NCT01775670

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 25, 2013

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

May 15, 2017

Completed
Last Updated

May 15, 2017

Status Verified

April 1, 2017

Enrollment Period

2.9 years

First QC Date

January 22, 2013

Results QC Date

January 13, 2016

Last Update Submit

April 6, 2017

Conditions

Trapeziometacarpal (TMC) Arthrosis

Keywords

Arthrosis

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (6)

  • Patient Reported Outcomes Measurement Information System (PROMIS) - Depression

    At Enrollment

  • PROMIS Pain - Interference

    At Enrollment

  • Thumb Metacarpophalangeal (MCP) Joint in Resting Position (Degrees)

    At Enrollment

  • Thumb MCP in Pinch Position (Degrees)

    At Enrollment

  • Thumb Pinch Strength

    At Enrollment

  • +1 more secondary outcomes

Study Arms (2)

Off-the-Shelf Splint

EXPERIMENTAL

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

Device: Off-the-shelf splint

OT Splint

ACTIVE COMPARATOR

Subjects in this arm will be managed with a custom-made splint made by the Massachusetts General Hospital Occupational Therapists.

Device: OT Splint

Interventions

Off-the-shelf splintDEVICE

Subjects will use an off-the-shelf splint

Off-the-Shelf Splint
OT SplintDEVICE

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

OT Splint

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age and older
  • Clinical or radiological diagnosis of TMC arthrosis by MD
  • English fluency and literacy

You may not qualify if:

  • Prior surgical treatment of TMC arthrosis on same side
  • Prior treatment of TMC arthrosis on same side with a splint during the last two months
  • Prior injury of the trapeziometacarpal joint
  • Rheumatoid arthritis
  • Pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Taylor Pong
Organization
Massachusetts General Hospital
tpong1@partners.org

Study Officials

  • David C Ring, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 22, 2013

First Posted

January 25, 2013

Study Start

February 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

May 15, 2017

Results First Posted

May 15, 2017

Record last verified: 2017-04

Locations

US(1)