Clinical trial NCT03821298: Psychosocial Factors a Prognostic Study of Pain in Patients With CMC Osteoarthritis
Official title: Psychosocial Factors a Prognostic Study of Pain Persistence in Patients With Thumb Carpometacarpal Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Osteoarthritis
Keywords: pain
osteoarthritis
function
Lead sponsor: Gannon University
Sponsor class: OTHER
Collaborators: name: University of Malaga
First posted: 2019-01-29
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cohort Study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline to 12 months Visual Analog Scale (VAS)
timeFrame: baseline, three, six and 12 months follow up
measure: Change from baseline to 12 months Quick Disabilities of the Arm, Shoulder and Hand
timeFrame: baseline, three, six and 12 months follow up
Secondary outcomes:
measure: Change from baseline to 12 months using the Pain Self-Efficacy Questionnaire
timeFrame: baseline, three, six and 12 months follow up
measure: Change from baseline to 12 months using the Tampa Scale of Kinesiophobia
timeFrame: baseline, three, six and 12 months follow up
measure: Change from baseline to 12 months using the Fear Avoidance Beliefs Questionnaire
timeFrame: baseline, three, six and 12 months follow up
measure: Change from baseline to 12 months using the Hospital Anxiety and Depression Scale
timeFrame: baseline, three, six and 12 months follow up
measure: Change in from baseline to 12 months using the Impairment and Functioning Inventory
timeFrame: baseline, three, six and 12 months follow up
Other outcomes:
Locations:
city: Ruskin
country: United States
facility: Gannon University
state: Florida
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.