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

January 29, 2024 updated by: Albert ÇAKAR, Istanbul Training and Research Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İstanbul, Turkey, 34098
        • Istanbul Training and Research Hospital, Department of Orthopedics and Traumatology,
      • İstanbul, Turkey, 34098
        • Istanbul Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients with a history of recent trauma,
  2. Congenital or neuromuscular disease or abnormality of the upper limb
  3. Previous upper limb surgery,
  4. History of rheumatic disease,
  5. History of cervical disc pathology or carpal tunnel syndrome
  6. Systemic corticosteroid treatment
  7. Any previous local injection treatment
  8. Patients with a history of previous allergic reaction towards local anesthetics and corticosteroids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Autologous Blood Injection Mixed With Local Anesthetic
Autologous Blood Injection group were administered 1ml of autologous venous blood mixed with 2ml of 2% prilocaine HCl(Priloc %2,Vem,Turkey) subcutaneously.
Drug: Autologous Blood
1 ml of autologous venous blood
Drug: Local Anesthetic
1 ml of 2% prilocaine HCl
Active Comparator: Corticosteroid Injection Mixed With Local Anesthetic
Corticosteroid Injection category were given 1ml of 40 mg methylprednisolone acetate(Prednol-L 40mg,Mustafa Nevzat,Turkey) mixed with 2ml of 2% prilocaine HCl(Priloc %2,Vem,Turkey) subcutaneously.
Drug: Local Anesthetic
1 ml of 2% prilocaine HCl
Drug: Corticosteroid
1 ml of 40 mg methylprednisolone acetate
Active Comparator: Combined Injection Mixed With Local Anesthetic
Combined Injection group received a mixture containing 1ml each of autologous venous blood and 40mg methylprednisolone acetate(Prednol-L 40mg,Mustafa Nevzat,Turkey), along with 1ml of 2% prilocaine HCl(Priloc %2,Vem,Turkey) subcutaneously.
Drug: Autologous Blood
1 ml of autologous venous blood
Drug: Local Anesthetic
1 ml of 2% prilocaine HCl
Drug: Corticosteroid
1 ml of 40 mg methylprednisolone acetate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Before the injection (baseline values), on Day 15, Day 30, and Day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before the injection (baseline values), on Day 15, Day 30, and Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Training and Research Hospital

Investigators

  • Principal Investigator: Albert ÇAKAR, MD, Istanbul Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

October 30, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

January 9, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

February 1, 2024

Study Record Updates

Last Update Posted (Actual)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TR13734

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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