Clinical trial NCT06236178: Comparing Autologous Blood, Corticosteroid, and Their Combined Injection for Treating Lateral Epicondylitis
Official title: Comparing Autologous Blood, Corticosteroid, and Their Combined Injection for Treating Lateral Epicondylitis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Epicondylitis
Comparing Autologous Blood Corticosteroid and Their Combined Injection for Treating Lateral Epicondylitis
Lead sponsor: Istanbul Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-02-01
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized Clinical Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Patient-rated tennis elbow evaluation questionnaire (PRTEE) scores
timeFrame: Before the injection (baseline values), on Day 15, Day 30, and Day 90
Secondary outcomes:
measure: Hand Grip Strength (HGS) measurements
timeFrame: Before the injection (baseline values), on Day 15, Day 30, and Day 90
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istanbul Training and Research Hospital, Department of Orthopedics and Traumatology,
city: İstanbul
country: Turkey
facility: Istanbul Training and Research Hospital
Study officials:
affiliation: Istanbul Training and Research Hospital
name: Albert ÇAKAR, MD
role: PRINCIPAL_INVESTIGATOR
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