Splint Versus Steroid Randomized Trial

Sponsor
National University Hospital, Singapore (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05165875
Collaborator
(none)
100
2
20

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The trial design is a multicentre, randomized controlled, assessor blinded, 2 arm 1:1 superiority trial.The trial design is a multicentre, randomized controlled, assessor blinded, 2 arm 1:1 superiority trial.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Splint Versus Steroid Injection for DeQuervain's Tenosynovitis: A Randomized Trial
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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
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.

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
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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
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:
  • Allergy to steroid (triamcinolone acetate) or local anaesthetic (lignocaine)

  • History of work related trauma

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • National University Hospital, Singapore

Investigators

  • Principal Investigator: Renita Sirisena, National University Hospital, Singapore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT05165875
Other Study ID Numbers:
  • 2019/00246
First Posted:
Dec 21, 2021
Last Update Posted:
Mar 9, 2022
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2022