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

Trigger Finger Clinical Trial

Official title:

A Randomized Comparative Trial of Relative Motion Splint Versus Metacarpophalangeal Joint Blocking Splint in the Management of Trigger Finger

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05763017
• Other study ID #: JEP-2022-319
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2022
• Est. completion date: June 2024

Study information

• Verified date: March 2024
• Source: National University of Malaysia
• Contact: Li Xian Leong, BSc (OT)
• Phone: +609-295 5333
• Email: lixianmetta[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stenosing Tenosynovitis
• Tendon Entrapment
• Tenosynovitis
• Trigger Finger
• Trigger Finger Disorder

Intervention

Other:
• Relative Motion Splint
Six weeks relative motion splint wear.
• Metacarpophalangeal Joint Blocking Splint
Six weeks metacarpophalangeal joint blocking splint wear.

Locations

Country	Name	City	State
Malaysia	Hospital Sultan Haji Ahmad Shah	Temerluh	Pahang

Sponsors (1)

Lead Sponsor	Collaborator
National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual Analog Scale (VAS) for pain	The left end of the VAS labelled as "no pain" and the right end labelled as "extreme pain".	Baseline, 6 weeks after splint wear
Secondary	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.	Baseline, 6 weeks after splint wear
Secondary	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.	Baseline, 6 weeks after splint wear
Secondary	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.	Baseline, 6 weeks after splint wear
Secondary	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".	Baseline, 3 and 6 weeks after splint wear
Secondary	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".	Baseline, 3 and 6 weeks after splint wear