Orthopaedic Treatment in Propulsive Metatarsalgia

Not Applicable

Completed

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

• Registration Number: NCT05713175
• Lead Sponsor: Universidad Complutense de Madrid

Brief Summary

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

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 Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-10-05
• Status Verified: 2023-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01
• Study First Submitted QC: 2023-02-01
• Last Update Submitted: 2023-02-01
• Study First Posted: 2023-02-06
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fixtoe device	Polypropylene plantar orthosis	Fixtoe device, simulating the metatarsophalangeal joint stabilization tape technique . Worn for one month, prior to definitive treatment.
Fixtoe device	Fixtoe device	Fixtoe device, simulating the metatarsophalangeal joint stabilization tape technique . Worn for one month, prior to definitive treatment.
Polypropylene plantar orthosis	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.
Fixtoe device	EVA plantar orthosis	Fixtoe device, simulating the metatarsophalangeal joint stabilization tape technique . Worn for one month, prior to definitive treatment.
EVA plantar orthosis	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.

Primary Outcome Measures

Name	Time	Method
Foot Pain	Up to 20 weeks.	Foot Pain measured using a 11-point VAS score. 0 is the lower (better) value and 10 is the higher (worst) value.
Foot Pain and Disability	Up to 20 weeks.	Measured using the Foot Function Index (FFI-Sp) questionnaire (Spanish version). Higher values mean worse outcome and lower values mean better outcome.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clínica Universitaria de Podología Complutense University Madrid; 🇪🇸 Madrid, Spain