Cognitive Behavior Therapy (CBT) and Mirror Training for Phantom Limb Pain

NCT00731614 | Completed Results

• 2 other identifiers: F6441-RUCSD IRB 080898
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this study is to test whether a combination of cognitive-behavior therapy and mirror training reduces phantom limb pain for veterans with amputations.

Conditions

Phantom Limb

Keywords

cognitive therapy; mirror training; nondirective therapy; veterans; amputees

Outcome Measures

Primary Outcomes (1)

• Phantom Limb Pain Questionnaire

  The primary outcome measure is the severity of phantom limb pain on a likert scale from 0 (no pain) to 10 (worst pain imaginable)

  Baseline, each weekly treatment session (1-8), 12 weeks post treatment, 24 weeks posttreatment.

Secondary Outcomes (1)

• Short Form-12 (SF-12)

  Baseline, end of treatment (8 weeks after baseline)

Study Arms (2)

Arm 1

EXPERIMENTAL

Cognitive Behavior Therapy + mirror retraining

Behavioral: Cognitive Behavioral Therapy and Mirror Retraining; Behavioral: Mirror retraining

Arm 2

ACTIVE COMPARATOR

Supportive psychotherapy

Behavioral: Supportive therapy

Interventions

Cognitive Behavioral Therapy and Mirror Retraining BEHAVIORAL

Cognitive Behavioral Pain Management treatment administered in 8 weeks of individual treatment, combined with training in use of a mirror device to reduce phantom limb pain.

Arm 1

Supportive therapy BEHAVIORAL

Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.

Also known as: Non-directive therapy

Arm 2

Mirror retraining BEHAVIORAL

Use of a mirror to produce an illusion of the missing limb. By attending to the reflected limb while moving the existing limb, the patient provides visual feedback that helps correct changes in the neural organization of the somatosensory cortex resulting from the amputation and contributing to the phantom limb pain

Also known as: Mirror box training

Arm 1

Eligibility Criteria

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

You may qualify if:

• Adult (21or over)
• unilateral amputation at or above wrist or ankle
• phantom limb pain occurring at least weekly
• living within 50 miles of a recruitment site (San Diego, San Francisco, or Long Beach VAs).
• able to read and speak English

You may not qualify if:

• Current alcohol or drug dependence
• active psychosis
• medical problems that preclude participation
• current enrollment in behavioral pain management

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

VA Medical Center, Long Beach

Long Beach, California, 90822, United States

Location

VA San Diego Healthcare System, San Diego

San Diego, California, 92161, United States

Location

VA Medical Center, San Francisco

San Francisco, California, 94121, United States

Location

MeSH Terms

Conditions

Phantom Limb

Interventions

Cognitive Behavioral Therapy; Palliative Care

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: John R. McQuaid, Ph.D.
• Organization: San Francisco VA Medical Center

john.mcquaid@va.gov

415-221-4810

Study Officials

• John R. McQuaid, PhD MS BA

  VA Medical Center, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2008
• First Posted: August 11, 2008
• Study Start: November 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2012
• Last Updated: October 29, 2019
• Results First Posted: June 18, 2015

Record last verified: 2019-10

Locations

US (3)