Clinical trial NCT05108493: Efficacy of Dry Needling in the Treatment of Lateral Epicondylitis
Official title: Efficacy of Dry Needling in the Treatment of Lateral Epicondylitis: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tennis Elbow
Dry Needling
Keywords: Lateral epicondylitis
Dry needling
Pain
Lead sponsor: Bozyaka Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* History of injection for lateral epicondylitis in the last 6 months
* Radial nerve compression
* History of arm/forearm fracture
* Pregnancy/lactation
* Thrombocytopenia
* Coagulopathy
* 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

Primary outcomes:
measure: The Patient-Rated Tennis Elbow Evaluation (PRTEE)
timeFrame: 0. week (baseline); 4. week; 12. week
measure: Visual Analogue Scale
timeFrame: 0. week (baseline); 4. week; 12. week
Secondary outcomes:
measure: Pain free handgrip strength
timeFrame: 0. week (baseline); 4. week; 12. week
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: University of Health Sciences Izmir Bozyaka Training and Research Hospital
state: Karabaglar
Study officials:
affiliation: University of Health Sciences Izmir Bozyaka Training and Research Hospital
name: Fikriye Elif Saka
role: STUDY_CHAIR
affiliation: University of Health Sciences Izmir Bozyaka Training and Research Hospital
name: Kamil Yamak
role: STUDY_CHAIR
References:
citation: 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.
citation: Krogh 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.
citation: Carayannopoulos 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.
citation: Navarro-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.
citation: Uygur 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.
citation: Uygur 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.
citation: Stoychev 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.