Trapeziometacarpal (TMC) Arthrosis
Conditions
Keywords
Arthrosis
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.
Interventions
DEVICEOff-the-shelf splint
Subjects will use an off-the-shelf splint
DEVICEOT Splint
Subjects will use a splint custom-made by Massachusetts General Hospital Occupational Therapists.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) | At 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. |
| Change From the Baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 2 Months After Enrollment | 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. |
| Thumb Pain at Enrollment | 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. |
| Average Satisfaction With the Splint 2 Months After Enrollment | At 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. |
| Average Pain 2 Months After Enrollment | At 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcomes Measurement Information System (PROMIS) - Depression | At Enrollment | 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. |
| Thumb Grip Strength | At Enrollment | 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. |
| PROMIS Pain - Interference | At Enrollment | 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. |
| Thumb Metacarpophalangeal (MCP) Joint in Resting Position (Degrees) | At Enrollment | Measurements of thumb metacarpophalangeal (MCP) joint in resting position. |
| Thumb MCP in Pinch Position (Degrees) | At Enrollment | Measurements of thumb MCP in pinch position. |
| Thumb Pinch Strength | At Enrollment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Off-the-Shelf Splint Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.
Off-the-shelf splint: Subjects will use an off-the-shelf splint | 1 |
| OT Splint Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.
OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists. | 3 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | OT Splint | Off-the-Shelf Splint | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 0 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Continuous | 66.3 years STANDARD_DEVIATION 4.2 | 60 years | 64.8 years STANDARD_DEVIATION 4.6 |
| Region of Enrollment United States | 3 participants | 1 participants | 4 participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 3 |
| other Total, other adverse events | 0 / 1 | 0 / 3 |
| serious Total, serious adverse events | 0 / 1 | 0 / 3 |
Outcome results
Primary
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
Population: Subjects did not complete the pain scale questionnaire at the follow up visit.
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OT Splint | Average Satisfaction With the Splint 2 Months After Enrollment | 4 units on a scale | Standard Deviation 1.4 |
Primary
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
Population: The one subject in the off-the-shelf group was lost to follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 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 units on a scale | Standard Deviation 6.85 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Off-the-Shelf Splint | Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) | 4.5 units on a scale | — |
| OT Splint | Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) | 29.5 units on a scale | Standard Deviation 6.43 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Off-the-Shelf Splint | Thumb Pain at Enrollment | 3 units on a scale | — |
| OT Splint | Thumb Pain at Enrollment | 5.5 units on a scale | Standard Deviation 3.5 |
Secondary
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
Population: The data was not recorded for the 1 patient randomized to the off-the-shelf group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OT Splint | Patient Reported Outcomes Measurement Information System (PROMIS) - Depression | 38.9 T score | Standard Deviation 6.6 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OT Splint | PROMIS Pain - Interference | 54.5 T score | Standard Deviation 2.33 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Off-the-Shelf Splint | Thumb Grip Strength | 24.67 pounds | — |
| OT Splint | Thumb Grip Strength | 39.67 pounds | Standard Deviation 14.61 |
Secondary
Thumb MCP in Pinch Position (Degrees)
Measurements of thumb MCP in pinch position.
Time frame: At Enrollment
Population: The measurement of the thumb MCP joint in a pinch position was the same, 10 degrees, for the 2 subjects in the OT splint group, therefore the standard deviation is 0.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OT Splint | Thumb MCP in Pinch Position (Degrees) | 10 degrees | Standard Deviation 0 |
Secondary
Thumb Metacarpophalangeal (MCP) Joint in Resting Position (Degrees)
Measurements of thumb metacarpophalangeal (MCP) joint in resting position.
Time frame: At Enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OT Splint | Thumb Metacarpophalangeal (MCP) Joint in Resting Position (Degrees) | 7.5 degrees | Standard Deviation 3.5 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Off-the-Shelf Splint | Thumb Pinch Strength | 7.67 pounds | — |
| OT Splint | Thumb Pinch Strength | 10.67 pounds | Standard Deviation 0.94 |