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Completed

NCT Number: NCT06657300

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

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Antalya Training and Research Hospital

Antalya, Muratpasa, 55400, Turkey (Türkiye)

About this study

Osteoarthritis(OA) which is the most prevalent form of arthritis, is a degenerative process eroding articular cartilage. Joints affected most commonly include hand, knee, hip and spine.The trapeziometacarpal joint of the thumb (CMC) is a common source of pain due to OA. Age adjusted prevalence of rhizarthrosis is reported as 5-17% in men and 7-21% in women. Although the effect of the CMC osteoarthritis (rhizarthrosis) on hand function and strength have been reported, it is likely underdiagnosed in clinical practice. Conservative treatment modalities range from therapy, orthoses, modification of daily activities to intraarticular injection in early stages. For patients who fail conservative measures or advanced stages, surgical treatment options are indicated.

Platelet-rich plasma (PRP) is the processed fraction of autologous peripheral blood with a platelet concentration above the baseline. PRP therapies have been used in the treatment of dejenerative joint disease and also in different fields of medicine for more than two decades. The rationale underlying the PRP therapy in OA is to stimulate the tissue repair and regeneration via growth factors and bioactive molecules involved in basic pathways such as inflammation, angiogenesis and cell migration in alpha granules of platelets. The studies evaluating the theuropatic effect of PRP in osteoarthritis generally include its application in the knee, hip and shoulder joints. There is very few article reporting the application of PRP in rhizarthrosis.

2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip, and Knee suggests "no recommendation in regard to osteoarthritis of the hand". Same guideline suggest that " intraarticular glucocorticoid injection is conditionally, rather than strongly, recommended for hand osteoarthritis. In "2018 update of the EULAR recommendation fort he management of hand osteoarthritis" did not mention the PRP application for hand osteoarthritis.

In our prospective, randomised, double-blind, clinical study we aimed to compare the results of the intraarticular application of corticosteroid and PRP in early stages of the rhizarthrosis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Platelet-rich plasma

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.

Other names: depo-medrol

Primary outcomes

  1. Visual Analog Scale

    Time frame: Baseline , 1st month, 3rd month, 6th month

    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).

Secondary outcomes

  1. Duruoz Hand Index (DHI)

    Time frame: Baseline , 1st month, 3rd month, 6th month

    DHI score, which quickly evaluates hand problems, consists of 18 questions.

  2. Pinch strength (thumb grip strength)

    Time frame: Baseline , 1st month, 3rd month, 6th month

    Pinch strength was determined by pincmeter (Jamar Digital Pinchmeter). The three types of thumb grip strengths; palmar grip strength, lateral grip strength, and end-to-end grip strength were measured. Each type of pinch measurements was performed 3 times by 1 minute intervals and mean of these three measurements was accepted as end result.

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Registry information

Official study title

Assessment and Comparison of Efficacy of Intra-Articular Platelet Rich Plasma and Corticosteroid on Pain, Hand Function and Pinch Strength in First Carpometacarpal Joint Osteoarthritis Treatment: a Randomized, Prospective, Double-blind Clinical Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 24, 2024
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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