Acupuncture Treatment to Reduce Burning Pain in Spinal Cord Injury

NCT00523016 | Completed DMC

• 1 other identifier: TRI REB # 07-045
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

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. 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. 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. 3.To obtain preliminary data to determine subject numbers for future studies evaluating the effect of the acupuncture protocol.

Conditions

Neuropathic Pain

Keywords

acupuncture; electroacupuncture; sham acupuncture; spinal cord injury; neuropathic pain; burning pain

Outcome Measures

Primary Outcomes (1)

• Improvement in burning pain

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

Secondary Outcomes (1)

• Improvement in Quality of Life measurements

  Baseline, end of study plus 1 month follow-up

Study Arms (2)

Electroacupuncture

EXPERIMENTAL

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)

Sham acupuncture

SHAM COMPARATOR

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

Interventions

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.

Also known as: Electroacupuncture, Acupuncture + Electrical Stimulation

Electroacupuncture

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.

Also known as: Placebo acupuncture

Sham acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Toronto Rehabilitation Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• University of British Columbia: collaborator

Study Sites (3)

G. F. Strong Rehabilitation Centre

Vancouver, British Columbia, V5Z 2G9, Canada

Location

Parkwood Hospital

London, Ontario, N6C 5J1, Canada

Location

Toronto Rehabilitation Institute Lyndhurst Centre

Toronto, Ontario, M4G 3V9, Canada

Location

MeSH Terms

Conditions

Neuralgia; Spinal Cord Injuries; Pain

Interventions

Electroacupuncture; Acupuncture Therapy; Electric Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia; Physical Stimulation; Investigative Techniques

Study Officials

• Linda M Rapson, MD

  Toronto Rehabilitation Institute Lyndhurst Centre

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Scientist

Study Record Dates

• First Submitted: August 29, 2007
• First Posted: August 30, 2007
• Study Start: September 1, 2007
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 22, 2013

Record last verified: 2013-05

Locations

CA (3)