Assessment and Comparison of Efficacy of Intra-Articular PRP and Corticosteroid in First CMC Joint OA Treatment

NCT06657300 | Completed Phase 4

• 1 other identifier: AntalyaTRHdabak01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: We aim to determine and compare the efficiency of single dose intra-articular (IA) platelet rich plasma (PRP) and corticosteroid (CS) injections for the treatment of first carpometacarpal joint osteoarthritis (1. CMC OA) on the basis of pain, hand function and pinch strength. Material and Method: Sixty patients meeting the criteria were included in the study. Patients were randomized into Group 1 (PRP group) or Group 2 (CS group). Patients were evaluated by Visual Analogue Scale (VAS), Duruoz Hand Index (DHI) and pinch meter for pain and function.

Conditions

Thumb Osteoarthritis; Hand Osteoarthritis; Platelet Rich Plasma; Corticosteroid; Intra-articular Injection; Ultrasonography

Keywords

thumb base osteoarthritis; hand osteoarthritis; platelet-rich plasma; corticosteroid; intra-articular injection; ultrasonography

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale

  The patient's symptoms were filled in, with the VAS score increasing from 0 to 10. The end of a 10 cm line with 0 cm indicating no complaints (best) and the end with 10 cm indicating very severe complaints (worst).

  Baseline , 1st month, 3rd month, 6th month

Secondary Outcomes (2)

• Duruoz Hand Index (DHI)

  Baseline , 1st month, 3rd month, 6th month

• Pinch strength (thumb grip strength)

  Baseline , 1st month, 3rd month, 6th month

Study Arms (2)

Group 1 (PRP group)

EXPERIMENTAL

A single dose of 1 ml PRP (Vacusera) was injected into the 1st CMC joint of the first group.

Drug: PRP

Group 2 (CS group)

EXPERIMENTAL

A single dose of 20 mg of methyl-prednisolone (Depo-Medrol) (complemented to 1 ml by adding 0.5 ml of saline) was injected to the 1st CMC joint of the second group

Drug: Corticosteroid

Interventions

PRP DRUG

A single dose of 1 ml PRP (Vacusera) was injected into the 1st CMC joint of the first group. Injection was performed under USG (Clarius; L7 HD Linear Ultrasound Scanner) guidance by the same physician after skin sterilization.

Also known as: Platelet-rich plasma

Group 1 (PRP group)

Corticosteroid DRUG

A single dose of 20 mg(1ml) of methyl-prednisolone (Depo-Medrol) (complemented to 1 ml by adding 0.5 ml of saline) was injected to the 1st CMC joint of the second group. Injection was performed under USG (Clarius; L7 HD Linear Ultrasound Scanner) guidance by the same physician after skin sterilization.

Also known as: depo-medrol

Group 2 (CS group)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pain in the first carpometacarpal joint for at least 3 months
• Patient diagnosed with rhizarthrosis which is classified as stage I-II-III according to Eaton-Littler classification on direct graphy,
• Patient aged 40-80 years who understood and accepted the written consent

You may not qualify if:

• Patient who has no intraarticular injection in the last 3 months.
• Oral and/or parenteral corticosteroid usage.
• Diacerein, chondroitin sulfate, glucosamine sulfate usage.
• Regular nonsteroidal anti-inflammatory drug usage.
• Oral anticoagulants and acetylsalicylic acid usage.
• History of rheumatological, inflammatory, autoimmune or hematological diseases.
• History of neurological diseases such as cervical radiculopathy, parkinson's disease, stroke or polyneuropathy.
• History of 1th CMC joint trauma or surgery
• Shoulder, elbow, wrist tendinopathy or soft tissue disorder in the same extremity and De Quervain's tenosynovitis, Duputyren's contracture or trigger finger.
• Liver or kidney dysfunction
• Local or systemic infections
• Pregnant or lactating patient
• History of malignancy

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead

Study Sites (1)

Antalya Training and Research Hospital

Antalya, Muratpasa, 55400, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Adrenal Cortex Hormones; Methylprednisolone Acetate

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Nimet Ezgi Dabak, M.D.

  Antalya Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 10 ml of blood required for PRP preparation was taken from all patients to make the patients blind to which treatment they received. The injectors were taped closed. Outcomes were measured at 1, 3 and 6 months after injection by the physician who performed the initial assessment and was blinded to the type of injection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 24, 2024
• Study Start: February 1, 2022
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)