Trial Outcomes & Findings for Off-the-Shelf Splints Versus Occupational Therapy Splints for Treatment of Trapeziometacarpal Arthrosis (NCT NCT01775670)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

At enrollment

Results posted on

2017-05-15

Participant Flow

Participant milestones

Participant milestones
Measure	Off-the-Shelf Splint Subjects in this arm will be managed with off-the-shelf splints for trapeziometacarpal (TMC) arthrosis. Off-the-shelf splint: Subjects will use an off-the-shelf splint	OT Splint Subjects in this arm will be managed with a custom-made splint made by the Massachusetts General Hospital (MGH) Occupational Therapists. Occupational Therapy (OT) Splint: Subjects will use a splint custom-made by MGH Occupational Therapists.
Overall Study STARTED	1	3
Overall Study COMPLETED	0	2
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Off-the-Shelf Splint Subjects in this arm will be managed with off-the-shelf splints for trapeziometacarpal (TMC) arthrosis. Off-the-shelf splint: Subjects will use an off-the-shelf splint	OT Splint Subjects in this arm will be managed with a custom-made splint made by the Massachusetts General Hospital (MGH) Occupational Therapists. Occupational Therapy (OT) Splint: Subjects will use a splint custom-made by MGH Occupational Therapists.
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Off-the-Shelf Splints Versus Occupational Therapy Splints for Treatment of Trapeziometacarpal Arthrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Off-the-Shelf Splint n=1 Participants 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	OT Splint n=3 Participants 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.	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	60 years STANDARD_DEVIATION NA • n=5 Participants	66.3 years STANDARD_DEVIATION 4.2 • n=7 Participants	64.8 years STANDARD_DEVIATION 4.6 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Off-the-Shelf Splint n=1 Participants 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	OT Splint n=2 Participants 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.
Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH)	4.5 units on a scale Standard Deviation NA There was only one participant's data available therefore no standard deviation calculated.	29.5 units on a scale Standard Deviation 6.43

PRIMARY outcome

Timeframe: 2 months after enrollment

Population: The one subject in the off-the-shelf group was lost to follow up.

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.

Outcome measures

Outcome measures
Measure	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	OT Splint n=2 Participants 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.
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 outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Off-the-Shelf Splint n=1 Participants 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	OT Splint n=2 Participants 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.
Thumb Pain at Enrollment	3 units on a scale Standard Deviation NA There was only one subject with data to analyze, therefore no standard deviation possible.	5.5 units on a scale Standard Deviation 3.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	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	OT Splint n=2 Participants 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.
Average Satisfaction With the Splint 2 Months After Enrollment	—	4 units on a scale Standard Deviation 1.4

PRIMARY outcome

Timeframe: At 2 months after enrollment

Population: Subjects did not complete the pain scale questionnaire at the follow up visit.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Enrollment

Population: The data was not recorded for the 1 patient randomized to the off-the-shelf group.

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.

Outcome measures

Outcome measures
Measure	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	OT Splint n=2 Participants 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.
Patient Reported Outcomes Measurement Information System (PROMIS) - Depression	—	38.9 T score Standard Deviation 6.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	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	OT Splint n=2 Participants 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.
PROMIS Pain - Interference	—	54.5 T score Standard Deviation 2.33

SECONDARY outcome

Timeframe: At Enrollment

Measurements of thumb metacarpophalangeal (MCP) joint in resting position.

Outcome measures

Outcome measures
Measure	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	OT Splint n=2 Participants 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.
Thumb Metacarpophalangeal (MCP) Joint in Resting Position (Degrees)	—	7.5 degrees Standard Deviation 3.5

SECONDARY outcome

Timeframe: 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.

Measurements of thumb MCP in pinch position.

Outcome measures

Outcome measures
Measure	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	OT Splint n=2 Participants 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.
Thumb MCP in Pinch Position (Degrees)	—	10 degrees Standard Deviation 0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Off-the-Shelf Splint n=1 Participants 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	OT Splint n=2 Participants 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.
Thumb Pinch Strength	7.67 pounds Standard Deviation NA There was only one subject's data available to analyze, therefore there is no standard deviation.	10.67 pounds Standard Deviation 0.94

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Off-the-Shelf Splint n=1 Participants 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	OT Splint n=2 Participants 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.
Thumb Grip Strength	24.67 pounds Standard Deviation NA There was only one subject's data available to analyze, therefore there is no standard deviation available to report.	39.67 pounds Standard Deviation 14.61

Adverse Events

Off-the-Shelf Splint

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

OT Splint

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Taylor Pong

Massachusetts General Hospital

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place