Trigger FingerNCT05942443
Comparative Effectiveness of the Two Splints in Trigger Finger
A study testing Pre-treatment and Post-treatment in people with Trigger Finger, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
RME orthosis is recommended for the treatment of trigger finger. However, its efficacy has not been studied in trigger finger patients. Given the increasing popularity of this orthosis among clinicians, it is important to evaluate their effectiveness to provide evidence for its use in trigger finger. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Trigger Finger
- What is being tested?
- Pre-treatment and Post-treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 1 May 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients diagnosed with Stage 1-3 trigger finger (Froimson Classification)
- A1 pulley triggering
Who cannot join
- trigger thumb
- multiple trigger fingers on one hand
- neurological disorders
- rheumatologic diseases
- pregnancy
- patients who had received a steroid injection in the affected finger within the previous six months
- patients who had previously undergone trigger release surgery
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
Official title: Treatment of Trigger Finger With Metacarpophalangeal Joint Blocking Orthosis Versus Relative Motion Extension Orthosis
RME orthosis is recommended for the treatment of trigger finger. However, its efficacy has not been studied in trigger finger patients. Given the increasing popularity of this orthosis among clinicians, it is important to evaluate their effectiveness to provide evidence for its use in trigger finger. The purpose of this study was to compare the efficacy of a 6-week orthotic intervention in a randomly selected group of patients with trigger finger using MCP-blocking and RME orthoses.
Read the detailed description
Generally, three types of orthoses are used in the treatment of trigger finger. Some authors used MCP blocking orthosis, while others used DIP or PIP blocking orthosis. Comparative studies are quite limited, as only one study comparing two orthotic designs found that the MCP blocking orthosis was more effective than the DIP blocking orthosis.The MCP blocking orthosis, which restricts the MCP joint to 10-15° of flexion, is commonly used in the conservative treatment of trigger finger.An RME orthosis could be an alternative orthotic treatment option for trigger finger because it holds the MCP in an extended position. The RME orthosis is thought to prevent flexion of the affected finger, thereby limiting tendon glide. This reduces the pressure on the A1 pulley, allowing the tendon to glide more smoothly, reducing the likelihood of triggering. Despite limiting motion,the orthosis still allows the patient to perform daily activities with the orthosis. Therefore, positioning the MCP joint in extension could provide additional benefits in trigger finger. The relative motion orthosis is a new orthotic design that positions the affected finger in 10-15 degrees of extension relative to the adjacent fingers.It also has several advantages, including small size, low-profile design, easy and inexpensive fabrication, and better patient compliance. The primary objective of this study was to compare the efficacy of a 6-week orthotic intervention for pain relief in a randomly selected group of patients with TF using the MCP blocking orthosis and the RME orthosis. The secondary objective was to determine the comparative effectiveness of the orthoses on function and satisfaction with the orthosis.
- Conditions
- Trigger Finger
- Being tested
- Pre-treatment, Post-treatment
- Keywords
- Trigger finger, relative motion splint, pain, function, satisfaction, static splint
- Medical subject headings
- Trigger Finger Disorder, Pain, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-treatmentProcedure or surgery
The custom MCP blocking orthosis was made of a 1.6-mm-thick thermoplastic material that extends from the palm over the MCP joint and includes a ring around the proximal phalanx. It is designed to block the MCP joint in flexion of 10°-20° while allowing full range of motion of the proximal and distal interphalangeal joints.
Post-treatmentProcedure or surgery
The RME orthosis was fabricated from 3.2-mm-thick thermoplastic material with the affected finger positioned at an extension of approximately 10°-20° relative to the adjacent fingers.
| Study group | Role | What they receive |
|---|---|---|
| MCP blocking orthosis | Active comparator | Patients received the MCP blocking orthosis Receives: Procedure: Pre-treatment; Procedure: Post-treatment |
| RME orthosis | Experimental | Patients received the RME orthosis for six weeks Receives: Procedure: Pre-treatment; Procedure: Post-treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Finger Pain
Numeric Pain Rating Scale (NPRS)
Measured: baseline, sixth week
Secondary outcomes (2)
Satisfaction with the orthosis
The Quebec Assistive Technology User Satisfaction Evaluation (Quest 2.0)
Measured: sixth week
Hand Function
Disabilities of Arm, Shoulder, and Hand Questionnaire (DASH)
Measured: baseline, sixth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start1 Jun 2021
- Primary completion30 Mar 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Patients were randomly assigned in a 1:1 ratio to either the MCP-blocking orthosis group or the RME orthosis group, using a simple random sampling method.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cigdem Ayhan, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942443
- Sponsor's protocol ID
- E-10840098-772.02-2507
- Status last verified
- Jul 2023
- First submitted
- 13 Jun 2023
- Last updated
- 12 Jul 2023
- 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 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Trigger Finger With Metacarpophalangeal Joint Blocking Orthosis Versus Relative Motion Extension Orthosis
- ClinicalTrials.gov ID
- NCT05942443
- Acronym / sponsor ID
- E-10840098-772.02-2507
- Conditions
- Trigger Finger
- Keywords
- Trigger finger, relative motion splint, pain, function, satisfaction, static splint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 12 Jul 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.
RME orthosis is recommended for the treatment of trigger finger. However, its efficacy has not been studied in trigger finger patients. Given the increasing popularity of this orthosis among clinicians, it is important to evaluate their effectiveness to provide evidence for its use in trigger finger. The purpose of this study was to compare the efficacy of a 6-week orthotic intervention in a randomly selected group of patients with trigger finger using MCP-blocking and RME orthoses.
Detailed description
Generally, three types of orthoses are used in the treatment of trigger finger. Some authors used MCP blocking orthosis, while others used DIP or PIP blocking orthosis. Comparative studies are quite limited, as only one study comparing two orthotic designs found that the MCP blocking orthosis was more effective than the DIP blocking orthosis.The MCP blocking orthosis, which restricts the MCP joint to 10-15° of flexion, is commonly used in the conservative treatment of trigger finger.An RME orthosis could be an alternative orthotic treatment option for trigger finger because it holds the MCP in an extended position. The RME orthosis is thought to prevent flexion of the affected finger, thereby limiting tendon glide. This reduces the pressure on the A1 pulley, allowing the tendon to glide more smoothly, reducing the likelihood of triggering. Despite limiting motion,the orthosis still allows the patient to perform daily activities with the orthosis. Therefore, positioning the MCP joint in extension could provide additional benefits in trigger finger. The relative motion orthosis is a new orthotic design that positions the affected finger in 10-15 degrees of extension relative to the adjacent fingers.It also has several advantages, including small size, low-profile design, easy and inexpensive fabrication, and better patient compliance. The primary objective of this study was to compare the efficacy of a 6-week orthotic intervention for pain relief in a randomly selected group of patients with TF using the MCP blocking orthosis and the RME orthosis. The secondary objective was to determine the comparative effectiveness of the orthoses on function and satisfaction with the orthosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients were randomly assigned in a 1:1 ratio to either the MCP-blocking orthosis group or the RME orthosis group, using a simple random sampling method.
| Arm | Type | Receives |
|---|---|---|
| MCP blocking orthosis | Active comparator | Procedure: Pre-treatment, Procedure: Post-treatmentPatients received the MCP blocking orthosis |
| RME orthosis | Experimental | Procedure: Pre-treatment, Procedure: Post-treatmentPatients received the RME orthosis for six weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients diagnosed with Stage 1-3 trigger finger (Froimson Classification)
- A1 pulley triggering
Key exclusion criteria (7 listed)
- trigger thumb
- multiple trigger fingers on one hand
- neurological disorders
- rheumatologic diseases
- pregnancy
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 |
|---|---|---|
| Pre-treatmentThe custom MCP blocking orthosis was made of a 1.6-mm-thick thermoplastic material that extends from the palm over the MCP joint and includes a ring around the proximal phalanx. It is designed to block the MCP joint in flexion of 10°-20° while allowing full range of motion of the proximal and distal interphalangeal joints. | Procedure or surgery | MCP blocking orthosis, RME orthosis |
| Post-treatmentThe RME orthosis was fabricated from 3.2-mm-thick thermoplastic material with the affected finger positioned at an extension of approximately 10°-20° relative to the adjacent fingers. | Procedure or surgery | MCP blocking orthosis, RME orthosis |
Primary outcome
Finger Pain
Time frame: baseline, sixth week
Numeric Pain Rating Scale (NPRS)
2 secondary outcomes
Satisfaction with the orthosis
Time frame: sixth week
Hand Function
Time frame: baseline, sixth week
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 12 Jul 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-treatment and Post-treatment in people with 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 2 inclusion and 7 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 12 Jul 2023. 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?
Finger Pain (time frame: baseline, sixth week). 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 12 Jul 2023.