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Psychosocial Factors a Prognostic Study of Pain in Patients With CMC Osteoarthritis

NCT ID: NCT03821298

Last Updated: 2019-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-04-01

Brief Summary

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In this clinical trial, females with a diagnosis of thumb CMC OA, will be recruited. The primary outcome of potential risk factors of osteoarthritis, pain and function will be measured using the demographic data, visual analog scale (VAS) and Disabilities of the Arm, Shoulder and Hand (QuickDASH). Secondary out-comes will include the Pain Self-Efficacy Questionnaire (PSEQ), Tampa Scale of Kinesiophobia (TSK), Fear Avoidance Beliefs Questionnaire (FABQ), Hospital Anxiety and Depression Scale (HADS) and Impairment and Functioning Inventory (IFI). Measurements will be taken at the baseline, three, six and 12 months follow up.

Detailed Description

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The study will start recruitment in April 2019.In this clinical trial, 50-100 females, aged 50 to 90 years of age, with a diagnosis of thumb CMC OA, will be recruited. The primary outcome of potential risk factors of osteoarthritis, pain and function will be measured using the demographic data, visual analog scale (VAS) and Disabilities of the Arm, Shoulder and Hand (QuickDASH). Secondary out-comes will include the Pain Self-Efficacy Questionnaire (PSEQ), Tampa Scale of Kinesiophobia (TSK), Fear Avoidance Beliefs Questionnaire (FABQ), Hospital Anxiety and Depression Scale (HADS) and Impairment and Functioning Inventory (IFI). Measurements will be tak-en at the baseline, three, six and 12 months follow up.

Conditions

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Pain Osteoarthritis

Keywords

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pain osteoarthritis function

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Cohort Study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard of Care

short thumb orthoses during ADL, joint reeducation for hand used, radial nerve gliding exercises and thumb proprioception exercises

Group Type EXPERIMENTAL

Standard of Care Hand Therapy

Intervention Type OTHER

8 sessions 2 times a week for 4 weeks

Interventions

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Standard of Care Hand Therapy

8 sessions 2 times a week for 4 weeks

Intervention Type OTHER

Other Intervention Names

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Orthosis Radial Nerve Gliding Joint Protection Education Proprioception exercises

Eligibility Criteria

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Inclusion Criteria

* women older than 18 years
* diagnosed with bilateral thumb CMC OA
* a reported pain intensity during activities of daily living (ADLs) of up to 4 of 10 on the visual analog scale (VAS)
* The referring hand surgeon will made the diagnosis of CMC OA based on radiographs and clinical exploration.

Exclusion Criteria

* neurologic disorder affecting the upper limb
* had received previous treatment for their hand problem in the last 6 months including an intra-articular joint injection to wrist, fingers, or thumb
* had fractures or a significant hand injury or previous surgery to the wrist or hand
* had hand or finger tenosynovitis and/or Dupuytren disease
* patients who did not complete any questionnaire or if they did not sign the informed consent.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Malaga

OTHER

Sponsor Role collaborator

Gannon University

OTHER

Sponsor Role lead

Responsible Party

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Kristin Valdes

Assistant Professor of Occupational Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gannon University

Ruskin, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kristin Valdes, OTD, OT, CHT

Role: CONTACT

Phone: 813 6584901

Email: [email protected]

Facility Contacts

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Kristin A Valdes, OTD

Role: primary

References

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Pincus T, Burton AK, Vogel S, Field AP. A systematic review of psychological factors as predictors of chronicity/disability in prospective cohorts of low back pain. Spine (Phila Pa 1976). 2002 Mar 1;27(5):E109-20. doi: 10.1097/00007632-200203010-00017.

Reference Type RESULT
PMID: 11880847 (View on PubMed)

Kerns RD, Sellinger J, Goodin BR. Psychological treatment of chronic pain. Annu Rev Clin Psychol. 2011;7:411-34. doi: 10.1146/annurev-clinpsy-090310-120430.

Reference Type RESULT
PMID: 21128783 (View on PubMed)

Haugen IK, Englund M, Aliabadi P, Niu J, Clancy M, Kvien TK, Felson DT. Prevalence, incidence and progression of hand osteoarthritis in the general population: the Framingham Osteoarthritis Study. Ann Rheum Dis. 2011 Sep;70(9):1581-6. doi: 10.1136/ard.2011.150078. Epub 2011 May 27.

Reference Type RESULT
PMID: 21622766 (View on PubMed)

Zhang W, Doherty M, Leeb BF, Alekseeva L, Arden NK, Bijlsma JW, Dincer F, Dziedzic K, Hauselmann HJ, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Maheu E, Martin-Mola E, Pavelka K, Punzi L, Reiter S, Sautner J, Smolen J, Verbruggen G, Zimmermann-Gorska I. EULAR evidence based recommendations for the management of hand osteoarthritis: report of a Task Force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis. 2007 Mar;66(3):377-88. doi: 10.1136/ard.2006.062091. Epub 2006 Oct 17.

Reference Type RESULT
PMID: 17046965 (View on PubMed)

Other Identifiers

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14-2018

Identifier Type: -

Identifier Source: org_study_id