- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06700278
Auricular Acupressure and Limb Massage for Neuropathic Pain in Spinal Cord Injury
Effect of Auricular Acupressure and Peripheral Limb Acupoint Massage on Neuropathic Pain, Activities of Daily Living and Quality of Life in Patients With Spinal Cord Injury
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a randomized controlled trial conducted in the rehabilitation ward of National Taiwan University Hospital, using a convenience sampling method. A total of 90 spinal cord injury patients who meet the inclusion criteria will be recruited and randomly assigned to either the experimental group (n=45) or the control group (n=45).
The experimental group will receive auricular acupressure in addition to rehabilitation therapy. The selected auricular acupoints include Shenmen (TF4), Subcortex (AT1), Liver (CO12), and Sympathetic (AH6a).
The control group will receive body acupoint massage in addition to rehabilitation therapy. The selected body acupoints include Quchi (LI11), Hegu (LI4), Sanyinjiao (SP6), and Zusanli (ST36).
Both groups will receive acupoint massage three times daily, with each acupoint being massaged for three minutes. The applied pressure will be adjusted to induce sensations of soreness, numbness, fullness, or mild pain. The intervention will be conducted five days per week for a total of three weeks.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Weng YUE CI
- Phone Number: +886 972739669
- Email: beck87413@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Over 18 years old.
- Spinal cord injury due to traumatic or non-traumatic reasons.
- Within one year after spinal cord injury.
- Spinal cord injuries are classified into ASIA grades B to D.
- DN4 scale ≥ 4 points and PainDETECT scale ≥ 19 points.
- Able to communicate in Mandarin and Taiwanese or able to read and write Chinese.
Exclusion Criteria:
- The auricle and surrounding skin are injured, infected or susceptible.
- Nerve block surgery has been performed previously.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: experimental group
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auricular acupressure was performed three times daily, with each acupoint massaged for three minutes at an optimal pressure level that induced sensations of soreness, numbness, distension, or mild pain.
This was conducted five days a week for three weeks, in addition to regular rehabilitation therapy provided five days per week.The selected auricular acupoints include Shenmen (TF4), Subcortex (AT1), Liver (CO12), and Sympathetic (AH6a).
|
|
Active Comparator: control group
Routine rehabilitation therapy and body acupoint massage.
|
The control group will receive acupoint massage three times daily, with each acupoint being massaged for three minutes.
The applied pressure will be adjusted to induce sensations of soreness, numbness, fullness, or mild pain.
The intervention will be conducted five days per week for a total of three weeks.
The selected body acupoints include Quchi (LI11), Hegu (LI4), Sanyinjiao (SP6), and Zusanli (ST36).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Douleur Neuropathique 4 questions(DN4)
Time Frame: Before the intervention and on the 5th, 12th, and 19th days of the intervention.
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Before the intervention and on the 5th, 12th, and 19th days of the intervention.
|
|
PainDetect Pain Questionnaire
Time Frame: Before the intervention and on the 5th, 12th, and 19th days of the intervention.
|
Before the intervention and on the 5th, 12th, and 19th days of the intervention.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Barthel Index
Time Frame: Before the intervention and on the 5th, 12th, and 19th days of the intervention.
|
Before the intervention and on the 5th, 12th, and 19th days of the intervention.
|
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WHOQOL-BREF
Time Frame: Before the intervention and on the 5th, 12th, and 19th days of the intervention.
|
Before the intervention and on the 5th, 12th, and 19th days of the intervention.
|
Collaborators and Investigators
Investigators
- Study Chair: Weng YUE CI, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202409079RIND
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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