Orthopaedic Treatment in Propulsive Metatarsalgia

Universidad Complutense de Madrid

Status: Completed

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

Treatments: Device: Polypropylene plantar orthosis; Device: EVA plantar orthosis; Device: Fixtoe device

Study type: Interventional

Funder types: Other

Identifiers

NCT05713175

Tesis Doc Maria Ruiz-Ramos

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 3 patient groups

EVA plantar orthosis

Active Comparator group

Description:

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:

Device: EVA plantar orthosis

Polypropylene plantar orthosis

Active Comparator group

Description:

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.

Treatment:

Device: Polypropylene plantar orthosis

Fixtoe device

Active Comparator group

Description:

Fixtoe device, simulating the metatarsophalangeal joint stabilization tape technique . Worn for one month, prior to definitive treatment.

Treatment:

Device: Polypropylene plantar orthosis

Device: EVA plantar orthosis

Device: Fixtoe device