search
Back to results

Comparative Effectiveness of the Two Splints in Trigger Finger

Primary Purpose

Trigger Finger

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pre-treatment
Post-treatment
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigger Finger focused on measuring Trigger finger, relative motion splint, pain, function, satisfaction, static splint

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients diagnosed with Stage 1-3 trigger finger (Froimson Classification) A1 pulley triggering Exclusion Criteria: 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

Sites / Locations

  • Hacettepe University Faculty of Physical Therapy and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

MCP blocking orthosis

RME orthosis

Arm Description

Patients received the MCP blocking orthosis

Patients received the RME orthosis for six weeks

Outcomes

Primary Outcome Measures

Finger Pain
Numeric Pain Rating Scale (NPRS)

Secondary Outcome Measures

Satisfaction with the orthosis
The Quebec Assistive Technology User Satisfaction Evaluation (Quest 2.0)
Hand Function
Disabilities of Arm, Shoulder, and Hand Questionnaire (DASH)

Full Information

First Posted
June 13, 2023
Last Updated
July 4, 2023
Sponsor
Hacettepe University
search

1. Study Identification

Unique Protocol Identification Number
NCT05942443
Brief Title
Comparative Effectiveness of the Two Splints in Trigger Finger
Official Title
Treatment of Trigger Finger With Metacarpophalangeal Joint Blocking Orthosis Versus Relative Motion Extension Orthosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Generally, three types of orthoses are used in the treatment of trigger finger. Some authors used MCP blocking orthosis, while others used DIP or PIP blocking orthosis. Comparative studies are quite limited, as only one study comparing two orthotic designs found that the MCP blocking orthosis was more effective than the DIP blocking orthosis.The MCP blocking orthosis, which restricts the MCP joint to 10-15° of flexion, is commonly used in the conservative treatment of trigger finger.An RME orthosis could be an alternative orthotic treatment option for trigger finger because it holds the MCP in an extended position. The RME orthosis is thought to prevent flexion of the affected finger, thereby limiting tendon glide. This reduces the pressure on the A1 pulley, allowing the tendon to glide more smoothly, reducing the likelihood of triggering. Despite limiting motion,the orthosis still allows the patient to perform daily activities with the orthosis. Therefore, positioning the MCP joint in extension could provide additional benefits in trigger finger. The relative motion orthosis is a new orthotic design that positions the affected finger in 10-15 degrees of extension relative to the adjacent fingers.It also has several advantages, including small size, low-profile design, easy and inexpensive fabrication, and better patient compliance. The primary objective of this study was to compare the efficacy of a 6-week orthotic intervention for pain relief in a randomly selected group of patients with TF using the MCP blocking orthosis and the RME orthosis. The secondary objective was to determine the comparative effectiveness of the orthoses on function and satisfaction with the orthosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Finger
Keywords
Trigger finger, relative motion splint, pain, function, satisfaction, static splint

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
Splints are fabricated by the orthotist and outcome assessments are performed by a physiotherapist.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MCP blocking orthosis
Arm Type
Active Comparator
Arm Description
Patients received the MCP blocking orthosis
Arm Title
RME orthosis
Arm Type
Experimental
Arm Description
Patients received the RME orthosis for six weeks
Intervention Type
Procedure
Intervention Name(s)
Pre-treatment
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Post-treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Finger Pain
Description
Numeric Pain Rating Scale (NPRS)
Time Frame
baseline, sixth week
Secondary Outcome Measure Information:
Title
Satisfaction with the orthosis
Description
The Quebec Assistive Technology User Satisfaction Evaluation (Quest 2.0)
Time Frame
sixth week
Title
Hand Function
Description
Disabilities of Arm, Shoulder, and Hand Questionnaire (DASH)
Time Frame
baseline, sixth week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients diagnosed with Stage 1-3 trigger finger (Froimson Classification) A1 pulley triggering Exclusion Criteria: 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
Facility Information:
Facility Name
Hacettepe University Faculty of Physical Therapy and Rehabilitation
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Comparative Effectiveness of the Two Splints in Trigger Finger

We'll reach out to this number within 24 hrs