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| Name | Class |
|---|---|
| University of Malaga | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Experimental | short thumb orthoses during ADL, joint reeducation for hand used, radial nerve gliding exercises and thumb proprioception exercises |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care Hand Therapy | Other | 8 sessions 2 times a week for 4 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to 12 months Visual Analog Scale (VAS) | Pain scale VAS; 0: no pain, 100: maximum pain | baseline, three, six and 12 months follow up |
| Change from baseline to 12 months Quick Disabilities of the Arm, Shoulder and Hand | Self Report Function,QuickDash scores range from 0 to 100, higher scores means more dysfunction | baseline, three, six and 12 months follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to 12 months using the Pain Self-Efficacy Questionnaire | Confidence in performing activities of daily living,They answer by circling a number on a 7-point Likert scale under each item, where 0 = not at all confident and 6= completely confident. A total score, ranging from 0 to 60, is calculated by adding the scores for each item. Higher scores reflect stronger self- efficacy beliefs. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristin Valdes, OTD, OT, CHT | Contact | 813 6584901 | valdes001@gannon.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gannon University | Recruiting | Ruskin | Florida | 33573 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11880847 | Result | 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. | |
| 21128783 | Result | 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. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
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| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| ID | Term |
|---|---|
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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Cohort Study
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| baseline, three, six and 12 months follow up |
| Change from baseline to 12 months using the Tampa Scale of Kinesiophobia | measure of fear of movement, the total score ranges between 17 and 68. A high value on the TSK indicates a high degree of kinesiophobia, and a cutoff score was developed by Vlaeyen (1995), where a score of 37or over is considered as a high score, while scores below that are considered as low scores. Use of a total score (including all 17 items) is recommended, although practitioners may wish to interpret results using two subscales | baseline, three, six and 12 months follow up |
| Change from baseline to 12 months using the Fear Avoidance Beliefs Questionnaire | self report measure of avoidance of activities of daily livin, The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance belief | baseline, three, six and 12 months follow up |
| Change from baseline to 12 months using the Hospital Anxiety and Depression Scale | Measure Depression and Anxiety,Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The higher the score indicates heightened anxiety or depression | baseline, three, six and 12 months follow up |
| Change in from baseline to 12 months using the Impairment and Functioning Inventory | Function, . It consists of 30 items with two related subscales: Daily Functioning and Impairment (perceived current level of functioning compared with the level of functioning before pain onset). 30 questions scored 0-4. Higher score indicates increased ability to perform activities of daily living | baseline, three, six and 12 months follow up |
| 21622766 | Result | 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. |
| 17046965 | Result | 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. |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |