Trapeziometacarpal (TMC) Arthrosis Clinical Trial
Official title:
Off-the-Shelf Splints Versus Occupational Therapy Splints for Treatment of Trapeziometacarpal Arthrosis
The specific aim is to compare the effectiveness of Off-the-Shelf splints and splints provided by Occupational Therapy for treatment of trapeziometacarpal (TMC) arthrosis.
Trapeziometacarpal (TMC) arthrosis is so common, particularly in women, that it should be
considered a normal part of the aging process. Overall radiographic prevalence of TMC
arthrosis has been described to be as high as 91% in patients older than eighty years of
age. It increases steadily from the age of 41 years, more rapidly in women than in men.
Another study, conducted in the Netherlands, showed that in a population of 55 years and
older, 67% of women and 55% of men had radiographic signs of arthrosis of the hand. It also
found that the distal interphalangeal (DIP) joints are most commonly affected (47%),
followed by the TMC joint (36%). However, it has been reported that in symptomatic
arthrosis, TMC arthrosis contributes more to pain and disability than arthrosis of the
interphalangeal joints. Psychosocial factors have been recognized as the strongest
determinants of highly variable pain intensity and arm-specific disability. The
pathophysiologic and psychosocial differences between patients who present to the doctor for
treatment and those who do not are incompletely understood.
A hand-based thumb spica splint with the interphalangeal (IP) joint free is a specific
nonoperative palliative treatment for TMC arthrosis. The goals of splint wear are improved
comfort and function. The data regarding specific splint materials are limited, but suggest
that shorter more flexible splints are preferred by patients and equally effective.
Recently, the investigators looked into if there was a difference between thermoplast and
neoprene hand-based thumb spica splints for treatment of TMC arthrosis. The neoprene splint
was rated more comfortable than the thermoplast splint but otherwise there was no
difference.
To the investigators' knowledge no studies have looked at the added value of occupational
therapy in splint treatment for TMC arthrosis. The investigators believe that the time spent
by occupational therapists (OTs) coaching patients on adaptive and palliative measures is
valuable in addition to their technical skills but the investigators cannot draw any
conclusions until the investigators research this in a prospective trial.
The investigators propose a two arm unblinded, randomized (1:1) controlled trial to evaluate
if there is a difference between prefabricated off-the-shelf splints and splints provided by
an OT with standard care coaching. The investigators want to determine if there is a
difference in arm-specific disability, average pain, and satisfaction at an average of 2
months between splints provided by an OT and prefabricated off-the-shelf splints.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment