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.

De Quervain Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06296472
• Other study ID #: MDQ23
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: February 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: Federico Pilla, MD
• Phone: 0516366
• Email: federico.pilla[@]ior.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: December 30, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• De Quervain Disease
• Tenosynovitis

Intervention

Other:
• Rehabilitation
-the experimental group will carry out a program of eccentric exercises following the infiltration and will also wear the wrist brace for 4 weeks.
• Standard
-the standard group will carry out a program of generic exercises following the infiltration and will also wear the wrist brace for 4 weeks.

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Ferrara PE, Codazza S, Cerulli S, Maccauro G, Ferriero G, Ronconi G. Physical modalities for the conservative treatment of wrist and hand's tenosynovitis: A systematic review. Semin Arthritis Rheum. 2020 Dec;50(6):1280-1290. doi: 10.1016/j.semarthrit.2020 — View Citation

Walker-Bone K, Palmer KT, Reading I, Coggon D, Cooper C. Prevalence and impact of musculoskeletal disorders of the upper limb in the general population. Arthritis Rheum. 2004 Aug 15;51(4):642-51. doi: 10.1002/art.20535. — View Citation

Wolf JM, Sturdivant RX, Owens BD. Incidence of de Quervain's tenosynovitis in a young, active population. J Hand Surg Am. 2009 Jan;34(1):112-5. doi: 10.1016/j.jhsa.2008.08.020. Epub 2008 Dec 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Pain Rating Scale	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.	At baseline (day 0)
Primary	Numeric Pain Rating Scale	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.	After 1 month
Primary	Numeric Pain Rating Scale	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.	After 3 months
Primary	Numeric Pain Rating Scale	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.	After 6 months
Secondary	Disabilities of Arm, Shoulder and Hand	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.	At baseline (day 0)
Secondary	Disabilities of Arm, Shoulder and Hand	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.	After 1 month
Secondary	Disabilities of Arm, Shoulder and Hand	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.	After 3 months
Secondary	Disabilities of Arm, Shoulder and Hand	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.	After 6 months
Secondary	Patient-Rated Wrist Evaluation	The Patient-Rated Wrist Evaluation (PRWE) is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living.	At baseline (day 0)
Secondary	Patient-Rated Wrist Evaluation	The Patient-Rated Wrist Evaluation (PRWE) is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living.	After 1 month
Secondary	Patient-Rated Wrist Evaluation	The Patient-Rated Wrist Evaluation (PRWE) is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living.	After 3 months
Secondary	Patient-Rated Wrist Evaluation	The Patient-Rated Wrist Evaluation (PRWE) is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living.	After 6 months