Acupuncture Treatment to Reduce Burning Pain in Spinal Cord Injury (APSCI)
|ClinicalTrials.gov Identifier: NCT00523016|
Recruitment Status : Completed
First Posted : August 30, 2007
Last Update Posted : May 22, 2013
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.
|Condition or disease||Intervention/treatment|
|Neuropathic Pain||Procedure: Lyndhurst Central Neuropathic Pain Acupuncture Protocol (LCCNPAP) Procedure: Sham acupuncture|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Pilot Study Investigating the Feasibility of Using Acupuncture Treatment to Reduce Below-Level Neuropathic Pain in Spinal Cord Injury.|
|Study Start Date :||September 2007|
|Primary Completion Date :||April 2013|
|Study Completion Date :||May 2013|
Subjects will receive Lyndhurst Central Neuropathic Pain Acupuncture Protocol (LCCNPAP) electroacupuncture protocol for 20 minutes per treatment session; a total of 13 treatments will be administered over 3-4 weeks.
Procedure: Lyndhurst Central Neuropathic Pain Acupuncture Protocol (LCCNPAP)
LCCNPAP: acupuncture needle insertion at acupuncture points on the head that will be stimulated with electricity from a battery-operated Chinese acupuncture stimulation device for 20 minutes. A total of 13 treatments will be administered over 3-4 weeks.
Sham Comparator: Sham acupuncture
Subjects will receive simulated acupuncture that includes insertion of acupuncture needles on the head. During each treatment session, needles will be stimulated with electricity for 20 minutes. A total of 13 treatments will be administered over 3-4 weeks. This group will be offered the LCCNPAP treatment at the completion of study participation.
Procedure: Sham acupuncture
Sham acupuncture: Simulated acupuncture that includes insertion of acupuncture needles on the head that will be stimulated with electricity from a battery-operated Chinese acupuncture stimulation device for 20 minutes. A total of 13 treatments will be administered over 3-4 weeks. This group will be offered the LCCNPAP treatment at the completion of study participation.
Other Name: Placebo acupuncture
- Improvement in burning pain [ Time Frame: Baseline, daily and weekly during treatment, end of study plus 1 month follow up ]
- Improvement in Quality of Life measurements [ Time Frame: Baseline, end of study plus 1 month follow-up ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00523016
|Canada, British Columbia|
|G. F. Strong Rehabilitation Centre|
|Vancouver, British Columbia, Canada, V5Z 2G9|
|London, Ontario, Canada, N6C 5J1|
|Toronto Rehabilitation Institute Lyndhurst Centre|
|Toronto, Ontario, Canada, M4G 3V9|
|Principal Investigator:||Linda M Rapson, MD||Toronto Rehabilitation Institute Lyndhurst Centre|
|Study Director:||Eva Widerström-Noga, PhD||University of Miami|
|Study Director:||Judith Hunter, PhD||University of Toronto|
|Study Director:||Judi Laprade, PhD||University of Toronto|
|Study Director:||John Clement, MD||Parkwood Hospital|
|Study Director:||Patrick Potter, MD||University of Western Ontario, Canada|
|Study Director:||Nimmi Bharatwal, MD||University of Toronto|
|Study Director:||Andrei Krassioukov, MD||University of British Columbia|