Auricular Acupressure and Limb Massage for Neuropathic Pain in Spinal Cord Injury

February 24, 2025 updated by: National Taiwan University Hospital

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

This randomized controlled trial included 90 patients with spinal cord injury, divided into an experimental group and a control group (45 each). The experimental group received auricular acupressure alongside rehabilitation therapy, while the control group received body acupoint massage alongside rehabilitation therapy. The intervention targeted specific auricular and body acupoints, performed three times daily, five days a week, for three weeks.

Study Overview

Status

Not yet recruiting

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

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Over 18 years old.
  2. Spinal cord injury due to traumatic or non-traumatic reasons.
  3. Within one year after spinal cord injury.
  4. Spinal cord injuries are classified into ASIA grades B to D.
  5. DN4 scale ≥ 4 points and PainDETECT scale ≥ 19 points.
  6. Able to communicate in Mandarin and Taiwanese or able to read and write Chinese.

Exclusion Criteria:

  1. The auricle and surrounding skin are injured, infected or susceptible.
  2. Nerve block surgery has been performed previously.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: experimental group
Behavioral: auricular acupressure
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.
Behavioral: 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.
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.
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

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

National Taipei University of Nursing and Health Sciences

Investigators

  • Study Chair: Weng YUE CI, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 15, 2024

First Submitted That Met QC Criteria

November 19, 2024

First Posted (Actual)

November 21, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202409079RIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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