Orthopaedic Treatment in Propulsive Metatarsalgia

Orthopedic Disorder Clinical Trial

Official title:

Effectiveness of Orthopaedic Treatment in Propulsive Metatarsalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05713175
• Other study ID #: Tesis Doc Maria Ruiz-Ramos
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: January 2023
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Foot
• Foot Diseases
• Metatarsalgia
• Musculoskeletal Diseases
• Orthopedic Disorder
• Toe Joint Deformity
• Treatment

Intervention

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.
• 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
Fixtoe Device, simulating the metatarsophalangeal stabilization tape technique is worn for one month, prior to definitive treatment consisting of a personalized plantar orthosis.

Locations

Country	Name	City	State
Spain	Clínica Universitaria de Podología Complutense University Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

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