Splint Versus Steroid Randomized Trial

De Quervain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05165875
• Other study ID #: 2019/00246
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2022
• Est. completion date: February 2024

Study information

• Verified date: December 2021
• Source: National University Hospital, Singapore
• Contact: Vanessa Wan
• Phone: 67728237
• Email: vanessa_wan[@]nuhs.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• De Quervain Syndrome

Intervention

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:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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