Rheumatoid ArthritisNCT03170947
Effects of Insoles in Patients With Rheumatoid Arthritis: Randomized Controlled Trial.
A study testing Custom Insoles and Standardized insoles in people with Rheumatoid Arthritis, run by University of Malaga at 1 site in Spain.
Trial summary
Deformity and foot pain is nearly omnipresent (90%) in rheumatoid arthritis (RA), due to the interaction between inflammation and abnormal biomechanical. These cause instability in the hindfoot, which cause deformity of the forefoot, and they cause more pressure on the plantar forefoot and more pain during daily… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Custom Insoles and Standardized insoles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSpain
- Study dates
- 21 Jan 2022to Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- More than 18 years of age
- Early RA
- To meet the criteria of American College of Rheumatology
- History of bilateral subtalar and/or ankle and/or talonavicular pain
- Informed consent
- Normal range of motions at the ankle, subtalar, and midtarsal joints.
Who cannot join
- Concomitant musculoskeletal disease
- Central or peripheral nervous system disease
- Endocrine disorders, especially diabetes mellitus with a level of insufficient foot sensitivity
- Patients with a history of orthopedic foot surgery
- Those currently using foot orthoses.
- Patients with foot trauma in the last 6 months previous to the study
- Vascular diseases affecting the foot, active synovitis and edema.
- Normal daily walking aids will be not permitted.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University of Malaga
Málaga, 29071
Gabriel Gijon Nogueron, PhD, 0034626449254, gagijon@uma.es
About this study
Official title: Effects of Insoles in Patients With Rheumatoid Arthritis Through Measurement of Quality of Life and Physical Activity: Randomized Controlled Trial.
Deformity and foot pain is nearly omnipresent (90%) in rheumatoid arthritis (RA), due to the interaction between inflammation and abnormal biomechanical. These cause instability in the hindfoot, which cause deformity of the forefoot, and they cause more pressure on the plantar forefoot and more pain during daily activities. Non-pharmacological interventions (insole, footwear) have an important role, reducing pain and disability, increasing the effectiveness and improving daily activities.
Read the detailed description
Randomized double-blind clinical trial. Two samples of patients will be taken: the control group, which will consist of patients with rheumatoid arthritis and standardized insoles, and other group, which will consist of patients with rheumatoid arthritis and insoles made with direct adaptation technique (TAD) and patients with rheumatoid arthritis and insoles made with an scanner (CAD-CAM). The variables that the investigators will measure are: age, sex, study level, current occupation, rheumatoid arthritis evolution time, quality of life and physical function, pain and health level and general function of the foot. The investigators will use: an accelerometer, and questionnaires: Foot and Ankle Ability Measures (FAAM), Manchester foot pain and disability index (MFPDI), Medical outcomes study short form-36 (SF-36) y Foot Function Index (FFI). This study will analyze patients in the Universities of Malaga and Salford for 6 months.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Custom Insoles, Standardized insoles
- Keywords
- Rheumatoid arthritis, Foot, Insoles, Quality of life, Physical Activity
- Medical subject headings
- Arthritis, Rheumatoid, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom InsolesDevice
Custom insoles will make with CAD-CAM using a laser scanning and casting for its construction. All this needs the assistance of a computer. From the digital image of a positive of the limb in foam the insole will be obtained.
Custom insoles make with direct adaptation technique (TAD) being of pvc resin. Once the resins are cut and with a temperature of 90º, they will be adapted to the foot (which will be protected with a sock) of the patient with the help of a vacuum. To this technique subtalar joint will be in a neutral position and metatarsal joints will be aligned.
Standardized insolesDevice
Standardized insoles were done by EVA material with shore of 18 and 180 kg/cm3 and manufactured, with an extension of 3/4. It was in contact with heel and plantar arch.
| Study group | Role | What they receive |
|---|---|---|
| Custom insoles | Experimental | Custom insoles will make with CAD-CAM using a laser scanning and casting for its construction. Custom insoles will make with direct adaptation technique (TAD) being of pvc resin. Receives: Device: Custom Insoles |
| Standardized insoles | Active comparator | Standardized insoles will be done by Ethylene-vinyl acetate (EVA) material. Receives: Device: Standardized insoles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Active graph (bracelet) at 3 months
This outcome will be measured with an activity monitor, accelerometer
Measured: one week, one month and three months
Secondary outcomes (4)
Change from Baseline quality of life at 3 months
This outcome will be measured with a self-reported questionnaire (SF-36)
Measured: one week, one month and three months
Change from Baseline foot function 3 months
This outcome will be measured with a self-reported questionnaire (foot function index)
Measured: one week, one month and three months
Change from Baseline pain intensity at 3 months
This outcome will be measured with a self-reported questionnaire (Manchester foot pain and disability index)
Measured: one week, one month and three months
Change from Baseline physical activity at 3 months
This outcome will be measured with a self-reported questionnaire (foot and ankle ability measure)
Measured: one week, one month and three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start21 Jan 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Gijon-Nogueron, University of Malaga
- Investigators
- Gabriel Gijon Nogueron, PhD, Principal investigator, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170947
- Sponsor's protocol ID
- UNIMalaga
- Status last verified
- Jan 2023
- First submitted
- 26 May 2017
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramos-Petersen L, Nester CJ, Ortega-Avila AB, Skidmore S, Gijon-Nogueron G. A qualitative study exploring the experiences and perceptions of patients with rheumatoid arthritis before and after wearing foot orthoses for 6 months. Health Soc Care Community. 2021 May;29(3):829-836. doi: 10.1111/hsc.13316. Epub 2021 Feb 9.
PubMed 33560583Ramos-Petersen L, Nester CJ, Gijon-Nogueron G, Ortega-Avila AB. Foot orthoses for people with rheumatoid arthritis, involving quantitative and qualitative outcomes: protocol for a randomised controlled trial. BMJ Open. 2020 Jul 19;10(7):e036433. doi: 10.1136/bmjopen-2019-036433.
PubMed 32690521
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Insoles in Patients With Rheumatoid Arthritis Through Measurement of Quality of Life and Physical Activity: Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03170947
- Acronym / sponsor ID
- UNIMalaga
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, Foot, Insoles, Quality of life, Physical Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 31 May 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.
Deformity and foot pain is nearly omnipresent (90%) in rheumatoid arthritis (RA), due to the interaction between inflammation and abnormal biomechanical. These cause instability in the hindfoot, which cause deformity of the forefoot, and they cause more pressure on the plantar forefoot and more pain during daily activities. Non-pharmacological interventions (insole, footwear) have an important role, reducing pain and disability, increasing the effectiveness and improving daily activities.
Detailed description
Randomized double-blind clinical trial. Two samples of patients will be taken: the control group, which will consist of patients with rheumatoid arthritis and standardized insoles, and other group, which will consist of patients with rheumatoid arthritis and insoles made with direct adaptation technique (TAD) and patients with rheumatoid arthritis and insoles made with an scanner (CAD-CAM). The variables that the investigators will measure are: age, sex, study level, current occupation, rheumatoid arthritis evolution time, quality of life and physical function, pain and health level and general function of the foot. The investigators will use: an accelerometer, and questionnaires: Foot and Ankle Ability Measures (FAAM), Manchester foot pain and disability index (MFPDI), Medical outcomes study short form-36 (SF-36) y Foot Function Index (FFI). This study will analyze patients in the Universities of Malaga and Salford for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Custom insoles | Experimental | Device: Custom InsolesCustom insoles will make with CAD-CAM using a laser scanning and casting for its construction. Custom insoles will make with direct adaptation technique (TAD) being of pvc resin. |
| Standardized insoles | Active comparator | Device: Standardized insolesStandardized insoles will be done by Ethylene-vinyl acetate (EVA) material. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- More than 18 years of age
- Early RA
- To meet the criteria of American College of Rheumatology
- History of bilateral subtalar and/or ankle and/or talonavicular pain
- Informed consent
Key exclusion criteria (8 listed)
- Concomitant musculoskeletal disease
- Central or peripheral nervous system disease
- Endocrine disorders, especially diabetes mellitus with a level of insufficient foot sensitivity
- Patients with a history of orthopedic foot surgery
- Those currently using foot orthoses.
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 |
|---|---|---|
| Custom InsolesCustom insoles will make with CAD-CAM using a laser scanning and casting for its construction. All this needs the assistance of a computer. From the digital image of a positive of the limb in foam the insole will be obtained. Custom insoles make with direct adaptation technique (TAD) being of pvc resin. Once the resins are cut and with a temperature of 90º, they will be adapted to the foot (which will be protected with a sock) of the patient with the help of a vacuum. To this technique subtalar joint will be in a neutral position and metatarsal joints will be aligned. | Device | Custom insoles |
| Standardized insolesStandardized insoles were done by EVA material with shore of 18 and 180 kg/cm3 and manufactured, with an extension of 3/4. It was in contact with heel and plantar arch. | Device | Standardized insoles |
Primary outcome
Change from Baseline Active graph (bracelet) at 3 months
Time frame: one week, one month and three months
This outcome will be measured with an activity monitor, accelerometer
4 secondary outcomes
Change from Baseline quality of life at 3 months
Time frame: one week, one month and three months
Change from Baseline foot function 3 months
Time frame: one week, one month and three months
Change from Baseline pain intensity at 3 months
Time frame: one week, one month and three months
Change from Baseline physical activity at 3 months
Time frame: one week, one month and three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Derived from this study: PubMed 33560583Ramos-Petersen L, Nester CJ, Ortega-Avila AB, Skidmore S, Gijon-Nogueron G. A qualitative study exploring the experiences and perceptions of patients with rheumatoid arthritis before and after wearing foot orthoses for 6 months. Health Soc Care Community. 2021 May;29(3):829-836. doi: 10.1111/hsc.13316. Epub 2021 Feb 9.
- Derived from this study: PubMed 32690521Ramos-Petersen L, Nester CJ, Gijon-Nogueron G, Ortega-Avila AB. Foot orthoses for people with rheumatoid arthritis, involving quantitative and qualitative outcomes: protocol for a randomised controlled trial. BMJ Open. 2020 Jul 19;10(7):e036433. doi: 10.1136/bmjopen-2019-036433.
- Individual participant dataSharing planned: No
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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.
Gabriel Gijon Nogueron, PhD principal investigator
University of Malaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom Insoles and Standardized insoles in people with Rheumatoid Arthritis, run by University of Malaga at 1 site in Spain.
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 8 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 18 Jan 2023. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Ramos Petersen, Podiatry (686583936 ext. +34, lauraramos.94@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Active graph (bracelet) at 3 months (time frame: one week, one month and three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03170947, which also lists 2 linked publications.
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 18 Jan 2023.