Efficacy of Dry Needling in the Treatment of Lateral Epicondylitis

February 20, 2022 updated by: Şeniz Akçay, Bozyaka Training and Research Hospital

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Karabaglar
      • Izmir, Karabaglar, Turkey
        • University of Health Sciences Izmir Bozyaka Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dry needling and home exercise

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
Three sessions dry needling of lateral epicondyle region, once per week with disposable acupuncture needles (0.25x25mm).
Other: Home exercise program
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.
Active Comparator: Home exercise

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
0. week (baseline); 4. week; 12. week
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).
0. week (baseline); 4. week; 12. week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain free handgrip strength
Time Frame: 0. week (baseline); 4. week; 12. week
Change in the pain-free handgrip strength. JAMAR hand dynamometer
0. week (baseline); 4. week; 12. week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bozyaka Training and Research Hospital

Investigators

  • Study Chair: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

October 25, 2021

First Submitted That Met QC Criteria

October 25, 2021

First Posted (Actual)

November 5, 2021

Study Record Updates

Last Update Posted (Actual)

March 8, 2022

Last Update Submitted That Met QC Criteria

February 20, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/138-11/08/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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