An interventional study of Lyndhurst Central Neuropathic Pain Acupuncture Protocol (LCCNPAP) and Sham acupuncture in Neuropathic Pain, sponsored by Toronto Rehabilitation Institute. Completed at 3 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-22.
Sponsored by Toronto Rehabilitation Institute · Not applicable, Interventional, and Treatment
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.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 33 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Toronto Rehabilitation Institute is the lead sponsor of 39 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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)
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
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.
Also known as: Electroacupuncture, Acupuncture + Electrical Stimulation
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.
Also known as: 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
This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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Toronto Rehabilitation Institute