Trigger Finger DisorderPhase 3NCT06532318
Comparative Study Between Platelet Rich Plasma and Steroid Injection in Trigger Finger Treatment
A Phase 3 study testing Platelet rich plasma and Pfizer Depo-medrol in people with Trigger Finger Disorder, run by Obafemi Awolowo University Teaching Hospital.
Trial summary
The goal of this clinical trial is to learn if platelet rich plasma works to treat early stage trigger finger in adults. It will also learn about the safety platelet rich plasma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigger Finger Disorder
- What is being tested?
- Platelet rich plasma and Pfizer Depo-medrol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 24 Jul 2024to 23 Jun 2025
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are 18year and above with mild or moderate trigger finger, who are willing to have intra-lesional administration of blood product.
- No previous treatment for the affected finger.
Who cannot join
- Previous steroid injection
- Previous Surgery to that finger
- Thrombocytopenic patients
- Hand and finger contracture
- Rheumatoid arthritis of the finger
About this study
Official title: Comparative Study Between Intralesional Injection of Platelet Rich Plasma and Intralesional Steroid for the Treatment of Trigger Finger in Black Patients
The goal of this clinical trial is to learn if platelet rich plasma works to treat early stage trigger finger in adults. It will also learn about the safety platelet rich plasma. The main questions it aims to answer are:
Does platelet rich plasma lower the pain associated with trigger finger of participants? Does it improve the hand grip strength and Q DASH score of participants? Researchers will compare platelet rich plasma to Depo-Medrol steroid (a known standard of care for early stage trigger finger) to see if platelet rich plasma works to treat early trigger finger.
Read more
Participants will:
Take platelet rich plasma or a depo-medrol steroid intralesional injection at recruitment into the intervention Visit the clinic once every 4 weeks for checkups and parameter measurements. Investigator will will keep a record of participants progress in symptom remission
- Conditions
- Trigger Finger Disorder
- Being tested
- Platelet rich plasma, Pfizer Depo-medrol
- Medical subject headings
- Trigger Finger Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich plasmaBiological
Freshly prepared autologus platelet rich plasma
Pfizer Depo-medrolDrug
Methylprednisolone acetate 20mg/ml injection
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients here will have one milliliter of freshly prepared autologus platelet rich plasma injection for the treatment of their trigger finger. Receives: Biological: Platelet rich plasma |
| Group B | Active comparator | Patients here will have one milliliter(20mg) injection of pfizer Depo-medrol(methylprednisolone acetate) injection for the treatment of their trigger finger. Receives: Drug: Pfizer Depo-medrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptom resolution post injection
reduction of pain using VAS and absence snapping of finger
Measured: 3 months
Secondary outcomes (2)
Hand grip strength
measured grip using hand dynamomter
Measured: 3 month
Q- DASH score
11-item self reported disability questionnaire that consider upper extremity as one functional unit
Measured: 3month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start24 Jul 2024 (estimated)
- Primary completion23 Dec 2024 (estimated)
- Study completion23 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger Finger DisorderStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Obafemi Awolowo University Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olorunfemi Olayiwola, Obafemi Awolowo University Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532318
- Sponsor's protocol ID
- ERC/2024/06/12
- Status last verified
- Jul 2024
- First submitted
- 29 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Intralesional Injection of Platelet Rich Plasma and Intralesional Steroid for the Treatment of Trigger Finger in Black Patients
- ClinicalTrials.gov ID
- NCT06532318
- Acronym / sponsor ID
- ERC/2024/06/12
- Conditions
- Trigger Finger Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Obafemi Awolowo University Teaching HospitalUniversity, hospital or other
- Study start
- 24 Jul 2024 (estimated)
- Primary completion
- 23 Dec 2024 (estimated)
- Study completion
- 23 Jun 2025 (estimated)
- First posted
- 1 Aug 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.
The goal of this clinical trial is to learn if platelet rich plasma works to treat early stage trigger finger in adults. It will also learn about the safety platelet rich plasma. The main questions it aims to answer are:
Does platelet rich plasma lower the pain associated with trigger finger of participants? Does it improve the hand grip strength and Q DASH score of participants? Researchers will compare platelet rich plasma to Depo-Medrol steroid (a known standard of care for early stage trigger finger) to see if platelet rich plasma works to treat early trigger finger.
Participants will:
Take platelet rich plasma or a depo-medrol steroid intralesional injection at recruitment into the intervention Visit the clinic once every 4 weeks for checkups and parameter measurements. Investigator will will keep a record of participants progress in symptom remission
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: Platelet rich plasmaPatients here will have one milliliter of freshly prepared autologus platelet rich plasma injection for the treatment of their trigger finger. |
| Group B | Active comparator | Drug: Pfizer Depo-medrolPatients here will have one milliliter(20mg) injection of pfizer Depo-medrol(methylprednisolone acetate) injection for the treatment of their trigger finger. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are 18year and above with mild or moderate trigger finger, who are willing to have intra-lesional administration of blood product.
- No previous treatment for the affected finger.
Key exclusion criteria (5 listed)
- Previous steroid injection
- Previous Surgery to that finger
- Thrombocytopenic patients
- Hand and finger contracture
- Rheumatoid arthritis of the finger
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 |
|---|---|---|
| Platelet rich plasmaFreshly prepared autologus platelet rich plasma | Biological | Group A |
| Pfizer Depo-medrolMethylprednisolone acetate 20mg/ml injection | Drug | Group B |
Primary outcome
symptom resolution post injection
Time frame: 3 months
reduction of pain using VAS and absence snapping of finger
2 secondary outcomes
Hand grip strength
Time frame: 3 month
Q- DASH score
Time frame: 3month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Platelet rich plasma and Pfizer Depo-medrol in people with Trigger Finger Disorder, run by Obafemi Awolowo University Teaching Hospital.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
symptom resolution post injection (time frame: 3 months). 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 1 Aug 2024.