NCT07839533

Brief Summary

Lateral epicondylitis, commonly known as tennis elbow, can cause pain and reduced hand and wrist function. This study evaluated whether adding acupuncture to a conservative rehabilitation program provides additional benefits for adults with lateral epicondylitis. Participants were randomly assigned to one of two treatment groups. One group received acupuncture in addition to kinesio taping, a wrist orthosis, and a home exercise program. The other group received the same kinesio taping, wrist orthosis, and exercise program without acupuncture. Acupuncture was applied twice weekly for three weeks, for a total of six sessions. Participants were assessed before treatment, at the end of the third week, and at three months. Outcomes included pain intensity, active wrist flexion and extension range of motion, pinch strength, and hand grip strength. The study aimed to determine whether acupuncture provides additional benefits when combined with standard conservative rehabilitation for lateral epicondylitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 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

April 5, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 19, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 24, 2026

Completed
Last Updated

September 28, 2026

Status Verified

September 1, 2026

Enrollment Period

5 months

First QC Date

September 19, 2026

Last Update Submit

September 24, 2026

Conditions

Keywords

Tennis ElbowLateral EpicondylitisAcupunctureKinesio TapingWrist OrthosisExercise TherapyRehabilitationPainGrip StrengthRange of Motion

Outcome Measures

Primary Outcomes (1)

  • Change in Pain Intensity From Baseline to Month 3

    Pain intensity was assessed using a 0-10 Visual Analog Scale (VAS), where 0 represents no pain and 10 represents the worst imaginable pain. The primary endpoint was the between-group difference in change in VAS pain from baseline to Month 3.

    Baseline and Month 3

Secondary Outcomes (4)

  • Change in Active Wrist Flexion Range of Motion

    Baseline, Week 3, and Month 3

  • Change in Active Wrist Extension Range of Motion

    Baseline, Week 3, and Month 3

  • Change in Pinch Strength

    Baseline, Week 3, and Month 3

  • Change in Hand Grip Strength

    Baseline, Week 3, and Month 3

Study Arms (2)

Adjunct Acupuncture + Multimodal Rehabilitation

EXPERIMENTAL

Participants received acupuncture in addition to kinesio taping, a custom volar wrist orthosis, and a home-based exercise program.

Procedure: AcupunctureProcedure: Kinesio TapingDevice: Volar Wrist OrthosisBehavioral: Home-Based Exercise Program

Multimodal Rehabilitation Without Acupuncture

ACTIVE COMPARATOR

Participants received kinesio taping, a custom volar wrist orthosis, and a home-based exercise program without acupuncture.

Procedure: Kinesio TapingDevice: Volar Wrist OrthosisBehavioral: Home-Based Exercise Program

Interventions

AcupuncturePROCEDURE

Acupuncture was administered twice weekly for 3 weeks, for a total of 6 sessions. Local and regional points included Ah-shi, Large Intestine 10 (LI10), Large Intestine 11 (LI11), and Lung 5 (LU5); distal and segmental points included Large Intestine 4 (LI4), San Jiao 5 (SJ5), Small Intestine 3 (SI3), Gallbladder 34 (GB34), and Liver 3 (LIV3). Sterile filiform needles were retained for 20-25 minutes and manually stimulated at approximately 5-minute intervals to elicit or maintain deqi.

Adjunct Acupuncture + Multimodal Rehabilitation

Kinesio taping was applied once weekly for 3 weeks. A 5-cm elastic therapeutic tape was applied with no stretch on the anchors and approximately 15-25% stretch over the therapeutic segments. An X/donut strip was centered over the lateral epicondyle and a Y-strip was applied along the wrist extensor muscle group.

Adjunct Acupuncture + Multimodal RehabilitationMultimodal Rehabilitation Without Acupuncture

A custom low-temperature thermoplastic volar wrist cock-up orthosis was fabricated with the wrist positioned at approximately 15-20 degrees of extension. Participants were instructed to wear the orthosis during daytime activities for 6 weeks, removing it for hygiene and skin checks.

Adjunct Acupuncture + Multimodal RehabilitationMultimodal Rehabilitation Without Acupuncture

The home-based exercise program focused on eccentric wrist extensor strengthening and progressive grip exercises. Eccentric wrist extension was initiated with 0.5 kg and progressed in repetitions and load. Grip exercises using therapeutic putty were progressively performed with the elbow flexed and then extended, in supination, neutral, and pronation positions.

Adjunct Acupuncture + Multimodal RehabilitationMultimodal Rehabilitation Without Acupuncture

Eligibility Criteria

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

You may qualify if:

  • Adults aged 18 to 65 years
  • Clinical diagnosis of lateral epicondylitis
  • Symptoms of lateral epicondylitis lasting at least 6 weeks

You may not qualify if:

  • Steroid injection to the affected elbow within the previous 6 months.
  • Previous elbow surgery.
  • Neurological disease affecting the tested upper limb.
  • Active cervical radiculopathy.
  • Systemic inflammatory disease.
  • Pregnancy.
  • Inability to comply with the study protocol or follow-up assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Traditional and Complementary Medicine Clinic

Ankara, Ankara, Turkey (Türkiye)

Location

Related Publications (4)

  • MacPherson H, Altman DG, Hammerschlag R, Li Y, Wu T, White A, Moher D; STRICTA Revision Group. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. Acupunct Med. 2010 Jun;28(2):83-93. doi: 10.1136/aim.2009.001370. Epub 2010 Jun 8.

    PMID: 20615861BACKGROUND
  • McQueen KS, Powell RK, Keener T, Whalley R, Calfee RP. Role of strengthening during nonoperative treatment of lateral epicondyle tendinopathy. J Hand Ther. 2021 Oct-Dec;34(4):619-626. doi: 10.1016/j.jht.2020.10.009. Epub 2020 Oct 16.

    PMID: 33250396BACKGROUND
  • Fink M, Wolkenstein E, Karst M, Gehrke A. Acupuncture in chronic epicondylitis: a randomized controlled trial. Rheumatology (Oxford). 2002 Feb;41(2):205-9. doi: 10.1093/rheumatology/41.2.205.

    PMID: 11886971BACKGROUND
  • Shin KM, Kim JH, Lee S, Shin MS, Kim TH, Park HJ, Lee MH, Hong KE, Lee S, Choi SM. Acupuncture for lateral epicondylitis (tennis elbow): study protocol for a randomized, practitioner-assessor blinded, controlled pilot clinical trial. Trials. 2013 Jun 14;14:174. doi: 10.1186/1745-6215-14-174.

    PMID: 23768129BACKGROUND

MeSH Terms

Conditions

Tennis ElbowPain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Enver Guven, PhD

    Ankara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors were blinded to group allocation. Participants and treating clinicians could not be blinded because of the nature of the interventions, including visible acupuncture needling, kinesio taping, orthosis fitting, and supervised exercise.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned in a 1:1 ratio to two parallel treatment groups. The intervention group received acupuncture in addition to kinesio taping, wrist orthosis, and exercise, while the control group received kinesio taping, wrist orthosis, and exercise without acupuncture.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 19, 2026

First Posted

September 24, 2026

Study Start

April 5, 2025

Primary Completion

September 12, 2025

Study Completion

September 12, 2025

Last Updated

September 28, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the results reported in this study may be made available upon reasonable request to the corresponding author. Data will be shared only in a form that protects participant confidentiality.

Time Frame
Data will be available beginning after publication of the study results and for 5 years following publication.
Access Criteria
De-identified data will be available to qualified researchers who submit a reasonable written request to the corresponding author describing the purpose of the proposed analysis. Requests will be reviewed by the study investigators. Data will be shared only for scientifically appropriate purposes and in accordance with participant confidentiality and applicable ethical requirements.

Locations