Lateral EpicondylitisNCT07839533
Acupuncture as an Adjunct Treatment for Lateral Epicondylitis
A study testing Acupuncture, Kinesio Taping and Volar Wrist Orthosis in people with Lateral Epicondylitis, run by Enver Guven at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Acupuncture, Kinesio Taping and Volar Wrist Orthosis
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2025to 12 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years
- Clinical diagnosis of lateral epicondylitis
- Symptoms of lateral epicondylitis lasting at least 6 weeks
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Traditional and Complementary Medicine Clinic
Ankara, Ankara
About this study
Official title: Effectiveness of Acupuncture in the Treatment of Lateral Epicondylitis: A Randomized Controlled Trial Comparing Kinesiotape, Orthosis, and Exercise
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.
Read the detailed description
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.
- Conditions
- Lateral Epicondylitis
- Being tested
- Acupuncture, Kinesio Taping, Volar Wrist Orthosis, Home-Based Exercise Program
- Keywords
- Tennis Elbow, Lateral Epicondylitis, Acupuncture, Kinesio Taping, Wrist Orthosis, Exercise Therapy, Rehabilitation, Pain, Grip Strength, Range of Motion
- Medical subject headings
- Tennis Elbow, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
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.
Kinesio TapingProcedure or surgery
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 OrthosisDevice
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 ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Adjunct Acupuncture + Multimodal Rehabilitation | Experimental | Participants received acupuncture in addition to kinesio taping, a custom volar wrist orthosis, and a home-based exercise program. Receives: Procedure: Acupuncture; Procedure: Kinesio Taping; Device: Volar Wrist Orthosis; Behavioral: 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. Receives: Procedure: Kinesio Taping; Device: Volar Wrist Orthosis; Behavioral: Home-Based Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Month 3
Secondary outcomes (4)
Change in Active Wrist Flexion Range of Motion
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.
Measured: Baseline, Week 3, and Month 3
Change in Active Wrist Extension Range of Motion
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.
Measured: Baseline, Week 3, and Month 3
Change in Pinch Strength
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.
Measured: Baseline, Week 3, and Month 3
Change in Hand Grip Strength
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.
Measured: Baseline, Week 3, and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start5 Apr 2025
- Primary completion12 Sep 2025
- Study completion12 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enver Guven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Enver Guven, Ankara University
- Investigators
- Enver Guven, PhD, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839533
- Sponsor's protocol ID
- E2-25-12563
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 20615861McQueen 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.
PubMed 33250396Fink 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.
PubMed 11886971Shin 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.
PubMed 23768129
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Acupuncture in the Treatment of Lateral Epicondylitis: A Randomized Controlled Trial Comparing Kinesiotape, Orthosis, and Exercise
- ClinicalTrials.gov ID
- NCT07839533
- Acronym / sponsor ID
- E2-25-12563
- Conditions
- Lateral Epicondylitis
- Keywords
- Tennis Elbow, Lateral Epicondylitis, Acupuncture, Kinesio Taping, Wrist Orthosis, Exercise Therapy, Rehabilitation, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Enver GuvenUniversity, hospital or other
- Study start
- 5 Apr 2025 (actual)
- Primary completion
- 12 Sep 2025 (actual)
- Study completion
- 12 Sep 2025 (actual)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Adjunct Acupuncture + Multimodal Rehabilitation | Experimental | Procedure: Acupuncture, Procedure: Kinesio Taping, Device: Volar Wrist Orthosis, Behavioral: Home-Based Exercise ProgramParticipants received acupuncture in addition to kinesio taping, a custom volar wrist orthosis, and a home-based exercise program. |
| Multimodal Rehabilitation Without Acupuncture | Active comparator | Procedure: Kinesio Taping, Device: Volar Wrist Orthosis, Behavioral: Home-Based Exercise ProgramParticipants received kinesio taping, a custom volar wrist orthosis, and a home-based exercise program without acupuncture. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 to 65 years
- Clinical diagnosis of lateral epicondylitis
- Symptoms of lateral epicondylitis lasting at least 6 weeks
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAcupuncture 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. | Procedure or surgery | Adjunct Acupuncture + Multimodal Rehabilitation |
| Kinesio TapingKinesio 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. | Procedure or surgery | Adjunct Acupuncture + Multimodal Rehabilitation, Multimodal Rehabilitation Without Acupuncture |
| Volar Wrist OrthosisA 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. | Device | Adjunct Acupuncture + Multimodal Rehabilitation, Multimodal Rehabilitation Without Acupuncture |
| Home-Based Exercise ProgramThe 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. | Behavioural | Adjunct Acupuncture + Multimodal Rehabilitation, Multimodal Rehabilitation Without Acupuncture |
Primary outcome
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.
4 secondary outcomes
Change in Active Wrist Flexion Range of Motion
Time frame: Baseline, Week 3, and Month 3
Change in Active Wrist Extension Range of Motion
Time frame: Baseline, Week 3, and Month 3
Change in Pinch Strength
Time frame: Baseline, Week 3, and Month 3
Change in Hand Grip Strength
Time frame: Baseline, Week 3, and Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Background: PubMed 20615861MacPherson 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.
- Background: PubMed 33250396McQueen 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.
- Background: PubMed 11886971Fink 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.
- Background: PubMed 23768129Shin 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enver Guven, PhD principal investigator
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture, Kinesio Taping and Volar Wrist Orthosis in people with Lateral Epicondylitis, run by Enver Guven at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity From Baseline to Month 3 (time frame: Baseline and Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07839533, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.