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NCT Number: NCT04395417

Injection Therapy in Patients With Lateral Epicondylitis

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 .

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Key information

Conditions

Lateral Epicondylitis Arm Injuries Elbow Injuries Elbow Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Injuries Tennis Elbow Wounds and Injuries

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hakan Apaydın

Ankara, 06560, Turkey (Türkiye)

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyaluronic acid

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.

Other names: Prostrolane

Prolotherapy

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.

Primary outcomes

  1. Pain via Visual Analogue Scale

    Time frame: Baseline, 6 week, 12 week

    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.

  2. Quick - Disabilities of the Arm, Shoulder and Hand (QuickDASH)

    Time frame: Baseline, 6 week, 12 week

    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 outcomes

  1. Grip strength via dynamometer

    Time frame: Baseline, 6 week, 12 week

    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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Injection Therapy in Patients With Lateral Epicondylitis: Hyaluronic Acid or Prolotherapy?

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 20, 2020
Registry last updated
May 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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