Splint Versus Steroid Randomized Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-30

Study Completion Date

2024-02-29

Brief Summary

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The primary aim is to compare the effectiveness of splinting versus steroid injection in improving the DASH scores in participants diagnosed with De Quervain's tenosynovitis over a period of 6 months.

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Detailed Description

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The primary hypothesis is that steroid injection into the first dorsal compartment is more effective compared with splinting at 3 months.

The secondary hypothesis is that steroid injection yields better clinical outcomes compared with splinting at 1 month, 3 months and 6 months.

Conditions

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De Quervain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The trial design is a multicentre, randomized controlled, assessor blinded, 2 arm 1:1 superiority trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Randomized: Steroid injection

1ml injection of a mixture of 0.5ml triamcinolone acetonide (50mg/5ml) and 0.5ml 1% lignoacaine is given intra-thecally into the first extensor compartment.

Group Type OTHER

Hydrocortisone-Lidocaine

Intervention Type DRUG

Intervention will be done on the same day based on the randomization.

For the steroid injection group, a 1ml injection of a mixture of 0.5ml triamcinolone acetonide (50mg/5ml) and 0.5ml 1% lignoacaine is given intra-thecally into the first extensor compartment.

For both groups, routine analgesia is not prescribed but the use is not restricted to the participants.

Randomized: Splint

a long thumb spica thermoplastic splint (wrist neutral, 30º CMCJ flexion, 30º thumb abduction, IPJ free) will be customized and intermittent active range of motion exercises will be taught for 4 weeks

Group Type OTHER

Splint

Intervention Type OTHER

Intervention will be done on the same day based on the randomization. For the splint group, a long thumb spica thermoplastic splint (wrist neutral, 30º CMCJ flexion, 30º thumb abduction, IPJ free) will be customized and intermittent active range of motion exercises will be taught for 4 weeks. Subsequently, the splint will be weaned and passive range of motion exercises taught.

For both groups, routine analgesia is not prescribed but the use is not restricted to the participants.

Interventions

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Hydrocortisone-Lidocaine

Intervention will be done on the same day based on the randomization.

For the steroid injection group, a 1ml injection of a mixture of 0.5ml triamcinolone acetonide (50mg/5ml) and 0.5ml 1% lignoacaine is given intra-thecally into the first extensor compartment.

For both groups, routine analgesia is not prescribed but the use is not restricted to the participants.

Intervention Type DRUG

Splint

Intervention will be done on the same day based on the randomization. For the splint group, a long thumb spica thermoplastic splint (wrist neutral, 30º CMCJ flexion, 30º thumb abduction, IPJ free) will be customized and intermittent active range of motion exercises will be taught for 4 weeks. Subsequently, the splint will be weaned and passive range of motion exercises taught.

For both groups, routine analgesia is not prescribed but the use is not restricted to the participants.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Confirmed diagnosis of de Quervain's tenosynovitis based on the de Quervain's screening tool (DQST) with scores ≥ 5 (refer to table 1)
* No prior treatment
* Above 21 years of age