Osteoarthritis HandNCT03173989
Strategies for Patients With Osteoarthritis, by Using Assistive Technology and Exercises.
A study testing Orthosis Exercises Orientation and Orientation in people with Osteoarthritis Hand, run by University of Sao Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis Hand
- What is being tested?
- Orthosis Exercises Orientation and Orientation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Aug 2014to 5 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Escola de Artes,Ciencias e Humanidades da Universidade d Sao Paulo
São Paulo, 03828-000
About this study
Official title: 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.
Read the 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).
- Conditions
- Osteoarthritis Hand
- Being tested
- Orthosis Exercises Orientation, Orientation
- Keywords
- osteoarthritis, hand deformities, hand strength, assistive technology, exercise, health education
- Medical subject headings
- Osteoarthritis, Hand Deformities, Motor Activity, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthosis Exercises OrientationDevice
Use of orthosis, exercises and orientation for home.
OrientationBehavioural
Orientation for home.
| Study group | Role | What they receive |
|---|---|---|
| Orthosis Exercises Orientation | Experimental | Patients used orthosis, made exercises and received orientation for home. Receives: Device: Orthosis Exercises Orientation |
| Orientation | Active comparator | Patients received orientation for home. Receives: Behavioral: Orientation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Functionality will be measured by scales and compared between groups.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start2 Aug 2014
- Primary completion5 Aug 2016
- Study completion5 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis HandStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Bandeira de Mello Monteiro, University of Sao Paulo
- Investigators
- Carlos BM Monteiro, Ph.D., Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173989
- Sponsor's protocol ID
- 60884416.3.0000.0068
- Status last verified
- May 2017
- First submitted
- 24 May 2017
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Care Strategies for Patients With Osteoarthritis of the Hands Based on the Use of Joint Protection, Assistive Technology and Exercises.
- ClinicalTrials.gov ID
- NCT03173989
- Acronym / sponsor ID
- 60884416.3.0000.0068
- Conditions
- Osteoarthritis Hand
- Keywords
- osteoarthritis, hand deformities, hand strength, assistive technology, exercise, health education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 2 Aug 2014 (actual)
- Primary completion
- 5 Aug 2016 (actual)
- Study completion
- 5 Nov 2016 (actual)
- First posted
- 2 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthosis Exercises Orientation | Experimental | Device: Orthosis Exercises OrientationPatients used orthosis, made exercises and received orientation for home. |
| Orientation | Active comparator | Behavioral: OrientationPatients received orientation for home. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orthosis Exercises OrientationUse of orthosis, exercises and orientation for home. | Device | Orthosis Exercises Orientation |
| OrientationOrientation for home. | Behavioural | Orientation |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos BM Monteiro, Ph.D. principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthosis Exercises Orientation and Orientation in people with Osteoarthritis Hand, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2017.