Acupuncture Treatment to Reduce Burning Pain in Spinal Cord Injury

Phase

N/A

Condition

Chronic Pain

Spinal Cord Injuries

Oral Facial Pain

Treatment

N/A

Clinical Study ID

NCT00523016

TRI REB # 07-045

Ages > 18
All Genders

Study Summary

Acupuncture has been used with good results for many years at Toronto Rehabilitation Institute Lyndhurst Centre (Toronto, ON, Canada), Parkwood Hospital (London, ON, Canada) and GF Strong Rehabilitation Institute (Vancouver, BC, Canada) to reduce burning pain in individuals with spinal cord injuries (SCI). This multi-centre RCT will test an acupuncture protocol for treatment of burning pain in 40 people with burning pain in SCI, using a sham acupuncture protocol as the control.

Objectives of Study:

To determine the feasibility of conducting a real acupuncture vs. sham acupuncture trial in a multi-centre study using the Lyndhurst Central Neuropathic Pain Acupuncture Protocol (LCCNPAP). This will inform a larger study which will directly evaluate the effect of the LCCNPAP on pain and Quality of Life (QOL) in individuals with SCI.
To determine which outcome measures are most responsive and the amount of change that could be expected, with respect to pain and QOL, for the larger study.
To obtain preliminary data to determine subject numbers for future studies evaluating the effect of the acupuncture protocol.

Eligibility Criteria

Inclusion

Inclusion Criteria:

inpatients or outpatients
over 18 years of age
traumatic Spinal Cord Injury* (SCI) onset as an adult. *Traumatic SCI for the purposesof this study, is defined as: 'SCI due to sudden forceful impact on the spinal cordwith or without bony injury'.This would include: falls, MVAs, hyperextension injuries,penetrating wounds (gunshot, knives), sports injuries, and exclude: tumours, vascularaccidents (AVM), demyelinating conditions, infection, and iatrogenic causes.
major symptom of burning pain below SCI level
screened as positive for Central Neuropathic Pain by clinical assessment by SiteInvestigators which includes completing the LANSS Questionnaire
English-speaking
capable of giving informed consent
on stable pain therapy (i.e. no changes in pain medications for 1 week)

Exclusion

Exclusion Criteria:

systemic illness
major psychiatric disorders
scalp lacerations or infections
hearing or language problems
history of diabetes or disease that would affect peripheral nerve function
pregnancy
serious co-morbidities
needle phobia
having undergone Lyndhurst Centre Central Neuropathic Pain Acupuncture Protocolpreviously
having had acupuncture in the last 30 days
treatment involving use of electrical therapy modalities (i.e. Codetron or TENS) inthe last 30 days
seizure disorders, convulsions

Study Design

September 01, 2007

May 31, 2013

Study Description

40 individuals with SCI below-level neuropathic pain who are at least 6 weeks post-injury will be recruited at the three study sites. Subjects will be randomized into either the experimental or control group using a random number table as they enter the study to determine whether they will undergo the real acupuncture treatment or sham treatment.

A total of 13 treatments will be administered over a maximum of 4 consecutive weeks with an ideal treatment frequency as follows: 5 times per week during weeks one and two; and 3 times per week during week three.

Following all sessions, whether LCCNPAP group or sham, any adverse events such as nausea, fainting, bleeding etc., will be recorded on an adverse effects sheet for each subject. Baseline arterial blood pressure and heart rate will be monitored at four points during each treatment session for both groups.

Connect with a study center

G. F. Strong Rehabilitation Centre
Vancouver, British Columbia V5Z 2G9
Canada
Site Not Available
Parkwood Hospital
London, Ontario N6C 5J1
Canada
Site Not Available
Toronto Rehabilitation Institute Lyndhurst Centre
Toronto, Ontario M4G 3V9
Canada
Site Not Available

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