NCT07798531

Brief Summary

This study compares two acupuncture-based treatments for shoulder pain. Adults with shoulder pain will be randomly assigned to one of two groups. One group will receive electroacupuncture at points chosen based on the anatomy of the painful muscle, combined with moving cupping therapy. The other group will receive electroacupuncture using a standard set of traditional acupuncture points. Both groups will receive daily treatment for 5 days. The main question is whether the combined treatment reduces pain and improves shoulder function more than standard electroacupuncture, measured using a shoulder pain and disability questionnaire completed before treatment and after each session.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 22, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2026

Completed
Last Updated

September 1, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

August 27, 2026

Last Update Submit

August 27, 2026

Conditions

Keywords

electroacupuncturecupping therapyshoulder pain and disability indexmyofascial trigger pointstraditional medicine

Outcome Measures

Primary Outcomes (2)

  • Change in Shoulder Pain and Disability Index (SPADI) Pain Subscale Score

    The SPADI pain subscale consists of 5 items, each scored 0-10, for a total raw score of 0-50, transformed to a 0-100 scale. Higher scores indicate greater pain severity. Assessed by patient self-report before treatment and after each of 5 daily treatment sessions.

    Baseline (T0), Day 1 (T1), Day 2 (T2), Day 3 (T3), Day 4 (T4), and Day 5 (T5)

  • Change in Shoulder Pain and Disability Index (SPADI) Disability Subscale Score

    The SPADI disability subscale consists of 8 items assessing activities of daily living, each scored 0-10, for a total raw score of 0-80, transformed to a 0-100 scale. Higher scores indicate greater functional limitation. Assessed by patient self-report before treatment and after each of 5 daily treatment sessions.

    Baseline (T0), Day 1 (T1), Day 2 (T2), Day 3 (T3), Day 4 (T4), and Day 5 (T5)

Study Arms (2)

Anatomically-Guided Electroacupuncture Plus Moving Cupping

EXPERIMENTAL

Participants received moving cupping therapy over the upper back and shoulder for 10-15 minutes every other day (3 sessions), followed by electroacupuncture at points selected according to the anatomical location of the affected muscle and the movement provoking pain, at 60-100 Hz for 20 minutes once daily for 5 consecutive days.

Procedure: Anatomically-guided electroacupunctureProcedure: Moving cupping therapy

Classical Electroacupuncture

ACTIVE COMPARATOR

Participants received electroacupuncture using a standard set of classical acupuncture points (SI15, SI14, BL11, GB21, TE14, LI15, LI14, SI9, SI11, plus distal points LI11, LI10, TE5, LI4) at 60-100 Hz for 20 minutes once daily for 5 consecutive days.

Procedure: Classical electroacupuncture

Interventions

Electroacupuncture using filiform needles inserted at ashi points (tender points) selected according to the anatomical location of the affected shoulder muscle and the movement provoking pain (e.g., SI9, SI11, TE14, LI15, GB21, BL17). Needles were stimulated electrically at 60-100 Hz and retained for 20 minutes, once daily for 5 consecutive days.

Anatomically-Guided Electroacupuncture Plus Moving Cupping

Moving cupping therapy applied over the upper back and shoulder region. Paraffin oil was applied to the skin, and a plastic cup (3-5 cm diameter) was moved along both sides of the thoracic spine, passing over the supraspinous and infraspinous fossae, using intermittent lifting to avoid localized bruising. Total duration 10-15 minutes per session, performed every other day for 3 sessions.

Anatomically-Guided Electroacupuncture Plus Moving Cupping

Electroacupuncture using filiform needles inserted at a standard set of classical acupuncture points following the protocol of the Vietnam Ministry of Health, including local points SI15, SI14, BL11, GB21, TE14, LI15, LI14, SI9, and SI11, plus distal points LI11, LI10, TE5, and LI4. Needles were stimulated electrically at 60-100 Hz, retained for 20 minutes, once daily for 5 consecutive days.

Classical Electroacupuncture

Eligibility Criteria

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

You may qualify if:

  • Adults over 18 years of age
  • Diagnosed with shoulder pain according to ICD-10 codes M75.0-M75.9
  • No infectious or malignant disease of the shoulder
  • Willing to provide informed consent to participate

You may not qualify if:

  • Complete rotator cuff tear on imaging requiring surgical intervention
  • Currently receiving systemic corticosteroid therapy
  • Concurrently receiving acupuncture treatment at another facility
  • Contraindication to electroacupuncture or cupping therapy, including coagulation disorders, skin infection at the treatment site, or cardiac pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thong Nhat hospital

Ho Chi Minh City, 70000, Vietnam

Location

Related Publications (10)

  • Mohamed AA, Zhang X, Jan YK. Evidence-based and adverse-effects analyses of cupping therapy in musculoskeletal and sports rehabilitation: A systematic and evidence-based review. J Back Musculoskelet Rehabil. 2023;36(1):3-19. doi: 10.3233/BMR-210242.

  • Sun KO, Chan KC, Lo SL, Fong DY. Acupuncture for frozen shoulder. Hong Kong Med J. 2001 Dec;7(4):381-91.

  • Chen ZY, Wang MH, Ye Z. Effect of electroacupuncture combined with rehabilitation techniques on shoulder function in patients with rotator cuff injuries. World J Clin Cases. 2024 Jul 26;12(21):4582-4589. doi: 10.12998/wjcc.v12.i21.4582.

  • Sujithra TS, Mangayarkarasi N, Manavalan N, Prabu P. Efficacy of Cupping Therapy Compared to Acupuncture in Patients with Periarthritis of Shoulder: A Comparative Study. Alternative and Integrative Medicine. 2021;10(2).

    RESULT
  • Lauche R, Spitzer J, Schwahn B, Ostermann T, Bernardy K, Cramer H, Dobos G, Langhorst J. Efficacy of cupping therapy in patients with the fibromyalgia syndrome-a randomised placebo controlled trial. Sci Rep. 2016 Nov 17;6:37316. doi: 10.1038/srep37316.

  • Karamanlioglu DS, Kaysin MY, Begoglu FA, Akpinar P, Ozkan FU, Aktas I. Effects of acupuncture on pain and function in patients with subacromial impingement syndrome: A randomized sham-controlled trial. Integr Med Res. 2024 Jun;13(2):101049. doi: 10.1016/j.imr.2024.101049. Epub 2024 May 25.

  • Stör, J., Stör, W. Die Studienlage zur Akupunkturwirkung bei Schulter-Arm-Syndrom (beispielsweise Frozen Shoulder, Periarthritis humeroscapularis). Dtsch Z Akupunkt 60, 20-22 (2017). https://doi.org/10.1016/S0415-6412(17)30080-2

    RESULT
  • Guerra de Hoyos JA, Martin MDCA, Leon EBYB, Lopez MV, Lopez TM, Morilla FAV, Moreno MJG. Randomised trial of long term effect of acupuncture for shoulder pain. Pain. 2004 Dec;112(3):289-298. doi: 10.1016/j.pain.2004.08.030.

  • Dorsher, P.T., Schmid, O. & Fleckenstein, J. The "most common" myofascial trigger points and classical acupuncture points. Part 1. Dtsch Z Akupunkt 68, 58-70 (2025). https://doi.org/10.1007/s42212-025-00735-8

    RESULT
  • Molsberger AF, Schneider T, Gotthardt H, Drabik A. German Randomized Acupuncture Trial for chronic shoulder pain (GRASP) - a pragmatic, controlled, patient-blinded, multi-centre trial in an outpatient care environment. Pain. 2010 Oct;151(1):146-154. doi: 10.1016/j.pain.2010.06.036. Epub 2010 Jul 23.

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hoang Tran, MD, MSc

    University of Medicine and Pharmacy at Ho Chi Minh City

    STUDY DIRECTOR
  • Dinh- Thanh Le, Assoc Prof, MD, PhD

    Thong Nhat Hospital

    STUDY CHAIR
  • Ly-Na T Vu, MD, MSc

    University of Medicine and Pharmacy at Ho Chi Minh City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Physician at Faculty of Traditional Medicine

Study Record Dates

First Submitted

August 27, 2026

First Posted

September 1, 2026

Study Start

December 22, 2025

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

September 1, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the results reported in this article, along with the study protocol, will be made available upon reasonable request to the corresponding author (Ly-Na T. Vu, vtlna@ump.edu.vn), for researchers who provide a methodologically sound proposal, beginning 9 months and ending 36 months after article publication. Data will be shared for the purpose of achieving the aims in the approved proposal, subject to a signed data access agreement.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Data will be available beginning 9 months and continuing until 36 months following publication of this article.
Access Criteria
Researchers who provide a methodologically sound proposal may request access to the de-identified individual participant data and study protocol by contacting the corresponding author (Ly-Na T. Vu, vtlna@ump.edu.vn). Requests will be reviewed by the study investigators, and access will be granted following execution of a data access agreement and approval, if required, by the Institutional Review Board of Biomedical Research, University of Medicine and Pharmacy at Ho Chi Minh City. Data will be shared for the purpose of achieving the aims specified in the approved proposal.

Locations