Tennis ElbowNCT05108493
Efficacy of Dry Needling in the Treatment of Lateral Epicondylitis
A study testing Dry needling and Home exercise program in people with Tennis Elbow and Dry Needling, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Lateral epicondylitis is painful tendinosis of the main extensor tendon that occurs at the fibro-osseous junction of the outer elbow region. Histopathological samples in patients with chronic lateral epicondylitis show that there is angiofibroblastic degeneration and failure in the normal tendon repair process rather… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tennis Elbow, Dry Needling
- What is being tested?
- Dry needling and Home exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 1 Dec 2022
- 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
- Tenderness and pain over lateral epicondylitis and provocation of the lateral elbow pain with one the following tests; resisted middle finger extension, resisted wrist extension, the passive stretch of wrist extensors.
- Participants had a direct radiograph of the elbow within the last 3 months
- Epicondylitis bandage users
Who cannot join
- History of injection for lateral epicondylitis in the last 6 months
- Radial nerve compression
- History of arm/forearm fracture
- Pregnancy/lactation
- Thrombocytopenia
- Coagulopathy
Show all 16Show fewer
- Bleeding diathesis
- Neuropathy
- Use of anticoagulants
- Widespread pain syndrome
- History of inflammatory arthritis
- Presence of trauma to the elbow region in the last 3 months
- Statement of the participant that he/she will not be able to continue the follow-ups for the research
- Fear of injection
- Untreated psychiatric illness
- Presence of drug/substance abuse
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Izmir Bozyaka Training and Research Hospital
Izmir, Karabaglar
About this study
Official title: Efficacy of Dry Needling in the Treatment of Lateral Epicondylitis: A Prospective Randomized Controlled Study
Lateral epicondylitis is painful tendinosis of the main extensor tendon that occurs at the fibro-osseous junction of the outer elbow region. Histopathological samples in patients with chronic lateral epicondylitis show that there is angiofibroblastic degeneration and failure in the normal tendon repair process rather than acute inflammation in this region. It has begun to be accepted that the main factor in lateral epicondylitis is not the inflammatory events but the degenerative process. There are many treatment methods that trigger structural healing in tendinopathies.
In this study, the investigators aimed to evaluate the effect of the dry needling method of the lateral epicondyle region.
Read the detailed description
Lateral epicondylitis occurs as a result of micro-tears and progressive degeneration caused by repetitive tension, especially at the attachment of the main extensor tendon to the lateral epicondyle. The treatment modality to be used, which causes an increase in functional cells, can prevent the apoptotic process; Thus, it is suggested that there are methods that can reconstruct tendon structure and function. Inflammation can have a positive effect on the healing process in the treatment of lateral epicondylitis. Methods such as prolotherapy and platelet-rich plasma therapy are among the methods that trigger the inflammation process in the lateral epicondyle region and subsequently contribute to the regeneration process. In all these treatments, there is evidence that the local healing process is triggered by the 'needle effect'.
Dry needle therapy is a method that has been widely used in musculoskeletal diseases for many years, and it is one of the safe and cost-effective applications.
In this study, the investigators planned to evaluate the clinical efficiency of dry needling of lateral epicondyle area those are the origin of the extensor muscle groups of the wrist in addition to the home exercise program and to compare the groups in terms of pain severity, functionality, and improvement in handgrip strength with the participants applied for the only home exercise program.
- Conditions
- Tennis Elbow, Dry Needling
- Being tested
- Dry needling, Home exercise program
- Keywords
- Lateral epicondylitis, Dry needling, Pain
- 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.
Dry needlingOther
Three sessions dry needling of lateral epicondyle region, once per week with disposable acupuncture needles (0.25x25mm).
Home exercise programOther
All participants will start the home exercise program during the study period consisting of range of motion exercises for wrist flexion, extension, ulnar and radial deviation, elbow flexion and extensor; forearm supinator, and pronator muscles; stretching exercises. Eccentric strengthening of the wrist flexor extensors, ulnar and radial deviation, forearm pronation, supination, and strengthening exercise training will be given to the elbow extensors and flexors. Progressive strengthening exercises will be added to the program. The exercise program will be terminated with stretching exercises. The exercises will be performed for 10 repetitions 2 times a day, stay in each position for 10 seconds, and rest for 30 seconds between periods. Both groups will be advised to continue the exercise program for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dry needling and home exercise | Experimental | The experimental intervention will consist of 3 sessions of dry needling of the lateral epicondyle region, once per week with disposable acupuncture needles (0.25x25mm).
Range of motion, stretching exercises, ulnar and radial deviation, forearm pronation, supination, elbow extensor, and flexor strengthening exercises will be given to all participants.
The exercise program will be performed for 10 repetitions 2 times a day. All participants will be advised to continue the exercise program for 12 weeks. Receives: Other: Dry needling; Other: Home exercise program |
| Home exercise | Active comparator | Range of motion, stretching exercises, ulnar and radial deviation, forearm pronation, supination, elbow extensor, and flexor strengthening exercises will be given to all participants.
The exercise program will be performed for 10 repetitions 2 times a day. All participants will be advised to continue the exercise program for 12 weeks. Receives: Other: Home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Patient-Rated Tennis Elbow Evaluation (PRTEE)
Change in the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire. PRTEE is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis. PRTEE allows patients to rate their levels of elbow pain and disability from 0 to 10. The test consists of 2 subscales: 1) Pain subscale [5 items] (0 = no pain, 10 = worst imaginable) 2) Function subscale [Specific activities - 6 items, Usual activities - 4 items] (0 = no difficulty, 10 = unable to do). A total score can be computed on a scale of 100 (0 = no disability).
Measured: 0. week (baseline); 4. week; 12. week
Visual Analogue Scale
Change in the Visual Analogue Scale. Pain on the lateral epicondyle at rest during the day was evaluated with the visual analog scale (VAS 0-10 cm).
Measured: 0. week (baseline); 4. week; 12. week
Secondary outcomes (1)
Pain free handgrip strength
Change in the pain-free handgrip strength. JAMAR hand dynamometer
Measured: 0. week (baseline); 4. week; 12. week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start1 Dec 2021
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Tennis ElbowStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şeniz Akçay, Bozyaka Training and Research Hospital
- Investigators
- Fikriye Elif Saka, Study chair, University of Health Sciences Izmir Bozyaka Training and Research HospitalKamil Yamak, Study chair, University of Health Sciences Izmir Bozyaka Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108493
- Sponsor's protocol ID
- 2021/138-11/08/2021
- Status last verified
- Jan 2023
- First submitted
- 25 Oct 2021
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jobe FW, Ciccotti MG. Lateral and Medial Epicondylitis of the Elbow. J Am Acad Orthop Surg. 1994 Jan;2(1):1-8. doi: 10.5435/00124635-199401000-00001.
PubMed 10708988Krogh TP, Bartels EM, Ellingsen T, Stengaard-Pedersen K, Buchbinder R, Fredberg U, Bliddal H, Christensen R. Comparative effectiveness of injection therapies in lateral epicondylitis: a systematic review and network meta-analysis of randomized controlled trials. Am J Sports Med. 2013 Jun;41(6):1435-46. doi: 10.1177/0363546512458237. Epub 2012 Sep 12.
PubMed 22972856Carayannopoulos A, Borg-Stein J, Sokolof J, Meleger A, Rosenberg D. Prolotherapy versus corticosteroid injections for the treatment of lateral epicondylosis: a randomized controlled trial. PM R. 2011 Aug;3(8):706-15. doi: 10.1016/j.pmrj.2011.05.011.
PubMed 21871414Navarro-Santana MJ, Sanchez-Infante J, Gomez-Chiguano GF, Cleland JA, Lopez-de-Uralde-Villanueva I, Fernandez-de-Las-Penas C, Plaza-Manzano G. Effects of trigger point dry needling on lateral epicondylalgia of musculoskeletal origin: a systematic review and meta-analysis. Clin Rehabil. 2020 Nov;34(11):1327-1340. doi: 10.1177/0269215520937468. Epub 2020 Jun 23.
PubMed 32576044Uygur E, Aktas B, Ozkut A, Erinc S, Yilmazoglu EG. Dry needling in lateral epicondylitis: a prospective controlled study. Int Orthop. 2017 Nov;41(11):2321-2325. doi: 10.1007/s00264-017-3604-1. Epub 2017 Aug 21.
PubMed 28828509Uygur E, Aktas B, Yilmazoglu EG. The use of dry needling vs. corticosteroid injection to treat lateral epicondylitis: a prospective, randomized, controlled study. J Shoulder Elbow Surg. 2021 Jan;30(1):134-139. doi: 10.1016/j.jse.2020.08.044. Epub 2020 Sep 17.
PubMed 32950674Stoychev V, Finestone AS, Kalichman L. Dry Needling as a Treatment Modality for Tendinopathy: a Narrative Review. Curr Rev Musculoskelet Med. 2020 Feb;13(1):133-140. doi: 10.1007/s12178-020-09608-0.
PubMed 31942676
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dry Needling in the Treatment of Lateral Epicondylitis: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05108493
- Acronym / sponsor ID
- 2021/138-11/08/2021
- Conditions
- Tennis Elbow, Dry Needling
- Keywords
- Lateral epicondylitis, Dry needling, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 5 Nov 2021 (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 is painful tendinosis of the main extensor tendon that occurs at the fibro-osseous junction of the outer elbow region. Histopathological samples in patients with chronic lateral epicondylitis show that there is angiofibroblastic degeneration and failure in the normal tendon repair process rather than acute inflammation in this region. It has begun to be accepted that the main factor in lateral epicondylitis is not the inflammatory events but the degenerative process. There are many treatment methods that trigger structural healing in tendinopathies.
In this study, the investigators aimed to evaluate the effect of the dry needling method of the lateral epicondyle region.
Detailed description
Lateral epicondylitis occurs as a result of micro-tears and progressive degeneration caused by repetitive tension, especially at the attachment of the main extensor tendon to the lateral epicondyle. The treatment modality to be used, which causes an increase in functional cells, can prevent the apoptotic process; Thus, it is suggested that there are methods that can reconstruct tendon structure and function. Inflammation can have a positive effect on the healing process in the treatment of lateral epicondylitis. Methods such as prolotherapy and platelet-rich plasma therapy are among the methods that trigger the inflammation process in the lateral epicondyle region and subsequently contribute to the regeneration process. In all these treatments, there is evidence that the local healing process is triggered by the 'needle effect'.
Dry needle therapy is a method that has been widely used in musculoskeletal diseases for many years, and it is one of the safe and cost-effective applications.
In this study, the investigators planned to evaluate the clinical efficiency of dry needling of lateral epicondyle area those are the origin of the extensor muscle groups of the wrist in addition to the home exercise program and to compare the groups in terms of pain severity, functionality, and improvement in handgrip strength with the participants applied for the only home exercise program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry needling and home exercise | Experimental | Other: Dry needling, Other: Home exercise programThe experimental intervention will consist of 3 sessions of dry needling of the lateral epicondyle region, once per week with disposable acupuncture needles (0.25x25mm). Range of motion, stretching exercises, ulnar and radial deviation, forearm pronation, supination, elbow extensor, and flexor strengthening exercises will be given to all participants. The exercise program will be performed for 10 repetitions 2 times a day. All participants will be advised to continue the exercise program for 12 weeks. |
| Home exercise | Active comparator | Other: Home exercise programRange of motion, stretching exercises, ulnar and radial deviation, forearm pronation, supination, elbow extensor, and flexor strengthening exercises will be given to all participants. The exercise program will be performed for 10 repetitions 2 times a day. All participants will be advised to continue the exercise program for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Tenderness and pain over lateral epicondylitis and provocation of the lateral elbow pain with one the following tests; resisted middle finger extension, resisted wrist extension, the passive stretch of wrist extensors.
- Participants had a direct radiograph of the elbow within the last 3 months
- Epicondylitis bandage users
Key exclusion criteria (16 listed)
- History of injection for lateral epicondylitis in the last 6 months
- Radial nerve compression
- History of arm/forearm fracture
- Pregnancy/lactation
- Thrombocytopenia
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 |
|---|---|---|
| Dry needlingThree sessions dry needling of lateral epicondyle region, once per week with disposable acupuncture needles (0.25x25mm). | Other | Dry needling and home exercise |
| Home exercise programAll participants will start the home exercise program during the study period consisting of range of motion exercises for wrist flexion, extension, ulnar and radial deviation, elbow flexion and extensor; forearm supinator, and pronator muscles; stretching exercises. Eccentric strengthening of the wrist flexor extensors, ulnar and radial deviation, forearm pronation, supination, and strengthening exercise training will be given to the elbow extensors and flexors. Progressive strengthening exercises will be added to the program. The exercise program will be terminated with stretching exercises. The exercises will be performed for 10 repetitions 2 times a day, stay in each position for 10 seconds, and rest for 30 seconds between periods. Both groups will be advised to continue the exercise program for 12 weeks. | Other | Dry needling and home exercise, Home exercise |
Primary outcome
The Patient-Rated Tennis Elbow Evaluation (PRTEE)
Time frame: 0. week (baseline); 4. week; 12. week
Change in the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire. PRTEE is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis. PRTEE allows patients to rate their levels of elbow pain and disability from 0 to 10. The test consists of 2 subscales: 1) Pain subscale [5 items] (0 = no pain, 10 = worst imaginable) 2) Function subscale [Specific activities - 6 items, Usual activities - 4 items] (0 = no difficulty, 10 = unable to do). A total score can be computed on a scale of 100 (0 = no disability).
Visual Analogue Scale
Time frame: 0. week (baseline); 4. week; 12. week
Change in the Visual Analogue Scale. Pain on the lateral epicondyle at rest during the day was evaluated with the visual analog scale (VAS 0-10 cm).
1 secondary outcome
Pain free handgrip strength
Time frame: 0. week (baseline); 4. week; 12. week
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 31 Jan 2023.
- Background: PubMed 10708988Jobe FW, Ciccotti MG. Lateral and Medial Epicondylitis of the Elbow. J Am Acad Orthop Surg. 1994 Jan;2(1):1-8. doi: 10.5435/00124635-199401000-00001.
- Background: PubMed 22972856Krogh TP, Bartels EM, Ellingsen T, Stengaard-Pedersen K, Buchbinder R, Fredberg U, Bliddal H, Christensen R. Comparative effectiveness of injection therapies in lateral epicondylitis: a systematic review and network meta-analysis of randomized controlled trials. Am J Sports Med. 2013 Jun;41(6):1435-46. doi: 10.1177/0363546512458237. Epub 2012 Sep 12.
- Background: PubMed 21871414Carayannopoulos A, Borg-Stein J, Sokolof J, Meleger A, Rosenberg D. Prolotherapy versus corticosteroid injections for the treatment of lateral epicondylosis: a randomized controlled trial. PM R. 2011 Aug;3(8):706-15. doi: 10.1016/j.pmrj.2011.05.011.
- Background: PubMed 32576044Navarro-Santana MJ, Sanchez-Infante J, Gomez-Chiguano GF, Cleland JA, Lopez-de-Uralde-Villanueva I, Fernandez-de-Las-Penas C, Plaza-Manzano G. Effects of trigger point dry needling on lateral epicondylalgia of musculoskeletal origin: a systematic review and meta-analysis. Clin Rehabil. 2020 Nov;34(11):1327-1340. doi: 10.1177/0269215520937468. Epub 2020 Jun 23.
- Background: PubMed 28828509Uygur E, Aktas B, Ozkut A, Erinc S, Yilmazoglu EG. Dry needling in lateral epicondylitis: a prospective controlled study. Int Orthop. 2017 Nov;41(11):2321-2325. doi: 10.1007/s00264-017-3604-1. Epub 2017 Aug 21.
- Background: PubMed 32950674Uygur E, Aktas B, Yilmazoglu EG. The use of dry needling vs. corticosteroid injection to treat lateral epicondylitis: a prospective, randomized, controlled study. J Shoulder Elbow Surg. 2021 Jan;30(1):134-139. doi: 10.1016/j.jse.2020.08.044. Epub 2020 Sep 17.
- Background: PubMed 31942676Stoychev V, Finestone AS, Kalichman L. Dry Needling as a Treatment Modality for Tendinopathy: a Narrative Review. Curr Rev Musculoskelet Med. 2020 Feb;13(1):133-140. doi: 10.1007/s12178-020-09608-0.
- Individual participant dataSharing planned: No
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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.
Fikriye Elif Saka study chair
University of Health Sciences Izmir Bozyaka Training and Research Hospital
Kamil Yamak study chair
University of Health Sciences Izmir Bozyaka Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling and Home exercise program in people with Tennis Elbow and Dry Needling, run by Bozyaka Training and Research Hospital 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 16 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 31 Jan 2023. 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?
The Patient-Rated Tennis Elbow Evaluation (PRTEE) (time frame: 0. week (baseline); 4. week; 12. week). The study lists 2 primary outcomes in all. 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 NCT05108493, which also lists 7 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 31 Jan 2023.