Cognitive-Behavioral Physical Therapy

NCT01131611 | Completed Phase 1 DMC

• 1 other identifier: 100508
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Stenosis

Keywords

Spinal Stenosis; Rehabilitation; Physical Therapy (specialty); Cognitive Behavior Therapy; Behavioral Research

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index

  The ODI measures disability

  6 months post-discharge from therapy

Secondary Outcomes (1)

• Brief Pain Inventory (BPI)

  6 months post-discharge from therapy

Study Arms (2)

CBPT intervention

EXPERIMENTAL

Standard PT treatment + CBPT

Behavioral: CBPT

Control-Attention

PLACEBO COMPARATOR

Standard PT treatment + weekly phone calls

Other: Control-Attention

Interventions

CBPT BEHAVIORAL

Cognitive-Behavioral Based Physical Therapy

CBPT intervention

Control-Attention OTHER

Standard of Care + weekly phone calls

Control-Attention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 secondary to pseudarthrosis, trauma, infection, or tumor.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt Orthopaedic Institute

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Kristin Archer, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 24, 2010
• First Posted: May 27, 2010
• Study Start: February 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 4, 2014

Record last verified: 2014-07

Locations

US (1)