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

NCT ID: NCT01775670

Last Updated: 2017-05-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2016-01-31

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.

Conditions

Trapeziometacarpal (TMC) Arthrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Off-the-Shelf Splint

Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.

Group Type: EXPERIMENTAL

Off-the-shelf splint

Intervention Type: DEVICE

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 Occupational Therapists.

Group Type: ACTIVE_COMPARATOR

OT Splint

Intervention Type: DEVICE

Subjects will use a splint custom-made by Massachusetts General Hospital Occupational Therapists.

Interventions

Off-the-shelf splint

Subjects will use an off-the-shelf splint

Intervention Type: DEVICE

OT Splint

Subjects will use a splint custom-made by Massachusetts General Hospital Occupational Therapists.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

David C. Ring, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David C Ring, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

1

Identifier Type: -

Identifier Source: org_study_id