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Comparative Effectiveness of the Two Splints in Trigger Finger

H

Hacettepe University

Status

Completed

Conditions

Trigger Finger

Treatments

Procedure: Pre-treatment
Procedure: Post-treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT05942443
E-10840098-772.02-2507

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

MCP blocking orthosis
Active Comparator group
Description:
Patients received the MCP blocking orthosis
Treatment:
Procedure: Pre-treatment
Procedure: Post-treatment
RME orthosis
Experimental group
Description:
Patients received the RME orthosis for six weeks
Treatment:
Procedure: Pre-treatment
Procedure: Post-treatment

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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