Acupuncture for Phantom Limb Pain
Primary Purpose
Phantom Limb Pain
Status
Suspended
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
acupuncture
placebo/sham acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Phantom Limb Pain focused on measuring acupuncture, amputation, phantom limb pain
Eligibility Criteria
Inclusion Criteria:
- Patients of either gender
- Age 18 years and older
- Scheduled for lower single limb amputation (above or below knee)
- Ability to comply with study protocol
Exclusion Criteria:
- Patients requiring limb amputation due to trauma
- Patients displaying symptoms of overt Axis-1 psychopathology such as Schizophrenia or Substance Abuse
- Inability to comply with the study protocol
- Previous experience with acupuncture treatment; current use of complementary or alternative medical treatments.
Sites / Locations
- Shaare Zedek Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
true acupuncture
placebo/sham acupuncture
Outcomes
Primary Outcome Measures
To study the effect of acupuncture on phantom limb pain at 4 weeks post-amputation
Secondary Outcome Measures
To study the effect of acupuncture on phantom limb pain at 3 months post-amputation
To study the effect of acupuncture on stump pain at 4 weeks post-amputation
To study the effect of acupuncture on analgesic use (Tramadol 100mg) during the first 4 weeks post-amputation
To study the effect of acupuncture on parameters of depression (using the Beck Depression Score) at 4 weeks and 3 months post-amputation
To study the safety of acupuncture treatment in patients following amputation with phantom limb pain
Full Information
NCT ID
NCT00460161
First Posted
April 12, 2007
Last Updated
February 17, 2009
Sponsor
Shaare Zedek Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00460161
Brief Title
Acupuncture for Phantom Limb Pain
Official Title
Acupuncture for Phantom Limb Pain: A Randomized, Double-Blind, Placebo/Sham - Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Suspended
Why Stopped
Lack of patients
Study Start Date
February 2009 (undefined)
Primary Completion Date
August 2009 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Shaare Zedek Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Phantom pain is a common complication following limb amputation, and is thought to result from a system of pathophysiological mechanisms - peripheral, spinal, central and psychological. Treatment is primarily medical, using antidepressant and anticonvulsant medications. At present, there is no evidence-based approach for the management of phantom limb pain (PLP). Acupuncture is an ancient Chinese treatment during which thin needles (diameter 0.20-0.30mm) are inserted into various points on the skin. Studies of this treatment have found significant benefit in a number of conditions with chronic pain.
We propose a randomized, double-blind, placebo/sham -controlled study to evaluate whether acupuncture is an effective and safe modality for preventing and reducing PLP in patients following lower limb amputation. Patients requiring lower limb amputation (above-ankle) will be randomized into two groups, for real or placebo/sham acupuncture treatment. Both groups will be treated twice-weekly with a standardized (as opposed to individualized) acupuncture treatment protocol, using either true or placebo needles at sham acupuncture points, for a period of four weeks (eight treatments).
The primary outcome to be evaluated will be PLP at 4 weeks, using a site-specific numerical rating pain scale (ss-NRS). Secondary outcome measures to be evaluated are: stump pain (ss-NRS); analgesic use (Tramadol, 100mg Tablet); and depressive symptoms, using the Beck Depression Score. Blinding of the participants will be evaluated using a Validation of Blinding Questionnaire at the end of the treatment period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phantom Limb Pain
Keywords
acupuncture, amputation, phantom limb pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
true acupuncture
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo/sham acupuncture
Intervention Type
Procedure
Intervention Name(s)
acupuncture
Intervention Description
2 treatments/week for 4 weeks
Intervention Type
Other
Intervention Name(s)
placebo/sham acupuncture
Intervention Description
2 treatments/week for 4 weeks
Primary Outcome Measure Information:
Title
To study the effect of acupuncture on phantom limb pain at 4 weeks post-amputation
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
To study the effect of acupuncture on phantom limb pain at 3 months post-amputation
Time Frame
3 months
Title
To study the effect of acupuncture on stump pain at 4 weeks post-amputation
Time Frame
4 weeks
Title
To study the effect of acupuncture on analgesic use (Tramadol 100mg) during the first 4 weeks post-amputation
Time Frame
4 weeks
Title
To study the effect of acupuncture on parameters of depression (using the Beck Depression Score) at 4 weeks and 3 months post-amputation
Time Frame
4 weeks and 3 months
Title
To study the safety of acupuncture treatment in patients following amputation with phantom limb pain
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of either gender
Age 18 years and older
Scheduled for lower single limb amputation (above or below knee)
Ability to comply with study protocol
Exclusion Criteria:
Patients requiring limb amputation due to trauma
Patients displaying symptoms of overt Axis-1 psychopathology such as Schizophrenia or Substance Abuse
Inability to comply with the study protocol
Previous experience with acupuncture treatment; current use of complementary or alternative medical treatments.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noah Samuels, M.D.
Organizational Affiliation
Shaare Zedek Medical Center, Jerusalem, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Acupuncture for Phantom Limb Pain
We'll reach out to this number within 24 hrs