Effectiveness of Insole on Morton's Neuroma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 主要终点
- Change in pain
研究概览
简要总结
Objective: The aim of the present study was to assess the effectiveness of insole with metatarsal support on pain in patients with Morton's neuroma and the impact of this insole on function, load distribution in the plantar region, gait variables, quality of life and satisfaction with insole use.
Methods: A randomized, controlled, double-blind, clinical trial with intent-to-treat analysis. Seventy-two patients with Morton's neuroma were randomly allocated into a study group and control group. One week following the baseline evaluation, the study group received insole with metatarsal support made of ethyl vinyl acetate and the control group received a flat insole of the same material, color and density. The groups were evaluated after 6, 12 and 24 weeks of insole use. The following assessment parameters employed: pain when walking and at rest (END); quality of life (SF-36); foot function (FFI and FHSQ); six-minute walk test (6MWT) and foot pressure analysis using the AM Cube FootWalk Pro program.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Placebo insole
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
- •Patient with clinical and radiological diagnosis (magnetic resonance or ultrasound) of Morton's neuroma.
- •Pain in the foot with VAS between 3-8 cm to walk.
- •Over 18 years.
- •No distinction of sex
- •Agree to participate of the study and sign the informed consent form.
排除标准
- •Other symptomatic musculoskeletal diseases in MMII.
- •Symptomatic diseases of the central and peripheral nervous system.
- •Diabetes Mellitus.
- •Rigid deformities on foot.
- •Use of insoles in the last three months.
- •Physiotherapy in the last three months.
- •Infiltrations on foot and ankles in the last three months.
- •Previous or expected surgery in the next twelve months.
- •Allergy to the material of the insole.
- •Mental deficiency.
- •Geographic inaccessibility .- Use of corticosteroids or NSAIDs in the last month
研究组 & 干预措施
Intervention Group
Customized insole with metatarsal support
干预措施: Insole (Device)
Control Group
Placebo flat insole
干预措施: Placebo Insole (Device)
结局指标
主要结局
Change in pain
时间窗: Baseline, after 6, 12 and 24 weeks
Measured by visual analogue scale from 0 cm to 10 cm
次要结局
- Change in function and foot health(Baseline, after 6, 12 and 24 weeks)
- Change in function, foot healt and quality of life(Baseline, after 6, 12 and 24 weeks)
- Change in function(Baseline, after 6, 12 and 24 weeks)
- Quality of life(Baseline, after 6, 12 and 24 weeks)
研究者
Hilda Alcantara Veiga de Oliveira
PT, MsC
Federal University of São Paulo