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Study of Medical Ultrasound for Rhizarthrosis

Primary Purpose

Rhizarthrosis

Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Hand therapy (18 treatments)
Therapeutic ultrasound (18 treatments)
Combined hand therapy and therapeutic ultrasound (18 treatments)
Sham ultrasound group (18 treatments)
Sponsored by
Waldfriede Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhizarthrosis focused on measuring Degeneration, Trapeziometacarpal osteoarthritis, Basal Joint Arthritis, Arthrosis, Hand, Thumb

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Waldfriede Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Arm Label

Hand therapy

Therapeutic ultrasound

Combined hand therapy and therapeutic ultrasound

Sham ultrasound group

Arm Description

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

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

9 weeks of standard hand therapy plus therapeutic ultrasound including two 30 min slots per week.

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Visual analogue scale (VAS) pain
From 0mm (no pain) to 100mm (maximum pain imaginable)
Short Form 36 SF-36
Scored review of health questionnaire
Functional assessment: Thumb force
Key pinch force measure of the thumb as measured in Kg.
Functional assessment: Goniometry
Measurement of the angle between the dorsal axis of the thumb and the index finger with a goniometer.

Full Information

First Posted
September 30, 2019
Last Updated
May 10, 2023
Sponsor
Waldfriede Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04115085
Brief Title
Study of Medical Ultrasound for Rhizarthrosis
Official Title
Study of Medical Ultrasound for Rhizarthrosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 7, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Waldfriede Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhizarthrosis
Keywords
Degeneration, Trapeziometacarpal osteoarthritis, Basal Joint Arthritis, Arthrosis, Hand, Thumb

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hand therapy
Arm Type
Experimental
Arm Description
9 weeks of standard hand therapy including two 20 min slots per week.
Arm Title
Therapeutic ultrasound
Arm Type
Experimental
Arm Description
9 weeks of standard ultra sound therapy including two 10 min slots per week.
Arm Title
Combined hand therapy and therapeutic ultrasound
Arm Type
Experimental
Arm Description
9 weeks of standard hand therapy plus therapeutic ultrasound including two 30 min slots per week.
Arm Title
Sham ultrasound group
Arm Type
Sham Comparator
Arm Description
9 weeks of sham ultrasound therapy including two 10 min slots per week.
Intervention Type
Procedure
Intervention Name(s)
Hand therapy (18 treatments)
Intervention Description
18 treatments (ea. 20 Min) within 9 weeks
Intervention Type
Procedure
Intervention Name(s)
Therapeutic ultrasound (18 treatments)
Intervention Description
18 treatments (ea. 10 Min) within 9 weeks
Intervention Type
Procedure
Intervention Name(s)
Combined hand therapy and therapeutic ultrasound (18 treatments)
Intervention Description
18 treatments (ea. 30 Min) within 9 weeks
Intervention Type
Procedure
Intervention Name(s)
Sham ultrasound group (18 treatments)
Intervention Description
Sham ultrasound group receive 18 treatments (ea. 10 Min) within 9 weeks
Primary Outcome Measure Information:
Title
Disabilities of the Arm, Shoulder and Hand (DASH)
Description
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 Outcome Measure Information:
Title
Visual analogue scale (VAS) pain
Description
From 0mm (no pain) to 100mm (maximum pain imaginable)
Time Frame
Change after 9 weeks and 3, 4 and 8 months
Title
Short Form 36 SF-36
Description
Scored review of health questionnaire
Time Frame
Change after 9 weeks and 3, 4 and 8 months
Title
Functional assessment: Thumb force
Description
Key pinch force measure of the thumb as measured in Kg.
Time Frame
Change after 9 weeks and 3, 4 and 8 months
Title
Functional assessment: Goniometry
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Bock, Dr. med.
Organizational Affiliation
Waldfriede Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Lautenbach, Dr. med.
Organizational Affiliation
Waldfriede Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Waldfriede Hospital
City
Berlin
ZIP/Postal Code
14163
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32487163
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.
Results Reference
derived

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Study of Medical Ultrasound for Rhizarthrosis

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