Splint Versus Steroid Randomized Trial

Not Applicable

• Conditions: De Quervain Syndrome
• Interventions: Drug: Hydrocortisone-Lidocaine; Other: Splint

• Registration Number: NCT05165875
• Lead Sponsor: National University Hospital, Singapore

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-01
• Study First Submitted QC: 2021-12-14
• Study First Posted: 2021-12-21
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-09
• Study Start: 2022-06
• Primary Completion: 2024-02
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Exclusion Criteria

• Allergy to steroid (triamcinolone acetate) or local anaesthetic (lignocaine)
• History of work related trauma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Randomized: Steroid injection	Hydrocortisone-Lidocaine	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.
Randomized: Splint	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

Primary Outcome Measures

Name	Time	Method
Quick Disability of Arm, Shoulder, Hand (QuickDASH)	6 months	Our co- primary outcome would be QuickDash. QuickDash is a disability score we use for the upper limb where the higher score indicates greater disability and severity. We would expect a decrease in QuickDash scores following a success in the treatment measure. The resultant score is reported on a scale of 0 to 100, where 0 represents no disability and 100 represents total disability
Patients who have recovered from De Quervain's Tenosynovitis	6 months	The other primary outcomes would be the number of patients who have completely recovered from De Quervain's tenosynovitis. This will be determined by the global improvement the patient feels that will be ranked on a 7 point Likert scale (1: very much worse, 2: much worse, 3:slightly worse, 4:no change, 5:slightly better, 6:much better, 7:completely resolved).