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

NCT06236178 | Completed

• 1 other identifier: TR13734
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Patient-rated tennis elbow evaluation questionnaire (PRTEE) scores

  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 Outcomes (1)

• Hand Grip Strength (HGS) measurements

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

Study Arms (3)

Autologous Blood Injection Mixed With Local Anesthetic

ACTIVE COMPARATOR

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; Drug: Local Anesthetic

Corticosteroid Injection Mixed With Local Anesthetic

ACTIVE COMPARATOR

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: Corticosteroid; Drug: Local Anesthetic

Combined Injection Mixed With Local Anesthetic

ACTIVE COMPARATOR

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: Corticosteroid; Drug: Autologous Blood; Drug: Local Anesthetic

Interventions

Corticosteroid DRUG

1 ml of 40 mg methylprednisolone acetate

Combined Injection Mixed With Local Anesthetic; Corticosteroid Injection Mixed With Local Anesthetic

Autologous Blood DRUG

1 ml of autologous venous blood

Autologous Blood Injection Mixed With Local Anesthetic; Combined Injection Mixed With Local Anesthetic

Local Anesthetic DRUG

1 ml of 2% prilocaine HCl

Autologous Blood Injection Mixed With Local Anesthetic; Combined Injection Mixed With Local Anesthetic; Corticosteroid Injection Mixed With Local Anesthetic

Eligibility Criteria

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

You may qualify if:

• Patients with LE whose complaints persisted for more than 3 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Training and Research Hospital: lead

Study Sites (2)

Istanbul Training and Research Hospital, Department of Orthopedics and Traumatology,

Istanbul, 34098, Turkey (Türkiye)

Location

Istanbul Training and Research Hospital

Istanbul, 34098, Turkey (Türkiye)

Location

Related Publications (25)

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  PMID: 38963583 DERIVED

MeSH Terms

Conditions

Tennis Elbow

Interventions

Adrenal Cortex Hormones; Blood Transfusion, Autologous; Anesthetics, Local

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Blood Transfusion; Biological Therapy; Therapeutics; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Albert ÇAKAR, MD

  Istanbul Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Orthopedic and Traumatology Surgeon

Model Details: A Randomized Clinical Trial

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: February 1, 2024
• Study Start: January 1, 2023
• Primary Completion: October 30, 2023
• Study Completion: November 30, 2023
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP

Locations

TU (2)