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

Pain Clinical Trial

— CMC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03821298
• Other study ID #: 14-2018
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: July 2019
• Source: Gannon University
• Contact: Kristin Valdes, OTD, OT, CHT
• Phone: 813 6584901
• Email: valdes001[@]gannon.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Pain

Intervention

Other:
• Standard of Care Hand Therapy
8 sessions 2 times a week for 4 weeks

Locations

Country	Name	City	State
United States	Gannon University	Ruskin	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Gannon University	University of Malaga

Country where clinical trial is conducted

United States, 

References & Publications (4)

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.201 — View 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. Review. — View 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. Review. — View Citation

Zhang W, Doherty M, Leeb BF, Alekseeva L, Arden NK, Bijlsma JW, Dinçer F, Dziedzic K, Häuselmann HJ, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Maheu E, Martín-Mola E, Pavelka K, Punzi L, Reiter S, Sautner J, Smolen J, Verbruggen G, Zimmermann-Górska — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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