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

Phantom Limb Clinical Trial

Official title:

Psychosocial and Visual Feedback Intervention for Phantom Limb Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00731614
• Other study ID #: F6441-R
• Secondary ID: UCSD IRB 080898
• Status: Completed
• Phase: N/A
• Start date: November 2008
• Est. completion date: December 2012

Study information

• Verified date: October 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The proposed study is a randomized controlled trial designed to test whether CBT plus mirror therapy (CBT+MT) is superior to supportive care (SC) for treatment of phantom limb pain (PLP) in amputees. The primary hypothesis is that CBT+ MT will lead to significantly greater reductions in PLP compared to SC. Secondary hypotheses will test whether CBT+MT also leads to significantly greater improvements in psychiatric symptoms, functioning, and quality of life than SC.

Eighty veterans from the San Diego VA Healthcare System (SDVAHS) will be recruited. All veterans will have a unilateral upper or lower limb amputation. All participants will complete an intake assessment prior to treatment randomization. The assessment will include measures of pain (Phantom Limb Pain Questionnaire, Descriptive Differential Scale, McGill Pain Questionnaire) psychiatric symptoms (Patient Health Questionnaire, Posttraumatic Stress disorder Checklist), psychiatric diagnosis (Mini-International Neuropsychiatric Interview) and functioning (Trinity Amputation and Prosthesis Experiences Scale, Short Form-36). Participants will then randomized to either CBT+MT or SC. Participants will complete pain and mood assessments weekly during treatment, and be retested on the full assessment battery at the end of treatment and 12 and 24 weeks posttreatment.

The CBT+MT intervention will consist of 8 individual sessions of CBT, including psychoeducation, cognitive restructuring, relaxation training, and acceptance techniques. Participants in the CBT+MT condition will also learn to use a mirror apparatus to reduce PLP, and will receive a set of mirrors to use at home. The SC treatment will consist of the therapist meeting with the patient and using listening and reflection skills to discuss the patient's pain. The SC condition will have no pain education or skills training component.

Data analyses will use a repeated-measures ANOVA approach to test whether the two conditions differ on change in the primary measure (Phantom Limb Pain Questionnaire) as well as in other pain, psychiatric symptom, functioning and quality of life measures. Exploratory analyses will test whether patient variables and amputation characteristics predict treatment outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Current alcohol or drug dependence

• active psychosis

• medical problems that preclude participation

• current enrollment in behavioral pain management

Related Conditions & MeSH terms

• Phantom Limb

Intervention

Behavioral:
• Cognitive Behavioral Therapy and Mirror Retraining
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.
• Supportive therapy
Non-directive, emotion focused psychotherapy to facilitate coping with pain, delivered in weekly individual sessions.
• Mirror retraining
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

Locations

Country	Name	City	State
United States	VA Medical Center, Long Beach	Long Beach	California
United States	VA San Diego Healthcare System, San Diego	San Diego	California
United States	VA Medical Center, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Short Form-12 (SF-12)	the Short Form-12 (SF-12) is a standardized self-report questionnaire that assesses mental and physical functioning. The Physical Component Summary (PCS) is scored on a scale from 0-100, with higher scores representing better reported health.	Baseline, end of treatment (8 weeks after baseline)