Clinical trial NCT04115085: Study of Medical Ultrasound for Rhizarthrosis
Official title: Study of Medical Ultrasound for Rhizarthrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rhizarthrosis
Keywords: Degeneration
Trapeziometacarpal osteoarthritis
Basal Joint Arthritis
Arthrosis
Hand
Thumb
Lead sponsor: Waldfriede Hospital
Sponsor class: OTHER
First posted: 2019-10-03
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: Change after 9 weeks and 3, 4 and 8 months
Secondary outcomes:
measure: Visual analogue scale (VAS) pain
timeFrame: Change after 9 weeks and 3, 4 and 8 months
measure: Short Form 36 SF-36
timeFrame: Change after 9 weeks and 3, 4 and 8 months
measure: Functional assessment: Thumb force
timeFrame: Change after 9 weeks and 3, 4 and 8 months
measure: Functional assessment: Goniometry
timeFrame: Change after 9 weeks and 3, 4 and 8 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Waldfriede Hospital
Study officials:
affiliation: Waldfriede Hospital
name: Markus Bock, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Waldfriede Hospital
name: Martin Lautenbach, Dr. med.
role: STUDY_CHAIR
References:
citation: 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.