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

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.

Study Overview

• Status: Terminated
• Conditions: Trapeziometacarpal (TMC) Arthrosis
• Intervention / Treatment: Device: Off-the-shelf splint; Device: OT Splint

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Off-the-Shelf Splint; Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.	Device: Off-the-shelf splint; Subjects will use an off-the-shelf splint
Active Comparator: OT 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 a splint custom-made by Massachusetts General Hospital Occupational Therapists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	At 2 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	At Enrollment
Thumb Metacarpophalangeal (MCP) Joint in Resting Position (Degrees)	Measurements of thumb metacarpophalangeal (MCP) joint in resting position.	At Enrollment
Thumb MCP in Pinch Position (Degrees)	Measurements of thumb MCP in pinch position.	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.	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.	At Enrollment

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: David C Ring, MD, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: January 22, 2013
• First Submitted That Met QC Criteria: January 24, 2013
• First Posted (Estimate): January 25, 2013

Study Record Updates

• Last Update Posted (Actual): May 15, 2017
• Last Update Submitted That Met QC Criteria: April 6, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Arthrosis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Joint Diseases
• Other Study ID Numbers: 1