Splint Versus Steroid Randomized Trial

Study Overview
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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.

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.

Official Title
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Splint Versus Steroid Injection for DeQuervain's Tenosynovitis: A Randomized Trial

Conditions
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De Quervain Syndrome

Intervention / Treatment
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* Drug: Hydrocortisone-Lidocaine
* Other: Splint


Participation Criteria
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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 Exclusion Criteria: Allergy to steroid (triamcinolone acetate) or local anaesthetic (lignocaine) History of work related trauma

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The trial design is a multicentre, randomized controlled, assessor blinded, 2 arm 1:1 superiority trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Randomized: Steroid injection<br>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. | Drug: Hydrocortisone-Lidocaine<br>* 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.<br>|
| Other: Randomized: Splint<br>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 | Other: Splint<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick Disability of Arm, Shoulder, Hand (QuickDASH) | 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 | 6 months | 
| Patients who have recovered from De Quervain's Tenosynovitis | 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). | 6 months |