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NCT Number: NCT06236178

Comparing Autologous Blood, Corticosteroid, and Their Combined Injection for Treating Lateral Epicondylitis

The goal of this clinical trial is to compare autologous blood, corticosteroid, and their combined injection for treating lateral epicondylitis. The main question it aims to answer are:

• Which of these highly used drugs in treatment of lateral epicondylitis is more effective? Participants were randomly allocated into three equal treatment groups (AB versus CS versus their combination) with sealed envelopes prepared by a computer-based random number generator. Patients in the AB Group received 1 ml of autologous venous blood mixed with 2 ml of 2% prilocaine HCl, patients in the CS Group received 1 ml of 40 mg methylprednisolone acetate mixed with 2 ml of 2% prilocaine HCl, and patients in the Combined Group (AB+CS) received 1 ml of autologous venous blood, 1 ml of 40 mg methylprednisolone acetate mixed with 1 ml of 2% prilocaine HCl. Each group received an equal amount of (3 ml) injected material. PRTEE and HGS measurements were assessed before the injection (baseline values), on Day 15, Day 30, and Day 90, in the same manner by the senior author.

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Key information

Conditions

Lateral Epicondylitis Arm Injuries Comparing Autologous Blood Corticosteroid and Their Combined Injection for Treating Lateral Epicondylitis Elbow Injuries Elbow Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Injuries Tennis Elbow Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Training and Research Hospital, Istanbul, Turkey (Türkiye)

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About this study

This study aimed to compare the efficacy of autologous blood (AB) and corticosteroid (CS) injections and their combination in treating lateral epicondylitis (LE), hypothesizing that the combined approach might offer immediate symptom resolution and lower recurrence. Methods: A total of 120 patients diagnosed with lateral epicondylitis were systematically distributed among three distinct therapeutic injection groups. Those in the AB group were administered 1ml of autologous venous blood mixed with 2ml of 2% prilocaine HCl. Participants in the CS category were given 1ml of 40 mg methylprednisolone acetate mixed with 2ml of 2% prilocaine HCl. Meanwhile, patients in the combined group received a mixture containing 1ml each of autologous venous blood and 40mg methylprednisolone acetate, along with 1ml of 2% prilocaine HCl. Prior to receiving their respective injections, a comprehensive assessment of all participants was carried out. Follow-up assessments were subsequently conducted on days 15, 30, and 90, utilizing metrics of patient-rated tennis elbow evaluation (PRTEE) and measurements of hand grip strength (HGS).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

1-Patients with LE whose complaints persisted for more than 3 months

Exclusion criteria

  • Patients with a history of recent trauma,
  • Congenital or neuromuscular disease or abnormality of the upper limb
  • Previous upper limb surgery,
  • History of rheumatic disease,
  • History of cervical disc pathology or carpal tunnel syndrome
  • Systemic corticosteroid treatment
  • Any previous local injection treatment
  • Patients with a history of previous allergic reaction towards local anesthetics and corticosteroids

Treatment and study plan

Corticosteroid

Drug

1 ml of 40 mg methylprednisolone acetate

Autologous Blood

Drug

1 ml of autologous venous blood

Local anesthetic

Drug

1 ml of 2% prilocaine HCl

Primary outcomes

  1. Patient-rated tennis elbow evaluation questionnaire (PRTEE) scores

    Time frame: Before the injection (baseline values), on Day 15, Day 30, and Day 90

    Patient-rated tennis elbow evaluation questionnaire (PRTEE) is consist of 2 steps, pain and function score.

    Pain Score is measured by sum of the 5 pain items (out of 50) (Best Score = 0, Worst Score = 50) Function Score is measured by sum of the of the 10 function items, divided by 2 (out of 50) (Best Score = 0, Worst Score = 50) Total Score is measured by sum of pain and function scores(Best Score = 0, Worst Score = 100)

Secondary outcomes

  1. Hand Grip Strength (HGS) measurements

    Time frame: Before the injection (baseline values), on Day 15, Day 30, and Day 90

    Hand grip strength (HGS) was measured with a digital hand dynamometer before and on Day 15, Day 30, and Day 90 after injection in all patients.

Sponsors and collaborators

Lead sponsor

Istanbul Training and Research Hospital

Other Gov

Registry information

Official study title

Comparing Autologous Blood, Corticosteroid, and Their Combined Injection for Treating Lateral Epicondylitis: A Randomized Clinical Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 1, 2024
Registry last updated
Feb 1, 2024

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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