- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05942443
Comparative Effectiveness of the Two Splints in Trigger Finger
July 4, 2023 updated by: Cigdem Ayhan, Hacettepe University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey
- Hacettepe University Faculty of Physical Therapy and Rehabilitation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- patients diagnosed with Stage 1-3 trigger finger (Froimson Classification)
- A1 pulley triggering
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: MCP blocking orthosis
Patients received the MCP blocking orthosis
|
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.
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.
|
Experimental: RME orthosis
Patients received the RME orthosis for six weeks
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Finger Pain
Time Frame: baseline, sixth week
|
Numeric Pain Rating Scale (NPRS)
|
baseline, sixth week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction with the orthosis
Time Frame: sixth week
|
The Quebec Assistive Technology User Satisfaction Evaluation (Quest 2.0)
|
sixth week
|
Hand Function
Time Frame: baseline, sixth week
|
Disabilities of Arm, Shoulder, and Hand Questionnaire (DASH)
|
baseline, sixth week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2021
Primary Completion (Actual)
March 30, 2022
Study Completion (Actual)
May 1, 2022
Study Registration Dates
First Submitted
June 13, 2023
First Submitted That Met QC Criteria
July 4, 2023
First Posted (Actual)
July 12, 2023
Study Record Updates
Last Update Posted (Actual)
July 12, 2023
Last Update Submitted That Met QC Criteria
July 4, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-772.02-2507
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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