Trigger FingerNCT05024617
Stage-Specific Recovery Changes in the International Classification of Functioning Components Following Conservative Rehabilitation of Trigger Finger
An observational study of Trigger Finger, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the effectiveness of conservative rehabilitation on the multi-dimensional health components based on WHO ICF model in Stage 1, Stage 2 and Stage 3 trigger finger and to determine the functional recovery patterns of each dimension during a three-month rehabilitation period. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Trigger Finger
- What is being tested?
- conservative treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Mar 2019to 31 Aug 2019
- Phase
- Observational
- 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Diagnosed with Stage 1, Stage 2 and Stage 3 trigger finger based on the Froimson Classification
Who may be able to join
- Diagnosed with Stage 1, Stage 2 and Stage 3 trigger finger based on the Froimson Classification
Who cannot join
- Paediatric trigger finger, trigger thumb, concomitant de'Quervain tenosynovitis, carpal tunnel syndrome, or Dupuytren's contracture, neurological or rheumatological diseases, chronic pain syndromes, pregnancy and patients with treatment history of related finger/fingers.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ankara
About this study
The aim of this study was to determine the effectiveness of conservative rehabilitation on the multi-dimensional health components based on WHO ICF model in Stage 1, Stage 2 and Stage 3 trigger finger and to determine the functional recovery patterns of each dimension during a three-month rehabilitation period. Thirty-four patients were participated in the study.
- Conditions
- Trigger Finger
- Being tested
- conservative treatment
- Keywords
- trigger finger, ICF, rehabilitation, splinting
- 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.
conservative treatmentOther
All patients had rehabilitation for a total of three months, including activity modification, splinting and exercises.
| Study group | Role | What they receive |
|---|---|---|
| trigger finger stage 1-2-3 | Volunteer patients between 35-65 years old diagnosed with Stage 1, Stage 2 and Stage 3 trigger finger based on the Froimson Classification were included in the study. Exclusion criteria include paediatric trigger finger, trigger thumb, concomitant de'Quervain tenosynovitis, carpal tunnel syndrome, or Dupuytren's contracture, neurological or rheumatological diseases, chronic pain syndromes, pregnancy and patients with treatment history of related finger/fingers Receives: Other: conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (VAS)
Measured: one month
Number of triggering (ten active fist test / 30 second active fist test)
Measured: one month
Grip strength (hand dynomometer and pinchmeter)
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start2 Mar 2019
- Primary completion20 May 2019
- Study completion31 Aug 2019
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 Trigger FingerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cigdem Ayhan, Hacettepe University
- Investigators
- Seda Namaldi, MSc, Principal investigator, Hacettepe University, Faculty of Physical Therapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024617
- Sponsor's protocol ID
- 16969557-437
- Status last verified
- Aug 2021
- First submitted
- 24 Aug 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Namaldi S, Kuru CA, Kuru I. Prediction of disability in trigger finger: a cross-sectional and longitudinal study. J Hand Surg Eur Vol. 2023 Feb;48(2):131-136. doi: 10.1177/17531934221131883. Epub 2022 Nov 2.
PubMed 36324191
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stage-Specific Recovery Changes in the International Classification of Functioning Components Following Conservative Rehabilitation of Trigger Finger
- ClinicalTrials.gov ID
- NCT05024617
- Acronym / sponsor ID
- 16969557-437
- Conditions
- Trigger Finger
- Keywords
- trigger finger, ICF, rehabilitation, splinting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 2 Mar 2019 (actual)
- Primary completion
- 20 May 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 27 Aug 2021 (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 aim of this study was to determine the effectiveness of conservative rehabilitation on the multi-dimensional health components based on WHO ICF model in Stage 1, Stage 2 and Stage 3 trigger finger and to determine the functional recovery patterns of each dimension during a three-month rehabilitation period. Thirty-four patients were participated in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| trigger finger stage 1-2-3 | – | Other: conservative treatmentVolunteer patients between 35-65 years old diagnosed with Stage 1, Stage 2 and Stage 3 trigger finger based on the Froimson Classification were included in the study. Exclusion criteria include paediatric trigger finger, trigger thumb, concomitant de'Quervain tenosynovitis, carpal tunnel syndrome, or Dupuytren's contracture, neurological or rheumatological diseases, chronic pain syndromes, pregnancy and patients with treatment history of related finger/fingers |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosed with Stage 1, Stage 2 and Stage 3 trigger finger based on the Froimson Classification
Key inclusion criteria (1 listed)
- Diagnosed with Stage 1, Stage 2 and Stage 3 trigger finger based on the Froimson Classification
Key exclusion criteria (1 listed)
- Paediatric trigger finger, trigger thumb, concomitant de'Quervain tenosynovitis, carpal tunnel syndrome, or Dupuytren's contracture, neurological or rheumatological diseases, chronic pain syndromes, pregnancy and patients with treatment history of related finger/fingers.
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 |
|---|---|---|
| conservative treatmentAll patients had rehabilitation for a total of three months, including activity modification, splinting and exercises. | Other | trigger finger stage 1-2-3 |
Primary outcome
Pain (VAS)
Time frame: one month
Number of triggering (ten active fist test / 30 second active fist test)
Time frame: one month
Grip strength (hand dynomometer and pinchmeter)
Time frame: one 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 27 Aug 2021.
- Derived from this study: PubMed 36324191Namaldi S, Kuru CA, Kuru I. Prediction of disability in trigger finger: a cross-sectional and longitudinal study. J Hand Surg Eur Vol. 2023 Feb;48(2):131-136. doi: 10.1177/17531934221131883. Epub 2022 Nov 2.
- 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.
Seda Namaldi, MSc principal investigator
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trigger Finger, run by Hacettepe University 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 1 inclusion and 1 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 27 Aug 2021. 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.
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?
Pain (VAS) (time frame: one month). The study lists 3 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 NCT05024617, 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 27 Aug 2021.