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

Primary Purpose

Pain, Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of Care Hand Therapy
Sponsored by
Gannon University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring pain, osteoarthritis, function

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Gannon UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Standard of Care

Arm Description

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

Outcomes

Primary Outcome Measures

Change from baseline to 12 months Visual Analog Scale (VAS)
Pain scale VAS; 0: no pain, 100: maximum pain
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

Secondary Outcome Measures

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.
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
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
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
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

Full Information

First Posted
January 26, 2019
Last Updated
July 29, 2019
Sponsor
Gannon University
Collaborators
University of Malaga
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1. Study Identification

Unique Protocol Identification Number
NCT03821298
Brief Title
Psychosocial Factors a Prognostic Study of Pain in Patients With CMC Osteoarthritis
Acronym
CMC
Official Title
Psychosocial Factors a Prognostic Study of Pain Persistence in Patients With Thumb Carpometacarpal Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Anticipated)
Study Completion Date
April 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gannon University
Collaborators
University of Malaga

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Osteoarthritis
Keywords
pain, osteoarthritis, function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Cohort Study
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Experimental
Arm Description
short thumb orthoses during ADL, joint reeducation for hand used, radial nerve gliding exercises and thumb proprioception exercises
Intervention Type
Other
Intervention Name(s)
Standard of Care Hand Therapy
Other Intervention Name(s)
Orthosis, Radial Nerve Gliding, Joint Protection Education, Proprioception exercises
Intervention Description
8 sessions 2 times a week for 4 weeks
Primary Outcome Measure Information:
Title
Change from baseline to 12 months Visual Analog Scale (VAS)
Description
Pain scale VAS; 0: no pain, 100: maximum pain
Time Frame
baseline, three, six and 12 months follow up
Title
Change from baseline to 12 months Quick Disabilities of the Arm, Shoulder and Hand
Description
Self Report Function,QuickDash scores range from 0 to 100, higher scores means more dysfunction
Time Frame
baseline, three, six and 12 months follow up
Secondary Outcome Measure Information:
Title
Change from baseline to 12 months using the Pain Self-Efficacy Questionnaire
Description
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.
Time Frame
baseline, three, six and 12 months follow up
Title
Change from baseline to 12 months using the Tampa Scale of Kinesiophobia
Description
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
Time Frame
baseline, three, six and 12 months follow up
Title
Change from baseline to 12 months using the Fear Avoidance Beliefs Questionnaire
Description
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
Time Frame
baseline, three, six and 12 months follow up
Title
Change from baseline to 12 months using the Hospital Anxiety and Depression Scale
Description
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
Time Frame
baseline, three, six and 12 months follow up
Title
Change in from baseline to 12 months using the Impairment and Functioning Inventory
Description
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
Time Frame
baseline, three, six and 12 months follow up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristin Valdes, OTD, OT, CHT
Phone
813 6584901
Email
valdes001@gannon.edu
Facility Information:
Facility Name
Gannon University
City
Ruskin
State/Province
Florida
ZIP/Postal Code
33573
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristin A Valdes, OTD
Phone
813-658-4905
Email
valdes001@gannon.edu
First Name & Middle Initial & Last Name & Degree
Nancy Naughton, OTD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11880847
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.
Results Reference
result
PubMed Identifier
21128783
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.
Results Reference
result
PubMed Identifier
21622766
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. Erratum In: Ann Rheum Dis. 2018 Oct;77(10):1546.
Results Reference
result
PubMed Identifier
17046965
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.
Results Reference
result

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

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