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

Psychosocial Factors a Prognostic Study of Pain Persistence in Patients With Thumb Carpometacarpal Osteoarthritis

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.

Study Overview

• Status: Unknown
• Conditions: Pain; Osteoarthritis
• Intervention / Treatment: Other: Standard of Care Hand Therapy

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristin Valdes, OTD, OT, CHT; Phone Number: 813 6584901; Email: valdes001@gannon.edu

Study Locations

• United States
  • Florida
    • Ruskin, Florida, United States, 33573
      • Recruiting
      • Gannon University
      • Contact: Kristin A Valdes, OTD; Phone Number: 813-658-4905; Email: valdes001@gannon.edu
      • Sub-Investigator: Nancy Naughton, OTD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard of Care; 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; Other Names: Orthosis; Radial Nerve Gliding; Joint Protection Education; Proprioception exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Gannon University
• Collaborators: University of Malaga

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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. Erratum In: Ann Rheum Dis. 2018 Oct;77(10):1546.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: January 26, 2019
• First Submitted That Met QC Criteria: January 28, 2019
• First Posted (Actual): January 29, 2019

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: osteoarthritis; pain; function
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 14-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No