Rheumatoid ArthritisNCT01546610
Rheumatoid Foot Insole
A study testing insoles intervention in people with Rheumatoid Arthritis, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The present study aims to evaluate the effect of insoles for foot arthritis. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- insoles intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2011to Nov 2012
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with established diagnosis RA according to criteria of the American College of Rheumatology (ACR) functional classes I, II and III
- Foot pain with VAS between 3 - 8 cm for walking
- Age 18-65 years
- Basic medication stable for at least three months
- Not made infiltrations in feet and ankles in the last three months and not during the study
- Agreed to participate and signed term of informed consent
Who cannot join
- Other musculoskeletal disorders in symptomatic lower limbs
- Diseases of the central and peripheral nervous system
- Decompensated diabetes mellitus
- No walking
- Rigid deformities in the feet
- Use of insoles in the last three months
Show all 9Show fewer
- Surgery scheduled in the next 12 months
- Allergy to the material
- Mental deficiency
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Emilia Moreira
São Paulo, São Paulo
Emilia PT Moreira, 551125942014, emilia.moreira@hotmail.com
Jamil MD Natour, PHD, 551155764239, jnatour@unifesp.br
About this study
Official title: Effect of Rheumatoid Foot Insole
The present study aims to evaluate the effect of insoles for foot arthritis.
Read the detailed description
A randomized, controlled, double-blind, prospective trial being conducted involving 80 patients with rheumatoid arthritis, according to American College of Rheumatology (ACR) criteria, and foot pain, selected from outpatient clinics - Federal University of Sao Paulo (UNIFESP).
Patients will be randomized in to two groups: experimental (40) and control (40).
The experimental group will use ethyl-vinyl acetate (EVA) foot orthoses, with support retrocapital and support of medial arch (insole intervention). The control group will use the same material flat insole (insole placebo).
- Conditions
- Rheumatoid Arthritis
- Being tested
- insoles intervention, placebo insole
- Keywords
- Rheumatoid foot, foot pain, insoles, foot function, electronic baropodometer, plantar pressure, gait analysis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insoles interventionOther
Also called Interventional group
EVA insole with arch support and bar retrocapital
placebo insoleOther
Also called control group
EVA insole flat
| Study group | Role | What they receive |
|---|---|---|
| intervention foot orthoses | Experimental | Ethyl vinyl acetate (EVA) insole with medial arch support and bar retrocapital Receives: Other: insoles intervention |
| placebo insole | Placebo comparator | Foot orthose with support retrocapital and support of medial arch insole intervention Receives: Other: placebo insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale of pain in feet during walking (VAS)
Assessing pain in the feet during walking through a visual analog scale from 0 to 10 centimeter (cm)
Measured: 12 months
Secondary outcomes (9)
Foot Function Index (FFI)
Function of the foot
Measured: 12 months
Foot Health Status Questionnaire (FHSQ-Br)
Foot Health Status
Measured: 12 months
Health Assessmente Questionnaire (HAQ)
Functional capacity assessed by HAQ in rheumatoid arthritis
Measured: 12 months
Visual analog scale of pain in feet at rest (VAS)
Assessing pain in the feet at rest through a visual analog scale from 0 to 10
Measured: 12 months
6-MINUTE WALK TEST
Assess functional capacity
Measured: 12 months
Shorth Form-36 (SF-36)
Quality of life by SF-36
Measured: 12 months
LIKERT SCALE
Likert scale by patients
Measured: 12 months
TESTS BAROPODOMETRIC
Evaluates charge distribution in the feet and gait variables
Measured: 12 months
TIME USE OF INSOLE
Control the use of time insole
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startNov 2011
- Primary completionNov 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Emilia Moreira, PT, Federal University of São Paulo
- Investigators
- EMILIA MOREIRA, PT, Principal investigator, Federal University of São PauloANAMARIA PT JONES, PHD, Study director, Federal University of São PauloJAMIL NATOUR, PHD, Study chair, Division of Rheumatology, Federal University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546610
- Sponsor's protocol ID
- 1348/09
- Status last verified
- Mar 2012
- First submitted
- 2 Mar 2012
- Last updated
- 9 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rheumatoid Foot Insole
- ClinicalTrials.gov ID
- NCT01546610
- Acronym / sponsor ID
- 1348/09
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid foot, foot pain, insoles, foot function, electronic baropodometer, plantar pressure, gait analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Nov 2011
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 7 Mar 2012 (estimated)
- 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.
The present study aims to evaluate the effect of insoles for foot arthritis.
Detailed description
A randomized, controlled, double-blind, prospective trial being conducted involving 80 patients with rheumatoid arthritis, according to American College of Rheumatology (ACR) criteria, and foot pain, selected from outpatient clinics - Federal University of Sao Paulo (UNIFESP).
Patients will be randomized in to two groups: experimental (40) and control (40).
The experimental group will use ethyl-vinyl acetate (EVA) foot orthoses, with support retrocapital and support of medial arch (insole intervention). The control group will use the same material flat insole (insole placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention foot orthoses | Experimental | Other: insoles interventionEthyl vinyl acetate (EVA) insole with medial arch support and bar retrocapital |
| placebo insole | Placebo comparator | Other: placebo insoleFoot orthose with support retrocapital and support of medial arch insole intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with established diagnosis RA according to criteria of the American College of Rheumatology (ACR) functional classes I, II and III
- Foot pain with VAS between 3 - 8 cm for walking
- Age 18-65 years
- Basic medication stable for at least three months
- Not made infiltrations in feet and ankles in the last three months and not during the study
Key exclusion criteria (9 listed)
- Other musculoskeletal disorders in symptomatic lower limbs
- Diseases of the central and peripheral nervous system
- Decompensated diabetes mellitus
- No walking
- Rigid deformities in the feet
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 |
|---|---|---|
| insoles interventionAlso: Interventional groupEVA insole with arch support and bar retrocapital | Other | intervention foot orthoses |
| placebo insoleAlso: control groupEVA insole flat | Other | placebo insole |
Primary outcome
Visual analog scale of pain in feet during walking (VAS)
Time frame: 12 months
Assessing pain in the feet during walking through a visual analog scale from 0 to 10 centimeter (cm)
9 secondary outcomes
Foot Function Index (FFI)
Time frame: 12 months
Foot Health Status Questionnaire (FHSQ-Br)
Time frame: 12 months
Health Assessmente Questionnaire (HAQ)
Time frame: 12 months
Visual analog scale of pain in feet at rest (VAS)
Time frame: 12 months
6-MINUTE WALK TEST
Time frame: 12 months
Shorth Form-36 (SF-36)
Time frame: 12 months
LIKERT SCALE
Time frame: 12 months
TESTS BAROPODOMETRIC
Time frame: 12 months
TIME USE OF INSOLE
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2012.
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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.
EMILIA MOREIRA, PT principal investigator
Federal University of São Paulo
ANAMARIA PT JONES, PHD study director
Federal University of São Paulo
JAMIL NATOUR, PHD study chair
Division of Rheumatology, Federal 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 insoles intervention in people with Rheumatoid Arthritis, run by Federal University of São 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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 9 Mar 2012. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilia Moreira (551125942014, emilia.moreira@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale of pain in feet during walking (VAS) (time frame: 12 months). 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 9 Mar 2012.