Clinical trial NCT06296472: 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.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: De Quervain Disease
Hand Tenosynovitis
Keywords: Hand rehabilitation
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: At baseline (day 0)
measure: Numeric Pain Rating Scale
timeFrame: After 1 month
measure: Numeric Pain Rating Scale
timeFrame: After 3 months
measure: Numeric Pain Rating Scale
timeFrame: After 6 months
Secondary outcomes:
measure: Disabilities of Arm, Shoulder and Hand
timeFrame: At baseline (day 0)
measure: Disabilities of Arm, Shoulder and Hand
timeFrame: After 1 month
measure: Disabilities of Arm, Shoulder and Hand
timeFrame: After 3 months
measure: Disabilities of Arm, Shoulder and Hand
timeFrame: After 6 months
measure: Patient-Rated Wrist Evaluation
timeFrame: At baseline (day 0)
measure: Patient-Rated Wrist Evaluation
timeFrame: After 1 month
measure: Patient-Rated Wrist Evaluation
timeFrame: After 3 months
measure: Patient-Rated Wrist Evaluation
timeFrame: After 6 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
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.
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.
citation: 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.