Orthopaedic Treatment in Propulsive Metatarsalgia

Effectiveness of Orthopaedic Treatment in Propulsive Metatarsalgia

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.

Study Overview

• Status: Completed
• Conditions: Foot Diseases; Orthopedic Disorder; Toe Joint Deformity; Treatment; Metatarsalgia; Foot; Subluxation of Toe Joint
• Intervention / Treatment: Device: EVA plantar orthosis; Device: Polypropylene plantar orthosis; Device: Fixtoe device

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Clínica Universitaria de Podología Complutense University Madrid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: EVA plantar orthosis; 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; 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.
ACTIVE_COMPARATOR: Polypropylene plantar orthosis; 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; 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.
ACTIVE_COMPARATOR: Fixtoe device; Fixtoe device, simulating the metatarsophalangeal joint stabilization tape technique . Worn for one month, prior to definitive treatment.	Device: EVA plantar orthosis; 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: Polypropylene plantar orthosis; 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: Fixtoe device; Fixtoe Device, simulating the metatarsophalangeal stabilization tape technique is worn for one month, prior to definitive treatment consisting of a personalized plantar orthosis.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Investigators: Study Director: Ángel M Orejana-García, PhD, Complutense University Madrid; Study Director: Raúl J Molines-Barroso, PhD, Complutense University Madrid; Study Director: José Luis Lázaro-Martínez, PhD, Complutense University Madrid; Principal Investigator: Maria Ruiz-Ramos, MSc, Complutense University Madrid

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2022
• Primary Completion (ACTUAL): January 1, 2023
• Study Completion (ACTUAL): January 1, 2023

Study Registration Dates

• First Submitted: October 5, 2022
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (ACTUAL): February 6, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 1, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Treatment; Forefoot; Foot Diseases; Metatarsalgia
• Additional Relevant MeSH Terms: Skin Diseases; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Foot Diseases; Metatarsalgia
• Other Study ID Numbers: Tesis Doc Maria Ruiz-Ramos

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No