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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standardized insoles | Active Comparator | Standardized insoles will be done by Ethylene-vinyl acetate (EVA) material. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Custom Insoles | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Active graph (bracelet) at 3 months | This outcome will be measured with an activity monitor, accelerometer | one week, one month and three months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline quality of life at 3 months | This outcome will be measured with a self-reported questionnaire (SF-36) | one week, one month and three months |
| Change from Baseline foot function 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Ramos Petersen, Podiatry | Contact | 686583936 | +34 | lauraramos.94@hotmail.com |
| Gabriel Gijon Nogueron, PhD | Contact | 951952872 | +34 | gagijon@uma.es |
| Name | Affiliation | Role |
|---|---|---|
| Gabriel Gijon Nogueron, PhD | University of Malaga | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Malaga | Recruiting | Málaga | 29071 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33560583 | Derived | 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. | |
| 32690521 |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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|
| Standardized insoles | Device | 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. |
|
This outcome will be measured with a self-reported questionnaire (foot function index)
| 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) | 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) | one week, one month and three months |
| Ramos-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. |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |