Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00523016
Status:
COMPLETED
Last Update Posted:
2013-05-22
First Post:
2007-08-29
Brief Title:
Acupuncture Treatment to Reduce Burning Pain in Spinal Cord Injury
Sponsor:
Toronto Rehabilitation Institute
Organization:
Toronto Rehabilitation Institute
Study Overview
Official Title:
A Pilot Study Investigating the Feasibility of Using Acupuncture Treatment to Reduce Below-Level Neuropathic Pain in Spinal Cord Injury
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APSCI
Brief 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
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None