Comparing Autologous Blood, Corticosteroid, and Their Combined Injection for Treating Lateral Epicondylitis: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 119
- Locations
- 2
- Primary Endpoint
- Patient-rated tennis elbow evaluation questionnaire (PRTEE) scores
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Local Anesthetic (Drug)
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.
Intervention: Local Anesthetic (Drug)
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.
Intervention: Autologous Blood (Drug)
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.
Intervention: Corticosteroid (Drug)
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.
Intervention: Corticosteroid (Drug)
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.
Intervention: Autologous Blood (Drug)
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.
Intervention: Local Anesthetic (Drug)
Outcomes
Primary Outcomes
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
- Hand Grip Strength (HGS) measurements(Before the injection (baseline values), on Day 15, Day 30, and Day 90)
Investigators
Albert ÇAKAR
MD, Orthopedic and Traumatology Surgeon
Istanbul Training and Research Hospital