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Evaluation of the Effectiveness of Night Orthosis in Treating Women With Symptomatic Osteoarthritis in the Interphalangeal Joint of the Dominant Hand

Evaluation of the Effectiveness of Night Orthosis in Treating Women With Symptomatic Osteoarthritis in the Interphalangeal Joint of the Dominant Hand

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02789852
Enrollment
52
Registered
2016-06-03
Start date
2016-05-30
Completion date
2017-04-30
Last updated
2017-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand Injuries

Brief summary

Evaluation of the effectiveness of using a night orthosis for II and III or fingers of the dominant hand in women diagnosed with symptomatic osteoarthritis compared to a control group.

Detailed description

Objective: To evaluate the effectiveness of using a night orthosis for II and III or fingers of the dominant hand in women diagnosed with symptomatic osteoarthritis compared to a control group. Methods: Through a randomized controlled clinical trial with blind assessment and follow-up of six months. Fifty-Two participants were randomized into two groups: group orthosis and control, and made a night orthosis II and or III fingers, thermoplastic will be used as a treatment for participants orthosis group. The participants underwent four evaluations at time 0, 45 days, 90 days and 180 days after its inclusion in the study. The variables studied were: the visual analog scale of pain, grip and pinch strength, questionnaires Cochin and Australian/Canadian Hand Osteoarthritis Index and functional Pick-up test.

Interventions

DEVICEOrthosis

use orthosis

Sponsors

Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Women aged between 40 and 80 years. * Patients diagnosed with osteoarthritis (OA) hand according to the American College of Rheumatology classification criteria. * Pain symptom in proximal interphalangeal (PIP's) or distal interphalangeal (DIP's) dominant hand in II and III or fingers. * Provide greater pain symptom of II and III or fingers between each other. * Complains of pain symptom measured by a visual analog scale (VAS) pain between 3 to 8 cm in the II and III or fingers of the dominant hand reported to perform joint movement (activity). * Thumb abduction with the II and III fingers without changing the pincer movement pulp-pulp.

Exclusion criteria

* Other rheumatic diseases, neurological and skeletal muscle that can affect the upper limb. * Fibromyalgia uncontrolled. * Pregnancy. * Geographical inaccessibility and transport. * Cognitive impairment that prevents the understanding of assessment tools.

Design outcomes

Primary

MeasureTime frameDescription
Change in PainT0 (inclusion), T45( 45 days after inclusion), T90 (90 days after inclusion) and T180 (180 days after inclusion)Pain was assessed using the visual analog scale ranging from 0 cm to 10 cm

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026