Effectiveness of Orthopaedic Treatment in Propulsive Metatarsalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Foot Pain
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The participant understands he is being part of a clinical trial but unknowns the treatment group he has been allocated.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: EVA plantar orthosis (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.
干预措施: Polypropylene plantar orthosis (Device)
Fixtoe device
Fixtoe device, simulating the metatarsophalangeal joint stabilization tape technique . Worn for one month, prior to definitive treatment.
干预措施: EVA plantar orthosis (Device)
Fixtoe device
Fixtoe device, simulating the metatarsophalangeal joint stabilization tape technique . Worn for one month, prior to definitive treatment.
干预措施: Polypropylene plantar orthosis (Device)
Fixtoe device
Fixtoe device, simulating the metatarsophalangeal joint stabilization tape technique . Worn for one month, prior to definitive treatment.
干预措施: Fixtoe device (Device)
结局指标
主要结局
Foot Pain
时间窗: 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
时间窗: 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.
次要结局
- Metatarsal formula(Day 1.)
- Foot clinical evaluation data: Lunge test(Day 1.)
- Foot clinical evaluation data: Arch index(Day 1, Day 4.)
- Foot clinical evaluation data: Navicular Drop Test(Day 1, Day 4.)
- Demographic data: Body Mass Index (BMI)(Day 1.)
- Demographic data: Adherence to treatment(Day 2, Day 3, Day 4.)
- Demographic data: Time with symptoms.(Day 1.)
- Foot orthosis data: Stability(Day 4.)
- Radiographical data: talar coverage angle(Day 1.)
- Radiographical data: 1st cuneiform - 5th metatarsal distance(Day 1.)
- Radiographical data: Meary's line(Day 1.)
- Foot orthosis data: Orthotic deformity test(Day 4.)
- Demographic data: Height(Day 1.)
- Demographic data: Age.(Day 1.)
- Demographic data: Gender(Day 1.)
- Demographic data: Wheight(Day 1.)
- Foot clinical evaluation data: Toes deformity(Day 1.)
- Foot clinical evaluation data: Paper pull-out test(Day 1, Day 2.)
- Foot clinical evaluation data: 1st metatarsophalangeal joint range of movement(Day 1, Day 4)
- Foot clinical evaluation data: Medial column of the foot stiffness(Day 1.)
- Foot clinical evaluation data: Functional Hallux Limitus(Day 1.)
- Foot clinical evaluation data: First ray mobility(Day 1.)
- Foot clinical evaluation data: Calcaneus relaxed standing position.(Day 1, Day 4.)
- Foot clinical evaluation data: Subtalar joint axis orientation(Day 1.)
- Radiographical data: HAV angle(Day 1.)
- Radiographical data: 1st metatarsophalangeal joint osteoarthritis(Day 1.)
- Foot orthosis data: Metatarsal dome location in relation to central metatarsal heads(Day 4.)
- Foot orthosis data: Metatarsal dome location in relation to 1st metatarsal head(Day 4.)
- Radiographical data: 2nd metatarsophalangeal joint angle(Day 1.)
- Radiographical data: 3rd metatarsophalangeal joint angle(Day 1.)
- Radiographical data: M1-M2 intermetatarsal angle(Day 1.)
- Radiographical data: 2nd- 3rd metatarsophalangeal joint impingement(Day 1.)
- Radiographical data: 2nd - 3rd metatatsophalangeal joint radiolucency.(Day 1.)
- Radiographical data: Metatarsus primus elevatus(Day 1.)
- Radiographical data: 1st cuneiform - 2nd metatarsal gap(Day 1.)