Clinical trial NCT00523016: Acupuncture Treatment to Reduce Burning Pain in Spinal Cord Injury
Official title: A Pilot Study Investigating the Feasibility of Using Acupuncture Treatment to Reduce Below-Level Neuropathic Pain in Spinal Cord Injury.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Pain
Keywords: acupuncture
electroacupuncture
sham acupuncture
spinal cord injury
neuropathic pain
burning pain
Lead sponsor: Toronto Rehabilitation Institute
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: University of British Columbia
First posted: 2007-08-30
Enrollment: 33
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: 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:

1. 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.
2. 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.
3. To obtain preliminary data to determine subject numbers for future studies evaluating the effect of the acupuncture protocol.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* inpatients or outpatients
* over 18 years of age
* traumatic Spinal Cord Injury\* (SCI) onset as an adult. \*Traumatic SCI for the purposes of this study, is defined as: 'SCI due to sudden forceful impact on the spinal cord with or without bony injury'.This would include: falls, MVAs, hyperextension injuries, penetrating wounds (gunshot, knives), sports injuries, and exclude: tumours, vascular accidents (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 Site Investigators 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 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 Protocol previously
* having had acupuncture in the last 30 days
* treatment involving use of electrical therapy modalities (i.e. Codetron or TENS) in the last 30 days
* seizure disorders, convulsions

Primary outcomes:
measure: Improvement in burning pain
timeFrame: Baseline, daily and weekly during treatment, end of study plus 1 month follow up
Secondary outcomes:
measure: Improvement in Quality of Life measurements
timeFrame: Baseline, end of study plus 1 month follow-up
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: G. F. Strong Rehabilitation Centre
state: British Columbia
city: London
country: Canada
facility: Parkwood Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute Lyndhurst Centre
state: Ontario
Study officials:
affiliation: Toronto Rehabilitation Institute Lyndhurst Centre
name: Linda M Rapson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Eva Widerström-Noga, PhD
role: STUDY_DIRECTOR
affiliation: University of Toronto
name: Judith Hunter, PhD
role: STUDY_DIRECTOR
affiliation: University of Toronto
name: Judi Laprade, PhD
role: STUDY_DIRECTOR
affiliation: Parkwood Hospital
name: John Clement, MD
role: STUDY_DIRECTOR
affiliation: Western University, Canada
name: Patrick Potter, MD
role: STUDY_DIRECTOR
affiliation: University of Toronto
name: Nimmi Bharatwal, MD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Andrei Krassioukov, MD
role: STUDY_DIRECTOR
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