Thumb Osteoarthritis Clinical Trial
— thumbOfficial title:
Investigation of Clinical Effects of a Proprioceptive Thumb Exercises Program in Patients With Carpometacarpal Joint Osteoarthritis: A Randomized Clinical Trial
NCT number | NCT04738201 |
Other study ID # | 2020 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 20, 2021 |
Est. completion date | June 10, 2021 |
Verified date | March 2022 |
Source | University of Malaga |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Osteoarthritis (OA) is a chronic and prevalent joint disorder with great impact on quality of life and high economic burden. Although a number of conservative therapies have proven to be effective for the management of hand OA, only modest treatment effects were reported for most individual interventions. The aim of the proposed study is to assess the effect of proprioceptive training on pain, function and sense perception in patients with carpometacarpal osteoarthritis (CMC OA).
Status | Completed |
Enrollment | 45 |
Est. completion date | June 10, 2021 |
Est. primary completion date | April 26, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Diagnosis of grade I, II or III thumb CMC joint OA in their dominant hand according to the Eaton Classification Stage - Pain rating of 4/10 on the Visual Analogue Scale (VAS) during activities of daily living (ADLs) at the time of the therapy initial evaluation. - The ability to read and understand the patient information sheets and exercises Exclusion Criteria: - Neurological disorder affecting the upper limb. - Had received specific treatment for hand or thumb pain in the same limb in the last 6 months including an intra-articular joint injection to wrist, fingers, or thumb; - Fractures or a significant hand injury or previous surgery to the wrist or hand; - Tenosynovitis and/or Dupuytren disease |
Country | Name | City | State |
---|---|---|---|
Spain | Raquel Cantero-Téllez | Malaga | Málaga |
Lead Sponsor | Collaborator |
---|---|
University of Malaga |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Joint position Sense (JPS) | Proprioception using active joint position sense (JPS) has been utilized in studies to establish a correlation between therapy intervention and proprioception. The target position of 30ยบ CMC abduction will be selected. Joint angle will be measured using a standard clear plastic goniometer. | baseline-4 and 12 weeks | |
Secondary | Visual Analogue Scale (VAS) | VAS has been shown to be a reliable and valid instrument for pain assessment which is used frequently for clinical and research purposes. It consists of a 10-cm line anchored at each end. The left-hand anchor reads 'no pain' and the right-hand anchor reads 'worst possible pain'; the patients marked a line to represent their pain level. | baseline-4 and 12 weeks | |
Secondary | Quick dash | The QuickDASH questionnaire will be used to measure upper extremity function. This tool consists of 11 items providing a total score ranging from 0 to 100 where 0 indicates no limitation and 100 suggests full disability. Eight items include questions about the ability of the patient to perform certain daily activities. | baseline-4 and 12 weeks | |
Secondary | Canadian Occupational Performance Measure | Patient's occupational performance will be measured with the Canadian Occupational Performance Measure (COPM). The COPM enables subjects to identify goals for hand therapy and engage in a subject-specific therapeutic process. It has been established that the COPM has good convergent validity and responsiveness for evaluating the relationship between patient self-perception and satisfaction for patients with CMC thumb OA . | baseline-4 and 12 weeks |
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