Strategies for Patients With Osteoarthritis, by Using Assistive Technology and Exercises.
Primary Purpose
Osteoarthritis Hand
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Orthosis Exercises Orientation
Orientation
Sponsored by

About this trial
This is an interventional treatment trial for Osteoarthritis Hand focused on measuring osteoarthritis, hand deformities, hand strength, assistive technology, exercise, health education
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Escola de Artes,Ciencias e Humanidades da Universidade d Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Orthosis Exercises Orientation
Orientation
Arm Description
Patients used orthosis, made exercises and received orientation for home.
Patients received orientation for home.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Patients with orthosis, exercises and orientation will show better results in the evaluation scales regarding functionality compared to the group with only orientation.
Functionality will be measured by scales and compared between groups.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03173989
Brief Title
Strategies for Patients With Osteoarthritis, by Using Assistive Technology and Exercises.
Official Title
Comparison Between Care Strategies for Patients With Osteoarthritis of the Hands Based on the Use of Joint Protection, Assistive Technology and Exercises.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 2, 2014 (Actual)
Primary Completion Date
August 5, 2016 (Actual)
Study Completion Date
November 5, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Participants
Were included 200 patients in the group of Bone Metabolic Diseases of the Institute of Orthopedics and Traumatology of the Faculty of Medicine of the University of São Paulo (FMUSP). Were included patients aged between 40 and 80 years, with involvement of osteoarthritis (OA) in the knees and of these, a sample of patients with involvement of the first carpometacarpal, metacarpophalangeal or interphalangeal joint of the thumb and the proximal or distal interphalangeal joint of fingers with from I to III degrees of classification of Kelgreen and Lawrence (KL).
For the calculation of the sample size, a pilot test was performed with 15 subjects and assumed: alpha of 5%, beta of 20% (power = 80%) and difference between the groups of 10% referring to the scores at each scale . With these data, a minimum of 200 individuals was calculated.
Intervention
Participants are patients in an OA treatment program in the Bone Metabolic Diseases group of the Orthopedics and Traumatology Institute of the Faculty of Medicine of the University of São Paulo (FMUSP).
These patients were evaluated for their ability to perform functional activities and anthropometric parameters of upper limbs. The Disability of the Arm, Shoulder and Hand (DASH), the Stanford Health Assessment Questionnaire (HAQ), questionnaires were applied, as well as grip strength measured with Jamar® dynamometer, key pinch, three point pinch, and a pulp pinch measured with B & L Pinch-gauge® dynamometer.
The force was established after arithmetic average of 3 trials. The tests were performed bilaterally. The presence of deformities has also been reported.
The total sample was divided into two groups. Both received guidelines on joint protection and energy conservation, including theoretical and practical classes aimed at protecting all joints that may be affected by OA.
Theoretical classes were carried out through slide presentation with concepts of joint protection, conservation of energy, organization of time, organization of the home and work environment and organization of daily routine. Printed information material was also provided.
The practical classes were carried out in a simulated house, mounted in two rooms of infirmary, suggesting all the environments of a conventional house. Adaptations made by therapists and commercials and conventional objects used in daily living activities were used for the guidelines described above.
The groups were divided between 1 and 2, which was group 1 with patients who presented osteoarthritis in the knees, without specific complaints of hand, but with radiographic findings and group 2 was characterized by patients with radiographic signs and symptoms of hands that presented larger functional limitations in the daily routine or that were eligible for rehabilitation treatment using orthosis models such as resting hand volar splints, thumb stabilization splints or finger volar 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 were performed in patients who presented significant improvement of pain.
Patients returned for reevaluation at 12 and 24 months after the initial evaluation.
Study Design
Prospective, analytical, experimental, case control study with mixed data collection (prospective and retrospective).
Statistical Analysis
The following variables were considered as dependent variables: HAQ, DASH (general questions, symptons and functions in athletes, performing artists and workers) and dynamometry (manual grip, key pinch, three point pinch and pulp pinch strenght) for the right and left hands. The dependent variables were submitted to ANOVA with factor 2 (Intervention: ortesis, exercises and orientation; orientation) by 8 (group of orientation: 8 different groups of orientation) by 3 (Moment of evaluation: 1- first evaluation [initial], 2- second evaluation [after 1 year], 3- third evaluation [after 2 years]) with repeated measures in the last factor. In order to compare the pain scores in the evaluation moments, the Friedman test was used for the three questions of the DASH's pain module, in a separated moment. Post-hoc comparisons were carried out using Tukey-HSD test (p<0.05).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis Hand
Keywords
osteoarthritis, hand deformities, hand strength, assistive technology, exercise, health education
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Orthosis Exercises Orientation
Arm Type
Experimental
Arm Description
Patients used orthosis, made exercises and received orientation for home.
Arm Title
Orientation
Arm Type
Active Comparator
Arm Description
Patients received orientation for home.
Intervention Type
Device
Intervention Name(s)
Orthosis Exercises Orientation
Intervention Description
Use of orthosis, exercises and orientation for home.
Intervention Type
Behavioral
Intervention Name(s)
Orientation
Intervention Description
Orientation for home.
Primary Outcome Measure Information:
Title
Patients with orthosis, exercises and orientation will show better results in the evaluation scales regarding strength compared to the group with only orientation.
Description
Strength will be measured dynamometer and compared between groups.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Patients with orthosis, exercises and orientation will show better results in the evaluation scales regarding functionality compared to the group with only orientation.
Description
Functionality will be measured by scales and compared between groups.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos BM Monteiro, Ph.D.
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Escola de Artes,Ciencias e Humanidades da Universidade d Sao Paulo
City
Sao Paulo
ZIP/Postal Code
03828-000
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Strategies for Patients With Osteoarthritis, by Using Assistive Technology and Exercises.
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