Thumb Osteoarthritis Clinical Trial
Official title:
Clinical Effects of a Proprioceptive Thumb Exercise for Individuals With Carpometacarpal Joint Osteoarthritis: A Prospective Quasi-experimental Study
NCT number | NCT04777526 |
Other study ID # | 19-20 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2, 2019 |
Est. completion date | July 18, 2020 |
Verified date | February 2021 |
Source | University of Malaga |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Objective: To establish the effectiveness of a proprioceptive training program as a complementary therapy for a traditional protocol in position control, pain intensity, upper limb function and occupation performance for patients with thumb CMC joint OA. Methods: Standard conservative thumb CMC joint OA treatments were received for both the control (n=26) and experimental groups (n=26) for a period of 12 weeks. The experimental group received a proprioceptive training program during the same intervention period, which was conducted twice weekly (24 sessions). The severity of pain with activity was measured according to the visual analog scale (VAS). QuickDASH questionnaire was used to measure upper extremity function. Patient's occupational performance was measured with the Canadian Occupational Performance Measure (COPM) and proprioception was assessed using Joint position sense (JPS) testing.
Status | Completed |
Enrollment | 52 |
Est. completion date | July 18, 2020 |
Est. primary completion date | January 30, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: Patients were included if they satisfied the following inclusion criteria; over 18 years of age with a diagnosis of grade I, II or III thumb CMC joint OA in their dominant hand according to the Eaton Classification Stage (14), a minimum 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,and the ability to read and understand the patient information sheets and exercises. Exclusion Criteria: Patients were excluded from participation if they had a 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, had fractures or a significant hand injury or previous surgery to the wrist or hand, or had hand or finger tenosynovitis and/or Dupuytren disease. We also excluded patients with cognitive impairments who were not able to understand the informed consent and/or exercise program. |
Country | Name | City | State |
---|---|---|---|
Spain | Raquel Cantero-Téllez | 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 30o CMC abduction will be selected. Joint angle will be measured using a standard clear plastic goniometer. | 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- 3- 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- 3- 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- 3- 12 weeks |
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