An interventional study of Off-the-shelf splint and OT Splint in Trapeziometacarpal (TMC) Arthrosis, sponsored by Massachusetts General Hospital. Terminated at 1 site in United States. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-15.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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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This study's enrollment of 4 is below the median of 70 across 3,474 interventional studies indexed under Osteoarthritis.
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Exclusion Criteria:
Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.
Device: Off-the-shelf splint
Subjects in this arm will be managed with a custom-made splint made by the Massachusetts General Hospital Occupational Therapists.
Device: OT Splint
Subjects will use an off-the-shelf splint
Subjects will use a splint custom-made by Massachusetts General Hospital Occupational Therapists.
Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH)
The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks.
Time frame: At enrollment
Change From the Baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 2 Months After Enrollment
The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks. This was measured 2-month after treatment.
Time frame: 2 months after enrollment
Thumb Pain at Enrollment
11-point ordinal pain scale to assess the amount of pain. The scale range is from 0-10, where 0 is no pain at all and 10 is the worst pain ever had.
Time frame: At enrollment
Average Satisfaction With the Splint 2 Months After Enrollment
Average satisfaction with splint treatment will be assessed 2 months after enrollment. 11-point ordinal pain scale to assess the amount of satisfaction. The scale range for satisfaction is from 0-10, where 0 is dissatisfaction and 10 is complete satisfaction with the splint.
Time frame: At 2 months after enrollment
Average Pain 2 Months After Enrollment
Average pain will be assessed 2 months after enrollment. 11-point ordinal pain scale to assess the amount of pain. The scale range for pain is from 0-10, where 0 is no pain and 10 is the worst pain.
Time frame: At 2 months after enrollment
Patient Reported Outcomes Measurement Information System (PROMIS) - Depression
A computerized assessment of depression measured at enrollment. The average T score of the U.S. population is 50, so the T score reported compares the study population to the U.S. population, where a T score greater than 50 is worse than the average and a T score less than 50 is better than the average.
Time frame: At Enrollment
PROMIS Pain - Interference
A computerized assessment of pain interference measured at enrollment. The average T score of the U.S. population is 50, so the T score reported compares the study population to the U.S. population, where a T score greater than 50 is worse than the average and a T score less than 50 is better than the average.
Time frame: At Enrollment
Thumb Metacarpophalangeal (MCP) Joint in Resting Position (Degrees)
Measurements of thumb metacarpophalangeal (MCP) joint in resting position.
Time frame: At Enrollment
Thumb MCP in Pinch Position (Degrees)
Measurements of thumb MCP in pinch position.
Time frame: At Enrollment
Thumb Pinch Strength
Measurement of thumb pinch strength using a pinch meter. Subjects place the pinch meter between their thumb and index finger and pinch down to record the pinch strength.
Time frame: At Enrollment
Thumb Grip Strength
Grip strength of the affected hand was measured at enrollment using a dynamometer. The subject squeezes the handle of the dynamometer to maximum capability to measure grip strength. Each subject completed the grip strength measurement 3 times on the affected hand to get an average grip strength of the affected hand.
Time frame: At Enrollment
| Milestone | Off-the-Shelf Splint | OT Splint |
|---|---|---|
| Started | 1 | 3 |
| Completed | 0 | 2 |
| Not completed | 1 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 |
The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks.
| units on a scale | Off-the-Shelf Splint | OT Splint |
|---|---|---|
| Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) | 4.5 ± NA | 29.5 ± 6.43 |
The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks. This was measured 2-month after treatment.
| units on a scale | Off-the-Shelf Splint | OT Splint |
|---|---|---|
| Change From the Baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 2 Months After Enrollment | — | 20.5 ± 6.85 |
11-point ordinal pain scale to assess the amount of pain. The scale range is from 0-10, where 0 is no pain at all and 10 is the worst pain ever had.
| units on a scale | Off-the-Shelf Splint | OT Splint |
|---|---|---|
| Thumb Pain at Enrollment | 3 ± NA | 5.5 ± 3.5 |
Average satisfaction with splint treatment will be assessed 2 months after enrollment. 11-point ordinal pain scale to assess the amount of satisfaction. The scale range for satisfaction is from 0-10, where 0 is dissatisfaction and 10 is complete satisfaction with the splint.
| units on a scale | Off-the-Shelf Splint | OT Splint |
|---|---|---|
| Average Satisfaction With the Splint 2 Months After Enrollment | — | 4 ± 1.4 |
A computerized assessment of depression measured at enrollment. The average T score of the U.S. population is 50, so the T score reported compares the study population to the U.S. population, where a T score greater than 50 is worse than the average and a T score less than 50 is better than the average.
| T score | Off-the-Shelf Splint | OT Splint |
|---|---|---|
| Patient Reported Outcomes Measurement Information System (PROMIS) - Depression | — | 38.9 ± 6.6 |
A computerized assessment of pain interference measured at enrollment. The average T score of the U.S. population is 50, so the T score reported compares the study population to the U.S. population, where a T score greater than 50 is worse than the average and a T score less than 50 is better than the average.
| T score | Off-the-Shelf Splint | OT Splint |
|---|---|---|
| PROMIS Pain - Interference | — | 54.5 ± 2.33 |
Measurements of thumb metacarpophalangeal (MCP) joint in resting position.
| degrees | Off-the-Shelf Splint | OT Splint |
|---|---|---|
| Thumb Metacarpophalangeal (MCP) Joint in Resting Position (Degrees) | — | 7.5 ± 3.5 |
Measurements of thumb MCP in pinch position.
| degrees | Off-the-Shelf Splint | OT Splint |
|---|---|---|
| Thumb MCP in Pinch Position (Degrees) | — | 10 ± 0 |
Measurement of thumb pinch strength using a pinch meter. Subjects place the pinch meter between their thumb and index finger and pinch down to record the pinch strength.
| pounds | Off-the-Shelf Splint | OT Splint |
|---|---|---|
| Thumb Pinch Strength | 7.67 ± NA | 10.67 ± 0.94 |
Grip strength of the affected hand was measured at enrollment using a dynamometer. The subject squeezes the handle of the dynamometer to maximum capability to measure grip strength. Each subject completed the grip strength measurement 3 times on the affected hand to get an average grip strength of the affected hand.
| pounds | Off-the-Shelf Splint | OT Splint |
|---|---|---|
| Thumb Grip Strength | 24.67 ± NA | 39.67 ± 14.61 |
Average pain will be assessed 2 months after enrollment. 11-point ordinal pain scale to assess the amount of pain. The scale range for pain is from 0-10, where 0 is no pain and 10 is the worst pain.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Off-the-Shelf Splint | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| OT Splint | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Age, Categorical(Participants) | Off-the-Shelf Splint | OT Splint | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 1 | 2 |
| >=65 years | 0 | 2 | 2 |
| Age, Continuous(years) | Off-the-Shelf Splint | OT Splint | Total |
|---|---|---|---|
| Mean | 60 ± NA | 66.3 ± 4.2 | 64.8 ± 4.6 |
| Sex: Female, Male(Participants) | Off-the-Shelf Splint | OT Splint | Total |
|---|---|---|---|
| Female | 1 | 3 | 4 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Off-the-Shelf Splint | OT Splint | Total |
|---|---|---|---|
| United States | 1 | 3 | 4 |
This study is terminated, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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