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

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

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.

Study Overview

• Status: Completed
• Conditions: Neuropathic Pain
• Intervention / Treatment: Procedure: Lyndhurst Central Neuropathic Pain Acupuncture Protocol (LCCNPAP); Procedure: Sham 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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 2G9
      • G. F. Strong Rehabilitation Centre
  • Ontario
    • London, Ontario, Canada, N6C 5J1
      • Parkwood Hospital
    • Toronto, Ontario, Canada, M4G 3V9
      • Toronto Rehabilitation Institute Lyndhurst Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Placebo acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement in burning pain	Baseline, daily and weekly during treatment, end of study plus 1 month follow up

Secondary Outcome Measures

Outcome Measure	Time Frame
Improvement in Quality of Life measurements	Baseline, end of study plus 1 month follow-up

Collaborators and Investigators

• Sponsor: Toronto Rehabilitation Institute
• Collaborators: University of British Columbia; Canadian Institutes of Health Research (CIHR)
• 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, Western University, Canada; Study Director: Nimmi Bharatwal, MD, University of Toronto; Study Director: Andrei Krassioukov, MD, University of British Columbia

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: August 29, 2007
• First Submitted That Met QC Criteria: August 29, 2007
• First Posted (Estimate): August 30, 2007

Study Record Updates

• Last Update Posted (Estimate): May 22, 2013
• Last Update Submitted That Met QC Criteria: May 20, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: acupuncture; neuropathic pain; spinal cord injury; electroacupuncture; sham acupuncture; burning pain
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Neuralgia; Spinal Cord Injuries
• Other Study ID Numbers: TRI REB # 07-045