Splint Versus Steroid Randomized Trial

NCT05165875 | Unknown

• 1 other identifier: 2019/00246
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

De Quervain Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Randomized: Steroid injection

OTHER

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

Randomized: Splint

OTHER

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

Hydrocortisone-Lidocaine DRUG

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.

Randomized: Steroid injection

Splint OTHER

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.

Randomized: Splint

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National University Hospital, Singapore: lead

MeSH Terms

Interventions

Splints

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Officials

• Renita Sirisena

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanessa Wan

CONTACT

67728237; vanessa_wan@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 21, 2021
• Study Start: June 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: March 9, 2022

Record last verified: 2021-12