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

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ClinicalTrials.gov Identifier: NCT01775670
Recruitment Status : Terminated (Due to the principal investigator leaving the institution and slow enrollment, we have decided to close the study prior to study completion)
First Posted : January 25, 2013
Results First Posted : May 15, 2017
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
David C. Ring, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Trapeziometacarpal (TMC) Arthrosis
Interventions Device: Off-the-shelf splint
Device: OT Splint
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Off-the-Shelf Splint OT Splint
Hide Arm/Group Description

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

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.

Period Title: Overall Study
Started 1 3
Completed 0 2
Not Completed 1 1
Reason Not Completed
Lost to Follow-up             1             1
Arm/Group Title Off-the-Shelf Splint OT Splint Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 1 3 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 3 participants 4 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
 100.0%
1
  33.3%
2
  50.0%
>=65 years
0
   0.0%
2
  66.7%
2
  50.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants 3 participants 4 participants
60 [1]   (NA) 66.3  (4.2) 64.8  (4.6)
[1]
There is only one participant in this study arm.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 3 participants 4 participants
Female
1
 100.0%
3
 100.0%
4
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 3 participants 4 participants
1 3 4
1.Primary Outcome
Title Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Off-the-Shelf Splint OT Splint
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 1 2
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.5 [1]   (NA) 29.5  (6.43)
[1]
There was only one participant's data available therefore no standard deviation calculated.
2.Primary Outcome
Title Change From the Baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 2 Months After Enrollment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The one subject in the off-the-shelf group was lost to follow up.
Arm/Group Title Off-the-Shelf Splint OT Splint
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 0 2
Mean (Standard Deviation)
Unit of Measure: units on a scale
20.5  (6.85)
3.Primary Outcome
Title Thumb Pain at Enrollment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Off-the-Shelf Splint OT Splint
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 1 2
Mean (Standard Deviation)
Unit of Measure: units on a scale
3 [1]   (NA) 5.5  (3.5)
[1]
There was only one subject with data to analyze, therefore no standard deviation possible.
4.Primary Outcome
Title Average Satisfaction With the Splint 2 Months After Enrollment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Off-the-Shelf Splint OT Splint
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 0 2
Mean (Standard Deviation)
Unit of Measure: units on a scale
4  (1.4)
5.Primary Outcome
Title Average Pain 2 Months After Enrollment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects did not complete the pain scale questionnaire at the follow up visit.
Arm/Group Title Off-the-Shelf Splint OT Splint
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Patient Reported Outcomes Measurement Information System (PROMIS) – Depression
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The data was not recorded for the 1 patient randomized to the off-the-shelf group.
Arm/Group Title Off-the-Shelf Splint OT Splint
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 0 2
Mean (Standard Deviation)
Unit of Measure: T score
38.9  (6.6)
7.Secondary Outcome
Title PROMIS Pain – Interference
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Off-the-Shelf Splint OT Splint
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 0 2
Mean (Standard Deviation)
Unit of Measure: T score
54.5  (2.33)
8.Secondary Outcome
Title Thumb Metacarpophalangeal (MCP) Joint in Resting Position (Degrees)
Hide Description Measurements of thumb metacarpophalangeal (MCP) joint in resting position.
Time Frame At Enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Off-the-Shelf Splint OT Splint
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 0 2
Mean (Standard Deviation)
Unit of Measure: degrees
7.5  (3.5)
9.Secondary Outcome
Title Thumb MCP in Pinch Position (Degrees)
Hide Description Measurements of thumb MCP in pinch position.
Time Frame At Enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Off-the-Shelf Splint OT Splint
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 0 2
Mean (Standard Deviation)
Unit of Measure: degrees
10  (0)
10.Secondary Outcome
Title Thumb Pinch Strength
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Off-the-Shelf Splint OT Splint
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 1 2
Mean (Standard Deviation)
Unit of Measure: pounds
7.67 [1]   (NA) 10.67  (0.94)
[1]
There was only one subject's data available to analyze, therefore there is no standard deviation.
11.Secondary Outcome
Title Thumb Grip Strength
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Off-the-Shelf Splint OT Splint
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 1 2
Mean (Standard Deviation)
Unit of Measure: pounds
24.67 [1]   (NA) 39.67  (14.61)
[1]
There was only one subject's data available to analyze, therefore there is no standard deviation available to report.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Off-the-Shelf Splint OT Splint
Hide Arm/Group Description

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

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.

All-Cause Mortality
Off-the-Shelf Splint OT Splint
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/3 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Off-the-Shelf Splint OT Splint
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Off-the-Shelf Splint OT Splint
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/3 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Taylor Pong
Organization: Massachusetts General Hospital
EMail: tpong1@partners.org
Layout table for additonal information
Responsible Party: David C. Ring, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01775670     History of Changes
Other Study ID Numbers: 1
First Submitted: January 22, 2013
First Posted: January 25, 2013
Results First Submitted: January 13, 2016
Results First Posted: May 15, 2017
Last Update Posted: May 15, 2017