Rhizarthrosis
Conditions
Keywords
Degeneration, Trapeziometacarpal osteoarthritis, Basal Joint Arthritis, Arthrosis, Hand, Thumb
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.
Interventions
PROCEDUREHand therapy (18 treatments)
18 treatments (ea. 20 Min) within 9 weeks
PROCEDURETherapeutic ultrasound (18 treatments)
18 treatments (ea. 10 Min) within 9 weeks
PROCEDURECombined hand therapy and therapeutic ultrasound (18 treatments)
18 treatments (ea. 30 Min) within 9 weeks
PROCEDURESham ultrasound group (18 treatments)
Sham ultrasound group receive 18 treatments (ea. 10 Min) within 9 weeks
Sponsors
Waldfriede Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disabilities of the Arm, Shoulder and Hand (DASH) | Change after 9 weeks and 3, 4 and 8 months | Disabilities as measured by the DASH scale; No Difficulty (1), Mild Difficulty (2), Moderate Difficulty (3), Severe Difficulty (4), Unable (5) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue scale (VAS) pain | Change after 9 weeks and 3, 4 and 8 months | From 0mm (no pain) to 100mm (maximum pain imaginable) |
| Short Form 36 SF-36 | Change after 9 weeks and 3, 4 and 8 months | Scored review of health questionnaire |
| Functional assessment: Thumb force | Change after 9 weeks and 3, 4 and 8 months | Key pinch force measure of the thumb as measured in Kg. |
| Functional assessment: Goniometry | Change after 9 weeks and 3, 4 and 8 months | Measurement of the angle between the dorsal axis of the thumb and the index finger with a goniometer. |
Countries
Germany
Outcome results
None listed