Clinical trial NCT06700278: Auricular Acupressure and Limb Massage for Neuropathic Pain in Spinal Cord Injury
Official title: 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 type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Cord Injury
Keywords: acupressure
neuropathic pain
quality of life
Activities of daily living
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Taipei University of Nursing and Health Sciences
First posted: 2024-11-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Douleur Neuropathique 4 questions(DN4)
timeFrame: Before the intervention and on the 5th, 12th, and 19th days of the intervention.
measure: PainDetect Pain Questionnaire
timeFrame: Before the intervention and on the 5th, 12th, and 19th days of the intervention.
Secondary outcomes:
measure: Barthel Index
timeFrame: Before the intervention and on the 5th, 12th, and 19th days of the intervention.
measure: WHOQOL-BREF
timeFrame: Before the intervention and on the 5th, 12th, and 19th days of the intervention.
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Weng YUE CI
role: STUDY_CHAIR
References: