Efficacy of Dry Needling in the Treatment of Lateral Epicondylitis

NCT05108493 | Completed

• 1 other identifier: 2021/138-11/08/2021
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Tennis Elbow; Dry Needling

Keywords

Lateral epicondylitis; Dry needling; Pain

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  0. week (baseline); 4. week; 12. week

Secondary Outcomes (1)

• Pain free handgrip strength

  0. week (baseline); 4. week; 12. week

Study Arms (2)

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.

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.

Other: Home exercise program

Interventions

Dry needling OTHER

Three sessions dry needling of lateral epicondyle region, once per week with disposable acupuncture needles (0.25x25mm).

Dry needling and home exercise

Home exercise program OTHER

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.

Dry needling and home exercise; Home exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences Izmir Bozyaka Training and Research Hospital

Izmir, Karabaglar, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 10708988 BACKGROUND

• 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.

  PMID: 22972856 BACKGROUND

• 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.

  PMID: 21871414 BACKGROUND

• 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.

  PMID: 32576044 BACKGROUND

• 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.

  PMID: 28828509 BACKGROUND

• 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.

  PMID: 32950674 BACKGROUND

• 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.

  PMID: 31942676 BACKGROUND

MeSH Terms

Conditions

Tennis Elbow; Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Fikriye Elif Saka

  University of Health Sciences Izmir Bozyaka Training and Research Hospital

  STUDY CHAIR

• Kamil Yamak

  University of Health Sciences Izmir Bozyaka Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 5, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)