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

NCT ID: NCT02789852

Last Updated: 2017-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-30
• Study Completion Date: 2017-04-30

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.

Conditions

Hand Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Orthosis Group

Will use the night orthosis for interphalangeal in the treatment of OA hand.

Group Type: EXPERIMENTAL

Orthosis

Intervention Type: DEVICE

use orthosis

Control Group

wait for treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Orthosis

use orthosis

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Paula Gabriel Silva

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade Federal de Sao Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

PGSilva

Identifier Type: -

Identifier Source: org_study_id