De Quervain's Disease in the Acute Phase:a Study Aimed at Evaluating the Effectiveness of Standard Physiotherapy Treatment (HANDGUIDE), Compared to Experimental Treatment After Performing Ultrasound-guided Infiltrative Therapy.

Not Applicable

Recruiting

• Conditions: De Quervain Disease; Hand Tenosynovitis
• Interventions: Other: Rehabilitation; Other: Standard

• Registration Number: NCT06296472
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

The objective of the study is to compare pain reduction and disability reduction in two groups of patients diagnosed with de Quervain syndrome who will undergo ultrasound-guided infiltrative treatment with corticosteroid as per normal clinical practice:

* the control group will subsequently be subjected to a standard treatment based on the European guidelines of the HANDGUIDE group,

* the experimental group will subsequently carry out a program of eccentric exercises.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-27
• Study First Submitted: 2024-02-29
• Study First Submitted QC: 2024-02-29
• Study First Posted: 2024-03-06
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29
• Primary Completion: 2026-04-01
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

• Patients of both sexes with a minimum age of 18 years;
• Medical diagnosis of de Quervain syndrome assessed through orthopedic clinical examination e confirmation by ultrasound;
• Signing of the informed consent and participation in the study.

Exclusion Criteria

• Patients who are not self-sufficient or not able to understand and want;
• Presence of other pathologies in the hand affected by de Quervain pathology, such as intersection syndrome, neuropathies, fractures, rhizoarthrosis, arthrosis of the radio-carpal or intercarpal joint, intercarpal instability, cervical radiculopathy, rheumatic or metabolic pathologies;
• Pregnant or breastfeeding women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Rehabilitation	-
Standard	Standard	-

Primary Outcome Measures

Name	Time	Method
Numeric Pain Rating Scale	After 6 months	An 11-point Numeric Pain Rating Scale (NPRS) ranging from 0 to 10 was anchored on the left with the phrase "No Pain" and on the right with the phrase "Worst Imaginable Pain." Patients rated their current, best, and worst level of pain during the last 24 hours.

Secondary Outcome Measures

Name	Time	Method
Disabilities of Arm, Shoulder and Hand	After 6 months	The Disabilities of Arm, Shoulder and Hand (DASH) score consists of 30 questions and is used to assess functional disorders of the upper extremity. The possible score ranges from 0 to 100 points. 0 points represent a complete, unrestricted function of the upper extremities, while 100 points represent the greatest possible functional impairment.
Patient-Rated Wrist Evaluation	After 6 months	The Patient-Rated Wrist Evaluation (PRWE) is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living.

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy