Orthopaedic Treatment in Propulsive Metatarsalgia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of Orthopaedic Treatment in Propulsive Metatarsalgia

Conditions
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Metatarsalgia, Treatment, Foot, Foot Diseases, Orthopedic Disorder, Subluxation of Toe Joint, Toe Joint Deformity

Intervention / Treatment
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* Device: EVA plantar orthosis
* Device: Polypropylene plantar orthosis
* Device: Fixtoe device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mechanical pain in the 2nd or 3rd metatarsophalangeal joint (MTPJ) Positive Laschman's drawer test in 2nd or 3rd MTPJ. (CITA) Physical exploration revealing pain upon the palpation in plantar plate ( when cranial-caudal pressure was directly applied in the plantar aspect of the 2nd or 3rd MTPJ). (CITA) Availability of dorsal-plantar and lateral wheightbearing radiography of the affected foot. Exclusion Criteria: Subjects with at least one of the following were excluded. Deformity of the 2nr or 3rd metatarsal head (MTH) (Freiberg's disease) Morton's neuroma and/or neuritic symptomatlogy y referred. Rigid claw or hammer toe (positive Kelikian test) whithin radiographic dislocation of 2nd or 3rd MTPJ. (CITA) Dermatological lesión plantar to 2nd or 3rd MTPJ (intractable plantar keratosis (IPK), foot ulcer, plantar wart, etc.) Neurological, methabolical, vascular or rheumatological not-controlled systemic disease with potential manifestations in foot and ankle. Previous history of foot or ankle surgery entailing limitations in mobility and/or alterations of the metatarsal parabola. Previous history of foot or ankle fracture Morpho-functional alteration of the lower limbs: clinical asymmetry greater than 10 mm and presence of asymmetric genu varus or valgus. Alterations of the cognitive state preventing to understand the objective of the study and guidelines to follow for their participation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Groups Open Randomised Clinical Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EVA plantar orthosis<br>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. | Device: EVA plantar orthosis<br>* 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.<br>|
| Active Comparator: Polypropylene plantar orthosis<br>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. | Device: Polypropylene plantar orthosis<br>* 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.<br>|
| Active Comparator: Fixtoe device<br>Fixtoe device, simulating the metatarsophalangeal joint stabilization tape technique . Worn for one month, prior to definitive treatment. | Device: EVA plantar orthosis<br>* 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.<br>Device: Polypropylene plantar orthosis<br>* 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.<br>Device: Fixtoe device<br>* Fixtoe Device, simulating the metatarsophalangeal stabilization tape technique is worn for one month, prior to definitive treatment consisting of a personalized plantar orthosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot Pain | Foot Pain measured using a 11-point VAS score. 0 is the lower (better) value and 10 is the higher (worst) value. | 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. | Up to 20 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic data: Age. | Expressed in years | Day 1. | 
| Demographic data: Gender | Women or Men | Day 1. | 
| Demographic data: Wheight | Expressed in kilograms. | Day 1. | 
| Demographic data: Height | Expressed in centimetres. | Day 1. | 
| Demographic data: Body Mass Index (BMI) | Weight and Height will be combined to report BMI in kg/m^2 | Day 1. | 
| Demographic data: Adherence to treatment | Good / Bad. Measured using a own questionnaire. | Day 2, Day 3, Day 4. | 
| Demographic data: Time with symptoms. | >12 months / 6-12 months / > 6 months / > 3 months | Day 1. | 
| Foot clinical evaluation data: Toes deformity | No deformity / Sagittal plane deformity / V sign | Day 1. | 
| Foot clinical evaluation data: Paper pull-out test | No resistence / Medium resistence / Resistence | Day 1, Day 2. | 
| Foot clinical evaluation data: 1st metatarsophalangeal joint range of movement | Expressed in degrees. | Day 1, Day 4 | 
| Foot clinical evaluation data: Medial column of the foot stiffness | Low / Moderate/ High | Day 1. | 
| Foot clinical evaluation data: Functional Hallux Limitus | Yes / No. According to Functional Hallux Limitus test. | Day 1. | 
| Foot clinical evaluation data: First ray mobility | Dorsal > Plantar / Similar / Dorsal < Plantar | Day 1. | 
| Foot clinical evaluation data: Lunge test | Positive / Negative | Day 1. | 
| Foot clinical evaluation data: Arch index | Expressed in degrees. | Day 1, Day 4. | 
| Foot clinical evaluation data: Navicular Drop Test | Expressed in centimetres. | Day 1, Day 4. | 
| Foot clinical evaluation data: Calcaneus relaxed standing position. | Expressed in degrees. | Day 1, Day 4. | 
| Foot clinical evaluation data: Subtalar joint axis orientation | Medial / Neutral / Lateral | Day 1. | 
| Radiographical data: HAV angle | Expressed in degrees. | Day 1. | 
| Radiographical data: 1st metatarsophalangeal joint osteoarthritis | 0/ 1/ 2/ 3/ 4 | Day 1. | 
| Metatarsal formula | According to the length of the metatarsal bones. | Day 1. | 
| Radiographical data: 2nd metatarsophalangeal joint angle | Expressed in degrees. | Day 1. | 
| Radiographical data: 3rd metatarsophalangeal joint angle | Expressed in degrees. | Day 1. | 
| Radiographical data: M1-M2 intermetatarsal angle | Expressed in degrees. | Day 1. | 
| Radiographical data: 2nd- 3rd metatarsophalangeal joint impingement | Yes / No | Day 1. | 
| Radiographical data: 2nd - 3rd metatatsophalangeal joint radiolucency. | Yes / No | Day 1. | 
| Radiographical data: Metatarsus primus elevatus | Yes / No | Day 1. | 
| Radiographical data: 1st cuneiform - 2nd metatarsal gap | Expressed in centimetres. | Day 1. | 
| Radiographical data: talar coverage angle | Expressed in degrees. | Day 1. | 
| Radiographical data: 1st cuneiform - 5th metatarsal distance | Expressed in centimetres. | Day 1. | 
| Radiographical data: Meary's line | Dorsal / Plantar | Day 1. | 
| Foot orthosis data: Metatarsal dome location in relation to central metatarsal heads | Similar / Distal / Proximal | Day 4. | 
| Foot orthosis data: Metatarsal dome location in relation to 1st metatarsal head | Similar / Distal / Proximal | Day 4. | 
| Foot orthosis data: Stability | Yes / No | Day 4. | 
| Foot orthosis data: Orthotic deformity test | Yes / No | Day 4. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metatarsalgia, Forefoot, Foot Diseases, Treatment