Clinical trial NCT01775670: Off-the-Shelf Splints Versus Occupational Therapy Splints for Treatment of Trapeziometacarpal Arthrosis
Official title: Off-the-Shelf Splints Versus Occupational Therapy Splints for Treatment of Trapeziometacarpal Arthrosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Trapeziometacarpal (TMC) Arthrosis
Keywords: Arthrosis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2013-01-25
Enrollment: 4
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 40 years of age and older
2. Clinical or radiological diagnosis of TMC arthrosis by MD
3. English fluency and literacy

Exclusion Criteria:

1. Prior surgical treatment of TMC arthrosis on same side
2. Prior treatment of TMC arthrosis on same side with a splint during the last two months
3. Prior injury of the trapeziometacarpal joint
4. Rheumatoid arthritis
5. Pregnant women.

Primary outcomes:
measure: Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH)
timeFrame: At enrollment
measure: Change From the Baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 2 Months After Enrollment
timeFrame: 2 months after enrollment
measure: Thumb Pain at Enrollment
timeFrame: At enrollment
measure: Average Satisfaction With the Splint 2 Months After Enrollment
timeFrame: At 2 months after enrollment
measure: Average Pain 2 Months After Enrollment
timeFrame: At 2 months after enrollment
Secondary outcomes:
measure: Patient Reported Outcomes Measurement Information System (PROMIS) - Depression
timeFrame: At Enrollment
measure: PROMIS Pain - Interference
timeFrame: At Enrollment
measure: Thumb Metacarpophalangeal (MCP) Joint in Resting Position (Degrees)
timeFrame: At Enrollment
measure: Thumb MCP in Pinch Position (Degrees)
timeFrame: At Enrollment
measure: Thumb Pinch Strength
timeFrame: At Enrollment
measure: Thumb Grip Strength
timeFrame: At Enrollment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: David C Ring, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: