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'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.

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.

Study Overview

• Status: Recruiting
• Conditions: De Quervain Disease; Hand Tenosynovitis
• Intervention / Treatment: Other: Standard; Other: Rehabilitation

• Study Type: Interventional
• Enrollment (Estimated): 134
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Federico Pilla, MD; Phone Number: 6926 0516366; Email: federico.pilla@ior.it
• Study Contact Backup: Name: Fabio Vita, MD; Phone Number: 6926 0516366; Email: fabio.vita@ior.it

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Recruiting
    • Istituto Ortopedico Rizzoli
    • Contact: Fabio Vita, MD; Email: fabio..vita@ior.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental	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.
Active Comparator: Standard	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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
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
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)
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
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
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

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Publications and helpful links

General Publications

• 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.
• 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.
• 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.2020.08.006. Epub 2020 Aug 29.

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Hand rehabilitation
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Tendinopathy; Tendon Entrapment; De Quervain Disease; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Aftercare; Continuity of Patient Care; Rehabilitation
• Other Study ID Numbers: MDQ23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No