Clinical trial NCT05247398: Mechanisms of a Dynamic Stability Approach
Official title: Mechanisms of a Dynamic Stability Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thumb Carpometacarpal Osteoarthritis
Thumb Basal Joint Osteoarthritis
Keywords: Arthritis
Exercise
Thumb
Treatment
Intervention
Dynamic stability
Hand
Therapy
Occupational
Physical
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective pre-postinterventional study
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Subluxation of thumb carpometacarpal joint as per CAT scan
timeFrame: baseline
measure: Subluxation of thumb carpometacarpal joint as per CAT scan
timeFrame: 9 weeks post intervention
measure: Subluxation of thumb carpometacarpal joint as per sonography
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: UMN
name: Corey McGee
role: PRINCIPAL_INVESTIGATOR
References: