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

This study has been terminated.
(Due to the principal investigator leaving the institution and slow enrollment, we have decided to close the study prior to study completion)
Sponsor:
Information provided by (Responsible Party):
David C. Ring, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01775670
First received: January 22, 2013
Last updated: April 6, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention
Trapeziometacarpal (TMC) Arthrosis Device: Off-the-shelf splint Device: OT Splint

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Off-the-Shelf Splints Versus Occupational Therapy Splints for Treatment of Trapeziometacarpal Arthrosis

Resource links provided by NLM:


Further study details as provided by David C. Ring, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) [ Time Frame: 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.

  • Change From the Baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 2 Months After Enrollment [ Time Frame: 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.

  • Thumb Pain at Enrollment [ Time Frame: 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.

  • Average Satisfaction With the Splint 2 Months After Enrollment [ Time Frame: 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.

  • Average Pain 2 Months After Enrollment [ Time Frame: At 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.


Secondary Outcome Measures:
  • Patient Reported Outcomes Measurement Information System (PROMIS) - Depression [ Time Frame: At Enrollment ]
    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.

  • PROMIS Pain - Interference [ Time Frame: 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.

  • Thumb Metacarpophalangeal (MCP) Joint in Resting Position (Degrees) [ Time Frame: At Enrollment ]
    Measurements of thumb metacarpophalangeal (MCP) joint in resting position.

  • Thumb MCP in Pinch Position (Degrees) [ Time Frame: At Enrollment ]
    Measurements of thumb MCP in pinch position.

  • Thumb Pinch Strength [ Time Frame: 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.

  • Thumb Grip Strength [ Time Frame: 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.


Enrollment: 4
Study Start Date: February 2013
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01775670

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: David C Ring, MD, PhD Massachusetts General Hospital
  More Information

Responsible Party: David C. Ring, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01775670     History of Changes
Other Study ID Numbers: 1
Study First Received: January 22, 2013
Results First Received: January 13, 2016
Last Updated: April 6, 2017

Keywords provided by David C. Ring, MD, Massachusetts General Hospital:
Arthrosis

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on June 26, 2017