NCT02252939

Brief Summary

The investigators are doing this research study to discover factors, such as job, hobbies, or race that are associated with arthrosis at the base of your thumb on X-rays. Thumb arthrosis is one of the most common kinds of arthritis. About 116 people will take part in this research study at Massachusetts General Hospital (MGH).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 30, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
3 months until next milestone

Results Posted

Study results publicly available

November 6, 2017

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

2.8 years

First QC Date

August 12, 2014

Results QC Date

September 5, 2017

Last Update Submit

August 13, 2019

Conditions

Trapeziometacarpal Arthrosis

Outcome Measures

Primary Outcomes (1)

  • Factors Associated With Eaton Classification of Trapeziometacarpal Arthrosis: Age

    Radiographs were scored using the Eaton score range.The Eaton score ranges from 1-4 where 1 is the least severe and 4 is the most severe for arthritis. Patients without TMC Arthritis would have a score of 0. Patients' age measured in years.

    Baseline at Day 1

Secondary Outcomes (2)

  • Factors Associated With Thumb Pain: Hyperextension of Metacarpophalangeal Joint

    Day 1, baseline

  • QuickDASH (Disability of the Arm, Shoulder, and Hand)

    Day 1, baseline

Study Arms (1)

Patients with Trapeziometacarpal (TMC) Arthrosis

EXPERIMENTAL

Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis

Radiation: X-Ray

Interventions

X-RayRADIATION

X-ray as part of standard care

Patients with Trapeziometacarpal (TMC) Arthrosis

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older
  • Not seeking care for TMC arthrosis from hand surgeon at the time of visit
  • english fluency and literacy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (17)

  • Allegrante JP, Marks R. Self-efficacy in management of osteoarthritis. Rheum Dis Clin North Am. 2003 Nov;29(4):747-68, vi-vii. doi: 10.1016/s0889-857x(03)00060-7.

    PMID: 14603581BACKGROUND

  • Bijsterbosch J, Visser W, Kroon HM, Stamm T, Meulenbelt I, Huizinga TW, Kloppenburg M. Thumb base involvement in symptomatic hand osteoarthritis is associated with more pain and functional disability. Ann Rheum Dis. 2010 Mar;69(3):585-7. doi: 10.1136/ard.2009.104562. Epub 2010 Feb 2.

    PMID: 20124359BACKGROUND

  • Buckelew SP, Parker JC. Coping with arthritis pain. A review of the literature. Arthritis Care Res. 1989 Dec;2(4):136-45. doi: 10.1002/anr.1790020408.

    PMID: 2487718BACKGROUND

  • Dahaghin S, Bierma-Zeinstra SM, Ginai AZ, Pols HA, Hazes JM, Koes BW. Prevalence and pattern of radiographic hand osteoarthritis and association with pain and disability (the Rotterdam study). Ann Rheum Dis. 2005 May;64(5):682-7. doi: 10.1136/ard.2004.023564. Epub 2004 Sep 16.

    PMID: 15374852BACKGROUND

  • Das De S, Vranceanu AM, Ring DC. Contribution of kinesophobia and catastrophic thinking to upper-extremity-specific disability. J Bone Joint Surg Am. 2013 Jan 2;95(1):76-81. doi: 10.2106/JBJS.L.00064.

    PMID: 23283376BACKGROUND

  • DeGood DE, Tait RC. Assessment of pain beliefs and pain coping. In: Turk DC, Melzack R (Eds.) Handbook of pain assessment, 2nd ed. New York, Guilford Press, 2001: 320-45.

    BACKGROUND

  • Dolce JJ, Crocker MF, Moletteire C, Doleys DM. Exercise quotas, anticipatory concern and self-efficacy expectancies in chronic pain: a preliminary report. Pain. 1986 Mar;24(3):365-372. doi: 10.1016/0304-3959(86)90122-3.

    PMID: 3960576BACKGROUND

  • Haara MM, Heliovaara M, Kroger H, Arokoski JP, Manninen P, Karkkainen A, Knekt P, Impivaara O, Aromaa A. Osteoarthritis in the carpometacarpal joint of the thumb. Prevalence and associations with disability and mortality. J Bone Joint Surg Am. 2004 Jul;86(7):1452-7. doi: 10.2106/00004623-200407000-00013.

    PMID: 15252092BACKGROUND

  • Hoffman BM, Papas RK, Chatkoff DK, Kerns RD. Meta-analysis of psychological interventions for chronic low back pain. Health Psychol. 2007 Jan;26(1):1-9. doi: 10.1037/0278-6133.26.1.1.

    PMID: 17209691BACKGROUND

  • Jensen MP, Turner JA, Romano JM, Karoly P. Coping with chronic pain: a critical review of the literature. Pain. 1991 Dec;47(3):249-283. doi: 10.1016/0304-3959(91)90216-K.

    PMID: 1784498BACKGROUND

  • Lorig K, Chastain RL, Ung E, Shoor S, Holman HR. Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum. 1989 Jan;32(1):37-44. doi: 10.1002/anr.1780320107.

    PMID: 2912463BACKGROUND

  • Lozano-Calderon SA, Souer JS, Jupiter JB, Ring D. Psychological differences between patients that elect operative or nonoperative treatment for trapeziometacarpal joint arthrosis. Hand (N Y). 2008 Sep;3(3):271-5. doi: 10.1007/s11552-008-9098-y. Epub 2008 Mar 29.

    PMID: 18780109BACKGROUND

  • Marshall M, van der Windt D, Nicholls E, Myers H, Dziedzic K. Radiographic thumb osteoarthritis: frequency, patterns and associations with pain and clinical assessment findings in a community-dwelling population. Rheumatology (Oxford). 2011 Apr;50(4):735-9. doi: 10.1093/rheumatology/keq371. Epub 2010 Dec 6.

    PMID: 21134961BACKGROUND

  • Ring D, Guss D, Malhotra L, Jupiter JB. Idiopathic arm pain. J Bone Joint Surg Am. 2004 Jul;86(7):1387-91. doi: 10.2106/00004623-200407000-00005.

    PMID: 15252084BACKGROUND

  • Sodha S, Ring D, Zurakowski D, Jupiter JB. Prevalence of osteoarthrosis of the trapeziometacarpal joint. J Bone Joint Surg Am. 2005 Dec;87(12):2614-2618. doi: 10.2106/JBJS.E.00104.

    PMID: 16322609BACKGROUND

  • Vranceanu AM, Barsky A, Ring D. Psychosocial aspects of disabling musculoskeletal pain. J Bone Joint Surg Am. 2009 Aug;91(8):2014-8. doi: 10.2106/JBJS.H.01512.

    PMID: 19651964BACKGROUND

  • Wolf JM, Delaronde S. Current trends in nonoperative and operative treatment of trapeziometacarpal osteoarthritis: a survey of US hand surgeons. J Hand Surg Am. 2012 Jan;37(1):77-82. doi: 10.1016/j.jhsa.2011.10.010. Epub 2011 Nov 25.

    PMID: 22119601BACKGROUND

MeSH Terms

Interventions

X-Rays

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Results Point of Contact

Title
Rachel Gottlieb, Research Coordinator
Organization
Massachusetts General Hospital
rgottileb3@mgh.harvard.edu
617-726-1569

Study Officials

  • Neal Chen, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

August 12, 2014

First Posted

September 30, 2014

Study Start

September 1, 2013

Primary Completion

July 1, 2016

Study Completion

August 1, 2017

Last Updated

August 14, 2019

Results First Posted

November 6, 2017

Record last verified: 2019-08

Locations

US(1)