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Splint Versus Steroid Randomized Trial

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05165875
Enrollment
100
Registered
2021-12-21
Start date
2022-06-30
Completion date
2024-02-29
Last updated
2022-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

De Quervain Syndrome

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.

Interventions

DRUGHydrocortisone-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.

OTHERSplint

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.

Sponsors

National University Hospital, Singapore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quick Disability of Arm, Shoulder, Hand (QuickDASH)6 monthsOur 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 Tenosynovitis6 monthsThe 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).

Contacts

Primary ContactVanessa Wan
vanessa_wan@nuhs.edu.sg67728237

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026