Thumb OsteoarthritisNCT04218591
A Study on the Effect of Platelet Rich Plasma (PRP) on Osteoarthritis in the Thumb Base
A study testing PRP in people with Thumb Osteoarthritis, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Randomized comparison between Platelet Rich Plasma (PRP) and placebo (Saline) for thumb base.osteoarthritis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thumb Osteoarthritis
- What is being tested?
- PRP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSweden
- Study dates
- 24 Feb 2020to 31 Dec 2023
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Arthritis in the thumb base.
- Radiological Eaton Littler class 1-3.
- Clinical signs of thumb base osteoarthritis: pain at palpation of the CMC-1 joint and pain during provocation/grinding test.
Who cannot join
- Rheumatoid arthritis.
- Ongoing infection in the hand or wrist.
- History of gout or pseudo gout.
- Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
- Intra-articular injection in the affected joint within 6 months.
- Eaton Littler class 4 (STT joint involved).
Trial locations and contacts
1 site in 1 country.
About this study
Randomized comparison between Platelet Rich Plasma (PRP) and placebo (Saline) for thumb base.osteoarthritis.
- Conditions
- Thumb Osteoarthritis
- Being tested
- PRP, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPOther
Platelet rich plasma
PlaceboOther
Saline
| Study group | Role | What they receive |
|---|---|---|
| PRP | Active comparator | Intra-articular injection PRP Receives: Other: PRP |
| Saline | Placebo comparator | Intra-articular injection Saline Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient-rated pain on load
Numerical rating scale 0-10p (10=worst possible pain).
Measured: 3 and 6 months after injection.
Secondary outcomes (8)
Change in Nelson Thumb score
Patient Rated Outcome Measure, 0-100p, lower score= more disability
Measured: 3 and 6 months after injection.
Change in EQ-5D
Weight mean value: 0=dead, 1= healthy
Measured: 3 and 6 months after injection.
Change in Patient-rated Wrist and Hand Evaluation (PRWHE)
Patient Rated Outcome Measure 0-100p, higher score=more disability
Measured: 3 and 6 months after injection.
Change in Disability of the Hand, Arm and Shoulder (DASH) score
Patient Rated Outcome Measure, 0-100p higher score=more disability
Measured: 3 and 6 months after injection.
Change in Hospital Anxiety and Depression Score (HADS),
2 subscores for anxiety (0-21p) and depression (0-21p), higher score = worse
Measured: 3 and 6 months after injection.
Change in Pain Catastrophizing Score (PCS).
0-52p, higher score = more pain catastrophizing
Measured: 3 and 6 months after injection.
Change in thumb range of motion
Radial and palmar abduction of the first metacarpal (degrees)
Measured: 3 and 6 months after injection.
Change in thumb strength
Key pinch and pinch strength (Kg)
Measured: 3 and 6 months after injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start24 Feb 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Wilcke, Karolinska Institutet
- Investigators
- Maria Wilcke, MD PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218591
- Sponsor's protocol ID
- PRP vs placebo
- Status last verified
- Jan 2024
- First submitted
- 19 Dec 2019
- Last updated
- 19 Jan 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 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Effect of Platelet Rich Plasma (PRP) on Osteoarthritis in the Thumb Base
- ClinicalTrials.gov ID
- NCT04218591
- Acronym / sponsor ID
- PRP vs placebo
- Conditions
- Thumb Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 6 Jan 2020 (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.
Randomized comparison between Platelet Rich Plasma (PRP) and placebo (Saline) for thumb base.osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP | Active comparator | Other: PRPIntra-articular injection PRP |
| Saline | Placebo comparator | Other: PlaceboIntra-articular injection Saline |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Arthritis in the thumb base.
- Radiological Eaton Littler class 1-3.
- Clinical signs of thumb base osteoarthritis: pain at palpation of the CMC-1 joint and pain during provocation/grinding test.
Key exclusion criteria (6 listed)
- Rheumatoid arthritis.
- Ongoing infection in the hand or wrist.
- History of gout or pseudo gout.
- Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
- Intra-articular injection in the affected joint within 6 months.
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 |
|---|---|---|
| PRPPlatelet rich plasma | Other | PRP |
| PlaceboSaline | Other | Saline |
Primary outcome
Change in patient-rated pain on load
Time frame: 3 and 6 months after injection.
Numerical rating scale 0-10p (10=worst possible pain).
8 secondary outcomes
Change in Nelson Thumb score
Time frame: 3 and 6 months after injection.
Change in EQ-5D
Time frame: 3 and 6 months after injection.
Change in Patient-rated Wrist and Hand Evaluation (PRWHE)
Time frame: 3 and 6 months after injection.
Change in Disability of the Hand, Arm and Shoulder (DASH) score
Time frame: 3 and 6 months after injection.
Change in Hospital Anxiety and Depression Score (HADS),
Time frame: 3 and 6 months after injection.
Change in Pain Catastrophizing Score (PCS).
Time frame: 3 and 6 months after injection.
Change in thumb range of motion
Time frame: 3 and 6 months after injection.
Change in thumb strength
Time frame: 3 and 6 months after injection.
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 19 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Thumb Osteoarthritis
Recruiting
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.
Maria Wilcke, MD PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP in people with Thumb Osteoarthritis, run by Karolinska Institutet at 1 site in Sweden.
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 6 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 19 Jan 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 Sweden. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change in patient-rated pain on load (time frame: 3 and 6 months after injection.). 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 19 Jan 2024.