Strategies for Patients With Osteoarthritis, by Using Assistive Technology and Exercises.

NCT03173989 | Completed

• 1 other identifier: 60884416.3.0000.0068
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Osteoarthritis is a disabling disease that can affect 6% to 12% of the adult population and more than a third of people over 65 years of age. Considering osteoarthritis of hands, existing research about the therapeutic treatment advocates actions such as (1) joint protection, (2) assistive technology and (3) exercises, however, doubts persist as to their effects. Objective: To verify the functional and analgesic effect of joint protection and energy conservation techniques, assistive technology (orthotics and adaptations) and exercises in the treatment of patients with osteoarthritis of the hands. Method: An epidemiological study in which a total sample of patients with knee osteoarthritis will receive joint protection and energy conservation guidelines. Subsequently, the sample will be divided into two groups, group 1 with radiological signs that suggest osteoarthritis of the hands and 2 with patients with radiological signs and symptoms of osteoarthritis of the hands, who present greater functional limitations in the daily life, being eligible for treatment of Rehabilitation, in which will be used orthosis aiming at the relief of pain, stabilization of the affected joints and the prevention of grievance of deformities and orientations of exercises to maintain muscle strength. Participants will be followed up for two years, evaluated with the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH), Stanford Health Assessment Questionnaire (HAQ), palmar grip strength measured with Jamar dynamometer, key pinch strength, three point pinch strength and pulp pinch strength measured with B \& L Pinch-gauge dynamometer. The groups will be divided between 1 and 2, the group 1 will be composed of patients who will only perform the orientations informed in the theoretical and practical classes, while the group 2, besides the orientations will receive orthoses with models such as volar hand rest splints, short thumb stabilization splints, and volar finger splints with nocturnal support, aiming at the relief of the pain, stabilization of the affected joints and the prevention of the appearance / aggravation of deformities. Exercise guidelines for maintenance of muscle strength for thumb and fingers will be performed on patients who present significant improvement of pain.

Conditions

Osteoarthritis Hand

Keywords

osteoarthritis; hand deformities; hand strength; assistive technology; exercise; health education

Outcome Measures

Primary Outcomes (1)

• Patients with orthosis, exercises and orientation will show better results in the evaluation scales regarding strength compared to the group with only orientation.

  Strength will be measured dynamometer and compared between groups.

  2 years

Secondary Outcomes (1)

• Patients with orthosis, exercises and orientation will show better results in the evaluation scales regarding functionality compared to the group with only orientation.

  2 years

Study Arms (2)

Orthosis Exercises Orientation

EXPERIMENTAL

Patients used orthosis, made exercises and received orientation for home.

Device: Orthosis Exercises Orientation

Orientation

ACTIVE COMPARATOR

Patients received orientation for home.

Behavioral: Orientation

Interventions

Orthosis Exercises Orientation DEVICE

Use of orthosis, exercises and orientation for home.

Orthosis Exercises Orientation

Orientation BEHAVIORAL

Orientation for home.

Orientation

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Kellgreen and Lawrence (KL) classification for I to III or painful IV osteoarthritis (with the use of orthoses for analgesia, in this case).
• Capacity to understand and agree to the consent form and questionnaires and evaluations.

You may not qualify if:

• Patients who had undergone previous non-medical therapeutic treatment for OA of the hands;
• Who had undergone some surgical procedure in the region or were involved in another clinical trial;
• Patients with rheumatoid arthritis or other rheumatologic disease, any neurological problems.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Escola de Artes,Ciencias e Humanidades da Universidade d Sao Paulo

São Paulo, 03828-000, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis; Hand Deformities; Motor Activity; Health Education

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Carlos BM Monteiro, Ph.D.

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: June 2, 2017
• Study Start: August 2, 2014
• Primary Completion: August 5, 2016
• Study Completion: November 5, 2016
• Last Updated: June 2, 2017

Record last verified: 2017-05

Locations

BR (1)