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

NCT05763017 | Completed

• 1 other identifier: JEP-2022-319
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Trigger Finger; Stenosing Tenosynovitis

Keywords

relative motion splint; metacarpophalangeal joint blocking splint

Outcome Measures

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

  Baseline, 6 weeks after splint wear

Secondary Outcomes (6)

• Visual Analog Scale (VAS) for pain

  Baseline, 6 weeks after splint wear

• Number of triggering events in ten active fists

  Baseline, 6 weeks after splint wear

• Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure

  Baseline, 6 weeks after splint wear

• Canadian Occupational Performance Measure (COPM)

  Baseline, 6 weeks after splint wear

• Visual Analog Scale (VAS) for splint comfort

  Baseline, 3 and 6 weeks after splint wear

Study Arms (2)

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.

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°.

Other: Metacarpophalangeal Joint Blocking Splint

Interventions

Relative Motion Splint OTHER

Six weeks relative motion splint wear.

Relative Motion Splint

Metacarpophalangeal Joint Blocking Splint OTHER

Six weeks metacarpophalangeal joint blocking splint wear.

Metacarpophalangeal Joint Blocking Splint

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Hospital Sultan Haji Ahmad Shah

Temerluh, Pahang, 28000, Malaysia

Location

Related Publications (2)

• 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. 2025 Jul 4:S0894-1130(25)00090-0. doi: 10.1016/j.jht.2025.05.018. Online ahead of print.

  PMID: 40617791 DERIVED

• Leong 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.

  PMID: 39137205 DERIVED

MeSH Terms

Conditions

Trigger Finger Disorder; Tendon Entrapment

Condition Hierarchy (Ancestors)

Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Siaw Chui Chai, PhD (OT)

  Occupational Therapy Programme, Center for Rehabilitation & Special Needs Studies (iCaRehab)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 10, 2023
• Study Start: June 28, 2022
• Primary Completion: April 24, 2024
• Study Completion: April 24, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)