Clinical trial NCT00460161: Acupuncture for Phantom Limb Pain
Official title: Acupuncture for Phantom Limb Pain: A Randomized, Double-Blind, Placebo/Sham - Controlled Study
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Phantom Limb Pain
Keywords: acupuncture
amputation
phantom limb pain
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2007-04-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: To study the effect of acupuncture on phantom limb pain at 4 weeks post-amputation
timeFrame: 4 weeks
Secondary outcomes:
measure: To study the effect of acupuncture on phantom limb pain at 3 months post-amputation
timeFrame: 3 months
measure: To study the effect of acupuncture on stump pain at 4 weeks post-amputation
timeFrame: 4 weeks
measure: To study the effect of acupuncture on analgesic use (Tramadol 100mg) during the first 4 weeks post-amputation
timeFrame: 4 weeks
measure: To study the effect of acupuncture on parameters of depression (using the Beck Depression Score) at 4 weeks and 3 months post-amputation
timeFrame: 4 weeks and 3 months
measure: To study the safety of acupuncture treatment in patients following amputation with phantom limb pain
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Shaare Zedek Medical Center, Jerusalem, Israel
name: Noah Samuels, M.D.
role: PRINCIPAL_INVESTIGATOR
References: