ClinicalTrials.gg
Active, not recruitingNCT04115085Updated May 12, 2023

Study of Medical Ultrasound for Rhizarthrosis

An interventional study of Hand therapy (18 treatments) and Therapeutic ultrasound (18 treatments) in Rhizarthrosis, sponsored by Waldfriede Hospital. Active, not recruiting at 1 site in Germany. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-05-12.

Sponsored by Waldfriede Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as active, not recruiting.

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Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
40 Years to 90 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 131 studies in Osteoarthritis with a site in Germany — 12 open to participants now, 27 under way, 3 of them phase 3. Osteoarthritis · Germany.

Enrollment
37th of 98
200 · median 139
Started
2019
with 1 other
No phase
36 of 131
5 open now
Primary completion
2023-12
later than 0 of 26 live
Registered
109th of 131
by date

Among the 131 studies in Osteoarthritis with a site in Germany, this one is the 37th largest by enrollment of the 98 interventional ones that give a count, is one of 2 that started in 2019, is one of 36 with no phase, reaches primary completion later than 0 of the 26 other live ones, and was the 109th registered.

Osteoarthritis

2,974 studies on the registry are indexed under Osteoarthritis; 437 are open to participants now.

Browse Osteoarthritis studies →

Open to participants now

12 of the 131 studies in Osteoarthritis with a site in Germany are open now. Recruiting first, the newest first:

7 more — sign in →

All 12 open studies →

A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →

Who these studies take

Of the 286 Osteoarthritis studies recruiting now, 158 (55%) set no upper age limit and 71 (25%) stop at 75 or younger; 22 take children under 18; 30 take healthy volunteers.

This study: 40 Years to 90 Years · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Rhizarthrosis

Browse trials for

Keywords

  • Degeneration
  • Trapeziometacarpal osteoarthritis
  • Basal Joint Arthritis
  • Arthrosis
  • Hand
  • Thumb
04

Who can participate

Ages eligible
40 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
  • Intraarterticular injections or RSO within the last 3 months
  • Pregnancy, lactation
  • Insulin-dependent type I diabetes mellitus
  • Significant cognitive impairment
  • 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 , to adhere to the rules of the protocol, or to complete the study
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    Hand therapy

    9 weeks of standard hand therapy including two 20 min slots per week.

    Procedure: Hand therapy (18 treatments)

  • Experimental
    Therapeutic ultrasound

    9 weeks of standard ultra sound therapy including two 10 min slots per week.

    Procedure: Therapeutic ultrasound (18 treatments)

  • 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)

  • Sham comparator
    Sham ultrasound group

    9 weeks of sham ultrasound therapy including two 10 min slots per week.

    Procedure: Sham ultrasound group (18 treatments)

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

06

What researchers measure

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)

    Time frame: Change after 9 weeks and 3, 4 and 8 months

Secondary outcomes

  1. Visual analogue scale (VAS) pain

    From 0mm (no pain) to 100mm (maximum pain imaginable)

    Time frame: Change after 9 weeks and 3, 4 and 8 months

  2. Short Form 36 SF-36

    Scored review of health questionnaire

    Time frame: Change after 9 weeks and 3, 4 and 8 months

  3. Functional assessment: Thumb force

    Key pinch force measure of the thumb as measured in Kg.

    Time frame: Change after 9 weeks and 3, 4 and 8 months

  4. Functional assessment: Goniometry

    Measurement of the angle between the dorsal axis of the thumb and the index finger with a goniometer.

    Time frame: Change after 9 weeks and 3, 4 and 8 months

07

Study locations

1 site
08

References and documents

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. PubMed 32487163 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2019 (actual). Primary completion is estimated for Dec 2023, 50 months after the start.

Of 578 non-industry interventional studies with no phase under Osteoarthritis, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 52. This study's planned 50 months is above that.

Counting every sponsor, half of 713 studies reached it within 28 months; a quarter within 11 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 30, 2019
First posted
Oct 3, 2019
StartActual
Oct 7, 2019
Primary completionEst.
Dec 31, 2023
CompletionEst.
Mar 31, 2024
Last update
May 12, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04115085
Lead sponsor
Waldfriede Hospital
Responsible party
Sponsor
First posted
Oct 3, 2019
Start date
Oct 7, 2019
Primary completion
Dec 31, 2023 (estimated)
Completion
Mar 31, 2024 (estimated)
Last update
May 12, 2023

Study contacts

Markus Bock, Dr. med.
principal investigator · Waldfriede Hospital
Martin Lautenbach, Dr. med.
study chair · Waldfriede Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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