The goal of this clinical trial is to compare the effectiveness of two conservative orthopedic treatments in propulsive metatarsalgia. The main question it aims to answer are: * To compare the effectiveness of treatments on foot pain and functionality in subjects diagnosed with propulsive metatarsalgia. * To determinate the influence of clinical and radiographical characteristics in pain improvement. Participants will wear the treatment for 3 months . Researchers will compare polypropylene and EVA insoles and Fixtoe Device® to see if a foot pain improvement is achieved.
Type of Study: Randomised Clinical Trial. Aim: To compare the effect of orthopedic treatment on foot pain and functionality in subjects diagnosed with propulsive metatarsalgia. Study Protocol Description: Prior to the start of the study, a calculation of the sample size will be made using the GRANMO Sample Size Calculator, version .12 April 2012, with an error of 5%, assuming a confidence level of 95% and values of ß that establish an analysis power of 80%. The study population will be randomly divided into two treatment groups, which, in turn, will be subdivided into two groups. Said randomization will be carried out using an online tool (www.randomization.com). Treatment groups are: * Group A: Treatment by custom insoles made of 4.5mm polypropylene, balanced in inversion 0-4º, MLA of the patient, 4mm-heel rise and metatarsal dome. * Group A1: Treatment from the date of diagnosis until the start of insoles use (3 weeks) using the Fix-Toe® device. * Group A2: Without orthopedic treatment from the date of diagnosis until the start of insoles use (3 weeks). * Group B: Treatment by custom insoles made of 45º shore A E.V.A with the patient's MLA, 4mm- heel rise and metatarsal dome. * Group B1: Treatment from the date of diagnosis until the start of insoles use (3 weeks) using the Fix-Toe® device. * Group B2: Without orthopedic treatment from the date of diagnosis until the start of insoles use (3 weeks). Visits protocol is as follows: * Day 1: inclusion, clinical and radiographical evaluation. Pain questionnaires fulfillment.Treatment group allocation. * Day 2 (3 weeks after Day 1): Pain questionnaires fulfillment. Starts insoles treatment. * Day 3 (6 weeks after Day 2): Pain questionnaires fulfillment (telephone). * Day 4 (6 weeks after Day 3): Pain questionnaires fulfillment. Clinical evaluation. End of study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
Treatment consisting of a personalized plantar orthosis fabricated in 45º shore A hardness Ethyl Vinyl Acetate (EVA), which incorporates a 4mm heel rise and metatarsal dome placed proximal to the 2nd-3rd-4th metatarsal heads. No modifications applied to the patients' medial longitudinal arch.
Treatment consisting of a personalized plantar orthosis fabricated in 4mm polypropylene, which incorporates a 4mm heel rise and metatarsal dome placed proximal to the 2nd-3rd-4th metatarsal heads. No modifications applied to the patients' medial longitudinal arch.Orthosis fabricated following the inverted orthotic technique.
Fixtoe Device, simulating the metatarsophalangeal stabilization tape technique is worn for one month, prior to definitive treatment consisting of a personalized plantar orthosis.
Clínica Universitaria de Podología Complutense University Madrid
Madrid, Spain
Foot Pain
Foot Pain measured using a 11-point VAS score. 0 is the lower (better) value and 10 is the higher (worst) value.
Time frame: Up to 20 weeks.
Foot Pain and Disability
Measured using the Foot Function Index (FFI-Sp) questionnaire (Spanish version). Higher values mean worse outcome and lower values mean better outcome.
Time frame: Up to 20 weeks.
Demographic data: Age.
Expressed in years
Time frame: Day 1.
Demographic data: Gender
Women or Men
Time frame: Day 1.
Demographic data: Wheight
Expressed in kilograms.
Time frame: Day 1.
Demographic data: Height
Expressed in centimetres.
Time frame: Day 1.
Demographic data: Body Mass Index (BMI)
Weight and Height will be combined to report BMI in kg/m\^2
Time frame: Day 1.
Demographic data: Adherence to treatment
Good / Bad. Measured using a own questionnaire.
Time frame: Day 2, Day 3, Day 4.
Demographic data: Time with symptoms.
\>12 months / 6-12 months / \> 6 months / \> 3 months
Time frame: Day 1.
Foot clinical evaluation data: Toes deformity
No deformity / Sagittal plane deformity / V sign
Time frame: Day 1.
Foot clinical evaluation data: Paper pull-out test
No resistence / Medium resistence / Resistence
Time frame: Day 1, Day 2.
Foot clinical evaluation data: 1st metatarsophalangeal joint range of movement
Expressed in degrees.
Time frame: Day 1, Day 4
Foot clinical evaluation data: Medial column of the foot stiffness
Low / Moderate/ High
Time frame: Day 1.
Foot clinical evaluation data: Functional Hallux Limitus
Yes / No. According to Functional Hallux Limitus test.
Time frame: Day 1.
Foot clinical evaluation data: First ray mobility
Dorsal \> Plantar / Similar / Dorsal \< Plantar
Time frame: Day 1.
Foot clinical evaluation data: Lunge test
Positive / Negative
Time frame: Day 1.
Foot clinical evaluation data: Arch index
Expressed in degrees.
Time frame: Day 1, Day 4.
Foot clinical evaluation data: Navicular Drop Test
Expressed in centimetres.
Time frame: Day 1, Day 4.
Foot clinical evaluation data: Calcaneus relaxed standing position.
Expressed in degrees.
Time frame: Day 1, Day 4.
Foot clinical evaluation data: Subtalar joint axis orientation
Medial / Neutral / Lateral
Time frame: Day 1.
Radiographical data: HAV angle
Expressed in degrees.
Time frame: Day 1.
Radiographical data: 1st metatarsophalangeal joint osteoarthritis
0/ 1/ 2/ 3/ 4
Time frame: Day 1.
Metatarsal formula
According to the length of the metatarsal bones.
Time frame: Day 1.
Radiographical data: 2nd metatarsophalangeal joint angle
Expressed in degrees.
Time frame: Day 1.
Radiographical data: 3rd metatarsophalangeal joint angle
Expressed in degrees.
Time frame: Day 1.
Radiographical data: M1-M2 intermetatarsal angle
Expressed in degrees.
Time frame: Day 1.
Radiographical data: 2nd- 3rd metatarsophalangeal joint impingement
Yes / No
Time frame: Day 1.
Radiographical data: 2nd - 3rd metatatsophalangeal joint radiolucency.
Yes / No
Time frame: Day 1.
Radiographical data: Metatarsus primus elevatus
Yes / No
Time frame: Day 1.
Radiographical data: 1st cuneiform - 2nd metatarsal gap
Expressed in centimetres.
Time frame: Day 1.
Radiographical data: talar coverage angle
Expressed in degrees.
Time frame: Day 1.
Radiographical data: 1st cuneiform - 5th metatarsal distance
Expressed in centimetres.
Time frame: Day 1.
Radiographical data: Meary's line
Dorsal / Plantar
Time frame: Day 1.
Foot orthosis data: Metatarsal dome location in relation to central metatarsal heads
Similar / Distal / Proximal
Time frame: Day 4.
Foot orthosis data: Metatarsal dome location in relation to 1st metatarsal head
Similar / Distal / Proximal
Time frame: Day 4.
Foot orthosis data: Stability
Yes / No
Time frame: Day 4.
Foot orthosis data: Orthotic deformity test
Yes / No
Time frame: Day 4.
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