor:
Information provided by (Responsible Party):
Kristin Archer, Vanderbilt University

Brief Summary:
The overall objective of this application is to conduct a two-group randomized controlled trial (RCT) to gather preliminary evidence on the efficacy of a brief cognitive-behavioral based PT (CBPT) intervention in patients at-risk for poor outcomes following lumbar spine surgery for degenerative conditions. Our central hypothesis is that incorporating cognitive and behavioral strategies into postoperative standard of care PT will improve surgical outcomes, through reductions in fear of movement and pain catastrophizing. We have established the feasibility of training therapists in the CBPT intervention, recruiting and retaining patients, and the procedures for data collection and study management. The long-term goal is to broaden the availability of well-accepted and effective CBT strategies by expanding the implementation from traditional providers, psychologists, to a group of providers, physical therapists, who routinely interact with musculoskeletal pain populations.

Condition or disease Intervention/treatment Phase
Spinal Stenosis Behavioral: CBPT Other: Control-Attention Phase 1 Phase 2

Detailed Description:
Despite surgical advances, up to 40% of patients continue to have chronic pain and functional disability after lumbar spine surgery. Our own data demonstrate that high fear of movement is a risk factor for increased pain and disability in this patient population. Cognitive-behavioral therapy (CBT) and physical therapy (PT) interventions targeting fear of movement have proven effective for decreasing persistent pain and functional disability in patients with chronic low back pain. However, the efficacy of a combined CBT and PT approach has not been well demonstrated in a surgical spine population. Therefore, we propose to conduct a two-group randomized controlled trial (RCT) to gather preliminary evidence on the efficacy of a brief cognitive-behavioral based PT (CBPT) intervention in patients at-risk for poor outcomes following lumbar spine surgery for degenerative conditions. We hypothesize that incorporating cognitive and behavioral strategies into postoperative standard of care PT will improve self-reported pain and disability and observed physical function, through reductions in fear of movement and pain catastrophizing (i.e., tendency to magnify pain sensations). This pilot study plans to recruit 80 patients with high postoperative fear of movement or pain catastrophizing. These eligible at-risk patients will be randomized to one of the two groups: (1) standard PT treatment + CBPT or (2) standard PT treatment + weekly phone calls to control for attention. The CBPT program consists of 1 in person and 5 telephone sessions and is based on well-accepted and effective CBT strategies. These strategies focus on relaxation, problem-solving training, cognitive restructuring, and behavioral self management. Primary outcomes include self-reported pain and disability as measured by the Brief Pain Inventory and the Oswestry Disability Index. Secondary outcomes consist of observed physical function as measured by performance-based tests of gait speed, balance, repeated chair stands, and mobility (Short Physical Performance Battery, Timed Up and Go). Outcome data will be collected at baseline (6 weeks after surgery), after treatment (3 months after surgery), and at 6 months following surgery. The proposed two-group RCT will provide estimates of effect sizes and sample sizes associated with the CBPT intervention and data on feasible recruitment and retention goals and the mechanisms through which the CBPT intervention affects long-term outcomes. This informative pilot data will guide a multicenter, three-group clinical trial to further validate the CBPT intervention. Our long-term objective is to broaden the availability of effective CBT strategies by expanding the implementation from traditional providers, psychologists, to a group of providers, physical therapists, who routinely interact with a large population of patients with musculoskeletal pain.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive-Behavioral Based Physical Therapy: Improving Surgical Spine Outcomes
Study Start Date : February 2012
Primary Completion Date : April 2014
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: CBPT intervention
Standard PT treatment + CBPT
Behavioral: CBPT
Cognitive-Behavioral Based Physical Therapy
Placebo Comparator: Control-Attention
Standard PT treatment + weekly phone calls
Other: Control-Attention
Standard of Care + weekly phone calls



Primary Outcome Measures :
  1. Oswestry Disability Index [ Time Frame: 6 months post-discharge from therapy ]
    The ODI measures disability


Secondary Outcome Measures :
  1. Brief Pain Inventory (BPI) [ Time Frame: 6 months post-discharge from therapy ]
    The BPI measures pain intensity and pain interference



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

English speaking adults of both sexes and all races scheduled for lumbar spine surgery for a degenerative condition (spinal stenosis, spondylosis with or without myelopathy, and spondylolisthesis) will be considered for study participation.

Inclusion criteria will include the following:

  1. Radiographic evidence of lumbar spinal stenosis secondary to degenerative changes;
  2. Surgical treatment using laminectomy with or without arthrodesis (i.e., fusion);
  3. Presence of back and/or lower extremity pain > 6 months;
  4. No history of neurological movement disorder;
  5. No presence of psychotic disease; and
  6. TSK score > 39

Exclusion criteria will include the following:

  1. Patients having microsurgical techniques as the primary procedure, such as an isolated laminotomy or microdiscectomy (individuals having these minimally invasive surgical techniques tend to have a less severe case of lumbar degeneration and a shorter recovery time than individuals having arthrodesis or laminectomy without arthrodesis);
  2. Patients having surgery for spinal deformity as the primary indication (patients with spinal deformity as the primary spinal disorder tend to have a different recovery trajectory compared to the inclusion population); and
  3. Patients having surgery secondary to pseudarthrosis, trauma, infection, or tumor.

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 ClinicalTrials.gov identifier (NCT number): NCT01131611


Locations
United States, Tennessee
Vanderbilt Orthopaedic Institute
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Kristin Archer, PhD Vanderbilt University Medical Center

Responsible Party: Kristin Archer, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01131611     History of Changes
Other Study ID Numbers: 100508
First Posted: May 27, 2010    Key Record Dates
Last Update Posted: July 4, 2014
Last Verified: July 2014

Keywords provided by Kristin Archer, Vanderbilt University:
Spinal Stenosis
Rehabilitation
Physical Therapy (specialty)
Cognitive Behavior Therapy
Behavioral Research

Additional relevant MeSH terms:
Spinal Stenosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases