- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06939309
Efficacy of Acupuncture for Shoulder Pain Based on Remote Point Selection According to the Meridians
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shih-Liang Yang
- Phone Number: 6102 +886-4-22294411
- Email: YSL451YSL@yahoo.com.tw
Study Contact Backup
- Name: Dong-Sheng Yang
- Phone Number: 6122 +886-4-22294411
- Email: dawndawn0226@gmail.com
Study Locations
-
-
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Taichung, Taiwan, 403
- Taichung Hospital, Ministry of Health and Welfare
-
Contact:
- Shih-Liang Yang
- Phone Number: 6102 +886-4-22294411
- Email: YSL451YSL@yahoo.com.tw
-
Principal Investigator:
- Shih-Liang Yang
-
Sub-Investigator:
- Dong-Sheng Yang
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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.
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Participants will complete a 30-minute rehabilitation session, which includes electrotherapy and thermotherapy applied to the shoulder.
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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.
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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.
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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.
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Collaborators and Investigators
Publications and helpful links
General Publications
- Chandran KP, Chandran PP, Arumugam N, Muthappan S. Effect of Remote and Local Acupuncture Points on Periarthritis of Shoulder: A Comparative Study. J Acupunct Meridian Stud. 2021 Feb 28;14(1):13-20. doi: 10.51507/j.jams.2021.14.1.13.
- Chen IW, Liao YT, Tseng H, Lin HC, Chou LW. Pain, function and peritendinous effusion improvement after dry needling in patients with long head of biceps brachii tendinopathy: a single-blind randomized clinical trial. Ann Med. 2024 Dec;56(1):2391528. doi: 10.1080/07853890.2024.2391528. Epub 2024 Aug 14.
- Takakura N, Takayama M, Kawase A, Kaptchuk TJ, Kong J, Vangel M, Yajima H. Acupuncture for Japanese Katakori (Chronic Neck Pain): A Randomized Placebo-Controlled Double-Blind Study. Medicina (Kaunas). 2023 Dec 9;59(12):2141. doi: 10.3390/medicina59122141.
- Calamita SAP, Biasotto-Gonzalez DA, De Melo NC, Fumagalli MA, Amorim CF, de Paula Gomes CAF, Politti F. Immediate Effect of Acupuncture on Electromyographic Activity of the Upper Trapezius Muscle and Pain in Patients With Nonspecific Neck Pain: A Randomized, Single-Blinded, Sham-Controlled, Crossover Study. J Manipulative Physiol Ther. 2018 Mar-Apr;41(3):208-217. doi: 10.1016/j.jmpt.2017.09.006.
- Ben-Arie E, Kao PY, Lee YC, Ho WC, Chou LW, Liu HP. The Effectiveness of Acupuncture in the Treatment of Frozen Shoulder: A Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2020 Sep 25;2020:9790470. doi: 10.1155/2020/9790470. eCollection 2020.
- Green S, Buchbinder R, Hetrick S. Acupuncture for shoulder pain. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD005319. doi: 10.1002/14651858.CD005319.
- Schroder S, Meyer-Hamme G, Friedemann T, Kirch S, Hauck M, Plaetke R, Friedrichs S, Gulati A, Briem D. Immediate Pain Relief in Adhesive Capsulitis by Acupuncture-A Randomized Controlled Double-Blinded Study. Pain Med. 2017 Nov 1;18(11):2235-2247. doi: 10.1093/pm/pnx052.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMUH113-REC3-192
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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