Acupuncture Treatment to Reduce Burning Pain in Spinal Cord Injury

NCT ID: NCT00523016

Last Updated: 2013-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2013-05-31

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.

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.

Conditions

Neuropathic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Lyndhurst Central Neuropathic Pain Acupuncture Protocol (LCCNPAP)

Intervention Type: PROCEDURE

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.

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.

Group Type: SHAM_COMPARATOR

Sham acupuncture

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Electroacupuncture; Acupuncture + Electrical Stimulation; Placebo acupuncture

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: collaborator

Toronto Rehabilitation Institute

OTHER

Sponsor Role: lead

Responsible Party

Linda M. Rapson

Adjunct Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Linda M Rapson, MD

Role: PRINCIPAL_INVESTIGATOR

Toronto Rehabilitation Institute Lyndhurst Centre

Eva Widerström-Noga, PhD

Role: STUDY_DIRECTOR

University of Miami

Judith Hunter, PhD

Role: STUDY_DIRECTOR

University of Toronto

Judi Laprade, PhD

Role: STUDY_DIRECTOR

University of Toronto

John Clement, MD

Role: STUDY_DIRECTOR

Parkwood Hospital

Patrick Potter, MD

Role: STUDY_DIRECTOR

Western University, Canada

Nimmi Bharatwal, MD

Role: STUDY_DIRECTOR

University of Toronto

Andrei Krassioukov, MD

Role: STUDY_DIRECTOR

University of British Columbia

Locations

G. F. Strong Rehabilitation Centre

Vancouver, British Columbia, Canada

Parkwood Hospital

London, Ontario, Canada

Toronto Rehabilitation Institute Lyndhurst Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

TRI REB # 07-045

Identifier Type: -

Identifier Source: org_study_id