Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Toronto Rehabilitation Institute |
---|---|
Information provided by: | Toronto Rehabilitation Institute |
ClinicalTrials.gov Identifier: | NCT00523016 |
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 burning pain in 40 people with burning pain in SCI, using a sham acupuncture protocol as the control.
Objectives of Study:
Condition | Intervention |
---|---|
Neuropathic Pain |
Procedure: Acupuncture + electrical stimulation Procedure: Sham acupuncture |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Study Investigating the Feasibility of Using Acupuncture Treatment to Reduce Below-Level Neuropathic Pain in Spinal Cord Injury. |
Estimated Enrollment: | 40 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Electroacupuncture at acupuncture sites on the head for 20 minutes, 13 times in 3-4 weeks
|
Procedure: Acupuncture + electrical stimulation
Acupuncture: 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 over 3-4 weeks.
|
B: Sham Comparator
Sham Acupuncture: Simulated acupuncture that includes insertion of acupuncture needles on the head. Needles will be stimulated with electricity for 20 minutes. A total of 13 treatments over 3-4 weeks. This group will be offered the real treatment at the completion of the series of treatments.
|
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 over 3-4 weeks. This group will be offered the real treatment at the completion of the series of treatments.
|
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 treatment or control groups 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 in the intervention for both groups.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Linda M Rapson, MD | 416-968-1366 | drrapson@sympatico.ca |
Contact: Andrei Krassioukov, MD | (604) 822-2673 | krassioukov@icord.org, Andrei.krassioukov@vch.ca |
Canada, British Columbia | |
G. F. Strong Rehabilitation Centre | Recruiting |
Vancouver, British Columbia, Canada, V5Z 2G9 | |
Contact: Jennifer Wonders 1 (604) 737-6221 jennifer.wonders@vch.ca | |
Principal Investigator: Andrei Krassioukov, MD | |
Canada, Ontario | |
Toronto Rehabilitation Institute Lyndhurst Centre | Recruiting |
Toronto, Ontario, Canada, M4G 3V9 | |
Contact: Jude Delparte, M.Sc. 1 (416) 597-3422 ext 6359 delparte.jude@torontorehab.on.ca | |
Principal Investigator: Nimmi Bharatwal, MD | |
Parkwood Hospital | Recruiting |
London, Ontario, Canada, N6C 5J1 | |
Contact: Heather Askes, HBSc 1-(519) 685-4292 ext 42940 Heather.Askes@sjhc.london.on.ca | |
Principal Investigator: Patrick Potter, MD |
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 |
Responsible Party: | Toronto Rehabilitation Institute ( Linda M. Rapson MD ) |
Study ID Numbers: | TRI REB # 07-045 |
Study First Received: | August 29, 2007 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00523016 History of Changes |
Health Authority: | Canada: Canadian Institutes of Health Research |
acupuncture electroacupuncture sham acupuncture |
spinal cord injury neuropathic pain burning pain |
Spinal Cord Injuries Spinal Cord Diseases Wounds and Injuries Disorders of Environmental Origin |
Central Nervous System Diseases Pain Trauma, Nervous System |
Spinal Cord Injuries Spinal Cord Diseases Nervous System Diseases Wounds and Injuries |
Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System |