Injection Therapy in Patients With Lateral Epicondylitis

NCT ID: NCT04395417

Last Updated: 2020-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-02
• Study Completion Date: 2018-09-25

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 .

Conditions

Lateral Epicondylitis; Tennis Elbow

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hyaluronic acid injection group

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

Group Type: EXPERIMENTAL

Hyaluronic Acid

Intervention Type: DRUG

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.

Prolotherapy injection group

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

Group Type: ACTIVE_COMPARATOR

Prolotherapy

Intervention Type: BIOLOGICAL

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.

Interventions

Hyaluronic Acid

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: DRUG

Prolotherapy

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Prostrolane

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Zilan Bazancir Apaydın

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zuhal Altay, MD

Role: STUDY_DIRECTOR

Inonu University Faculy of Medicine

Locations

Hakan Apaydın

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 32931308 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2018/12

Identifier Type: -

Identifier Source: org_study_id