Back to results

Acupuncture Treatment to Reduce Burning Pain in Spinal Cord Injury (APSCI)

Primary Purpose

Neuropathic Pain

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Lyndhurst Central Neuropathic Pain Acupuncture Protocol (LCCNPAP)

Sham acupuncture

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring acupuncture, electroacupuncture, sham acupuncture, spinal cord injury, neuropathic pain, burning pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

inpatients or outpatients
over 18 years of age
traumatic Spinal Cord Injury* (SCI) onset as an adult. *Traumatic SCI for the purposes of this study, is defined as: 'SCI due to sudden forceful impact on the spinal cord with or without bony injury'.This would include: falls, MVAs, hyperextension injuries, penetrating wounds (gunshot, knives), sports injuries, and exclude: tumours, vascular accidents (AVM), demyelinating conditions, infection, and iatrogenic causes.
major symptom of burning pain below SCI level
screened as positive for Central Neuropathic Pain by clinical assessment by Site Investigators which includes completing the LANSS Questionnaire
English-speaking
capable of giving informed consent
on stable pain therapy (i.e. no changes in pain medications for 1 week)

Exclusion Criteria:

systemic illness
major psychiatric disorders
scalp lacerations or infections
hearing or language problems
history of diabetes or disease that would affect peripheral nerve function
pregnancy
serious co-morbidities
needle phobia
having undergone Lyndhurst Centre Central Neuropathic Pain Acupuncture Protocol previously
having had acupuncture in the last 30 days
treatment involving use of electrical therapy modalities (i.e. Codetron or TENS) in the last 30 days
seizure disorders, convulsions

Sites / Locations

G. F. Strong Rehabilitation Centre
Parkwood Hospital
Toronto Rehabilitation Institute Lyndhurst Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Electroacupuncture

Sham acupuncture

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Improvement in burning pain

Secondary Outcome Measures

Improvement in Quality of Life measurements

Full Information

NCT ID

NCT00523016

First Posted

August 29, 2007

Last Updated

May 20, 2013

Sponsor

Toronto Rehabilitation Institute

Collaborators

Canadian Institutes of Health Research (CIHR), University of British Columbia

1. Study Identification

Unique Protocol Identification Number

NCT00523016

Brief Title

Acupuncture Treatment to Reduce Burning Pain in Spinal Cord Injury

Acronym

APSCI

Official Title

A Pilot Study Investigating the Feasibility of Using Acupuncture Treatment to Reduce Below-Level Neuropathic Pain in Spinal Cord Injury.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Toronto Rehabilitation Institute

Collaborators

Canadian Institutes of Health Research (CIHR), University of British Columbia

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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: 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuropathic Pain

Keywords

acupuncture, electroacupuncture, sham acupuncture, spinal cord injury, neuropathic pain, burning pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Electroacupuncture

Arm Type

Experimental

Arm Description

Arm Title

Sham acupuncture

Arm Type

Sham Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Lyndhurst Central Neuropathic Pain Acupuncture Protocol (LCCNPAP)

Other Intervention Name(s)

Electroacupuncture, Acupuncture + Electrical Stimulation

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Sham acupuncture

Other Intervention Name(s)

Placebo acupuncture

Intervention Description

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.

Primary Outcome Measure Information:

Title

Improvement in burning pain

Time Frame

Baseline, daily and weekly during treatment, end of study plus 1 month follow up

Secondary Outcome Measure Information:

Title

Improvement in Quality of Life measurements

Time Frame

Baseline, end of study plus 1 month follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: inpatients or outpatients over 18 years of age traumatic Spinal Cord Injury* (SCI) onset as an adult. *Traumatic SCI for the purposes of this study, is defined as: 'SCI due to sudden forceful impact on the spinal cord with or without bony injury'.This would include: falls, MVAs, hyperextension injuries, penetrating wounds (gunshot, knives), sports injuries, and exclude: tumours, vascular accidents (AVM), demyelinating conditions, infection, and iatrogenic causes. major symptom of burning pain below SCI level screened as positive for Central Neuropathic Pain by clinical assessment by Site Investigators which includes completing the LANSS Questionnaire English-speaking capable of giving informed consent on stable pain therapy (i.e. no changes in pain medications for 1 week) Exclusion Criteria: systemic illness major psychiatric disorders scalp lacerations or infections hearing or language problems history of diabetes or disease that would affect peripheral nerve function pregnancy serious co-morbidities needle phobia having undergone Lyndhurst Centre Central Neuropathic Pain Acupuncture Protocol previously having had acupuncture in the last 30 days treatment involving use of electrical therapy modalities (i.e. Codetron or TENS) in the last 30 days seizure disorders, convulsions

Overall Study Officials: