Acupuncture Treatment to Reduce Burning Pain in Spinal Cord Injury

Neuropathic Pain Clinical Trial

— APSCI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00523016
• Other study ID #: TRI REB # 07-045
• Status: Completed
• Phase: N/A
• First received: August 29, 2007
• Last updated: May 20, 2013
• Start date: September 2007
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: Toronto Rehabilitation Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Spinal Cord Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Parkwood Hospital	London	Ontario
Canada	Toronto Rehabilitation Institute Lyndhurst Centre	Toronto	Ontario
Canada	G. F. Strong Rehabilitation Centre	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Toronto Rehabilitation Institute	Canadian Institutes of Health Research (CIHR), University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in burning pain		Baseline, daily and weekly during treatment, end of study plus 1 month follow up	No
Secondary	Improvement in Quality of Life measurements		Baseline, end of study plus 1 month follow-up	No