Acupuncture for Phantom Limb Pain

Status Suspended

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.

Clinical Trial Description

n/a

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

Clinical Trial Details

NCT number	NCT00460161
Study type	Interventional
Source	Shaare Zedek Medical Center
Contact
Status	Suspended
Phase	Phase 3
Start date	February 2009

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04060875` - Research Protocol for Karuna Labs Inc.: Safety and Efficacy of Virtual Reality Graded Motor Imagery for Chronic Pain
Active, not recruiting	`NCT02519907` - Surface Electrical Stimulation for Treatment of Phantom Limb Pain	N/A
Completed	`NCT02281539` - Myoelectrically Controlled Augmented Reality and Gaming for the Treatment of Phantom Limb Pain	N/A
Completed	`NCT01608035` - Sciatic Perineural Versus Stump Catheter for Below Knee Amputation	Phase 0
Completed	`NCT03111277` - MR Guided Focused Ultrasound for Treatment of Neuropathic Pain	N/A
Recruiting	`NCT05188183` - Pragmatic Trial of Remote tDCS and Somatosensory Training for Phantom Limb Pain With Machine Learning to Predict Treatment Response	N/A
Active, not recruiting	`NCT02221934` - Electrical Nerve Block for Amputation Pain	N/A
Active, not recruiting	`NCT03029884` - Closed-loop Deep Brain Stimulation to Treat Refractory Neuropathic Pain	N/A
Completed	`NCT04538417` - C-RFA of Residual Limb Neuroma	N/A
Completed	`NCT03317600` - Postamputation Pain: Peripheral Mechanisms	N/A
Completed	`NCT01996254` - Electrical Stimulation for the Treatment of Post-Amputation Pain Using the SPRINT System	N/A
Terminated	`NCT00771862` - Prevention of Phantom Limb and Stump Pain Using Ambulatory Continuous Peripheral Nerve Blocks: A Pilot Study	Phase 4
Completed	`NCT00462566` - The Efficacy of Motor Cortex Stimulation for Pain Control	N/A
Completed	`NCT05684445` - The Effect of Distant Reiki on Pain and Holistic Well-being	N/A
Completed	`NCT02784548` - Virtual Reality for Phantom Limb Pain	N/A
Recruiting	`NCT05915065` - VR to Evaluate Phantom Limb Pain	N/A
Completed	`NCT00797849` - Controlled Study of Farabloc for Chronic Phantom Limb Pain Among Veteran Amputees	N/A
Enrolling by invitation	`NCT05807607` - Study of Lower-limb Phantom Pain Syndrome Using Peripheral Nerve and Spinal Cord Stimulation	N/A
Completed	`NCT03350061` - Prosthesis With Sensations	N/A
Enrolling by invitation	`NCT05650931` - Study of Phantom Limb Pain Using Peripheral Nerve and Spinal Cord Stimulation	N/A