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CompletedNCT05763017Updated Sep 19, 2024

Comparing Relative Motion Splint and Metacarpophalangeal Joint Blocking Splint for Trigger Finger

An interventional study of Relative Motion Splint and Metacarpophalangeal Joint Blocking Splint in Trigger Finger and Stenosing Tenosynovitis, sponsored by National University of Malaysia. Completed at 1 site in Malaysia. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by National University of Malaysia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Trigger Finger
  • Stenosing Tenosynovitis

Keywords

  • relative motion splint
  • metacarpophalangeal joint blocking splint
03

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Relative Motion Splint

    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.

    Other: Relative Motion Splint

  • Active comparator
    Metacarpophalangeal Joint Blocking Splint

    In the metacarpophalangeal joint blocking splint, the metacarpophalangeal joint of the affected finger(s) positioned in 0°.

    Other: Metacarpophalangeal Joint Blocking Splint

Interventions

  • OtherRelative Motion Splint

    Six weeks relative motion splint wear.

  • OtherMetacarpophalangeal Joint Blocking Splint

    Six weeks metacarpophalangeal joint blocking splint wear.

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline, 6 weeks after splint wear

Secondary outcomes

  1. Visual Analog Scale (VAS) for pain

    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

  2. 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.

    Time frame: Baseline, 6 weeks after splint wear

  3. 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.

    Time frame: Baseline, 6 weeks after splint wear

  4. 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.

    Time frame: Baseline, 6 weeks after splint wear

  5. 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".

    Time frame: Baseline, 3 and 6 weeks after splint wear

  6. 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".

    Time frame: Baseline, 3 and 6 weeks after splint wear

06

Study locations

1 site
  • Hospital Sultan Haji Ahmad Shah
    Temerluh, Pahang 28000, Malaysia
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05763017
Lead sponsor
National University of Malaysia
Responsible party
Sponsor
First posted
Mar 10, 2023
Start date
Jun 28, 2022
Primary completion
Apr 24, 2024
Completion
Apr 24, 2024
Last update
Sep 19, 2024

Study contacts

Siaw Chui Chai, PhD (OT)
principal investigator · Occupational Therapy Programme, Center for Rehabilitation & Special Needs Studies (iCaRehab)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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