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

Trapeziometacarpal (TMC) Arthrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01775670
• Other study ID #: 1
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 22, 2013
• Last updated: February 12, 2015
• Start date: February 2013

Study information

• Verified date: February 2015
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Joint Diseases
• Osteoarthritis
• Trapeziometacarpal (TMC) Arthrosis

Intervention

Device:
• Off-the-shelf splint
Subjects will use an off-the-shelf splint
• OT Splint
Subjects will use a splint custom-made by MGH Occupational Therapists.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH)	The Quick-DASH measures the patient's ability to do following activities in the week before a visit.	At enrollment	No
Primary	Change from the baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 2 months after enrollment	2-month change in the Quick-DASH, which measures the patient's ability to do following activities in the week before a visit.	2 months after enrollment	No
Primary	Thumb pain at enrollment	Patient's thumb pain will be recorded on a numerical rating scale	At enrollment	No
Primary	Average thumb pain and satisfaction with the splint 2 months after enrollment	Average thumb pain on a numerical scale and satisfaction with splint treatment will be assessed 2 months after enrollment.	At 2 months after enrollment	No
Secondary	Patient Reported Outcomes Measurement Information System (PROMIS) - Depression	A computerized assessment of depression measured at enrollment.	At Enrollment	No
Secondary	PROMIS Pain - Interference	A computerized assessment of pain interference measured at enrollment.	At Enrollment	No
Secondary	Thumb metacarpophalangeal (MCP) hyperextension, and grip and pinch strength	Various measurements of thumb extension, grip and punch strength will be measured at enrollment.	At Enrollment	No