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Injection in the Treatment of Lateral Epicondylitis. Randomized Controlled Trial

Primary Purpose

Epicondylitis, Lateral

Status
Completed
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
plate-rich plasma
saline (0.9 NACI)
betametazon
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epicondylitis, Lateral

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients over the age of 18
  2. Clinical diagnosis-
  3. Symptoms lasting more than 3 months and no injection within this period
  4. Radiologically diagnosed -

Exclusion Criteria:

- 1. symptoms for less than 3 months 2. Having been given injection treatment within 3 months

3. Surgical procedure for lateral epicondylitis 4. Having pain caused by the cervical spine 5. Restricted elbow range of motion 6.Having an elbow bony deformity

Sites / Locations

  • Istanbul University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

saline injection

platet riched plasma injection

betametazon injection

Arm Description

2ml %0.9 NACI(Saline )injection to effected lateral epicondyle

2 ml prp )injection to effected lateral epicondyle

2 ml betametazon )injection to effected lateral epicondyle

Outcomes

Primary Outcome Measures

CHANGE İN VAS: Visual Analog Skala
we ask questions for vas score ıt has explained https://www.orthopaedicscore.com/, minum score 1 maximum 10 The higher the score, the greater the pain, and we expect it to decrease after the process.
CHANGE İN DASH: The Disabilities of the Arm, Shoulder and Hand
we ask questions which has explained in https://www.orthopaedicscore.com/ The scores are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability)-this is called the DASH score. we expect it to decrease after the process.
CHANGE İN PRTEE: The Patient-Rated Tennis Elbow Evaluation
The Patient-Rated Tennis Elbow Evaluation (PRTEE) is designed to evaluate pain and disability in subjects with lateral elbow tendinopathy. This questionnaire is available in Swedish, Italian, and some other languages. A Persian language version of the questionnaire is needed for both research and clinical purposes. The higher the score, the greater the pain, and we expect it to decrease after the process.

Secondary Outcome Measures

evaluation common extensor morphology and vascularity with ultrasound
ıt will perform by radiology doctor in istanbul university radiology department , In order to assess common extensor tendon morphology and vascularity, ana-tomic grayscale US images of the injected elbow wereperformed to establish the degree of tendinosis, using anL17-5 linear-phased transducer (Philips Medical Systems,Bothell, WA, USA) with the elbow in flexion and forearmpronated to the "thumbs up"position. Contrast harmonicimaging, using an amplitude modulation technique, wasperformed with the patient sitting and the elbow in flexionusing an L12-5 phased-array linear transducer with an IU22US scanner (Phillips Medical Systems, Bothell, WA, USA)to visualize the common extensor tendon at the lateralepicondyle

Full Information

First Posted
April 29, 2021
Last Updated
March 24, 2023
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT04875338
Brief Title
Injection in the Treatment of Lateral Epicondylitis. Randomized Controlled Trial
Official Title
Platelet-rich Plasma, Glucocorticoid, Saline Injection in the Treatment of Lateral Epicondylitis. Randomized Controlled Trial
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

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

5. Study Description

Brief Summary
The aim of the study is to compare the effectiveness of injection techniques in the treatment of elbow lateral epicondylitis. The functional and pain levels of the patients will be evaluated with scores such as DASH, VAS, PRTEE. At the same time, USG imaging will be evaluated before injection and in the third month after injection. The study was planned as a randomized controlled prospective study.
Detailed Description
Patients diagnosed with epicondylitis in our outpatient clinic will be divided into 3 groups, and patients who will receive saline in 1 group and betamethasone sodium in a group will be selected in accordance with the specified conditions and their treatment will be started, and the treatment will be started, which patient will receive which treatment will be determined by the computerized randomization program. ), 1ml prp (plate-rich plasma to be prepared with the blood taken from the patient on the day of injection), 1 ml saline (0.9 NACI), while the patient is in the supine position, the affected elbow is 90 flexion and neutral rotation, The non-dominant thumb will be placed at the sensitive point in the lateral epicondyle. The injection will be applied to the point with a 23 g needle. After the injection, the subjects will be taught a stretching exercise of the joint extensors of the wrist and fingers. Subjects will be asked to do this exercise five times in one session, two sessions a day.Examination and functional scores to be applied to the patients during follow-up: VAS, DASH and PRTEE scores will be checked in the 1st 6th week, 3rd month, 6th month and 12th month VAS: Visual Analog Scale DASH: The Disabilities of the Arm, Shoulder and Hand PRTEE: The Patient-Rated Tennis Elbow Evaluation 2. It will be evaluated by USG in the 3rd month.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epicondylitis, Lateral

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
propective randomize
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
saline injection
Arm Type
Active Comparator
Arm Description
2ml %0.9 NACI(Saline )injection to effected lateral epicondyle
Arm Title
platet riched plasma injection
Arm Type
Active Comparator
Arm Description
2 ml prp )injection to effected lateral epicondyle
Arm Title
betametazon injection
Arm Type
Active Comparator
Arm Description
2 ml betametazon )injection to effected lateral epicondyle
Intervention Type
Drug
Intervention Name(s)
plate-rich plasma
Intervention Description
1ml prp (plate-rich plasma to be prepared with the blood taken from the patient on the day of injection), , while the patient is in the supine position, the affected elbow is 90 flexion and neutral rotation, The non-dominant thumb will be placed at the sensitive point in the lateral epicondyle. The injection will be applied to the point with a 23 g needle. After the injection, the subjects will be taught a stretching exercise of the joint extensors of the wrist and fingers. Subjects will be asked to do this exercise five times in one session, two sessions a day
Intervention Type
Drug
Intervention Name(s)
saline (0.9 NACI)
Intervention Description
1 ml saline (0.9 NACI) while the patient is in the supine position, the affected elbow is 90 flexion and neutral rotation, The non-dominant thumb will be placed at the sensitive point in the lateral epicondyle. The injection will be applied to the point with a 23 g needle. After the injection, the subjects will be taught a stretching exercise of the joint extensors of the wrist and fingers. Subjects will be asked to do this exercise five times in one session, two sessions a day
Intervention Type
Drug
Intervention Name(s)
betametazon
Intervention Description
1 ml betametazon while the patient is in the supine position, the affected elbow is 90 flexion and neutral rotation, The non-dominant thumb will be placed at the sensitive point in the lateral epicondyle. The injection will be applied to the point with a 23 g needle. After the injection, the subjects will be taught a stretching exercise of the joint extensors of the wrist and fingers. Subjects will be asked to do this exercise five times in one session, two sessions a day
Primary Outcome Measure Information:
Title
CHANGE İN VAS: Visual Analog Skala
Description
we ask questions for vas score ıt has explained https://www.orthopaedicscore.com/, minum score 1 maximum 10 The higher the score, the greater the pain, and we expect it to decrease after the process.
Time Frame
baseline and 6th week, 3rd month, 6th month and 12th month
Title
CHANGE İN DASH: The Disabilities of the Arm, Shoulder and Hand
Description
we ask questions which has explained in https://www.orthopaedicscore.com/ The scores are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability)-this is called the DASH score. we expect it to decrease after the process.
Time Frame
baseline and 6th week, 3rd month, 6th month and 12th month
Title
CHANGE İN PRTEE: The Patient-Rated Tennis Elbow Evaluation
Description
The Patient-Rated Tennis Elbow Evaluation (PRTEE) is designed to evaluate pain and disability in subjects with lateral elbow tendinopathy. This questionnaire is available in Swedish, Italian, and some other languages. A Persian language version of the questionnaire is needed for both research and clinical purposes. The higher the score, the greater the pain, and we expect it to decrease after the process.
Time Frame
baseline and 6th week, 3rd month, 6th month and 12th month
Secondary Outcome Measure Information:
Title
evaluation common extensor morphology and vascularity with ultrasound
Description
ıt will perform by radiology doctor in istanbul university radiology department , In order to assess common extensor tendon morphology and vascularity, ana-tomic grayscale US images of the injected elbow wereperformed to establish the degree of tendinosis, using anL17-5 linear-phased transducer (Philips Medical Systems,Bothell, WA, USA) with the elbow in flexion and forearmpronated to the "thumbs up"position. Contrast harmonicimaging, using an amplitude modulation technique, wasperformed with the patient sitting and the elbow in flexionusing an L12-5 phased-array linear transducer with an IU22US scanner (Phillips Medical Systems, Bothell, WA, USA)to visualize the common extensor tendon at the lateralepicondyle
Time Frame
baseline and 3 months after enjection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over the age of 18 Clinical diagnosis- Symptoms lasting more than 3 months and no injection within this period Radiologically diagnosed - Exclusion Criteria: - 1. symptoms for less than 3 months 2. Having been given injection treatment within 3 months 3. Surgical procedure for lateral epicondylitis 4. Having pain caused by the cervical spine 5. Restricted elbow range of motion 6.Having an elbow bony deformity
Facility Information:
Facility Name
Istanbul University
City
Istanbul
State/Province
Fatih
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23001116
Citation
Chaudhury S, de La Lama M, Adler RS, Gulotta LV, Skonieczki B, Chang A, Moley P, Cordasco F, Hannafin J, Fealy S. Platelet-rich plasma for the treatment of lateral epicondylitis: sonographic assessment of tendon morphology and vascularity (pilot study). Skeletal Radiol. 2013 Jan;42(1):91-7. doi: 10.1007/s00256-012-1518-y. Epub 2012 Sep 22.
Results Reference
background
PubMed Identifier
21705157
Citation
Wolf JM, Ozer K, Scott F, Gordon MJ, Williams AE. Comparison of autologous blood, corticosteroid, and saline injection in the treatment of lateral epicondylitis: a prospective, randomized, controlled multicenter study. J Hand Surg Am. 2011 Aug;36(8):1269-72. doi: 10.1016/j.jhsa.2011.05.014. Epub 2011 Jun 25.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/21705157/
Description
https://www.sciencedirect.com/science/article/abs/pii/S0363502311006289

Learn more about this trial

Injection in the Treatment of Lateral Epicondylitis. Randomized Controlled Trial

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