RhizarthrosisNCT04115085
Study of Medical Ultrasound for Rhizarthrosis
A study testing Hand therapy (18 treatments), Therapeutic ultrasound (18 treatments) and Combined hand therapy and therapeutic ultrasound (18 treatments) in people with Rhizarthrosis, run by Waldfriede Hospital at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Rhizarthrosis
- What is being tested?
- Hand therapy (18 treatments), Therapeutic ultrasound (18 treatments) and Combined hand therapy and therapeutic ultrasound (18 treatments)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 7 Oct 2019to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Rhizarthrosis
- Being tested
- Hand therapy (18 treatments), Therapeutic ultrasound (18 treatments), Combined hand therapy and therapeutic ultrasound (18 treatments), Sham ultrasound group (18 treatments)
- Keywords
- Degeneration, Trapeziometacarpal osteoarthritis, Basal Joint Arthritis, Arthrosis, Hand, Thumb
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand therapy (18 treatments)Procedure or surgery
18 treatments (ea. 20 Min) within 9 weeks
Therapeutic ultrasound (18 treatments)Procedure or surgery
18 treatments (ea. 10 Min) within 9 weeks
Combined hand therapy and therapeutic ultrasound (18 treatments)Procedure or surgery
18 treatments (ea. 30 Min) within 9 weeks
Sham ultrasound group (18 treatments)Procedure or surgery
Sham ultrasound group receive 18 treatments (ea. 10 Min) within 9 weeks
| Study group | Role | What they receive |
|---|---|---|
| Hand therapy | Experimental | 9 weeks of standard hand therapy including two 20 min slots per week. Receives: Procedure: Hand therapy (18 treatments) |
| Therapeutic ultrasound | Experimental | 9 weeks of standard ultra sound therapy including two 10 min slots per week. Receives: Procedure: Therapeutic ultrasound (18 treatments) |
| Combined hand therapy and therapeutic ultrasound | Experimental | 9 weeks of standard hand therapy plus therapeutic ultrasound including two 30 min slots per week. Receives: Procedure: Combined hand therapy and therapeutic ultrasound (18 treatments) |
| Sham ultrasound group | Sham comparator | 9 weeks of sham ultrasound therapy including two 10 min slots per week. Receives: Procedure: Sham ultrasound group (18 treatments) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Change after 9 weeks and 3, 4 and 8 months
Secondary outcomes (4)
Visual analogue scale (VAS) pain
From 0mm (no pain) to 100mm (maximum pain imaginable)
Measured: Change after 9 weeks and 3, 4 and 8 months
Short Form 36 SF-36
Scored review of health questionnaire
Measured: 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.
Measured: 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.
Measured: Change after 9 weeks and 3, 4 and 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start7 Oct 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RhizarthrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Waldfriede Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus Bock, Dr. med., Principal investigator, Waldfriede HospitalMartin Lautenbach, Dr. med., Study chair, Waldfriede Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04115085
- Sponsor's protocol ID
- SUR
- Status last verified
- May 2023
- First submitted
- 30 Sep 2019
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Medical Ultrasound for Rhizarthrosis
- ClinicalTrials.gov ID
- NCT04115085
- Acronym / sponsor ID
- SUR
- Conditions
- Rhizarthrosis
- Keywords
- Degeneration, Trapeziometacarpal osteoarthritis, Basal Joint Arthritis, Arthrosis, Hand, Thumb
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Waldfriede HospitalUniversity, hospital or other
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hand therapy | Experimental | Procedure: Hand therapy (18 treatments)9 weeks of standard hand therapy including two 20 min slots per week. |
| Therapeutic ultrasound | Experimental | Procedure: Therapeutic ultrasound (18 treatments)9 weeks of standard ultra sound therapy including two 10 min slots per week. |
| Combined hand therapy and therapeutic ultrasound | Experimental | Procedure: Combined hand therapy and therapeutic ultrasound (18 treatments)9 weeks of standard hand therapy plus therapeutic ultrasound including two 30 min slots per week. |
| Sham ultrasound group | Sham comparator | Procedure: Sham ultrasound group (18 treatments)9 weeks of sham ultrasound therapy including two 10 min slots per week. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand therapy (18 treatments)18 treatments (ea. 20 Min) within 9 weeks | Procedure or surgery | Hand therapy |
| Therapeutic ultrasound (18 treatments)18 treatments (ea. 10 Min) within 9 weeks | Procedure or surgery | Therapeutic ultrasound |
| Combined hand therapy and therapeutic ultrasound (18 treatments)18 treatments (ea. 30 Min) within 9 weeks | Procedure or surgery | Combined hand therapy and therapeutic ultrasound |
| Sham ultrasound group (18 treatments)Sham ultrasound group receive 18 treatments (ea. 10 Min) within 9 weeks | Procedure or surgery | Sham ultrasound group |
Primary outcome
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: 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)
4 secondary outcomes
Visual analogue scale (VAS) pain
Time frame: Change after 9 weeks and 3, 4 and 8 months
Short Form 36 SF-36
Time frame: Change after 9 weeks and 3, 4 and 8 months
Functional assessment: Thumb force
Time frame: Change after 9 weeks and 3, 4 and 8 months
Functional assessment: Goniometry
Time frame: Change after 9 weeks and 3, 4 and 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Derived from this study: PubMed 32487163Bock 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Bock, Dr. med. principal investigator
Waldfriede Hospital
Martin Lautenbach, Dr. med. study chair
Waldfriede Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand therapy (18 treatments), Therapeutic ultrasound (18 treatments) and Combined hand therapy and therapeutic ultrasound (18 treatments) in people with Rhizarthrosis, run by Waldfriede Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disabilities of the Arm, Shoulder and Hand (DASH) (time frame: Change after 9 weeks and 3, 4 and 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04115085, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.