Psychosocial Factors a Prognostic Study of Pain Persistence in Patients With Thumb Carpometacarpal Osteoarthritis
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change from baseline to 12 months Visual Analog Scale (VAS)
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Standard of Care
short thumb orthoses during ADL, joint reeducation for hand used, radial nerve gliding exercises and thumb proprioception exercises
Intervention: Standard of Care Hand Therapy (Other)
Outcomes
Primary Outcomes
Change from baseline to 12 months Visual Analog Scale (VAS)
Time Frame: baseline, three, six and 12 months follow up
Pain scale VAS; 0: no pain, 100: maximum pain
Change from baseline to 12 months Quick Disabilities of the Arm, Shoulder and Hand
Time Frame: baseline, three, six and 12 months follow up
Self Report Function,QuickDash scores range from 0 to 100, higher scores means more dysfunction
Secondary Outcomes
- Change from baseline to 12 months using the Pain Self-Efficacy Questionnaire(baseline, three, six and 12 months follow up)
- Change from baseline to 12 months using the Tampa Scale of Kinesiophobia(baseline, three, six and 12 months follow up)
- Change from baseline to 12 months using the Fear Avoidance Beliefs Questionnaire(baseline, three, six and 12 months follow up)
- Change from baseline to 12 months using the Hospital Anxiety and Depression Scale(baseline, three, six and 12 months follow up)
- Change in from baseline to 12 months using the Impairment and Functioning Inventory(baseline, three, six and 12 months follow up)
Investigators
Kristin Valdes
Assistant Professor of Occupational Therapy
Gannon University