Clinical trial NCT04395417: Injection Therapy in Patients With Lateral Epicondylitis
Official title: Injection Therapy in Patients With Lateral Epicondylitis: Hyaluronic Acid or Prolotherapy?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Epicondylitis
Tennis Elbow
Keywords: Lateral epicondylitis
Prolotherapy
Hyaluronic acid
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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 .

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

Primary outcomes:
measure: Pain via Visual Analogue Scale
timeFrame: Baseline, 6 week, 12 week
measure: Quick - Disabilities of the Arm, Shoulder and Hand (QuickDASH)
timeFrame: Baseline, 6 week, 12 week
Secondary outcomes:
measure: Grip strength via dynamometer
timeFrame: Baseline, 6 week, 12 week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hakan Apaydın
Study officials:
affiliation: Inonu University Faculy of Medicine
name: Zuhal Altay, MD
role: STUDY_DIRECTOR
References:
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.