Injection Therapy in Patients With Lateral Epicondylitis

NCT04395417 | Completed

• 1 other identifier: 2018/12
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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 .

Conditions

Lateral Epicondylitis; Tennis Elbow

Keywords

Lateral epicondylitis; Prolotherapy; Hyaluronic acid

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, 6 week, 12 week

• 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

  Baseline, 6 week, 12 week

Secondary Outcomes (1)

• Grip strength via dynamometer

  Baseline, 6 week, 12 week

Study Arms (2)

Hyaluronic acid injection group

EXPERIMENTAL

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

Drug: Hyaluronic Acid

Prolotherapy injection group

ACTIVE COMPARATOR

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

Biological: Prolotherapy

Interventions

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.

Also known as: Prostrolane

Hyaluronic acid injection group

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.

Prolotherapy injection group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hakan Apaydın

Ankara, 06560, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 32931308 DERIVED

MeSH Terms

Conditions

Tennis Elbow

Interventions

Hyaluronic Acid; Prolotherapy

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Complementary Therapies; Therapeutics

Study Officials

• Zuhal Altay, MD

  Inonu University Faculy of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients and the researcher who were responsible for the analyzing of the data were blinded to the randomization results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 20, 2020
• Study Start: May 2, 2018
• Primary Completion: September 15, 2018
• Study Completion: September 25, 2018
• Last Updated: May 20, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: starting 12 months after publication
• Access Criteria: Access criteria IPD and additional supporting information will share, analysis of primer and sekonder outcomes and clinical data will share after publication,

Locations

TU (1)