Study of Medical Ultrasound for Rhizarthrosis

Rhizarthrosis Clinical Trial

Official title:

Study of Medical Ultrasound for Rhizarthrosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04115085
• Other study ID #: SUR
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 7, 2019
• Est. completion date: March 31, 2024

Study information

• Verified date: May 2023
• Source: Waldfriede Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Rhizarthrosis

Intervention

Procedure:
• Hand therapy (18 treatments)
18 treatments (ea. 20 Min) within 9 weeks
• Therapeutic ultrasound (18 treatments)
18 treatments (ea. 10 Min) within 9 weeks
• Combined hand therapy and therapeutic ultrasound (18 treatments)
18 treatments (ea. 30 Min) within 9 weeks
• Sham ultrasound group (18 treatments)
Sham ultrasound group receive 18 treatments (ea. 10 Min) within 9 weeks

Locations

Country	Name	City	State
Germany	Waldfriede Hospital	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Waldfriede Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual analogue scale (VAS) pain	From 0mm (no pain) to 100mm (maximum pain imaginable)	Change after 9 weeks and 3, 4 and 8 months
Secondary	Short Form 36 SF-36	Scored review of health questionnaire	Change after 9 weeks and 3, 4 and 8 months
Secondary	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
Secondary	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