Clinical trial NCT03177577: Strengthening of the First Dorsal Interosseous for Thumb Carpometacarpal Osteoarthritis
Official title: Strengthening of the First Dorsal Interosseous for Thumb Carpometacarpal Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thumb Osteoarthritis
First Dorsal Interosseous Strengthening
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effect of first dorsal interosseus (FDI) strengthening in patients with thumb carpometacarpal (CMC) osteoarthritis.

Detailed description: Thumb CMC osteoarthritis is a normal part of aging. Most patients are able to adapt to symptoms of pain and disability, other patients might benefit from non-operative interventions; e.g. splinting, corticosteroid injections, pain medication, and multiple hand exercises.

The dorsal ligament complex is one of the components for stability of the thumb CMC joint. These ligaments specifically create stability for pinch and grip during the final phase of opposition. Both, the opponens pollicis (OP) and the first dorsal interosseous (FDI) play a key role in centralizing the metacarpal on the trapezium. A retrospective study showed that a dynamic stability modeled approach, including targeting the FDI, reduced pain and improved function in patients with thumb CMC osteoarthritis. Recently, another study demonstrated that reduction of radial subluxation - the thumb metacarpal versus the trapezium CMC joint - was achieved by contraction of the dynamic stabilizers of the healthy hand, specifically with the focus on the FDI.

More clinical research is needed to determine if there are efficacious (effective and low-cost) evidence-based exercise programs for pain reduction and functional improvement in patients with thumb CMC osteoarthritis. The investigators are interested in the effect of FDI strengthening in patients with thumb CMC osteoarthritis. Therefore, the investigators hypothesized that there is no difference in the change of lateral pinch strength at 12 weeks between patients treated with a splint versus patients treated with a splint and FDI strengthening for thumb CMC osteoarthritis. We also tested the same hypothesis for 3-point chuck strength, VAS for pain, and PROMIS Upper Extremity CAT.

Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* English-speaking
* Splint treatment for thumb carpometacarpal (CMC) osteoarthritis

Exclusion Criteria:

* Less than 18 years old
* Rheumatoid Arthritis or post-traumatic carpometacarpal (CMC) osteoarthritis
* Patients that received a corticosteroid injection during the appointment for treatment of thumb carpometacarpal (CMC) osteoarthritis

Primary outcomes:
measure: Difference in 3-point chuck strength at 12 weeks
timeFrame: At enrollment and 12 week follow up
measure: Difference in Lateral pinch strength at 12 weeks
timeFrame: At enrollment and 12 week follow up
measure: Visual Analog Scale (VAS) for Pain
timeFrame: At enrollment and 12 week follow up
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Computer Adaptive Test (CAT) at 12 weeks
timeFrame: At Enrollment and 12 week follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Neal Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sodha S, Ring D, Zurakowski D, Jupiter JB. Prevalence of osteoarthrosis of the trapeziometacarpal joint. J Bone Joint Surg Am. 2005 Dec;87(12):2614-2618. doi: 10.2106/JBJS.E.00104.
citation: Edmunds JO. Traumatic dislocations and instability of the trapeziometacarpal joint of the thumb. Hand Clin. 2006 Aug;22(3):365-92. doi: 10.1016/j.hcl.2006.05.001.
citation: O'Brien VH, Giveans MR. Effects of a dynamic stability approach in conservative intervention of the carpometacarpal joint of the thumb: a retrospective study. J Hand Ther. 2013 Jan-Mar;26(1):44-51; quiz 52. doi: 10.1016/j.jht.2012.10.005. Epub 2012 Nov 21.
citation: McGee C, O'Brien V, Van Nortwick S, Adams J, Van Heest A. First dorsal interosseous muscle contraction results in radiographic reduction of healthy thumb carpometacarpal joint. J Hand Ther. 2015 Oct-Dec;28(4):375-80; quiz 381. doi: 10.1016/j.jht.2015.06.002. Epub 2015 Jun 27.