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

G

Gannon University

Status

Unknown

Conditions

Osteoarthritis
Pain

Treatments

Other: Standard of Care Hand Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03821298
14-2018

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

Female

Ages

18 to 90 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Standard of Care
Experimental group
Description:
short thumb orthoses during ADL, joint reeducation for hand used, radial nerve gliding exercises and thumb proprioception exercises
Treatment:
Other: Standard of Care Hand Therapy

Trial contacts and locations

1

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Central trial contact

Kristin Valdes, OTD, OT, CHT

Data sourced from clinicaltrials.gov

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