Thumb OsteoarthritisPhase 4NCT06657300
Assessment and Comparison of Efficacy of Intra-Articular PRP and Corticosteroid in First CMC Joint OA Treatment
A Phase 4 study testing PRP and Corticosteroid in people with Thumb Osteoarthritis and Hand Osteoarthritis, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Thumb Osteoarthritis, Hand Osteoarthritis, Platelet Rich Plasma
- What is being tested?
- PRP and Corticosteroid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 30 Jul 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital
Antalya, Muratpasa, 55400
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Thumb Osteoarthritis, Hand Osteoarthritis, Platelet Rich Plasma, Corticosteroid, Intra-articular Injection, Ultrasonography
- Being tested
- PRP, Corticosteroid
- Keywords
- thumb base osteoarthritis, hand osteoarthritis, platelet-rich plasma, corticosteroid, intra-articular injection, ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPDrug
Also called Platelet-rich plasma
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.
CorticosteroidDrug
Also called depo-medrol
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (PRP group) | Experimental | A single dose of 1 ml PRP (Vacusera) was injected into the 1st CMC joint of the first group. Receives: 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 Receives: Drug: Corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline , 1st month, 3rd month, 6th month
Secondary outcomes (2)
Duruoz Hand Index (DHI)
DHI score, which quickly evaluates hand problems, consists of 18 questions.
Measured: Baseline , 1st month, 3rd month, 6th month
Pinch strength (thumb grip strength)
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.
Measured: Baseline , 1st month, 3rd month, 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start1 Feb 2022
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thumb OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nimet Ezgi Dabak, M.D., Principal investigator, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657300
- Sponsor's protocol ID
- AntalyaTRHdabak01
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06657300
- Acronym / sponsor ID
- AntalyaTRHdabak01
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (PRP group) | Experimental | Drug: PRPA single dose of 1 ml PRP (Vacusera) was injected into the 1st CMC joint of the first group. |
| Group 2 (CS group) | Experimental | Drug: CorticosteroidA 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 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRPAlso: Platelet-rich plasmaA 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. | Drug | Group 1 (PRP group) |
| CorticosteroidAlso: depo-medrolA 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. | Drug | Group 2 (CS group) |
Primary outcome
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).
2 secondary outcomes
Duruoz Hand Index (DHI)
Time frame: Baseline , 1st month, 3rd month, 6th month
Pinch strength (thumb grip strength)
Time frame: Baseline , 1st month, 3rd month, 6th month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Thumb Osteoarthritis
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Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb
Thumb Osteoarthritis
Active, not recruitingPhase 4
Intraarticular Steroids, Saline and Occupational Therapy in People With CMC1 Osteoarthritis
Osteoarthritis Thumb
Recruiting
Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
Not yet recruitingObservational study
Thumb Muscle Activation During Different Activities of Daily Living in Thumb Base Osteoarthritis and Healthy Controls
Trapeziometacarpal Osteoarthritis
RecruitingPhase 2
Thumb Base Osteoarthritis: Ultrasound-guided Platelet-rich Plasma Versus Placebo Injection
Thumb Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nimet Ezgi Dabak, M.D. principal investigator
Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PRP and Corticosteroid in people with Thumb Osteoarthritis and Hand Osteoarthritis, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: Baseline , 1st month, 3rd month, 6th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.