Clinical trial NCT05713175: Orthopaedic Treatment in Propulsive Metatarsalgia
Official title: Effectiveness of Orthopaedic Treatment in Propulsive Metatarsalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metatarsalgia
Treatment
Foot
Foot Diseases
Orthopedic Disorder
Subluxation of Toe Joint
Toe Joint Deformity
Keywords: Metatarsalgia
Forefoot
Foot Diseases
Treatment
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Groups Open Randomised Clinical Trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Foot Pain
timeFrame: Up to 20 weeks.
measure: Foot Pain and Disability
timeFrame: Up to 20 weeks.
Secondary outcomes:
measure: Demographic data: Age.
timeFrame: Day 1.
measure: Demographic data: Gender
timeFrame: Day 1.
measure: Demographic data: Wheight
timeFrame: Day 1.
measure: Demographic data: Height
timeFrame: Day 1.
measure: Demographic data: Body Mass Index (BMI)
timeFrame: Day 1.
measure: Demographic data: Adherence to treatment
timeFrame: Day 2, Day 3, Day 4.
measure: Demographic data: Time with symptoms.
timeFrame: Day 1.
measure: Foot clinical evaluation data: Toes deformity
timeFrame: Day 1.
measure: Foot clinical evaluation data: Paper pull-out test
timeFrame: Day 1, Day 2.
measure: Foot clinical evaluation data: 1st metatarsophalangeal joint range of movement
timeFrame: Day 1, Day 4
measure: Foot clinical evaluation data: Medial column of the foot stiffness
timeFrame: Day 1.
measure: Foot clinical evaluation data: Functional Hallux Limitus
timeFrame: Day 1.
measure: Foot clinical evaluation data: First ray mobility
timeFrame: Day 1.
measure: Foot clinical evaluation data: Lunge test
timeFrame: Day 1.
measure: Foot clinical evaluation data: Arch index
timeFrame: Day 1, Day 4.
measure: Foot clinical evaluation data: Navicular Drop Test
timeFrame: Day 1, Day 4.
measure: Foot clinical evaluation data: Calcaneus relaxed standing position.
timeFrame: Day 1, Day 4.
measure: Foot clinical evaluation data: Subtalar joint axis orientation
timeFrame: Day 1.
measure: Radiographical data: HAV angle
timeFrame: Day 1.
measure: Radiographical data: 1st metatarsophalangeal joint osteoarthritis
timeFrame: Day 1.
measure: Metatarsal formula
timeFrame: Day 1.
measure: Radiographical data: 2nd metatarsophalangeal joint angle
timeFrame: Day 1.
measure: Radiographical data: 3rd metatarsophalangeal joint angle
timeFrame: Day 1.
measure: Radiographical data: M1-M2 intermetatarsal angle
timeFrame: Day 1.
measure: Radiographical data: 2nd- 3rd metatarsophalangeal joint impingement
timeFrame: Day 1.
measure: Radiographical data: 2nd - 3rd metatatsophalangeal joint radiolucency.
timeFrame: Day 1.
measure: Radiographical data: Metatarsus primus elevatus
timeFrame: Day 1.
measure: Radiographical data: 1st cuneiform - 2nd metatarsal gap
timeFrame: Day 1.
measure: Radiographical data: talar coverage angle
timeFrame: Day 1.
measure: Radiographical data: 1st cuneiform - 5th metatarsal distance
timeFrame: Day 1.
measure: Radiographical data: Meary's line
timeFrame: Day 1.
measure: Foot orthosis data: Metatarsal dome location in relation to central metatarsal heads
timeFrame: Day 4.
measure: Foot orthosis data: Metatarsal dome location in relation to 1st metatarsal head
timeFrame: Day 4.
measure: Foot orthosis data: Stability
timeFrame: Day 4.
measure: Foot orthosis data: Orthotic deformity test
timeFrame: Day 4.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Clínica Universitaria de Podología Complutense University Madrid
Study officials:
affiliation: Complutense University Madrid
name: Ángel M Orejana-García, PhD
role: STUDY_DIRECTOR
affiliation: Complutense University Madrid
name: Raúl J Molines-Barroso, PhD
role: STUDY_DIRECTOR
affiliation: Complutense University Madrid
name: José Luis Lázaro-Martínez, PhD
role: STUDY_DIRECTOR
affiliation: Complutense University Madrid
name: Maria Ruiz-Ramos, MSc
role: PRINCIPAL_INVESTIGATOR
References: