Recruiting

Observational Study

Sponsor:

Gannon University

Code:

NCT03821298

Conditions

Pain

Osteoarthritis

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Standard of Care Hand Therapy

Study Details

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

Study ID

NCT03821298

Start date

Apr 1, 2019

Status verified date

Jul, 2019

Completion date

Apr 1, 2020

Anticipated

Primary completion date

Apr 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Standard of Care

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

Interventions

Standard of Care Hand Therapy

8 sessions 2 times a week for 4 weeks

Primary outcome measure

  • Change from baseline to 12 months Visual Analog Scale (VAS) [ Time Frame: baseline, three, six and 12 months follow up ]
  • Change from baseline to 12 months Quick Disabilities of the Arm, Shoulder and Hand [ Time Frame: baseline, three, six and 12 months follow up ]

Central Contacts and Locations

Central contacts

Kristin Valdes, OTD, OT, CHT

813 6584901valdes001@gannon.edu

Locations

Gannon University

Recruiting

Ruskin, Florida, United States, 33573

Contacts

Kristin A Valdes, OTD

813-658-4905valdes001@gannon.edu

More Information

Sponsor

Gannon University

Last update posted

Jul 31, 2019

Last verified

Jul, 2019

Keywords

  • pain
  • osteoarthritis
  • function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Gannon University on 2019-07-31.