Sponsor study identifier
Secondary identifiers
NIH
NIH
interventional
21
1 country
1
Study Start
July 18, 2022
Actual (reported)Primary Completion
June 30, 2024
Actual (reported)Study Completion
June 30, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 27, 2022
Actual (reported)February 18, 2022
Actual (reported)July 18, 2022
Actual (reported)June 30, 2024
Actual (reported)June 30, 2024
Actual (reported)November 20, 2025
Actual (reported)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 millimeters.
baseline
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 millimeters.
9 weeks post 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. The intervention focuses on enhancing mobility and strength of the thumb for use during daily activities.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Fluoroscopic measurements were initially planned rather than CAT but the instrumentation proved unreliable and inaccessible. CAT imaging offered a more robust and reliable solution but additional time was needed for procedural changes and IRB approval. While CAT data affords opportunities for more rigorous assessment of joint kinematics, the negligible joint space found within the thumbs of many participants has slowed our capacity to segment the images when preparing 3D models.
Corey McGee
UMN
21 participants (actual enrollment reported by the registry).
First Submitted
January 27, 2022
First Posted
February 18, 2022
Study Start
July 18, 2022
Actual (reported)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
baseline
Michigan Hand Questionnaire
Baseline
Michigan Hand Questionnaire
9 weeks
Numerical Pain Rating
Baseline
Numerical Pain Rating
9 weeks
Contact the study team to confirm eligibility.
Primary Completion
June 30, 2024
Actual (reported)Study Completion
June 30, 2024
Actual (reported)Last Updated
November 20, 2025
Results First Posted
November 20, 2025
Record last verified: 2025-11
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Source: ClinicalTrials.gov.
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