An interventional study of Standard of Care Hand Therapy in Pain and Osteoarthritis, sponsored by Gannon University. Status unknown at 1 site in United States. Open to female participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-07-31.
Sponsored by Gannon University · Not applicable, Interventional, and Treatment
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.
2,450 studies on the registry are indexed under Pain; 945 are open to participants now.
This study's planned enrollment of 50 is below the median of 70 across 2,101 interventional studies indexed under Pain.
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Exclusion Criteria:
short thumb orthoses during ADL, joint reeducation for hand used, radial nerve gliding exercises and thumb proprioception exercises
Other: Standard of Care Hand Therapy
8 sessions 2 times a week for 4 weeks
Also known as: Orthosis, Radial Nerve Gliding, Joint Protection Education, Proprioception exercises
Change from baseline to 12 months Visual Analog Scale (VAS)
Pain scale VAS; 0: no pain, 100: maximum pain
Time frame: 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
Time frame: baseline, three, six and 12 months follow up
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline, three, six and 12 months follow up
Plan to share: No
This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Gannon University