Efficacy of Acupuncture for Shoulder Pain Based on Remote Point Selection According to the Meridians

April 22, 2025 updated by: China Medical University Hospital
This double blind randomized controlled trial investigates the immediate efficacy of acupuncture for shoulder pain using remote point selection based on meridian theory. A total of 90 participants with shoulder pain (Numerical Rating Scale ≥ 4) will be randomly assigned in a 1:1:1 ratio to one of three groups: acupuncture SC, acupuncture CS, and rehabilitation. Meridian selection will be determined based on the patient's most painful shoulder movement and corresponding pain location, followed by standardized distal acupoint application. Outcome measures include changes in pain intensity (NRS) and shoulder range of motion assessed at baseline, post-first acupuncture, post-second acupuncture, and 30 minutes post-treatment. Blinded evaluators will conduct all assessments. The study aims to assess the effectiveness of meridian-based remote acupuncture and explore its relationship with shoulder movement patterns and soft tissue involvement.

Study Overview

Status

Not yet recruiting

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

Study Contact Backup

Study Locations

      • Taichung, Taiwan, 403
        • Taichung Hospital, Ministry of Health and Welfare
        • Contact:
        • Principal Investigator:
          • Shih-Liang Yang
        • Sub-Investigator:
          • Dong-Sheng Yang

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:

  • Participants must be at least 18 years old.
  • Shoulder pain persisting for at least one week.
  • Numerical Rating Scale (NRS) score ≥ 4.

Exclusion Criteria:

  • Patients with cervical radiculopathy or other localized neurological disorders affecting the upper limb.
  • Psychiatric disorders that may interfere with examination, treatment, or evaluation of disease progression.
  • Pregnant patients.
  • Inability to provide informed consent.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupuncture SC Group
The most affected meridian is determined based on location and movements. The physician first applies acupuncture to one standardized acupoint (LI10, TE7, SI7, or LU6) on the most affected meridian. After 3 minutes (3 minutes after the first acupuncture), the assessor performs the first evaluation. The physician then applies acupuncture to a controlled acupoint (PC6) not directly related to shoulder function. After another 5 minutes (8 minutes after the first acupuncture), the assessor performs the second evaluation. The final evaluation is conducted 30 minutes after the first acupuncture. The patient is instructed to perform shoulder movements throughout the treatment.
In this study, both the acupuncture SC group and the acupuncture CS group will receive two acupuncture treatments in one session. The SC group will first receive acupuncture at the standardized acupoint followed by the controlled acupoint, while the CS group will first receive acupuncture at the controlled acupoint followed by the standardized acupoint.
Experimental: Acupuncture CS Group
The most affected meridian is determined using the same method by location and movements. The physician first applies acupuncture to the controlled acupoint (PC6). After 3 minutes, the assessor performs the first evaluation. The physician then applies acupuncture to one standardized acupoint (LI10, TE7, SI7, or LU6) on the most affected meridian. After another 5 minutes (8 minutes after the first acupuncture), the assessor performs the second evaluation. The final evaluation is conducted 30 minutes after the first acupuncture. The patient is instructed to perform shoulder movements throughout the treatment.
In this study, both the acupuncture SC group and the acupuncture CS group will receive two acupuncture treatments in one session. The SC group will first receive acupuncture at the standardized acupoint followed by the controlled acupoint, while the CS group will first receive acupuncture at the controlled acupoint followed by the standardized acupoint.
Active Comparator: Rehabilitation Group
Participants will complete a 30-minute rehabilitation session, followed by an outcome assessment.
Participants will complete a 30-minute rehabilitation session, which includes electrotherapy and thermotherapy applied to the shoulder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity (Numerical Rating Scale, NRS: 0-10)
Time Frame: Baseline evaluation before intervention. First evaluation: 3 minutes after the first acupuncture. Second evaluation: 3 minutes after the second acupuncture (8 minutes after the first). Final evaluation: 30 minutes after the first acupuncture.

Patients will be asked to rate their pain intensity using a numerical scale. 0: No pain. 1-3: Mild pain - the patient feels pain but can tolerate it; normal daily activities and sleep are not disturbed.

4-6: Moderate pain - the pain is noticeable and difficult to tolerate; sleep may be disturbed, such as waking up due to pain; patients may request pain medication.

7-10: Severe pain - the pain is intense and intolerable; sleep is severely disturbed or impossible; pain medication is often necessary.

Baseline evaluation before intervention. First evaluation: 3 minutes after the first acupuncture. Second evaluation: 3 minutes after the second acupuncture (8 minutes after the first). Final evaluation: 30 minutes after the first acupuncture.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of Motion
Time Frame: Baseline evaluation before intervention. First evaluation: 3 minutes after the first acupuncture. Second evaluation: 3 minutes after the second acupuncture (8 minutes after the first). Final evaluation: 30 minutes after the first acupuncture.
A goniometer will be used to measure the range of motion of the affected shoulder joint in the following movements: flexion, abduction, external rotation, and internal rotation.
Baseline evaluation before intervention. First evaluation: 3 minutes after the first acupuncture. Second evaluation: 3 minutes after the second acupuncture (8 minutes after the first). Final evaluation: 30 minutes after the first acupuncture.

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 18, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2025

Last Update Submitted That Met QC Criteria

April 22, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • CMUH113-REC3-192

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to institutional policy and data privacy considerations. The study data include sensitive health information that cannot be fully de-identified, and there are currently no resources allocated for managing data sharing requests.

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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