Trigger FingerNCT05763017
Comparing Relative Motion Splint and Metacarpophalangeal Joint Blocking Splint for Trigger Finger
A study testing Relative Motion Splint and Metacarpophalangeal Joint Blocking Splint in people with Trigger Finger and Stenosing Tenosynovitis, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
The purpose of this study is to compare the effectiveness of relative motion splint and metacarpophalangeal joint blocking splints in terms of sign and symptoms, hand function, occupational performance, and perception of splint wearability (comfort and satisfaction) after six weeks of TF management. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Trigger Finger, Stenosing Tenosynovitis
- What is being tested?
- Relative Motion Splint and Metacarpophalangeal Joint Blocking Splint
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteMalaysia
- Study dates
- 28 Jun 2022to 24 Apr 2024
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- single or multiple trigger finger
- unilateral or bilateral trigger finger
- neutral metacarpophalangeal joint position can be attained during passive isolated metacarpophalangeal joint extension of the affected finger
Who cannot join
- trigger thumb
- steroid injection of the affected finger within last six months
- A1 pulley release of the affected finger.
- history of fracture, tendon injury, nerve injury, Dupuytren's contracture, and other soft tissue injuries of the affected finger or adjacent fingers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Comparative Trial of Relative Motion Splint Versus Metacarpophalangeal Joint Blocking Splint in the Management of Trigger Finger
The purpose of this study is to compare the effectiveness of relative motion splint and metacarpophalangeal joint blocking splints in terms of sign and symptoms, hand function, occupational performance, and perception of splint wearability (comfort and satisfaction) after six weeks of TF management.
- Conditions
- Trigger Finger, Stenosing Tenosynovitis
- Being tested
- Relative Motion Splint, Metacarpophalangeal Joint Blocking Splint
- Keywords
- relative motion splint, metacarpophalangeal joint blocking splint
- Medical subject headings
- Trigger Finger Disorder, Tendon Entrapment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relative Motion SplintOther
Six weeks relative motion splint wear.
Metacarpophalangeal Joint Blocking SplintOther
Six weeks metacarpophalangeal joint blocking splint wear.
| Study group | Role | What they receive |
|---|---|---|
| Relative Motion Splint | Experimental | In the relative motion splint, the metacarpophalangeal joint of the affected finger(s) positioned in approximately 20°-25° more extension/flexion than metacarpophalangeal joint of the adjacent fingers. Receives: Other: Relative Motion Splint |
| Metacarpophalangeal Joint Blocking Splint | Active comparator | In the metacarpophalangeal joint blocking splint, the metacarpophalangeal joint of the affected finger(s) positioned in 0°. Receives: Other: Metacarpophalangeal Joint Blocking Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stages of Stenosing Tenosynovitis (SST)
SST is a grading system that divides trigger finger into six stages. Stage 1 is normal; Stage 2 is uneven finger movement; Stage 3 is triggering or clicking or catching; Stage 4 is locking of finger in flexion or extension, which can be unlocked by active finger movement; Stage 5 is locking of finger in flexion or extension, which requires application of passive force to unlock; and Stage 6 is locked finger in flexion or extension
Measured: Baseline, 6 weeks after splint wear
Secondary outcomes (6)
Visual Analog Scale (VAS) for pain
The left end of the VAS labelled as "no pain" and the right end labelled as "extreme pain".
Measured: Baseline, 6 weeks after splint wear
Number of triggering events in ten active fists
The number of triggering events (0 - 10) can be obtained by asking the patient to make 10 active full fists.
Measured: Baseline, 6 weeks after splint wear
Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure
DASH is a 30-item, self-report questionnaire that range from 0-100 score, with higher scores represent more severe disability or poorer hand function.
Measured: Baseline, 6 weeks after splint wear
Canadian Occupational Performance Measure (COPM)
COPM is a interview-based assessment tool for measuring occupational performance. The importance, satisfaction, and performance of an activity are rated using a 10-point rating scale.
Measured: Baseline, 6 weeks after splint wear
Visual Analog Scale (VAS) for splint comfort
The left end of the VAS labelled as "not at all comfortable' and the right end labelled as "extremely comfortable".
Measured: Baseline, 3 and 6 weeks after splint wear
Visual Analog Scale (VAS) for splint satisfaction
The left end of the VAS labelled as "not at all satisfied" and the right end labelled as "extremely satisfied".
Measured: Baseline, 3 and 6 weeks after splint wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start28 Jun 2022
- Primary completion24 Apr 2024
- Study completion24 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Siaw Chui Chai, PhD (OT), Principal investigator, Occupational Therapy Programme, Center for Rehabilitation & Special Needs Studies (iCaRehab)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763017
- Sponsor's protocol ID
- JEP-2022-319
- Status last verified
- Sep 2024
- First submitted
- 28 Feb 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leong LX, Chai SC, Howell JW, Rasdi HFM, Rahman NRA. A randomized comparative trial: Relative motion vs metacarpophalangeal joint blocking orthoses for trigger finger management. J Hand Ther. 2026 Apr-Jun;39(2):342-352. doi: 10.1016/j.jht.2025.05.018. Epub 2025 Jul 4.
PubMed 40617791Leong LX, Chai SC, Howell JW, Mohd Rasdi HF, Abdul Rahman NR. Relative motion splints versus metacarpophalangeal joint blocking splints in the management of trigger finger: Study protocol for a randomized comparative trial. PLoS One. 2024 Aug 13;19(8):e0307033. doi: 10.1371/journal.pone.0307033. eCollection 2024.
PubMed 39137205
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparative Trial of Relative Motion Splint Versus Metacarpophalangeal Joint Blocking Splint in the Management of Trigger Finger
- ClinicalTrials.gov ID
- NCT05763017
- Acronym / sponsor ID
- JEP-2022-319
- Conditions
- Trigger Finger, Stenosing Tenosynovitis
- Keywords
- relative motion splint, metacarpophalangeal joint blocking splint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 28 Jun 2022 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 10 Mar 2023 (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 purpose of this study is to compare the effectiveness of relative motion splint and metacarpophalangeal joint blocking splints in terms of sign and symptoms, hand function, occupational performance, and perception of splint wearability (comfort and satisfaction) after six weeks of TF management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relative Motion Splint | Experimental | Other: Relative Motion SplintIn the relative motion splint, the metacarpophalangeal joint of the affected finger(s) positioned in approximately 20°-25° more extension/flexion than metacarpophalangeal joint of the adjacent fingers. |
| Metacarpophalangeal Joint Blocking Splint | Active comparator | Other: Metacarpophalangeal Joint Blocking SplintIn the metacarpophalangeal joint blocking splint, the metacarpophalangeal joint of the affected finger(s) positioned in 0°. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- single or multiple trigger finger
- unilateral or bilateral trigger finger
- neutral metacarpophalangeal joint position can be attained during passive isolated metacarpophalangeal joint extension of the affected finger
Key exclusion criteria (4 listed)
- trigger thumb
- steroid injection of the affected finger within last six months
- A1 pulley release of the affected finger.
- history of fracture, tendon injury, nerve injury, Dupuytren's contracture, and other soft tissue injuries of the affected finger or adjacent 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 |
|---|---|---|
| Relative Motion SplintSix weeks relative motion splint wear. | Other | Relative Motion Splint |
| Metacarpophalangeal Joint Blocking SplintSix weeks metacarpophalangeal joint blocking splint wear. | Other | Metacarpophalangeal Joint Blocking Splint |
Primary outcome
Stages of Stenosing Tenosynovitis (SST)
Time frame: Baseline, 6 weeks after splint wear
SST is a grading system that divides trigger finger into six stages. Stage 1 is normal; Stage 2 is uneven finger movement; Stage 3 is triggering or clicking or catching; Stage 4 is locking of finger in flexion or extension, which can be unlocked by active finger movement; Stage 5 is locking of finger in flexion or extension, which requires application of passive force to unlock; and Stage 6 is locked finger in flexion or extension
6 secondary outcomes
Visual Analog Scale (VAS) for pain
Time frame: Baseline, 6 weeks after splint wear
Number of triggering events in ten active fists
Time frame: Baseline, 6 weeks after splint wear
Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure
Time frame: Baseline, 6 weeks after splint wear
Canadian Occupational Performance Measure (COPM)
Time frame: Baseline, 6 weeks after splint wear
Visual Analog Scale (VAS) for splint comfort
Time frame: Baseline, 3 and 6 weeks after splint wear
Visual Analog Scale (VAS) for splint satisfaction
Time frame: Baseline, 3 and 6 weeks after splint wear
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 Sep 2024.
- Derived from this study: PubMed 40617791Leong LX, Chai SC, Howell JW, Rasdi HFM, Rahman NRA. A randomized comparative trial: Relative motion vs metacarpophalangeal joint blocking orthoses for trigger finger management. J Hand Ther. 2026 Apr-Jun;39(2):342-352. doi: 10.1016/j.jht.2025.05.018. Epub 2025 Jul 4.
- Derived from this study: PubMed 39137205Leong LX, Chai SC, Howell JW, Mohd Rasdi HF, Abdul Rahman NR. Relative motion splints versus metacarpophalangeal joint blocking splints in the management of trigger finger: Study protocol for a randomized comparative trial. PLoS One. 2024 Aug 13;19(8):e0307033. doi: 10.1371/journal.pone.0307033. eCollection 2024.
- 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.
Siaw Chui Chai, PhD (OT) principal investigator
Occupational Therapy Programme, Center for Rehabilitation & Special Needs Studies (iCaRehab)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relative Motion Splint and Metacarpophalangeal Joint Blocking Splint in people with Trigger Finger and Stenosing Tenosynovitis, run by National University of Malaysia at 1 site in Malaysia.
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 4 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 Sep 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 Malaysia. 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?
Stages of Stenosing Tenosynovitis (SST) (time frame: Baseline, 6 weeks after splint wear). 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 NCT05763017, which also lists 2 linked publications.
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 Sep 2024.