Study of Medical Ultrasound for Rhizarthrosis

Study Overview
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Brief Summary
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It was never investigated which preservative non-invasive treatments are superior to treat rhizarthrosis. This randomized study compares the effect of 1. hand therapy vs. 2. therapeutic ultrasound vs. 3. hand therapy plus therapeutic ultrasound in the treatment of rhizarthrosis.

Official Title
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Study of Medical Ultrasound for Rhizarthrosis

Conditions
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Rhizarthrosis

Intervention / Treatment
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* Procedure: Hand therapy (18 treatments)
* Procedure: Therapeutic ultrasound (18 treatments)
* Procedure: Combined hand therapy and therapeutic ultrasound (18 treatments)
* Procedure: Sham ultrasound group (18 treatments)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients aged 40 to 90 years Pain intensity in the region of the thumb base in pain phases ≥ 40 mm on the VAS of 0 to 100 mm (relative to the last 24 hours) Complaints for at least 3 months X-ray Stadium Eaton I-IV at least once secured Exclusion Criteria: History of surgery on the affected hand, wrist or forearm Planned surgery in the next 8 months Anticoagulation (Marcumar, Heparin) Haemophilia, V. Willebrandt Jürgens syndrome, thrombocytopathy and other blood anomalies acute pain medication (<7 days) Systemic medication with corticoids or immunosuppressants Intraarterticular injections or RSO within the last 3 months Pregnancy, lactation Insulin-dependent type I diabetes mellitus Significant cognitive impairment clinically relevant or progressive disease (e.g., liver, kidney, cardiovascular system, respiratory tract, vascular system, brain, metabolism, thyroid) that could affect the course of the study Malignant disease Simultaneous participation in an interventional study or participation in an interventional study in the last two months before study inclusion Clinically relevant addiction or substance abuse disorder (defined as alcohol, drug and drug abuse) Insufficient mental possibility of cooperation Therapy with oral anticoagulants (e.g., Marcumar) Suspected lack of compliance Medical, psychiatric or other conditions that restrict the patient's following abilities: to interpret the study information, to give informed consent, to adhere to the rules of the protocol, or to complete the study

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hand therapy<br>9 weeks of standard hand therapy including two 20 min slots per week. | Procedure: Hand therapy (18 treatments)<br>* 18 treatments (ea. 20 Min) within 9 weeks<br>|
| Experimental: Therapeutic ultrasound<br>9 weeks of standard ultra sound therapy including two 10 min slots per week. | Procedure: Therapeutic ultrasound (18 treatments)<br>* 18 treatments (ea. 10 Min) within 9 weeks<br>|
| Experimental: Combined hand therapy and therapeutic ultrasound<br>9 weeks of standard hand therapy plus therapeutic ultrasound including two 30 min slots per week. | Procedure: Combined hand therapy and therapeutic ultrasound (18 treatments)<br>* 18 treatments (ea. 30 Min) within 9 weeks<br>|
| Sham Comparator: Sham ultrasound group<br>9 weeks of sham ultrasound therapy including two 10 min slots per week. | Procedure: Sham ultrasound group (18 treatments)<br>* Sham ultrasound group receive 18 treatments (ea. 10 Min) within 9 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disabilities of the Arm, Shoulder and Hand (DASH) | Disabilities as measured by the DASH scale; No Difficulty (1), Mild Difficulty (2), Moderate Difficulty (3), Severe Difficulty (4), Unable (5) | Change after 9 weeks and 3, 4 and 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale (VAS) pain | From 0mm (no pain) to 100mm (maximum pain imaginable) | Change after 9 weeks and 3, 4 and 8 months | 
| Short Form 36 SF-36 | Scored review of health questionnaire | Change after 9 weeks and 3, 4 and 8 months | 
| Functional assessment: Thumb force | Key pinch force measure of the thumb as measured in Kg. | Change after 9 weeks and 3, 4 and 8 months | 
| Functional assessment: Goniometry | Measurement of the angle between the dorsal axis of the thumb and the index finger with a goniometer. | Change after 9 weeks and 3, 4 and 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Degeneration, Trapeziometacarpal osteoarthritis, Basal Joint Arthritis, Arthrosis, Hand, Thumb