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

Not Applicable

• Conditions: Pain; Osteoarthritis
• Interventions: Other: Standard of Care Hand Therapy

• Registration Number: NCT03821298
• Lead Sponsor: Gannon University

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 Timeline

• Study First Submitted: 2019-01-26
• Study First Submitted QC: 2019-01-28
• Study First Posted: 2019-01-29
• Study Start: 2019-04-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-07-31
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care Hand Therapy	short thumb orthoses during ADL, joint reeducation for hand used, radial nerve gliding exercises and thumb proprioception exercises

Primary Outcome Measures

Name	Time	Method
Change from baseline to 12 months Visual Analog Scale (VAS)	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	baseline, three, six and 12 months follow up	Self Report Function,QuickDash scores range from 0 to 100, higher scores means more dysfunction

Secondary Outcome Measures

Name	Time	Method
Change from baseline to 12 months using the Pain Self-Efficacy Questionnaire	baseline, three, six and 12 months follow up	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.
Change from baseline to 12 months using the Tampa Scale of Kinesiophobia	baseline, three, six and 12 months follow up	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
Change from baseline to 12 months using the Fear Avoidance Beliefs Questionnaire	baseline, three, six and 12 months follow up	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
Change from baseline to 12 months using the Hospital Anxiety and Depression Scale	baseline, three, six and 12 months follow up	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
Change in from baseline to 12 months using the Impairment and Functioning Inventory	baseline, three, six and 12 months follow up	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

Trial Locations

Locations (1)

Gannon University; 🇺🇸 Ruskin, Florida, United States