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

This study has been completed.
Sponsor:
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
First received: August 29, 2007
Last updated: May 20, 2013
Last verified: May 2013
  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 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.

Condition Intervention
Neuropathic Pain
Procedure: Lyndhurst Central Neuropathic Pain Acupuncture Protocol (LCCNPAP)
Procedure: Sham acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
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:


Further study details as provided by Toronto Rehabilitation Institute:

Primary Outcome Measures:
  • Improvement in burning pain [ Time Frame: Baseline, daily and weekly during treatment, end of study plus 1 month follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in Quality of Life measurements [ Time Frame: Baseline, end of study plus 1 month follow-up ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: September 2007
Study Completion Date: May 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Electroacupuncture
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)
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.
Other Names:
  • Electroacupuncture
  • Acupuncture + Electrical Stimulation
Sham Comparator: Sham acupuncture
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
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.
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 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.

  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. *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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, British Columbia
G. F. Strong Rehabilitation Centre
Vancouver, British Columbia, Canada, V5Z 2G9
Canada, Ontario
Parkwood Hospital
London, Ontario, Canada, N6C 5J1
Toronto Rehabilitation Institute Lyndhurst Centre
Toronto, Ontario, Canada, M4G 3V9
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: May 20, 2013
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:
Spinal Cord Injuries
Neuralgia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014