Effects of Customized Insoles for Individuals With Symptomatic Hallux Valgus: Protocol for a Sham-controlled Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in Numerical Pain Scale (END)
研究概览
简要总结
Hallux valgus is one of the most common forefoot deformities. Its prevalence increases with age, representing approximately 23% in adulthood, being more common in females. Some studies indicate that the use of the insole associated with the finger separator promotes pain relief and that this may be related to better alignment of the hallux. However, there is still no consensus about the ideal insole or how long it should be used to relieve pain or improve function in patients with hallux valgus. Therefore, the objective of this study will be to evaluate the effect of the customized insole on pain and function of individuals with symptomatic hallux valgus.
详细描述
This is a protocol for a randomized, controlled, blinded clinical trial. Eighty participants with hallux valgus pain will be evaluated and randomized into two intervention groups (40 per group): customized insole group or sham insole group. Assessments will be performed at baseline (T0), after six weeks (T6) and twelve weeks (T12) of insoles use, in addition to the follow-up that will be performed four weeks after the end of the intervention (T16). The primary outcome will be pain, assessed by the Numerical Pain Scale and the secondary outcome will be foot functionality, assessed by the Foot Function Index questionnaire. Statistical analysis: For normal data, analysis of variance with a mixed design will be considered, and for non-normal data, the Friedman test will be used, in addition to the interaction of time per group and intergroup and intragroup differences. The Bonferroni test will be performed in post hoc analyses. Intent-to-treat analysis will be used. A significance level of 5% and CI 95% will be adopted for all statistical analyses.
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)
盲法说明
All assessments will be performed by researcher A, who will not be involved with the interventions and will remain blind to the identification of groups. The results of the evaluations will be delivered to researcher C, a researcher with experience in making the insoles, so that they can be made. GPC participants will receive the insoles according to the assessment measurements, five days after the assessment start date.
Each participant will remain identified by numbers and not names. Participants will be informed about the purpose of the study to compare the two interventions using customized insoles. In order not to compromise the blinding of the study, all participants will be submitted to the same evaluation before the production and delivery of the insoles. When the insoles are ready, participants will be scheduled for removal at different times, avoiding possible meetings or exchange of information.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals of both sexes aged over 18 years;
- •Presence of mild to moderate hallux valgus, according to the Manchester scale;
- •Presenting no hallux with intensity greater than or equal to 3 points up to 8 points, according to the Numerical Pain Scale (END);
- •Be available to actively use the insole for at least 4 hours/day;
- •Commitment to wear closed shoes, for example (sneakers, shoes used by the patient, due to: wide toe cap and heel height of 2 to 3 cm) during the study.
排除标准
- •Being in physical therapy treatment for hallux valgus concomitantly with the research;
- •Previous hallux valgus surgeries performed in the last 5 years;
- •Presence of foot wounds and wounds, dislocations or metatarsophalangeal fractures in the foot with HV, in the last 5 years
- •Presence of diseases such as rheumatoid arthritis, decompensated diabetes, gout, neurodegenerative diseases;
- •Cognitive and mental disorder being unable to respond; those related to the study
结局指标
主要结局
Change in Numerical Pain Scale (END)
时间窗: baseline, 6 weeks, 12 weeks, 16 weeks
Pain intensity will be assessed using the Numerical Pain Scale (END), in which individuals will classify their pain on a numerical scale from 0 to 10 points. This scale will be positioned in front of the participant and will vary from zero to ten points, with zero being the complete absence of pain and ten being the worst pain imaginable by the individual. The quantification of pain intensity will be evaluated at the first steps in the morning and throughout the day.
次要结局
- Change in Blinding test(16 weeks)
- Change in Treatment expectation(baseline)
- Change in Hours of insole use(16 weeks)
- Change in Foot Function Index (FFI)(baseline, 6 weeks, 12 weeks, 16 weeks)
- Change in Self-assessment of treatment(16 weeks)
研究者
Marcelo Cardoso de Souza, PT, PhD.
Adjunct Professor
Universidade Federal do Rio Grande do Norte