NCT05942443

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

10 months

First QC Date

June 13, 2023

Last Update Submit

July 4, 2023

Conditions

Trigger Finger

Keywords

Trigger fingerrelative motion splintpainfunctionsatisfactionstatic splint

Outcome Measures

Primary Outcomes (1)

  • Finger Pain

    Numeric Pain Rating Scale (NPRS)

    baseline, sixth week

Secondary Outcomes (2)

  • Satisfaction with the orthosis

    sixth week

  • Hand Function

    baseline, sixth week

Study Arms (2)

MCP blocking orthosis

ACTIVE COMPARATOR

Patients received the MCP blocking orthosis

Procedure: Pre-treatmentProcedure: Post-treatment

RME orthosis

EXPERIMENTAL

Patients received the RME orthosis for six weeks

Procedure: Pre-treatmentProcedure: Post-treatment

Interventions

Pre-treatmentPROCEDURE

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.

MCP blocking orthosisRME orthosis
Post-treatmentPROCEDURE

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.

MCP blocking orthosisRME orthosis

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients diagnosed with Stage 1-3 trigger finger (Froimson Classification)
  • A1 pulley triggering

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Trigger Finger DisorderPainPersonal Satisfaction

Interventions

Treatment ExpectationsAftercare

Condition Hierarchy (Ancestors)

Tendon EntrapmentTendinopathyMuscular DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Treatment OutcomePrognosisDiagnosisOutcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationHealth Care Evaluation MechanismsHealth Care Quality, Access, and EvaluationContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesPrimary Health CareComprehensive Health CarePatient Care Management

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Splints are fabricated by the orthotist and outcome assessments are performed by a physiotherapist.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients were randomly assigned in a 1:1 ratio to either the MCP-blocking orthosis group or the RME orthosis group, using a simple random sampling method.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor doctor

Study Record Dates

First Submitted

June 13, 2023

First Posted

July 12, 2023

Study Start

June 1, 2021

Primary Completion

March 30, 2022

Study Completion

May 1, 2022

Last Updated

July 12, 2023

Record last verified: 2023-07

Locations

TU(1)