Acupuncture Treatment to Reduce Burning Pain in Spinal Cord Injury - Full Text View

Sponsor:	Toronto Rehabilitation Institute
Collaborators:	Canadian Institutes of Health Research (CIHR) University of British Columbia
Information provided by (Responsible Party):	Linda M. Rapson, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier:	NCT00523016

Purpose

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 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 SCI patients.
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.

Condition	Intervention
Neuropathic Pain	Procedure: Acupuncture + electrical stimulation Procedure: Sham acupuncture

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	A Pilot Study Investigating the Feasibility of Using Acupuncture Treatment to Reduce Below-Level Neuropathic Pain in Spinal Cord Injury.

Resource links provided by NLM:

MedlinePlus related topics: Acupuncture Acute Bronchitis Burns Rehabilitation Spinal Cord Injuries

U.S. FDA Resources

Further study details as provided by Toronto Rehabilitation Institute:

Primary Outcome Measures:

Improvement in burning pain [ Time Frame: Daily, weekly and end of study plus 1 month follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Improvement in Quality of Life measurements [ Time Frame: End of study + one month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	September 2007
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Electroacupuncture at acupuncture sites on the head for 20 minutes, 13 times in 3-4 weeks	Procedure: Acupuncture + electrical stimulation Acupuncture: 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 over 3-4 weeks. Other Name: Electroacupuncture
Sham Comparator: B Sham Acupuncture: Simulated acupuncture that includes insertion of acupuncture needles on the head. Needles will be stimulated with electricity for 20 minutes. A total of 13 treatments over 3-4 weeks. This group will be offered the real treatment at the completion of the series of treatments.	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 over 3-4 weeks. This group will be offered the real treatment at the completion of the series of treatments. Other Name: Placebo acupuncture

Arms

Assigned Interventions

Experimental: A

Electroacupuncture at acupuncture sites on the head for 20 minutes, 13 times in 3-4 weeks

Procedure: Acupuncture + electrical stimulation

Acupuncture: 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 over 3-4 weeks.

Other Name: Electroacupuncture

Sham Comparator: B

Sham Acupuncture: Simulated acupuncture that includes insertion of acupuncture needles on the head. Needles will be stimulated with electricity for 20 minutes. A total of 13 treatments over 3-4 weeks. This group will be offered the real treatment at the completion of the series of treatments.

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 over 3-4 weeks. This group will be offered the real treatment at the completion of the series of treatments.

Other Name: Placebo acupuncture

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 treatment or control groups 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 in the intervention for both groups.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Inpatients or outpatients
Over 18 years of age
Traumatic Spinal Cord Injury (SCI) onset as an adult
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

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 14 days
treatment involving use of electrical therapy modalities (ie., Codetron or TENS) in the last 14 days
seizure disorders, convulsions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523016

Contacts

Contact: Linda M Rapson, MD	416-968-1366	drrapson@sympatico.ca
Contact: Andrei Krassioukov, MD	(604) 822-2673	krassioukov@icord.org, Andrei.krassioukov@vch.ca

Locations

Canada, British Columbia
G. F. Strong Rehabilitation Centre	Recruiting
Vancouver, British Columbia, Canada, V5Z 2G9
Contact: David Metcalf 1 (604) 734-1313 x 2213 Dave.Metcalf@vch.ca
Principal Investigator: Andrei Krassioukov, MD
Canada, Ontario
Parkwood Hospital	Recruiting
London, Ontario, Canada, N6C 5J1
Contact: Heather Askes, HBSc 1-(519) 685-4292 ext 42940 Heather.Askes@sjhc.london.on.ca
Principal Investigator: Patrick Potter, MD
Toronto Rehabilitation Institute Lyndhurst Centre	Recruiting
Toronto, Ontario, Canada, M4G 3V9
Contact: Meredith Kuipers, B.Sc. 1 (416) 597-3422 ext 6199 kuipers.meredith@torontorehab.on.ca
Principal Investigator: Nimmi Bharatwal, MD

Sponsors and Collaborators

Toronto Rehabilitation Institute

Canadian Institutes of Health Research (CIHR)

University of British Columbia

Investigators

Principal Investigator:	Linda M Rapson, MD	Toronto Rehabilitation Institute Lyndhurst Centre
Study Director:	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	University of Western Ontario, Canada
Study Director:	Nimmi Bharatwal, MD	University of Toronto
Study Director:	Andrei Krassioukov, MD	University of British Columbia

More Information

No publications provided

Responsible Party:	Linda M. Rapson, Adjunct Scientist, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier:	NCT00523016 History of Changes
Other Study ID Numbers:	TRI REB # 07-045
Study First Received:	August 29, 2007
Last Updated:	November 13, 2011
Health Authority:	Canada: Canadian Institutes of Health Research

Keywords provided by Toronto Rehabilitation Institute:

acupuncture
electroacupuncture
sham acupuncture

spinal cord injury
neuropathic pain
burning pain

Additional relevant MeSH terms:

Neuralgia
Spinal Cord Injuries
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases

Neuromuscular Diseases
Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on February 21, 2012