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

Not Applicable

Completed

• Conditions: Hand Injuries
• Interventions: Device: Orthosis

• Registration Number: NCT02789852
• Lead Sponsor: Federal University of São Paulo

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.

Study Timeline

• Study First Submitted: 2016-05-23
• Study Start: 2016-05-30
• Study First Submitted QC: 2016-05-30
• Study First Posted: 2016-06-03
• Primary Completion: 2017-01-30
• Status Verified: 2017-04
• Study Completion: 2017-04
• Last Update Submitted: 2017-04-10
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Orthosis Group	Orthosis	Will use the night orthosis for interphalangeal in the treatment of OA hand.

Primary Outcome Measures

Name	Time	Method
Change in Pain	T0 (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

Trial Locations

Locations (1)

Universidade Federal de Sao Paulo; 🇧🇷 Sao Paulo, SP, Brazil