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Status unknownNCT05165875Updated Mar 9, 2022

Splint Versus Steroid Randomized Trial

An interventional study of Hydrocortisone-Lidocaine and Splint in De Quervain Syndrome, sponsored by National University Hospital, Singapore. Status unknown. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2022-03-09.

Sponsored by National University Hospital, Singapore · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
21 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • De Quervain Syndrome
03

In context

Lead sponsor

National University Hospital, Singapore is the lead sponsor of 444 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
Female
Accepts 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

Exclusion Criteria:

  • Allergy to steroid (triamcinolone acetate) or local anaesthetic (lignocaine)
  • History of work related trauma
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    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.

    Drug: Hydrocortisone-Lidocaine

  • Other
    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

    Other: Splint

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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months

  2. 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).

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05165875
Lead sponsor
National University Hospital, Singapore
Responsible party
Sponsor
First posted
Dec 21, 2021
Start date
Jun 2022 (estimated)
Primary completion
Feb 2024 (estimated)
Completion
Feb 2024 (estimated)
Last update
Mar 9, 2022

Study contacts

Vanessa Wan
Contact
vanessa_wan@nuhs.edu.sg
67728237
Renita Sirisena
principal investigator · National University Hospital, Singapore

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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