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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:
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.
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:
Visits protocol is as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVA plantar orthosis | Active Comparator | 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 | Active Comparator | 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 | Active Comparator | Fixtoe device, simulating the metatarsophalangeal joint stabilization tape technique . Worn for one month, prior to definitive treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVA plantar orthosis | Device | 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic data: Age. | Expressed in years | Day 1. |
| Demographic data: Gender | Women or Men | Day 1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
| Maria Ruiz-Ramos, MSc | Complutense University Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clínica Universitaria de Podología Complutense University Madrid | Madrid | 28040 | Spain |
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| ID | Term |
|---|---|
| D037061 | Metatarsalgia |
| D005534 | Foot Diseases |
| D009140 | Musculoskeletal Diseases |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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Parallel Groups Open Randomised Clinical Trial
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The participant understands he is being part of a clinical trial but unknowns the treatment group he has been allocated.
|
| Polypropylene plantar orthosis | Device | 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 | Device | Fixtoe Device, simulating the metatarsophalangeal stabilization tape technique is worn for one month, prior to definitive treatment consisting of a personalized plantar orthosis. |
|
| 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |