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Injection Therapy in Patients With Lateral Epicondylitis

Primary Purpose

Lateral Epicondylitis, Tennis Elbow

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hyaluronic Acid
Prolotherapy
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis focused on measuring Lateral epicondylitis, Prolotherapy, Hyaluronic acid

Eligibility Criteria

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

Inclusion Criteria:

  1. aged 20-60 years,
  2. had a clinical diagnosis of lateral epicondylitis, defined as pain over the lateral humeral epicondyle of at least 6 months' duration,
  3. provoked by palpation and resisted wrist/middle finger extension or gripping,
  4. participants needed to score at least 30/100 on Visual analogue scale (VAS),
  5. be able to understand enough Turkish to complete the outcome questionnaire.

Exclusion Criteria:

  1. Any treatment for their elbow pain by a health care practitioner within the preceding 6 months,
  2. Concomitant neck or other arm pain causing disability or requiring treatment within the last 6 months,
  3. Clinical evidence of other primary sources of lateral elbow pain,
  4. Upper limb fractures within the preceding 10 years,
  5. Prior elbow surgery
  6. Elbow steroid injection in the past 3 months
  7. Systemic inflammatory disorder or malignancy,
  8. Pregnancy or breastfeeding

Sites / Locations

  • Hakan Apaydın

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hyaluronic acid injection group

Prolotherapy injection group

Arm Description

This is the study group in whom Hyaluronic acid injection was injected at lateral epicondylitis site.

This is the control group in whom prolotherapy injection was given at lateral epicondyle site.

Outcomes

Primary Outcome Measures

Pain via Visual Analogue Scale
Change from baseline at 6 week and at 12 week Pain of the participants will be assessed by most widely used and accepted "visual analogue scale". It consists of a 10 centimeter line marked at one end with "no pain" and at other end with "worst pain ever". Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, baseline, 6 and 12 weeks of follow-ups. Numerical score is given to it simply by measuring length between "no pain" to patients mark.
Quick - Disabilities of the Arm, Shoulder and Hand (QuickDASH)
Change from baseline at 6 week and at 12 week The elbow disability scale was assessed using the Quick DASH (disability of arm, shoulder & hand) questionnaire containing 11 questions with five choices for each question. The final score can range between 0 (best condition) and 100 (worst condition). Participant is asked to answer the Quick DASH at baseline, 6 and 12 weeks of follow-ups

Secondary Outcome Measures

Grip strength via dynamometer
Change from baseline at 6 week and at 12 week Pain-free grip strength is a commonly used objective measure of lateral epicondilitis-related disability with high reliability and validity. In the study, we used a hand dynamometer (Baseline® Hydraulic Hand Dynamometer 200 LB Standard). Patients were asked to sit, adduct the shoulder, flex the elbow to 90 degrees and put their forearm in a neutral position, then squeeze the dynamometer for three to five seconds. This test was conducted three times with 60-second intervals for each patient, and the mean patient grip strength was recorded at baseline, 6 and 12 weeks of follow-ups.

Full Information

First Posted
May 11, 2020
Last Updated
May 18, 2020
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04395417
Brief Title
Injection Therapy in Patients With Lateral Epicondylitis
Official Title
Injection Therapy in Patients With Lateral Epicondylitis: Hyaluronic Acid or Prolotherapy?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 2, 2018 (Actual)
Primary Completion Date
September 15, 2018 (Actual)
Study Completion Date
September 25, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Lateral epicondylitis is a painful enthesopathy of the common extensor tendon at the lateral part of the elbow, with a prevalence of 1-3 % in the general population. In the treatment of lateral epicondylitis, the role of biological-based therapies has begun to investigate regeneration and optimize tendon healing. Prolotherapy (PrT) and hyaluronic acid (HA) injections are biological based treatments. Previous studies have shown benefit of PrT in the treatment of tendinopathies. Preliminary findings demonstrated that HA could be clinically effective in the treatment of enthesopathies. Considering the paucity of HA studies (which also lack a control group) and the proposed mechanism of action of both PrT and HA is through cell proliferation and the healing process of tendons, this study was conducted to compare the effect of PrT and HA in chronic lateral epicondylitis .
Detailed Description
Lateral epicondylitis and other chronic tendinopathies are now understood to be non-inflammatory conditions characterized by collagen degeneration, fibroblast proliferation, mucoid degeneration and neovascularization Biological-based treatments can trigger the release of cytokines and growth factors from platelets, leukocytes, macrophages and other inflammatory cells. These growth factors support neovascularization and the chemotaxis of fibroblasts and tenocytes. It stimulates proliferation and collagen remodeling of fibroblasts and tenocytes. PrT involves multiple injections of a small amount of irritant or sclerosing solution. Common irritants include hypertonic dextrose, phenol-glycerin-glucose and sodium morrhuate. PrT injection mechanism is as follows; while hypertonic dextrose causes cell rupture through osmosis, monosodium morrhuate attracts inflammatory mediators and improves blood flow of the diseased tendon.Previous studies have shown benefit of PrT in the treatment of tendinopathies HA injection is a treatment method that increases the ability of sliding with its viscoelastic properties, reduces tendon surface friction and accelerates regeneration. In vitro models suggest that HA can increase collagen I production and accumulation with a dose-dependent positive collagen I / collagen III ratio. However, controlled randomised studies are still needed. Mechanism of action of both PrT and HA is cell proliferation and the healing process of tendons, this study was conducted to compare the effect of PrT and HA in chronic lateral epicondylitis .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis, Tennis Elbow
Keywords
Lateral epicondylitis, Prolotherapy, Hyaluronic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Participant
Masking Description
The patients and the researcher who were responsible for the analyzing of the data were blinded to the randomization results.
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hyaluronic acid injection group
Arm Type
Experimental
Arm Description
This is the study group in whom Hyaluronic acid injection was injected at lateral epicondylitis site.
Arm Title
Prolotherapy injection group
Arm Type
Active Comparator
Arm Description
This is the control group in whom prolotherapy injection was given at lateral epicondyle site.
Intervention Type
Drug
Intervention Name(s)
Hyaluronic Acid
Other Intervention Name(s)
Prostrolane
Intervention Description
Patients were infiltrated with injection single dose 30 mg/2 ml 1500 kilodalton high molecular weight hyaluronic acid at the lateral epicondyle according to the standard technique.
Intervention Type
Biological
Intervention Name(s)
Prolotherapy
Intervention Description
Patients were infiltrated with 5cc of dextrose 15% at the lateral epicondyle according to the standard technique. For solution, 1 cc 2% lidocaine, 5 cc 30% hypertonic dextrose and 4 cc 0.9 % isotonic were used.
Primary Outcome Measure Information:
Title
Pain via Visual Analogue Scale
Description
Change from baseline at 6 week and at 12 week Pain of the participants will be assessed by most widely used and accepted "visual analogue scale". It consists of a 10 centimeter line marked at one end with "no pain" and at other end with "worst pain ever". Participant is asked to indicate where on the line he or she rates the pain on the day of presentation, baseline, 6 and 12 weeks of follow-ups. Numerical score is given to it simply by measuring length between "no pain" to patients mark.
Time Frame
Baseline, 6 week, 12 week
Title
Quick - Disabilities of the Arm, Shoulder and Hand (QuickDASH)
Description
Change from baseline at 6 week and at 12 week The elbow disability scale was assessed using the Quick DASH (disability of arm, shoulder & hand) questionnaire containing 11 questions with five choices for each question. The final score can range between 0 (best condition) and 100 (worst condition). Participant is asked to answer the Quick DASH at baseline, 6 and 12 weeks of follow-ups
Time Frame
Baseline, 6 week, 12 week
Secondary Outcome Measure Information:
Title
Grip strength via dynamometer
Description
Change from baseline at 6 week and at 12 week Pain-free grip strength is a commonly used objective measure of lateral epicondilitis-related disability with high reliability and validity. In the study, we used a hand dynamometer (Baseline® Hydraulic Hand Dynamometer 200 LB Standard). Patients were asked to sit, adduct the shoulder, flex the elbow to 90 degrees and put their forearm in a neutral position, then squeeze the dynamometer for three to five seconds. This test was conducted three times with 60-second intervals for each patient, and the mean patient grip strength was recorded at baseline, 6 and 12 weeks of follow-ups.
Time Frame
Baseline, 6 week, 12 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged 20-60 years, had a clinical diagnosis of lateral epicondylitis, defined as pain over the lateral humeral epicondyle of at least 6 months' duration, provoked by palpation and resisted wrist/middle finger extension or gripping, participants needed to score at least 30/100 on Visual analogue scale (VAS), be able to understand enough Turkish to complete the outcome questionnaire. Exclusion Criteria: Any treatment for their elbow pain by a health care practitioner within the preceding 6 months, Concomitant neck or other arm pain causing disability or requiring treatment within the last 6 months, Clinical evidence of other primary sources of lateral elbow pain, Upper limb fractures within the preceding 10 years, Prior elbow surgery Elbow steroid injection in the past 3 months Systemic inflammatory disorder or malignancy, Pregnancy or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zuhal Altay, MD
Organizational Affiliation
Inonu University Faculy of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Hakan Apaydın
City
Ankara
ZIP/Postal Code
06560
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected IPD, all IPD that underlie results in a publication
IPD Sharing Time Frame
starting 12 months after publication
IPD Sharing Access Criteria
Access criteria IPD and additional supporting information will share, analysis of primer and sekonder outcomes and clinical data will share after publication,
Citations:
PubMed Identifier
32931308
Citation
Apaydin H, Bazancir Z, Altay Z. Injection Therapy in Patients with Lateral Epicondylalgia: Hyaluronic Acid or Dextrose Prolotherapy? A Single-Blind, Randomized Clinical Trial. J Altern Complement Med. 2020 Dec;26(12):1169-1175. doi: 10.1089/acm.2020.0188. Epub 2020 Sep 15.
Results Reference
derived

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Injection Therapy in Patients With Lateral Epicondylitis

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