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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| University of British Columbia | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electroacupuncture | Experimental | 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. |
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| Sham acupuncture | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lyndhurst Central Neuropathic Pain Acupuncture Protocol (LCCNPAP) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in burning pain | Baseline, daily and weekly during treatment, end of study plus 1 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Quality of Life measurements | Baseline, end of study plus 1 month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda M Rapson, MD | Toronto Rehabilitation Institute Lyndhurst Centre | Principal Investigator |
| 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 | Western University, Canada | Study Director |
| Nimmi Bharatwal, MD | University of Toronto | Study Director |
| Andrei Krassioukov, MD | University of British Columbia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| G. F. Strong Rehabilitation Centre | Vancouver | British Columbia | V5Z 2G9 | Canada | ||
| Parkwood Hospital |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D013119 | Spinal Cord Injuries |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D015671 | Electroacupuncture |
| D015670 | Acupuncture Therapy |
| D004558 | Electric Stimulation |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D000529 | Complementary Therapies |
| D004599 | Electric Stimulation Therapy |
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|
| Sham acupuncture | Procedure | 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. |
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|
| London |
| Ontario |
| N6C 5J1 |
| Canada |
| Toronto Rehabilitation Institute Lyndhurst Centre | Toronto | Ontario | M4G 3V9 | Canada |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |