NCT06939309

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Apr 2025Jun 2026

First Submitted

Initial submission to the registry

April 15, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

April 18, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

1.2 years

First QC Date

April 15, 2025

Last Update Submit

April 22, 2025

Conditions

Keywords

Shoulder painAcupunctureMeridians

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity (Numerical Rating Scale, NRS: 0-10)

    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 Outcomes (1)

  • Range of Motion

    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.

Study Arms (3)

Acupuncture SC Group

EXPERIMENTAL

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.

Procedure: Acupuncture

Acupuncture CS Group

EXPERIMENTAL

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.

Procedure: Acupuncture

Rehabilitation Group

ACTIVE COMPARATOR

Participants will complete a 30-minute rehabilitation session, followed by an outcome assessment.

Procedure: Rehabilitation

Interventions

AcupuncturePROCEDURE

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.

Acupuncture CS GroupAcupuncture SC Group

Participants will complete a 30-minute rehabilitation session, which includes electrotherapy and thermotherapy applied to the shoulder.

Rehabilitation Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Hospital, Ministry of Health and Welfare

Taichung, 403, Taiwan

Location

Related Publications (7)

  • 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;2005(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.

MeSH Terms

Conditions

Shoulder Pain

Interventions

Acupuncture TherapyRehabilitation

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsAftercareContinuity of Patient CarePatient CareHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2025

First Posted

April 22, 2025

Study Start

April 18, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

April 24, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

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.

Locations