Acupuncture for Phantom Limb Pain

Phantom Limb Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00460161
• Other study ID #: ACP.PLP.10.06
• Status: Suspended
• Phase: Phase 3
• First received: April 12, 2007
• Last updated: February 17, 2009
• Start date: February 2009

Study information

• Verified date: August 2008
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Phantom Limb
• Phantom Limb Pain

Intervention

Procedure:
• acupuncture
2 treatments/week for 4 weeks

Other:
• placebo/sham acupuncture
2 treatments/week for 4 weeks

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To study the effect of acupuncture on phantom limb pain at 4 weeks post-amputation		4 weeks	No
Secondary	To study the effect of acupuncture on phantom limb pain at 3 months post-amputation		3 months	No
Secondary	To study the effect of acupuncture on stump pain at 4 weeks post-amputation		4 weeks	No
Secondary	To study the effect of acupuncture on analgesic use (Tramadol 100mg) during the first 4 weeks post-amputation		4 weeks	No
Secondary	To study the effect of acupuncture on parameters of depression (using the Beck Depression Score) at 4 weeks and 3 months post-amputation		4 weeks and 3 months	No
Secondary	To study the safety of acupuncture treatment in patients following amputation with phantom limb pain		4 weeks	Yes