Study of Medical Ultrasound for Rhizarthrosis
1 other identifier
interventional
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2019
CompletedFirst Posted
Study publicly available on registry
October 3, 2019
CompletedStudy Start
First participant enrolled
October 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2024
CompletedMay 12, 2023
May 1, 2023
4.2 years
September 30, 2019
May 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Visual analogue scale (VAS) pain
Change after 9 weeks and 3, 4 and 8 months
Short Form 36 SF-36
Change after 9 weeks and 3, 4 and 8 months
Functional assessment: Thumb force
Change after 9 weeks and 3, 4 and 8 months
Functional assessment: Goniometry
Change after 9 weeks and 3, 4 and 8 months
Study Arms (4)
Hand therapy
EXPERIMENTAL9 weeks of standard hand therapy including two 20 min slots per week.
Therapeutic ultrasound
EXPERIMENTAL9 weeks of standard ultra sound therapy including two 10 min slots per week.
Combined hand therapy and therapeutic ultrasound
EXPERIMENTAL9 weeks of standard hand therapy plus therapeutic ultrasound including two 30 min slots per week.
Sham ultrasound group
SHAM COMPARATOR9 weeks of sham ultrasound therapy including two 10 min slots per week.
Interventions
18 treatments (ea. 10 Min) within 9 weeks
18 treatments (ea. 30 Min) within 9 weeks
Sham ultrasound group receive 18 treatments (ea. 10 Min) within 9 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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)
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Waldfriede Hospital
Berlin, 14163, Germany
Related Publications (1)
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.
PMID: 32487163DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Markus Bock, Dr. med.
Waldfriede Hospital
- STUDY CHAIR
Martin Lautenbach, Dr. med.
Waldfriede Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2019
First Posted
October 3, 2019
Study Start
October 7, 2019
Primary Completion
December 31, 2023
Study Completion
March 31, 2024
Last Updated
May 12, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share