Acupuncture for Phantom Limb Pain - Tabular View

Tracking Information

First Received Date ^ICMJE

April 12, 2007

Last Updated Date

February 17, 2009

Start Date ^ICMJE

February 2009

Estimated Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To study the effect of acupuncture on phantom limb pain at 4 weeks post-amputation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

To study the effect of acupuncture on phantom limb pain at 4 weeks post-amputation

Change History

Complete list of historical versions of study NCT00460161 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To study the effect of acupuncture on phantom limb pain at 3 months post-amputation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
To study the effect of acupuncture on stump pain at 4 weeks post-amputation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
To study the effect of acupuncture on analgesic use (Tramadol 100mg) during the first 4 weeks post-amputation [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
To study the safety of acupuncture treatment in patients following amputation with phantom limb pain [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

Acupuncture for Phantom Limb Pain

Official Title ^ICMJE

Acupuncture for Phantom Limb Pain: A Randomized, Double-Blind, Placebo/Sham - Controlled Study

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Phantom Limb Pain

Intervention ^ICMJE

Procedure: acupuncture
Other: placebo/sham acupuncture

Study Arms / Comparison Groups

Active Comparator: true acupuncture
Placebo Comparator: placebo/sham acupuncture

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT ID ^ICMJE

NCT00460161

Responsible Party

Dr. Noah Samuels, Shaare Zedek Medical Center

Study ID Numbers ^ICMJE

ACP.PLP.10.06

Study Sponsor ^ICMJE

Shaare Zedek Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Noah Samuels, M.D.

Shaare Zedek Medical Center, Jerusalem, Israel

Information Provided By

Shaare Zedek Medical Center

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP