Effects of Insoles Adapted in Flip-flop Sandals in People With Heel Pain: a Randomized, Double-blind Clinical, Controlled Study
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
- Change in Numerical pain intensity scale - NPS
研究概览
简要总结
Introduction: Persistent hindfoot pains are very common and prevalent complaints in the Brazilian population. One of the treatments recommended for these conditions in the literature is the use of insoles. However, to use this resource it is necessary that the individual wear closed shoes and this is an obstacle to treatment in cities with hot climate. Thinking about an alternative treatment, the customized slippers with the corrective elements of the insoles can be an alternative to increase adherence to this type of treatment. Objective: To compare different types of hindfoot elements in insoles adapted in slippers in individuals with persistent hindfoot pain.
详细描述
Methodology: This is a protocol for a controlled, randomized, blinded clinical trial. Eighty participants with persistent hindfoot pain will be evaluated and randomized into two intervention groups: insoles adapted to flip-flops and flip-flops with sham insole. The evaluations will be carried out at baseline (T0), after six (T6) and twelve weeks (T12) of the use of flip-flops, in addition to the follow-up that will be carried out four weeks after the end of the intervention (T16). The primary outcome will be pain, using the Numerical Pain Scale and the secondary outcomes will be: foot function, using the Foot Function Index questionnaire, functional capacity in walking, using the Six-Minute Walk Test and pain catastrophizing using the Scale. of Pain Catastrophizing. Statistical analysis: Data will be analyzed by T-student, Mann-Whitney and repeated measures ANOVA tests and will be analyzed by intention to treat. Ethics and disclosure: This protocol was approved by the Ethics Committee of UFRN/FACISA (number 4,018,821). The results of the study will be disseminated to participants and submitted to a peer-reviewed journal and scientific meetings.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals of both sexes, aged 18 to 65 years;
- •Persistent heel pain for at least three months based on self-reported criteria: heel pain accompanying the first steps in the morning, after a period of inactivity, and/or during prolonged weight-bearing;
- •Pain intensity between 3 and 8 points, according to the Numerical Rating Scale (NRS) [22];
- •Individuals who can wear flip-flop sandals for at least four hours per day for 12 weeks.
排除标准
- •Clinical diagnosis of neuropathic pain or neurodegenerative disorders, persistent heel pain due to rheumatic conditions, and previous ankle and foot surgeries;
- •Physical therapy treatment in the last three months;
- •Corticosteroid injection into feet in the last six months;
- •inability to answer study-related questionnaires;
- •Individuals scheduled to travel in the next six months.
研究组 & 干预措施
Experimental group
Group 1- The intervention group I will receive a customized strip slipper with a 3mm EVA horseshoe piece (Shore A 32). And 2.5mm EVA cover (Shore A 28).
干预措施: Insoles adapted in flip-flop sandals (Other)
Sham group
Group 2- The control group will receive a slipper with a 2.5mm EVA cover (Shore A 32) identical to the one used by the intervention group, but without corrective par
干预措施: Insoles adapted in flip-flop sandals (Other)
结局指标
主要结局
Change in Numerical pain intensity scale - NPS
时间窗: baseline, 6 weeks after, 12 weeks after, 16 weeks folow up
Pain intensity will be evaluated with the 10-point Numerical Pain Rating Scale, where 0 is "pain-free" and 10 is "maximum pain.
次要结局
- Change in Functional capacity - 6MWT(baseline and 12 weeks after)
- Change in Foot function - FFI(baseline, 6 weeks after, 12 weeks after, 16 weeks folow up)
- Change in Pain Catastrophizing Scale (PCS)(baseline and 12 weeks after)
- Expectation for treatment(baseline)
- Satisfaction with treatment(16 weeks after)
研究者
Marcelo Cardoso de Souza, PT, PhD.
Adjunct Professor
Universidade Federal do Rio Grande do Norte