Back to resultsComparing Relative Motion Splint and Metacarpophalangeal Joint Blocking Splint for Trigger Finger
Primary Purpose
Trigger Finger, Stenosing Tenosynovitis
Status
Recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Relative Motion Splint
Metacarpophalangeal Joint Blocking Splint
Sponsored by
About this trial
This is an interventional treatment trial for Trigger Finger focused on measuring relative motion splint, metacarpophalangeal joint blocking splint
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Sites / Locations
- Hospital Sultan Haji Ahmad ShahRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Relative Motion Splint
Metacarpophalangeal Joint Blocking Splint
Arm Description
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.
In the metacarpophalangeal joint blocking splint, the metacarpophalangeal joint of the affected finger(s) positioned in 0°.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Visual Analog Scale (VAS) for pain
The left end of the VAS labelled as "no pain" and the right end labelled as "extreme pain".
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.
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.
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.
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".
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".
Full Information
NCT ID
NCT05763017
First Posted
February 28, 2023
Last Updated
February 28, 2023
Sponsor
National University of Malaysia
1. Study Identification
Unique Protocol Identification Number
NCT05763017
Brief Title
Comparing Relative Motion Splint and Metacarpophalangeal Joint Blocking Splint for Trigger Finger
Official Title
A Randomized Comparative Trial of Relative Motion Splint Versus Metacarpophalangeal Joint Blocking Splint in the Management of Trigger Finger
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University of Malaysia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Finger, Stenosing Tenosynovitis
Keywords
relative motion splint, metacarpophalangeal joint blocking splint
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Relative Motion Splint
Arm Type
Experimental
Arm Description
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.
Arm Title
Metacarpophalangeal Joint Blocking Splint
Arm Type
Active Comparator
Arm Description
In the metacarpophalangeal joint blocking splint, the metacarpophalangeal joint of the affected finger(s) positioned in 0°.
Intervention Type
Other
Intervention Name(s)
Relative Motion Splint
Intervention Description
Six weeks relative motion splint wear.
Intervention Type
Other
Intervention Name(s)
Metacarpophalangeal Joint Blocking Splint
Intervention Description
Six weeks metacarpophalangeal joint blocking splint wear.
Primary Outcome Measure Information:
Title
Stages of Stenosing Tenosynovitis (SST)
Description
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
Time Frame
Baseline, 6 weeks after splint wear
Secondary Outcome Measure Information:
Title
Visual Analog Scale (VAS) for pain
Description
The left end of the VAS labelled as "no pain" and the right end labelled as "extreme pain".
Time Frame
Baseline, 6 weeks after splint wear
Title
Number of triggering events in ten active fists
Description
The number of triggering events (0 - 10) can be obtained by asking the patient to make 10 active full fists.
Time Frame
Baseline, 6 weeks after splint wear
Title
Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure
Description
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.
Time Frame
Baseline, 6 weeks after splint wear
Title
Canadian Occupational Performance Measure (COPM)
Description
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.
Time Frame
Baseline, 6 weeks after splint wear
Title
Visual Analog Scale (VAS) for splint comfort
Description
The left end of the VAS labelled as "not at all comfortable' and the right end labelled as "extremely comfortable".
Time Frame
Baseline, 3 and 6 weeks after splint wear
Title
Visual Analog Scale (VAS) for splint satisfaction
Description
The left end of the VAS labelled as "not at all satisfied" and the right end labelled as "extremely satisfied".
Time Frame
Baseline, 3 and 6 weeks after splint wear
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Xian Leong, BSc (OT)
Phone
+609-295 5333
Email
lixianmetta@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siaw Chui Chai, PhD (OT)
Organizational Affiliation
Occupational Therapy Programme, Center for Rehabilitation & Special Needs Studies (iCaRehab)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Sultan Haji Ahmad Shah
City
Temerluh
State/Province
Pahang
ZIP/Postal Code
28000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Xian Leong, BSc (OT)
Email
lixianmetta@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparing Relative Motion Splint and Metacarpophalangeal Joint Blocking Splint for Trigger Finger
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