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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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06296472
Enrollment
134
Registered
2024-03-06
Start date
2024-02-27
Completion date
2026-12-30
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

De Quervain Disease, Hand Tenosynovitis

Keywords

Hand rehabilitation

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.

Interventions

OTHERRehabilitation

-the experimental group will carry out a program of eccentric exercises following the infiltration and will also wear the wrist brace for 4 weeks.

OTHERStandard

-the standard group will carry out a program of generic exercises following the infiltration and will also wear the wrist brace for 4 weeks.

Sponsors

Istituto Ortopedico Rizzoli
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Numeric Pain Rating ScaleAt baseline (day 0)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

MeasureTime frameDescription
Disabilities of Arm, Shoulder and HandAt baseline (day 0)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 EvaluationAt baseline (day 0)The Patient-Rated Wrist Evaluation (PRWE) is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living.

Countries

Italy

Contacts

CONTACTFederico Pilla, MD
federico.pilla@ior.it0516366
CONTACTFabio Vita, MD
fabio.vita@ior.it0516366

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 5, 2026