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

NCT03821298 | Unknown

• 1 other identifier: 14-2018
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Osteoarthritis

Keywords

pain; osteoarthritis; function

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Study Arms (1)

Standard of Care

EXPERIMENTAL

short thumb orthoses during ADL, joint reeducation for hand used, radial nerve gliding exercises and thumb proprioception exercises

Other: Standard of Care Hand Therapy

Interventions

Standard of Care Hand Therapy OTHER

8 sessions 2 times a week for 4 weeks

Also known as: Orthosis, Radial Nerve Gliding, Joint Protection Education, Proprioception exercises

Standard of Care

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gannon University: lead
• University of Malaga: collaborator

Study Sites (1)

Gannon University

Ruskin, Florida, 33573, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 11880847 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.

  PMID: 21128783 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.

  PMID: 21622766 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.

  PMID: 17046965 RESULT

MeSH Terms

Conditions

Pain; Osteoarthritis

Interventions

Orthotic Devices

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Central Study Contacts

Kristin Valdes, OTD, OT, CHT

CONTACT

813 6584901; valdes001@gannon.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Occupational Therapy

Model Details: Cohort Study

Study Record Dates

• First Submitted: January 26, 2019
• First Posted: January 29, 2019
• Study Start: April 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: July 31, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)