Orthopaedic Treatment in Propulsive Metatarsalgia

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.

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.