Trapeziometacarpal ArthrosisNCT02252939

Factors Associated With Radiographic Pathophysiology for Trapeziometacarpal Arthrosis in Patients Not Seeking Care for This Condition

A study testing X-Ray in people with Trapeziometacarpal Arthrosis, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 55 years and older
Conditions the study is for: Trapeziometacarpal Arthrosis
What is being tested?: X-Ray
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 1 siteUnited States
Study dates: Sep 2013to Aug 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Conditions: Trapeziometacarpal Arthrosis
Being tested: X-Ray

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

X-RayRadiation
X-ray as part of standard care

Study groups in NCT02252939
Study group	Role	What they receive
Patients with Trapeziometacarpal (TMC) Arthrosis	Experimental	Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis Receives: Radiation: X-Ray

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline at Day 1

Secondary outcomes (2)

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)
Measured: Day 1, baseline
QuickDASH (Disability of the Arm, Shoulder, and Hand)
Measured: Day 1, baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2013Aug 2017

First posted30 Sep 2014 (estimated)
Study startSep 2013
Primary completionJul 2016
Study completionAug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Trapeziometacarpal ArthrosisStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02252939
Sponsor's protocol ID: 2013P000827
Status last verified: Aug 2019
First submitted: 12 Aug 2014
Last updated: 14 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 14603581
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.
PubMed 20124359
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.
PubMed 2487718
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.
PubMed 15374852
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.
PubMed 23283376
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):365-372. doi: 10.1016/0304-3959(86)90122-3.
PubMed 3960576
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.
PubMed 15252092
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.
PubMed 17209691
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.
PubMed 1784498
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.
PubMed 2912463
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.
PubMed 18780109
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.
PubMed 21134961
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.
PubMed 15252084
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.
PubMed 16322609

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
Not yet recruitingObservational study
Thumb Muscle Activation During Different Activities of Daily Living in Thumb Base Osteoarthritis and Healthy Controls
Trapeziometacarpal Osteoarthritis
RecruitingPhase 2
Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of Trapeziometacarpal Osteoarthritis
Trapeziometacarpal Osteoarthritis
RecruitingObservational study
ICF-Based Biopsychosocial Assessment With AI-Assisted Profile Prediction: Trapeziometacarpal Osteoarthritis Model
Trapeziometacarpal Osteoarthritis, Thumb Osteoarthritis
RecruitingPhase 2
Corticosteroid Against Saline Injections for Thumb Osteoarthritis (CASITOA)
Trapeziometacarpal Osteoarthritis

All Trapeziometacarpal Arthrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Factors Associated With Radiographic Pathophysiology for Trapeziometacarpal Arthrosis in Patients Not Seeking Care for This Condition
ClinicalTrials.gov ID: NCT02252939
Acronym / sponsor ID: 2013P000827
Conditions: Trapeziometacarpal Arthrosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: Sep 2013
Primary completion: Jul 2016 (actual)
Study completion: Aug 2017 (actual)
First posted: 30 Sep 2014 (estimated)
Results: Posted 6 Nov 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Patients with Trapeziometacarpal (TMC) Arthrosis	Experimental	Radiation: X-RayPatients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
X-RayX-ray as part of standard care	Radiation	Patients with Trapeziometacarpal (TMC) Arthrosis

Primary outcome

Factors Associated With Eaton Classification of Trapeziometacarpal Arthrosis: Age
Time frame: Baseline at Day 1
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.

2 secondary outcomes

Factors Associated With Thumb Pain: Hyperextension of Metacarpophalangeal Joint
Time frame: Day 1, baseline
QuickDASH (Disability of the Arm, Shoulder, and Hand)
Time frame: Day 1, baseline

Results and safety

Results posted to the registry on 6 Nov 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients With Trapeziometacarpal (TMC) Arthrosis	62	59

Primary outcome: Factors Associated With Eaton Classification of Trapeziometacarpal Arthrosis: Age

Time frame: Baseline at Day 1. Median (Inter-Quartile Range). Unit: Years

Measure	Patients With Trapeziometacarpal Arthrosis Eaton Stage I n = 5	Patients With Trapeziometacarpal Arthrosis Eaton Stage II n = 36	Patients With Trapeziometacarpal Arthrosis Eaton Stage III-IV n = 18
Value	61 (56 to 66)	66 (62 to 70)	75 (66 to 82)

Population analysed: Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis X-Ray: X-ray as part of standard care

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients With Trapeziometacarpal (TMC) Arthrosis	0 of 59 (0%)	0 of 59 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 14603581Allegrante 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.
Background: PubMed 20124359Bijsterbosch 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.
Background: PubMed 2487718Buckelew 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.
Background: PubMed 15374852Dahaghin 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.
Background: PubMed 23283376Das 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.
BackgroundDeGood 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: PubMed 3960576Dolce 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.
Background: PubMed 15252092Haara 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.
Background: PubMed 17209691Hoffman 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.
Background: PubMed 1784498Jensen 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.
Background: PubMed 2912463Lorig 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.
Background: PubMed 18780109Lozano-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.

Related trials for Trapeziometacarpal Arthrosis

Recruiting
Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
Not yet recruitingObservational study
Thumb Muscle Activation During Different Activities of Daily Living in Thumb Base Osteoarthritis and Healthy Controls
Trapeziometacarpal Osteoarthritis
RecruitingPhase 2
Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of Trapeziometacarpal Osteoarthritis
Trapeziometacarpal Osteoarthritis
RecruitingObservational study
ICF-Based Biopsychosocial Assessment With AI-Assisted Profile Prediction: Trapeziometacarpal Osteoarthritis Model
Trapeziometacarpal Osteoarthritis, Thumb Osteoarthritis
RecruitingPhase 2
Corticosteroid Against Saline Injections for Thumb Osteoarthritis (CASITOA)
Trapeziometacarpal Osteoarthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Neal Chen, MD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing X-Ray in people with Trapeziometacarpal Arthrosis, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Factors Associated With Eaton Classification of Trapeziometacarpal Arthrosis: Age (time frame: Baseline at Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02252939, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.