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Completed

NCT Number: NCT05247398

Mechanisms of a Dynamic Stability Approach

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.

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Key information

Conditions

Thumb Carpometacarpal Osteoarthritis Arthritis Behavior Joint Diseases Motor Activity Musculoskeletal Diseases Thumb Basal Joint Osteoarthritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dynamic Stability Exercise Program

Other

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 outcomes

  1. Subluxation of Thumb Carpometacarpal Joint as Per CAT Scan

    Time frame: baseline

    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.

  2. Subluxation of Thumb Carpometacarpal Joint as Per CAT Scan

    Time frame: 9 weeks post intervention

    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.

  3. Subluxation of Thumb Carpometacarpal Joint as Per Sonography

    Time frame: baseline

    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 outcomes

  1. Michigan Hand Questionnaire

    Time frame: Baseline

    Disability was measured with the Michigan Hand Outcomes Questionnaire (MHQ), an upper extremity-specific self-report questionnaire assessing symptomology and disability across 6 domains: hand function, activities of daily living, work performance, satisfaction, aesthetics/cosmesis, and pain. Right- and left-hand total and subscale scores are produced. Scores range from 0-100, with higher total scores and scores across the first 5 subscales indicating greater abilities or better results, and lower scores on the last subscale indicating less pain. The MHQ has high reliability, validity, and responsiveness among adults with upper extremity rheumatic conditions including OA. For this study, only the total score of the affected hand was reported. Given the high prevalence of bilateral CMC1 OA, the total score from the dominant hand was selected when bilateral CMC1 OA was present.

  2. Michigan Hand Questionnaire

    Time frame: 9 weeks

    Disability was measured with the Michigan Hand Outcomes Questionnaire (MHQ), an upper extremity-specific self-report questionnaire assessing symptomology and disability across 213 6 domains: hand function, activities of daily living, work performance, satisfaction, aesthetics/cosmesis, and pain. Right- and left-hand total and subscale scores are produced. Scores range from 0-100, with higher total scores and scores across the first 5 subscales indicating greater abilities or better results, and lower scores on the last subscale indicating less pain. The MHQ has high reliability, validity, and responsiveness among adults with upper extremity rheumatic conditions including OA. For this study, only the total score of the affected 219 hand was reported. Given the high prevalence of bilateral CMC1 OA, the total score from the dominant hand was selected when bilateral CMC1 OA was present.

  3. Numerical Pain Rating

    Time frame: Baseline

    Pain severity was measured with a 0-10 Numerical Pain Rating Scale (NPRS), from which participants rated their pain intensity during daily activities over the last 24 hours, with 0 indicating no pain and 10 indicating the worst imaginable pain. The NPRS was selected because it has been established as a clinically relevant tool in persons with various rheumatic diagnoses including CMC1 OA.

  4. Numerical Pain Rating

    Time frame: 9 weeks

    Pain severity was measured with a 0-10 Numerical Pain Rating Scale (NPRS), from which participants rated their pain intensity during daily activities over the last 24 hours, with 0 indicating no pain and 10 indicating the worst imaginable pain. The NPRS was selected because it has been established as a clinically relevant tool in persons with various rheumatic diagnoses including CMC1 OA.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 18, 2022
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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