Phantom Limb Pain
Conditions
Keywords
acupuncture, amputation, phantom limb pain
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.
Interventions
PROCEDUREacupuncture
2 treatments/week for 4 weeks
2 treatments/week for 4 weeks
Sponsors
Shaare Zedek Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the effect of acupuncture on phantom limb pain at 4 weeks post-amputation | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| To study the effect of acupuncture on phantom limb pain at 3 months post-amputation | 3 months |
| To study the effect of acupuncture on stump pain at 4 weeks post-amputation | 4 weeks |
| To study the effect of acupuncture on analgesic use (Tramadol 100mg) during the first 4 weeks post-amputation | 4 weeks |
| 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 |
| To study the safety of acupuncture treatment in patients following amputation with phantom limb pain | 4 weeks |
Countries
Israel
Outcome results
None listed