Neuropathic PainAPSCINCT00523016
Acupuncture Treatment to Reduce Burning Pain in Spinal Cord Injury
A study testing Lyndhurst Central Neuropathic Pain Acupuncture Protocol (LCCNPAP) in people with Neuropathic Pain, run by Toronto Rehabilitation Institute at 3 sites in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Lyndhurst Central Neuropathic Pain Acupuncture Protocol (LCCNPAP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 3 sitesCanada
- Study dates
- Sep 2007to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Parkwood Hospital
London, Ontario, N6C 5J1
Toronto Rehabilitation Institute Lyndhurst Centre
Toronto, Ontario, M4G 3V9
G. F. Strong Rehabilitation Centre
Vancouver, British Columbia, V5Z 2G9
About this study
Official title: 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:
- 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.
- 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.
- To obtain preliminary data to determine subject numbers for future studies evaluating the effect of the acupuncture protocol.
Read the 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
- Being tested
- Lyndhurst Central Neuropathic Pain Acupuncture Protocol (LCCNPAP), Sham acupuncture
- Keywords
- acupuncture, electroacupuncture, sham acupuncture, spinal cord injury, neuropathic pain, burning pain
- Medical subject headings
- Neuralgia, Spinal Cord Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lyndhurst Central Neuropathic Pain Acupuncture Protocol (LCCNPAP)Procedure or surgery
Also called Electroacupuncture, Acupuncture + Electrical Stimulation
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 acupunctureProcedure or surgery
Also called Placebo 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in burning pain
Measured: Baseline, daily and weekly during treatment, end of study plus 1 month follow up
Secondary outcomes (1)
Improvement in Quality of Life measurements
Measured: Baseline, end of study plus 1 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2007 (estimated)
- Study startSep 2007
- Primary completionApr 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of British Columbia
- Responsible party
- Principal investigator, Linda M. Rapson, Toronto Rehabilitation Institute
- Investigators
- Linda M Rapson, MD, Principal investigator, Toronto Rehabilitation Institute Lyndhurst CentreEva Widerström-Noga, PhD, Study director, University of MiamiJudith Hunter, PhD, Study director, University of TorontoJudi Laprade, PhD, Study director, University of TorontoJohn Clement, MD, Study director, Parkwood HospitalPatrick Potter, MD, Study director, Western University, CanadaNimmi Bharatwal, MD, Study director, University of TorontoAndrei Krassioukov, MD, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523016
- Sponsor's protocol ID
- TRI REB # 07-045
- Acronym
- APSCI
- Status last verified
- May 2013
- First submitted
- 29 Aug 2007
- Last updated
- 22 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Investigating the Feasibility of Using Acupuncture Treatment to Reduce Below-Level Neuropathic Pain in Spinal Cord Injury.
- ClinicalTrials.gov ID
- NCT00523016
- Acronym / sponsor ID
- APSCI / TRI REB # 07-045
- Conditions
- Neuropathic Pain
- Keywords
- acupuncture, electroacupuncture, sham acupuncture, spinal cord injury, neuropathic pain, burning pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Toronto Rehabilitation InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of British Columbia
- Study start
- Sep 2007
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 30 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture | Experimental | Procedure: Lyndhurst Central Neuropathic Pain Acupuncture Protocol (LCCNPAP)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. |
| Sham acupuncture | Sham comparator | Procedure: Sham acupunctureSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- systemic illness
- major psychiatric disorders
- scalp lacerations or infections
- hearing or language problems
- history of diabetes or disease that would affect peripheral nerve function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lyndhurst Central Neuropathic Pain Acupuncture Protocol (LCCNPAP)Also: Electroacupuncture, Acupuncture + Electrical StimulationLCCNPAP: 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. | Procedure or surgery | Electroacupuncture |
| Sham acupunctureAlso: Placebo acupunctureSham 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. | Procedure or surgery | Sham acupuncture |
Primary outcome
Improvement in burning pain
Time frame: Baseline, daily and weekly during treatment, end of study plus 1 month follow up
1 secondary outcome
Improvement in Quality of Life measurements
Time frame: Baseline, end of study plus 1 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda M Rapson, MD principal investigator
Toronto Rehabilitation Institute Lyndhurst Centre
Eva Widerström-Noga, PhD study director
University of Miami
Judith Hunter, PhD study director
University of Toronto
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lyndhurst Central Neuropathic Pain Acupuncture Protocol (LCCNPAP) in people with Neuropathic Pain, run by Toronto Rehabilitation Institute at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in burning pain (time frame: Baseline, daily and weekly during treatment, end of study plus 1 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2013.