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NCT Number: 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.

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.

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Key information

Conditions

De Quervain Disease Hand Tenosynovitis Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Entrapment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location status: Recruiting

Location contact

Fabio Vita, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Numeric Pain Rating Scale

    Time frame: At 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.

  2. Numeric Pain Rating Scale

    Time frame: After 1 month

    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.

  3. Numeric Pain Rating Scale

    Time frame: After 3 months

    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.

  4. Numeric Pain Rating Scale

    Time frame: After 6 months

    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 outcomes

  1. Disabilities of Arm, Shoulder and Hand

    Time frame: At 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.

  2. Disabilities of Arm, Shoulder and Hand

    Time frame: After 1 month

    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.

  3. Disabilities of Arm, Shoulder and Hand

    Time frame: After 3 months

    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.

  4. Disabilities of Arm, Shoulder and Hand

    Time frame: After 6 months

    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.

  5. Patient-Rated Wrist Evaluation

    Time frame: At 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.

  6. Patient-Rated Wrist Evaluation

    Time frame: After 1 month

    The Patient-Rated Wrist Evaluation (PRWE) is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living.

  7. Patient-Rated Wrist Evaluation

    Time frame: After 3 months

    The Patient-Rated Wrist Evaluation (PRWE) is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living.

  8. Patient-Rated Wrist Evaluation

    Time frame: After 6 months

    The Patient-Rated Wrist Evaluation (PRWE) is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living.

Study contacts

Contact information is provided by the study sponsor or research team.

Fabio Vita, MD

CONTACT

[email protected]

0516366 ext. 6926

Federico Pilla, MD

CONTACT

[email protected]

0516366 ext. 6926

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2024
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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