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RecruitingNCT06296472Updated May 4, 2026

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.

An interventional study of Rehabilitation and Standard in De Quervain Disease and Hand Tenosynovitis, sponsored by Istituto Ortopedico Rizzoli. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by Istituto Ortopedico Rizzoli · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Feb 2024; still recruiting 2 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
134
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • De Quervain Disease
  • Hand Tenosynovitis

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Keywords

  • Hand rehabilitation
03

In context

De Quervain Disease

31 studies on the registry are indexed under De Quervain Disease; 9 are open to participants now.

This study's planned enrollment of 134 is above the median of 58 across 27 interventional studies indexed under De Quervain Disease.

Browse De Quervain Disease studies →

Lead sponsor

Istituto Ortopedico Rizzoli is the lead sponsor of 298 studies on the registry; 102 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
134 participants (estimated)

Study arms

  • Active comparator
    Standard

    Other: Standard

  • Experimental
    Experimental

    Other: Rehabilitation

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At baseline (day 0)

  2. 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.

    Time frame: After 1 month

  3. 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.

    Time frame: After 3 months

  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.

    Time frame: After 6 months

Secondary outcomes

  1. 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.

    Time frame: At baseline (day 0)

  2. 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.

    Time frame: After 1 month

  3. 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.

    Time frame: After 3 months

  4. 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.

    Time frame: After 6 months

  5. 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.

    Time frame: At baseline (day 0)

  6. 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.

    Time frame: After 1 month

  7. 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.

    Time frame: After 3 months

  8. 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.

    Time frame: After 6 months

07

Study locations

1 of 1 sites recruiting
  • Istituto Ortopedico Rizzoli
    Bologna, 40136, Italy
    Recruiting
08

References and documents

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. PubMed 19081683 ↗
  • 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. PubMed 15334439 ↗
  • 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. PubMed 33065423 ↗

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06296472
Lead sponsor
Istituto Ortopedico Rizzoli
Responsible party
Sponsor
First posted
Mar 6, 2024
Start date
Feb 27, 2024
Primary completion
May 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
May 4, 2026

Study contacts

Federico Pilla, MD
Contact
federico.pilla@ior.it
0516366 ext. 6926
Fabio Vita, MD
Contact
fabio.vita@ior.it
0516366 ext. 6926

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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