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

May 31, 2017 updated by: Carlos Bandeira de Mello Monteiro, University of Sao Paulo

Comparison Between Care Strategies for Patients With Osteoarthritis of the Hands Based on the Use of Joint Protection, Assistive Technology and Exercises.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 03828-000
        • Escola de Artes,Ciencias e Humanidades da Universidade d Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Orthosis Exercises Orientation
Patients used orthosis, made exercises and received orientation for home.
Device: Orthosis Exercises Orientation
Use of orthosis, exercises and orientation for home.
Active Comparator: Orientation
Patients received orientation for home.
Behavioral: Orientation
Orientation for home.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patients with orthosis, exercises and orientation will show better results in the evaluation scales regarding strength compared to the group with only orientation.
Time Frame: 2 years
Strength will be measured dynamometer and compared between groups.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patients with orthosis, exercises and orientation will show better results in the evaluation scales regarding functionality compared to the group with only orientation.
Time Frame: 2 years
Functionality will be measured by scales and compared between groups.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carlos BM Monteiro, Ph.D., University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 2, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 5, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 5, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 60884416.3.0000.0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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