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.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstituto Ortopedico Rizzoli

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rehabilitation

    Other intervention

    -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 intervention

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

Treatment groups

134 Participants
are divided into 2 treatment groups
Group A: StandardActive comparator 1 intervention
Group B: ExperimentalExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

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