Study of Medical Ultrasound for Rhizarthrosis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Rhizarthrosis
• Intervention / Treatment: 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)

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Markus Bock, Dr. med.; Phone Number: 00493081810201; Email: m.bock@waldfriede.de

Study Locations

• Germany
  • Berlin, Germany, 14163
    • Waldfriede Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Waldfriede Hospital
• Investigators: Principal Investigator: Markus Bock, Dr. med., Waldfriede Hospital; Study Chair: Martin Lautenbach, Dr. med., Waldfriede Hospital

Publications and helpful links

General Publications

• Bock M, Eisenschenk A, Lorenzen H, Lautenbach M. Study of Medical Ultrasound for Rhizarthrosis (SUR): study protocol for a randomized controlled single-center pilot-trial. Trials. 2020 Jun 1;21(1):450. doi: 10.1186/s13063-020-04375-2.

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): March 31, 2024

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: October 2, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Hand; Arthrosis; Thumb; Degeneration; Trapeziometacarpal osteoarthritis; Basal Joint Arthritis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: SUR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No