Study of Medical Ultrasound for Rhizarthrosis

Waldfriede Hospital

Status: Active, not recruiting

Conditions: Rhizarthrosis

Treatments: Procedure: Hand therapy (18 treatments); Procedure: Therapeutic ultrasound (18 treatments); Procedure: Sham ultrasound group (18 treatments); Procedure: Combined hand therapy and therapeutic ultrasound (18 treatments)

Study type: Interventional

Funder types: Other

Identifiers

NCT04115085

SUR

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

Hand therapy

Experimental group

Description:

9 weeks of standard hand therapy including two 20 min slots per week.

Treatment:

Procedure: Hand therapy (18 treatments)

Therapeutic ultrasound

Experimental group

Description:

9 weeks of standard ultra sound therapy including two 10 min slots per week.

Treatment:

Procedure: Therapeutic ultrasound (18 treatments)

Combined hand therapy and therapeutic ultrasound

Experimental group

Description:

9 weeks of standard hand therapy plus therapeutic ultrasound including two 30 min slots per week.

Treatment:

Procedure: Combined hand therapy and therapeutic ultrasound (18 treatments)

Sham ultrasound group

Sham Comparator group

Description:

9 weeks of sham ultrasound therapy including two 10 min slots per week.

Treatment:

Procedure: Sham ultrasound group (18 treatments)