Mechanisms of a Dynamic Stability Approach
Primary Purpose
Thumb Carpometacarpal Osteoarthritis, Thumb Basal Joint Osteoarthritis
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dynamic Stability Exercise Program
Sponsored by
About this trial
This is an interventional treatment trial for Thumb Carpometacarpal Osteoarthritis focused on measuring Arthritis, Exercise, Thumb, Treatment, Intervention, Dynamic stability, Hand, Therapy, Occupational, Physical
Eligibility Criteria
Inclusion Criteria:
- adults with radiographically-confirmed thumb CMC OA
Exclusion Criteria:
- Persons who have had cortisone treatments to the affected thumb within the prior three months, thumb CMC joint replacement, inflammatory arthritis, Ehlers Danlos Syndrome, Marfan's disease, pregnancy or questionable pregnancy, cognitive disorders which would preclude a client from following the testing commands and home program participation, concomitant conditions affecting the arthritic thumb, grade 4 arthritis staging, no ongoing hand rehabilitation (i.e., within prior 6 months), non-English Speaking, and pain which precludes participants from completing testing
Sites / Locations
- University of MinnesotaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dynamic Stability Exercise Program
Arm Description
Involves four 60-minute occupational therapy visits as well as a daily home program across a 8-week period. Clinic visits focus primarily on home program coaching, and progression of the exercise regimen. Home programs involve daily exercises which follow the intensity and duration recommended for older adults. The intervention focuses on enhancing mobility and strength of the thumb for use during daily activities.
Outcomes
Primary Outcome Measures
Subluxation of thumb carpometacarpal joint as per CAT scan
CAT scan will be used at baseline and 9 weeks to obtain measurements as per the American College of Radiology's 2013 Technical Standards. A validated positioning jig reproduced by our lab will be used to maintain standardized joint positioning and standardize stress to the thumb metacarpal during fluoroscopic examination. "Joint subluxation" is a measure of thumb CMC instability and will be measured in centimeters.
Subluxation of thumb carpometacarpal joint as per CAT scan
CAT scan will be used at baseline and 9 weeks to obtain measurements as per the American College of Radiology's 2013 Technical Standards. A validated positioning jig reproduced by our lab will be used to maintain standardized joint positioning and standardize stress to the thumb metacarpal during fluoroscopic examination. "Joint subluxation" is a measure of thumb CMC instability and will be measured in centimeters.
Subluxation of thumb carpometacarpal joint as per sonography
Sonographic assessment of thumb carpometacarpal subluxation will occur at the time of participants' baseline CAT scan. The same views, position jig and standardized upper limb postures used for the fluoroscopic assessments will again be employed. The thumb CMC joint sonographic procedures described by Oo et al. and the general guidelines put forth by American Institute of Ultrasound in Medicine will be followed. Long axis views of the dorsal and radial borders of the thumb CMC joint will be visualized via use of the Philips Lumify Portable Sonography Device. In these views, the amount of translation of metacarpal base with respect to trapezium will be quantified in millimeters
Secondary Outcome Measures
Full Information
NCT ID
NCT05247398
First Posted
January 27, 2022
Last Updated
February 24, 2023
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT05247398
Brief Title
Mechanisms of a Dynamic Stability Approach
Official Title
Mechanisms of a Dynamic Stability Approach
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 18, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background. Arthritis is the leading cause of disability in the United States and osteoarthritis (OA) of the hand affects an estimated 25.6 US residents. OA of the thumb carpometacarpal (CMC) joint is the most disabling form of hand OA. Rehabilitation for persons with thumb CMC OA is recommended as the initial treatment and often involves instruction on joint protection and fitting of a splint to reduce joint stress and pain. More recently, evidence has suggested that specialized exercise may impact a factor linked to this condition, altered joint mechanics. Health records data also suggests that these exercises reduce pain and disability more than what would be experienced by those receiving standard care (SOC) rehabilitation. However, there has not yet been a prospective investigation on how these dynamic stability (DS) exercises alter joint mechanics, improve function, and reduce pain relative to standard treatment. Relatedly, thumb CMC mechanics are most often assessed by physicians through CAT scan and although rehabilitation therapists are not licensed to conduct such assessments, they could benefit from 'real-time' imaging to inform and evaluate the mechanical effects of treatment. Sonography might afford therapists the precision to evaluate mechanical response to treatment yet it is not yet known if thumb CMC sonography corresponds with the gold standard, CAT scan.
Goal and Specific Aims. The long term goal this line of study is to reduce the effects of thumb CMC OA on activity performance and participation through non-invasive and non- pharmacological interventions. We expect to achieve our goals by pursuit of the following two specific aims: 1). Determine if a novel exercise regimen reduces radiographic thumb CMC joint misalignment among persons with thumb carpometacarpal osteoarthritis and 2) Evaluate the accuracy of ultrasound compared with CAT scan (reference standard) for quantifying thumb CMC subluxation
Design and Methods. Specific aim 1 will be addressed through a prospective pre-post interventional study of a 8-week clinic-based dynamic stability program and will undergo a CAT scan before treatment and upon completion of the program (9 weeks) and specific aim 3 will be addressed through a psychometric 'concurrent validity' design.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thumb Carpometacarpal Osteoarthritis, Thumb Basal Joint Osteoarthritis
Keywords
Arthritis, Exercise, Thumb, Treatment, Intervention, Dynamic stability, Hand, Therapy, Occupational, Physical
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
prospective pre-postinterventional study
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dynamic Stability Exercise Program
Arm Type
Experimental
Arm Description
Involves four 60-minute occupational therapy visits as well as a daily home program across a 8-week period. Clinic visits focus primarily on home program coaching, and progression of the exercise regimen. Home programs involve daily exercises which follow the intensity and duration recommended for older adults. The intervention focuses on enhancing mobility and strength of the thumb for use during daily activities.
Intervention Type
Other
Intervention Name(s)
Dynamic Stability Exercise Program
Intervention Description
The thumb CMC DS intervention involves four 60-minute occupational therapy visits as well as a daily home program across a 8-week period. Clinic visits focus primarily on home program coaching, and progression of the exercise regimen. Home programs involve daily exercises which follow the intensity and duration recommended for older adults.
Primary Outcome Measure Information:
Title
Subluxation of thumb carpometacarpal joint as per CAT scan
Description
CAT scan will be used at baseline and 9 weeks to obtain measurements as per the American College of Radiology's 2013 Technical Standards. A validated positioning jig reproduced by our lab will be used to maintain standardized joint positioning and standardize stress to the thumb metacarpal during fluoroscopic examination. "Joint subluxation" is a measure of thumb CMC instability and will be measured in centimeters.
Time Frame
baseline
Title
Subluxation of thumb carpometacarpal joint as per CAT scan
Description
CAT scan will be used at baseline and 9 weeks to obtain measurements as per the American College of Radiology's 2013 Technical Standards. A validated positioning jig reproduced by our lab will be used to maintain standardized joint positioning and standardize stress to the thumb metacarpal during fluoroscopic examination. "Joint subluxation" is a measure of thumb CMC instability and will be measured in centimeters.
Time Frame
9 weeks post intervention
Title
Subluxation of thumb carpometacarpal joint as per sonography
Description
Sonographic assessment of thumb carpometacarpal subluxation will occur at the time of participants' baseline CAT scan. The same views, position jig and standardized upper limb postures used for the fluoroscopic assessments will again be employed. The thumb CMC joint sonographic procedures described by Oo et al. and the general guidelines put forth by American Institute of Ultrasound in Medicine will be followed. Long axis views of the dorsal and radial borders of the thumb CMC joint will be visualized via use of the Philips Lumify Portable Sonography Device. In these views, the amount of translation of metacarpal base with respect to trapezium will be quantified in millimeters
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adults with radiographically-confirmed thumb CMC OA
Exclusion Criteria:
Persons who have had cortisone treatments to the affected thumb within the prior three months, thumb CMC joint replacement, inflammatory arthritis, Ehlers Danlos Syndrome, Marfan's disease, pregnancy or questionable pregnancy, cognitive disorders which would preclude a client from following the testing commands and home program participation, concomitant conditions affecting the arthritic thumb, grade 4 arthritis staging, no ongoing hand rehabilitation (i.e., within prior 6 months), non-English Speaking, and pain which precludes participants from completing testing
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Corey McGee
Phone
6126265645
Email
mcgee0062@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corey McGee
Organizational Affiliation
UMN
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corey McGee
Phone
612-626-5645
Email
mcgee0062@umn.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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