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Cognitive-Behavioral Physical Therapy (CBPT)

Primary Purpose

Spinal Stenosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CBPT
Control-Attention
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Stenosis focused on measuring Spinal Stenosis, Rehabilitation, Physical Therapy (specialty), Cognitive Behavior Therapy, Behavioral Research

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Vanderbilt Orthopaedic Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CBPT intervention

Control-Attention

Arm Description

Standard PT treatment + CBPT

Standard PT treatment + weekly phone calls

Outcomes

Primary Outcome Measures

Oswestry Disability Index
The ODI measures disability

Secondary Outcome Measures

Brief Pain Inventory (BPI)
The BPI measures pain intensity and pain interference

Full Information

First Posted
May 24, 2010
Last Updated
July 2, 2014
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT01131611
Brief Title
Cognitive-Behavioral Physical Therapy
Acronym
CBPT
Official Title
Cognitive-Behavioral Based Physical Therapy: Improving Surgical Spine Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Stenosis
Keywords
Spinal Stenosis, Rehabilitation, Physical Therapy (specialty), Cognitive Behavior Therapy, Behavioral Research

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBPT intervention
Arm Type
Experimental
Arm Description
Standard PT treatment + CBPT
Arm Title
Control-Attention
Arm Type
Placebo Comparator
Arm Description
Standard PT treatment + weekly phone calls
Intervention Type
Behavioral
Intervention Name(s)
CBPT
Intervention Description
Cognitive-Behavioral Based Physical Therapy
Intervention Type
Other
Intervention Name(s)
Control-Attention
Intervention Description
Standard of Care + weekly phone calls
Primary Outcome Measure Information:
Title
Oswestry Disability Index
Description
The ODI measures disability
Time Frame
6 months post-discharge from therapy
Secondary Outcome Measure Information:
Title
Brief Pain Inventory (BPI)
Description
The BPI measures pain intensity and pain interference
Time Frame
6 months post-discharge from therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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: Radiographic evidence of lumbar spinal stenosis secondary to degenerative changes; Surgical treatment using laminectomy with or without arthrodesis (i.e., fusion); Presence of back and/or lower extremity pain > 6 months; No history of neurological movement disorder; No presence of psychotic disease; and TSK score > 39 Exclusion criteria will include the following: 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); 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 Patients having surgery secondary to pseudarthrosis, trauma, infection, or tumor.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Archer, PhD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt Orthopaedic Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

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Cognitive-Behavioral Physical Therapy

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