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Efficacy of Dry Needling in the Treatment of Lateral Epicondylitis

Primary Purpose

Tennis Elbow, Dry Needling

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Dry needling
Home exercise program
Sponsored by
Bozyaka Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tennis Elbow focused on measuring Lateral epicondylitis, Dry needling, Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Health Sciences Izmir Bozyaka Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dry needling and home exercise

Home exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

Pain free handgrip strength
Change in the pain-free handgrip strength. JAMAR hand dynamometer

Full Information

First Posted
October 25, 2021
Last Updated
January 28, 2023
Sponsor
Bozyaka Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05108493
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bozyaka Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tennis Elbow, Dry Needling
Keywords
Lateral epicondylitis, Dry needling, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry needling and home exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Home exercise
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dry needling
Intervention Description
Three sessions dry needling of lateral epicondyle region, once per week with disposable acupuncture needles (0.25x25mm).
Intervention Type
Other
Intervention Name(s)
Home exercise program
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Patient-Rated Tennis Elbow Evaluation (PRTEE)
Description
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).
Time Frame
0. week (baseline); 4. week; 12. week
Title
Visual Analogue Scale
Description
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).
Time Frame
0. week (baseline); 4. week; 12. week
Secondary Outcome Measure Information:
Title
Pain free handgrip strength
Description
Change in the pain-free handgrip strength. JAMAR hand dynamometer
Time Frame
0. week (baseline); 4. week; 12. week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fikriye Elif Saka
Organizational Affiliation
University of Health Sciences Izmir Bozyaka Training and Research Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kamil Yamak
Organizational Affiliation
University of Health Sciences Izmir Bozyaka Training and Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
University of Health Sciences Izmir Bozyaka Training and Research Hospital
City
Izmir
State/Province
Karabaglar
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10708988
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.
Results Reference
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PubMed Identifier
22972856
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.
Results Reference
background
PubMed Identifier
21871414
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.
Results Reference
background
PubMed Identifier
32576044
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.
Results Reference
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PubMed Identifier
28828509
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.
Results Reference
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PubMed Identifier
32950674
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.
Results Reference
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PubMed Identifier
31942676
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.
Results Reference
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Efficacy of Dry Needling in the Treatment of Lateral Epicondylitis

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