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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

Tracking Information
First Submitted Date  ICMJE January 22, 2013
First Posted Date  ICMJE January 25, 2013
Results First Submitted Date  ICMJE January 13, 2016
Results First Posted Date  ICMJE May 15, 2017
Last Update Posted Date May 15, 2017
Study Start Date  ICMJE February 2013
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 24, 2013)
  • Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) [ Time Frame: At enrollment ]
    The Quick-DASH measures the patient's ability to do following activities in the week before a visit.
  • 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 ]
    2-month change in the Quick-DASH, which measures the patient's ability to do following activities in the week before a visit.
  • Thumb Pain at Enrollment [ Time Frame: At enrollment ]
    Patient's thumb pain will be recorded on a numerical rating scale
  • Average thumb pain and satisfaction with the splint 2 months after enrollment [ Time Frame: At 2 months after enrollment ]
    Average thumb pain on a numerical scale and satisfaction with splint treatment will be assessed 2 months after enrollment.
Change History Complete list of historical versions of study NCT01775670 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2013)
  • Patient Reported Outcomes Measurement Information System (PROMIS) - Depression [ Time Frame: At Enrollment ]
    A computerized assessment of depression measured at enrollment.
  • PROMIS Pain - Interference [ Time Frame: At Enrollment ]
    A computerized assessment of pain interference measured at enrollment.
  • Thumb metacarpophalangeal (MCP) hyperextension, and grip and pinch strength [ Time Frame: At Enrollment ]
    Various measurements of thumb extension, grip and punch strength will be measured at enrollment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Off-the-Shelf Splints Versus Occupational Therapy Splints for Treatment of Trapeziometacarpal Arthrosis
Official Title  ICMJE Off-the-Shelf Splints Versus Occupational Therapy Splints for Treatment of Trapeziometacarpal Arthrosis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Trapeziometacarpal (TMC) Arthrosis
Intervention  ICMJE
  • Device: Off-the-shelf splint
    Subjects will use an off-the-shelf splint
  • Device: OT Splint
    Subjects will use a splint custom-made by Massachusetts General Hospital Occupational Therapists.
Study Arms  ICMJE
  • Experimental: Off-the-Shelf Splint
    Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.
    Intervention: Device: 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.
    Intervention: Device: OT Splint
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 6, 2017)
4
Original Estimated Enrollment  ICMJE
 (submitted: January 24, 2013)
90
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01775670
Other Study ID Numbers  ICMJE 1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David C. Ring, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David C Ring, MD, PhD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP