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Completed

NCT Number: NCT00523016

Acupuncture Treatment to Reduce Burning 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.

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Key information

Conditions

Neuropathic Pain Central Nervous System Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

G. F. Strong Rehabilitation Centre, Vancouver, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lyndhurst Central Neuropathic Pain Acupuncture Protocol (LCCNPAP)

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.

Other names: Electroacupuncture, Acupuncture + Electrical Stimulation

Sham acupuncture

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.

Other names: Placebo acupuncture

Primary outcomes

  1. Improvement in burning pain

    Time frame: Baseline, daily and weekly during treatment, end of study plus 1 month follow up

Secondary outcomes

  1. Improvement in Quality of Life measurements

    Time frame: Baseline, end of study plus 1 month follow-up

Sponsors and collaborators

Lead sponsor

Toronto Rehabilitation Institute

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • University of British Columbia

Registry information

Official study title

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

Acronym: APSCI

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Aug 30, 2007
Registry last updated
May 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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