Tendon EntrapmentNCT04167098
Effectiveness of Platelet-rich Plasma for Treatment of Trigger Finger
A study testing PRP injection and Corticosteroid injection in people with Tendon Entrapment, run by Töölö Hospital at 1 site in Finland.
Trial summary
Study purpose is to evaluate the effectiveness of Platelet-rich Plasma (PRP) injection in the treatment of trigger finger. We compare PRP to a corticosteroid (methylprednisolone) injection in a prospective randomized triple-blind placebo-controlled study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tendon Entrapment
- What is being tested?
- PRP injection and Corticosteroid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 1 siteFinland
- Study dates
- 1 Nov 2019to 1 Jul 2022
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 75
- Symptom duration > 3 months
Who cannot join
- Diabetes
- Rheumatoid arthritis or other condition requiring continuous oral corticosteroids
- Previous history of surgery or injection to the affected ray
- Alcohol or drug abuse
- Mental instability
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Töölö Hospital (Helsinki University Hospital)
Helsinki
Samuli Aspinen, M.D., Ph.D., +358406360546, samuli.aspinen@hus.fi
Jussi Kosola, M.D., Ph.D., jussi.kosola@helsinki.fi
About this study
Official title: A Prospective Randomized Placebo-controlled Trial Comparing Platelet-rich Plasma and Corticosteroid Injection for Treatment of Trigger Finger
Study purpose is to evaluate the effectiveness of Platelet-rich Plasma (PRP) injection in the treatment of trigger finger. We compare PRP to a corticosteroid (methylprednisolone) injection in a prospective randomized triple-blind placebo-controlled study.
Patients with clinically confirmed trigger finger are randomized (1:1:1 computer generated sequence with random block size) to three parallel groups and will receive an injection of either PRP, corticosteroid or placebo (0.9% saline) around the affected tendon sheath in a double-blind setting.
Read more
Baseline data is collected and is followed by a phone call at 1 month, and follow-up visits at 3, 6, 12 and 24 months after the intervention. Unveiling of the allocation is at 6 months post-intervention.
The primary outcome measures are:
- Symptom resolution
- Patient-Rated Wrist Evaluation
Secondary outcomes:
- Quick-Disabilities of the Arm, Shoulder and Hand
- Pain Visual Analogue Score
- Global improvement (7-step Likert-scale)
- Grip strength
- Finger range of motion
- Conditions
- Tendon Entrapment
- Being tested
- PRP injection, Corticosteroid injection, Placebo injection
- Keywords
- Platelet-Rich Plasma, Trigger Finger
- Medical subject headings
- Tendon Entrapment, Trigger Finger Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP injectionOther
0.5 ml Platelet-rich Plasma around A1 tendon sheath
Corticosteroid injectionOther
0.5 ml methylprednisolone around A1 tendon sheath
Placebo injectionOther
0.5 ml 0.9% saline around A1 tendon sheath
| Study group | Role | What they receive |
|---|---|---|
| Platelet-Rich Plasma | Experimental | Not described Receives: Other: PRP injection |
| Corticosteroid | Active comparator | Not described Receives: Other: Corticosteroid injection |
| 0.9% saline | Placebo comparator | Not described Receives: Other: Placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom resolution
4-step Likert (0 = no response; 1 = partial response, but not satisfactory, warranting further treatment; 2 = partial response, satisfactory, not warranting further treatment; 3 = complete resolution of symptoms and signs)
Measured: 24 months
Patient-Rated Wrist Evaluation
The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists two subscales: Pain and Function (0=best possible outcome, 10=worst possible outcome)
Measured: 24 months
Secondary outcomes (5)
Quick-Disabilities of the Arm, Shoulder and Hand
he QuickDASH is self-reported questionnaire and shortened version of DASH outcome measure to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb in 11 dimensions in 1-5 scale (1=best possible outcome, 5=worst possible outcome)
Measured: 24 months
Pain (Visual Analogue Scale)
The VAS is derived by health care professional question of pain in scale 0 to 10 (0=no pain, 10=worst possible pain).
Measured: 24 months
Global improvement
Global rating to treatment effect will be evaluated by question: "How would you rate the function of your hand compared to the situation before the treatment?". The options are in 5-step Likert scale from (-2) Much worse to (+2) Much better
Measured: 24 months
Grip strength
Grip strength is measured with a dynamometer in kg as the mean of three measurements. It will be numbered in kg and percentage of the unaffected side.
Measured: 24 months
Finger range of motion (ROM)
The ROM of the finger is measured on both hands with a handheld goniometer in degrees.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start1 Nov 2019
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tendon EntrapmentStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Töölö Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuli Aspinen, Töölö Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167098
- Sponsor's protocol ID
- 2845/2019
- Status last verified
- Dec 2020
- First submitted
- 10 Nov 2019
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aspinen S, Nordback PH, Anttila T, Stjernberg-Salmela S, Ryhanen J, Kosola J. Platelet-rich plasma versus corticosteroid injection for treatment of trigger finger: study protocol for a prospective randomized triple-blind placebo-controlled trial. Trials. 2020 Nov 27;21(1):984. doi: 10.1186/s13063-020-04907-w.
PubMed 33246497
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Placebo-controlled Trial Comparing Platelet-rich Plasma and Corticosteroid Injection for Treatment of Trigger Finger
- ClinicalTrials.gov ID
- NCT04167098
- Acronym / sponsor ID
- 2845/2019
- Conditions
- Tendon Entrapment
- Keywords
- Platelet-Rich Plasma, Trigger Finger
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Töölö HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 18 Nov 2019 (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.
Study purpose is to evaluate the effectiveness of Platelet-rich Plasma (PRP) injection in the treatment of trigger finger. We compare PRP to a corticosteroid (methylprednisolone) injection in a prospective randomized triple-blind placebo-controlled study.
Patients with clinically confirmed trigger finger are randomized (1:1:1 computer generated sequence with random block size) to three parallel groups and will receive an injection of either PRP, corticosteroid or placebo (0.9% saline) around the affected tendon sheath in a double-blind setting.
Baseline data is collected and is followed by a phone call at 1 month, and follow-up visits at 3, 6, 12 and 24 months after the intervention. Unveiling of the allocation is at 6 months post-intervention.
The primary outcome measures are:
- Symptom resolution
- Patient-Rated Wrist Evaluation
Secondary outcomes:
- Quick-Disabilities of the Arm, Shoulder and Hand
- Pain Visual Analogue Score
- Global improvement (7-step Likert-scale)
- Grip strength
- Finger range of motion
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Platelet-Rich Plasma | Experimental | Other: PRP injection |
| Corticosteroid | Active comparator | Other: Corticosteroid injection |
| 0.9% saline | Placebo comparator | Other: Placebo injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 - 75
- Symptom duration > 3 months
Key exclusion criteria (5 listed)
- Diabetes
- Rheumatoid arthritis or other condition requiring continuous oral corticosteroids
- Previous history of surgery or injection to the affected ray
- Alcohol or drug abuse
- Mental instability
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 |
|---|---|---|
| PRP injection0.5 ml Platelet-rich Plasma around A1 tendon sheath | Other | Platelet-Rich Plasma |
| Corticosteroid injection0.5 ml methylprednisolone around A1 tendon sheath | Other | Corticosteroid |
| Placebo injection0.5 ml 0.9% saline around A1 tendon sheath | Other | 0.9% saline |
Primary outcome
Symptom resolution
Time frame: 24 months
4-step Likert (0 = no response; 1 = partial response, but not satisfactory, warranting further treatment; 2 = partial response, satisfactory, not warranting further treatment; 3 = complete resolution of symptoms and signs)
Patient-Rated Wrist Evaluation
Time frame: 24 months
The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists two subscales: Pain and Function (0=best possible outcome, 10=worst possible outcome)
5 secondary outcomes
Quick-Disabilities of the Arm, Shoulder and Hand
Time frame: 24 months
Pain (Visual Analogue Scale)
Time frame: 24 months
Global improvement
Time frame: 24 months
Grip strength
Time frame: 24 months
Finger range of motion (ROM)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Derived from this study: PubMed 33246497Aspinen S, Nordback PH, Anttila T, Stjernberg-Salmela S, Ryhanen J, Kosola J. Platelet-rich plasma versus corticosteroid injection for treatment of trigger finger: study protocol for a prospective randomized triple-blind placebo-controlled trial. Trials. 2020 Nov 27;21(1):984. doi: 10.1186/s13063-020-04907-w.
- Individual participant dataSharing planned: No
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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.
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 injection and Corticosteroid injection in people with Tendon Entrapment, run by Töölö Hospital at 1 site in Finland.
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 17 Dec 2020. 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 Finland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samuli Aspinen, M.D., Ph.D (+358406360546, samuli.aspinen@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom resolution (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04167098, which also lists 1 linked publication.
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 17 Dec 2020.