Spinal Cord InjuryNCT06700278
Auricular Acupressure and Limb Massage for Neuropathic Pain in Spinal Cord Injury
A study testing auricular acupressure and body acupoint massage in people with Spinal Cord Injury, run by National Taiwan University Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- auricular acupressure and body acupoint massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- The auricle and surrounding skin are injured, infected or susceptible.
- Nerve block surgery has been performed previously.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Spinal Cord Injury
- Being tested
- auricular acupressure, body acupoint massage
- Keywords
- acupressure, neuropathic pain, quality of life, Activities of daily living
- Medical subject headings
- Spinal Cord Injuries, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auricular acupressureBehavioural
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).
body acupoint massageBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Not described Receives: Behavioral: auricular acupressure |
| control group | Active comparator | Routine rehabilitation therapy and body acupoint massage. Receives: Behavioral: body acupoint massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Douleur Neuropathique 4 questions(DN4)
Measured: Before the intervention and on the 5th, 12th, and 19th days of the intervention.
PainDetect Pain Questionnaire
Measured: Before the intervention and on the 5th, 12th, and 19th days of the intervention.
Secondary outcomes (2)
Barthel Index
Measured: Before the intervention and on the 5th, 12th, and 19th days of the intervention.
WHOQOL-BREF
Measured: Before the intervention and on the 5th, 12th, and 19th days of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start1 Apr 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taipei University of Nursing and Health Sciences
- Responsible party
- Sponsor
- Investigators
- Weng YUE CI, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700278
- Sponsor's protocol ID
- 202409079RIND
- Status last verified
- Nov 2024
- First submitted
- 15 Nov 2024
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06700278
- Acronym / sponsor ID
- 202409079RIND
- Conditions
- Spinal Cord Injury
- Keywords
- acupressure, neuropathic pain, quality of life, Activities of daily living
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Taipei University of Nursing and Health Sciences
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Nov 2024 (actual)
- 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: auricular acupressure |
| control group | Active comparator | Behavioral: body acupoint massageRoutine rehabilitation therapy and body acupoint massage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- The auricle and surrounding skin are injured, infected or susceptible.
- Nerve block surgery has been performed previously.
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 |
|---|---|---|
| auricular acupressureauricular 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). | Behavioural | experimental group |
| body acupoint massageThe 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). | Behavioural | control group |
Primary outcome
Douleur Neuropathique 4 questions(DN4)
Time frame: 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.
2 secondary outcomes
Barthel Index
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Weng YUE CI study chair
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing auricular acupressure and body acupoint massage in people with Spinal Cord Injury, run by National Taiwan University Hospital.
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 6 inclusion and 2 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: opening soon, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weng YUE CI (+886 972739669, beck87413@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Douleur Neuropathique 4 questions(DN4) (time frame: Before the intervention and on the 5th, 12th, and 19th days of the intervention.). The study lists 2 primary outcomes in all. 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 26 Feb 2025.