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.

NCT06296472 | Recruiting

• 1 other identifier: MDQ23
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

De Quervain Disease; Hand Tenosynovitis

Keywords

Hand rehabilitation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Disabilities of Arm, Shoulder and Hand

  At baseline (day 0)

• Disabilities of Arm, Shoulder and Hand

  After 1 month

• Disabilities of Arm, Shoulder and Hand

  After 3 months

• Disabilities of Arm, Shoulder and Hand

  After 6 months

• Patient-Rated Wrist Evaluation

  At baseline (day 0)

Study Arms (2)

Standard

ACTIVE COMPARATOR

Other: Standard

Experimental

EXPERIMENTAL

Other: Rehabilitation

Interventions

Rehabilitation OTHER

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

Experimental

Standard OTHER

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

Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

Related Publications (3)

• 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.

  PMID: 19081683 RESULT

• 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.

  PMID: 15334439 RESULT

• 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.

  PMID: 33065423 RESULT

MeSH Terms

Conditions

De Quervain Disease

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Federico Pilla, MD

CONTACT

0516366; federico.pilla@ior.it

Fabio Vita, MD

CONTACT

0516366; fabio.vita@ior.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 6, 2024
• Study Start: February 27, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)