Clinical trial NCT03170947: Effects of Insoles in Patients With Rheumatoid Arthritis: Randomized Controlled Trial.
Official title: Effects of Insoles in Patients With Rheumatoid Arthritis Through Measurement of Quality of Life and Physical Activity: Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Foot
Insoles
Quality of life
Physical Activity
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline Active graph (bracelet) at 3 months
timeFrame: one week, one month and three months
Secondary outcomes:
measure: Change from Baseline quality of life at 3 months
timeFrame: one week, one month and three months
measure: Change from Baseline foot function 3 months
timeFrame: one week, one month and three months
measure: Change from Baseline pain intensity at 3 months
timeFrame: one week, one month and three months
measure: Change from Baseline physical activity at 3 months
timeFrame: one week, one month and three months
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: University of Malaga
Study officials:
affiliation: University of Malaga
name: Gabriel Gijon Nogueron, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.