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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02252939
Other study ID # 2013P000827
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2013
Est. completion date August 2017

Study information

Verified date August 2019
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date August 2017
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group 55 Years and older
Eligibility Inclusion Criteria:

- 55 years and older

- Not seeking care for TMC arthrosis from hand surgeon at the time of visit

- english fluency and literacy

Exclusion Criteria:

-

Study Design


Intervention

Radiation:
X-Ray
X-ray as part of standard care

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, 

References & 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. Review. — View Citation

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. Erratum in: Ann Rheum Dis. 2011 Nov;70(11):2060. Ann Rheum Dis. 2012 Jun;71(6):1106. — View Citation

Buckelew SP, Parker JC. Coping with arthritis pain. A review of the literature. Arthritis Care Res. 1989 Dec;2(4):136-45. Review. — View Citation

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. Epub 2004 Sep 16. Erratum in: Ann Rheum Dis. 2005 Aug;64(8):1248. — View Citation

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. — View Citation

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.

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):365-72. — View Citation

Haara MM, Heliövaara M, Kröger H, Arokoski JP, Manninen P, Kärkkäinen 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. — View Citation

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. — View Citation

Jensen MP, Turner JA, Romano JM, Karoly P. Coping with chronic pain: a critical review of the literature. Pain. 1991 Dec;47(3):249-83. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Ring D, Guss D, Malhotra L, Jupiter JB. Idiopathic arm pain. J Bone Joint Surg Am. 2004 Jul;86(7):1387-91. — View Citation

Sodha S, Ring D, Zurakowski D, Jupiter JB. Prevalence of osteoarthrosis of the trapeziometacarpal joint. J Bone Joint Surg Am. 2005 Dec;87(12):2614-8. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 17 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Factors Associated With Thumb Pain: Hyperextension of Metacarpophalangeal Joint Thumb pain measured on a scale of 0-10 and dichotomized by having thumb pain (yes/no), hyperextension dichotomized (yes/no) Day 1, baseline
Secondary QuickDASH (Disability of the Arm, Shoulder, and Hand) Day 1, baseline
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