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

Hand Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02789852
• Other study ID #: PGSilva
• Status: Completed
• Phase: N/A
• First received: May 23, 2016
• Last updated: April 10, 2017
• Start date: May 30, 2016
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 2017
• Est. primary completion date: January 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hand Injuries
• Osteoarthritis

Intervention

Device:
• Orthosis
use orthosis

Locations

Country	Name	City	State
Brazil	Universidade Federal de Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain	Pain was assessed using the visual analog scale ranging from 0 cm to 10 cm	T0 (inclusion), T45( 45 days after inclusion), T90 (90 days after inclusion) and T180 (180 days after inclusion)