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Completed

NCT Number: NCT07839533

Acupuncture as an Adjunct Treatment for Lateral Epicondylitis

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.

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Key information

Conditions

Lateral Epicondylitis Arm Injuries Elbow Injuries Elbow Tendinopathy Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Tendinopathy Tendon Injuries Tennis Elbow Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Traditional and Complementary Medicine Clinic

Ankara, Turkey (Türkiye)

About this study

This was a prospective, single-center, two-arm randomized controlled clinical trial designed to evaluate the additional effects of acupuncture when combined with a standardized conservative rehabilitation program in adults with lateral epicondylitis.

Eligible adults aged 18 to 65 years with a clinical diagnosis of lateral epicondylitis and symptoms lasting at least six weeks were randomly allocated in a 1:1 ratio to two parallel treatment groups using a computer-generated randomization sequence. Allocation was concealed using sequentially numbered, opaque, sealed envelopes. Outcome assessments were performed by a blinded assessor.

The intervention group received acupuncture in addition to kinesio taping, a custom low-temperature thermoplastic volar wrist orthosis, and a home-based exercise program. Acupuncture was administered twice weekly for three weeks, for a total of six sessions. The acupuncture protocol included local, regional, and distal points and was performed by a physician trained in acupuncture.

Both groups received kinesio taping once weekly for three weeks, a custom volar wrist orthosis positioned at approximately 15-20 degrees of wrist extension for six weeks, and a home exercise program emphasizing eccentric wrist extensor strengthening and progressive grip exercises. Exercise performance and adherence were reviewed during follow-up visits.

Assessments were performed at baseline, at the end of week 3, and at month 3. The primary outcome was pain intensity measured using a 0-10 Visual Analog Scale. Secondary outcomes included active wrist flexion and extension range of motion measured with a goniometer, pinch strength measured with a pinch gauge, and hand grip strength measured with a Jamar hydraulic dynamometer. Adverse events related to acupuncture, kinesio taping, orthosis use, and exercise were also monitored throughout the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

Acupuncture

Procedure

Acupuncture was administered twice weekly for 3 weeks, for a total of 6 sessions. Local and regional points included Ah-shi, LI10, LI11, and LU5; distal/segmental points included LI4, SJ5, SI3, GB34, and LIV3. Sterile filiform needles were retained for 20-25 minutes and manually stimulated at approximately 5-minute intervals to elicit or maintain deqi.

KINESIO TAPING

Procedure

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.

Volar Wrist Orthosis

Device

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.

Home-based Exercise Program

Behavioral

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.

Primary outcomes

  1. Change in Pain Intensity From Baseline to Month 3

    Time frame: Baseline and 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.

Secondary outcomes

  1. Change in Active Wrist Flexion Range of Motion

    Time frame: Baseline, Week 3, and Month 3

    Active wrist flexion range of motion was measured in degrees using a standard goniometer. Three measurements were obtained at each assessment and the mean value was analyzed.

  2. Change in Active Wrist Extension Range of Motion

    Time frame: Baseline, Week 3, and Month 3

    Active wrist extension range of motion was measured in degrees using a standard goniometer. Three measurements were obtained at each assessment and the mean value was analyzed.

  3. Change in Pinch Strength

    Time frame: Baseline, Week 3, and Month 3

    Pinch strength was measured in kilograms using a Baseline® pinch gauge in a standardized position. Three measurements were obtained at each assessment and the mean value was analyzed.

  4. Change in Hand Grip Strength

    Time frame: Baseline, Week 3, and Month 3

    Hand grip strength was measured in kilograms using a Jamar hydraulic dynamometer in a standardized position. Three measurements were obtained at each assessment and the mean value was analyzed.

Sponsors and collaborators

Lead sponsor

Enver Guven

Other

Registry information

Official study title

Effectiveness of Acupuncture in the Treatment of Lateral Epicondylitis: A Randomized Controlled Trial Comparing Kinesiotape, Orthosis, and Exercise

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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