Cognitive-Behavioral Physical Therapy (CBPT)

July 2, 2014 updated by: Kristin Archer, Vanderbilt University

Cognitive-Behavioral Based Physical Therapy: Improving Surgical Spine Outcomes

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Orthopaedic Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index
Time Frame: 6 months post-discharge from therapy
The ODI measures disability
6 months post-discharge from therapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Brief Pain Inventory (BPI)
Time Frame: 6 months post-discharge from therapy
The BPI measures pain intensity and pain interference
6 months post-discharge from therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vanderbilt University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kristin Archer, PhD, Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 27, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 4, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 100508

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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