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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date February 2021
Source University of Malaga
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Proprioception exercises
Exercises for recognition of thumb position and thumb force sense.
Joint protection program
Reeducation in the activities daily life
Thumb orthosis
Thumb night orthosis
Manual distraction
Manual distraction of CMC joint

Locations

Country Name City State
Spain Raquel Cantero-Téllez Málaga

Sponsors (1)

Lead Sponsor Collaborator
University of Malaga

Country where clinical trial is conducted

Spain, 

Outcome

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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