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

NCT06700278 | Not Yet Recruiting

• 1 other identifier: 202409079RIND
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Spinal Cord Injury

Keywords

acupressure; neuropathic pain; quality of life; Activities of daily living

Outcome Measures

Primary Outcomes (2)

• Douleur Neuropathique 4 questions(DN4)

  Before the intervention and on the 5th, 12th, and 19th days of the intervention.

• PainDetect Pain Questionnaire

  Before the intervention and on the 5th, 12th, and 19th days of the intervention.

Secondary Outcomes (2)

• Barthel Index

  Before the intervention and on the 5th, 12th, and 19th days of the intervention.

• WHOQOL-BREF

  Before the intervention and on the 5th, 12th, and 19th days of the intervention.

Study Arms (2)

experimental group

EXPERIMENTAL

Behavioral: auricular acupressure

control group

ACTIVE COMPARATOR

Routine rehabilitation therapy and body acupoint massage.

Behavioral: body acupoint massage

Interventions

auricular acupressure BEHAVIORAL

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).

experimental group

body acupoint massage BEHAVIORAL

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).

control group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Taipei University of Nursing and Health Sciences: collaborator

MeSH Terms

Conditions

Spinal Cord Injuries; Neuralgia

Condition Hierarchy (Ancestors)

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

Study Officials

• Weng YUE CI

  National Taiwan University Hospital

  STUDY CHAIR

Central Study Contacts

Weng YUE CI

CONTACT

+886 972739669; beck87413@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 21, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 26, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share