Study of Medical Ultrasound for Rhizarthrosis

May 10, 2023 updated by: Waldfriede Hospital
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Berlin, Germany, 14163
        • Waldfriede Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hand therapy
9 weeks of standard hand therapy including two 20 min slots per week.
Procedure: Hand therapy (18 treatments)
18 treatments (ea. 20 Min) within 9 weeks
Experimental: Therapeutic ultrasound
9 weeks of standard ultra sound therapy including two 10 min slots per week.
Procedure: Therapeutic ultrasound (18 treatments)
18 treatments (ea. 10 Min) within 9 weeks
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)
18 treatments (ea. 30 Min) within 9 weeks
Sham Comparator: Sham ultrasound group
9 weeks of sham ultrasound therapy including two 10 min slots per week.
Procedure: Sham ultrasound group (18 treatments)
Sham ultrasound group receive 18 treatments (ea. 10 Min) within 9 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Change after 9 weeks and 3, 4 and 8 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual analogue scale (VAS) pain
Time Frame: Change after 9 weeks and 3, 4 and 8 months
From 0mm (no pain) to 100mm (maximum pain imaginable)
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
Scored review of health questionnaire
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
Key pinch force measure of the thumb as measured in Kg.
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
Measurement of the angle between the dorsal axis of the thumb and the index finger with a goniometer.
Change after 9 weeks and 3, 4 and 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Waldfriede Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Markus Bock, Dr. med., Waldfriede Hospital
  • Study Chair: Martin Lautenbach, Dr. med., Waldfriede Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 7, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 3, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SUR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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