Acupuncture Treatment to Reduce Burning Pain in Spinal Cord Injury
NCT00523016 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2013-05-22
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.
Conditions
- Neuropathic Pain
Interventions
- 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.
- 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.
Sponsors & Collaborators
-
Canadian Institutes of Health Research (CIHR)
collaborator OTHER_GOV -
University of British Columbia
collaborator OTHER -
Toronto Rehabilitation Institute
lead OTHER
Principal Investigators
-
Linda M Rapson, MD · Toronto Rehabilitation Institute Lyndhurst Centre
-
Eva Widerström-Noga, PhD · University of Miami
-
Judith Hunter, PhD · University of Toronto
-
Judi Laprade, PhD · University of Toronto
-
John Clement, MD · Parkwood Hospital
-
Patrick Potter, MD · Western University, Canada
-
Nimmi Bharatwal, MD · University of Toronto
-
Andrei Krassioukov, MD · University of British Columbia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-09-30
- Primary Completion
- 2013-04-30
- Completion
- 2013-05-31
Countries
- Canada
Study Locations
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