Effects of Insoles in Patients With Rheumatoid Arthritis: Randomized Controlled Trial.

Rheumatoid Arthritis Clinical Trial

Official title:

Effects of Insoles in Patients With Rheumatoid Arthritis Through Measurement of Quality of Life and Physical Activity: Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03170947
• Other study ID #: UNIMalaga
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2022
• Est. completion date: December 2024

Study information

• Verified date: January 2023
• Source: University of Malaga
• Contact: Laura Ramos Petersen, Podiatry
• Phone: 686583936
• Email: lauraramos.94[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 activities. Non-pharmacological interventions (insole, footwear) have an important role, reducing pain and disability, increasing the effectiveness and improving daily activities.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Device:
• Custom Insoles
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 insoles
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.

Locations

Country	Name	City	State
Spain	University of Malaga	Malaga

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaga

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Change from Baseline foot function 3 months	This outcome will be measured with a self-reported questionnaire (foot function index)	one week, one month and three months
Secondary	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
Secondary	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