Comparison of the Immediate Effects of Mobilization and Manipulation Versus Sham Manipulation on Plantar Pressure in Patients With Hallux Valgus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pedobarographic Analysis
研究概览
简要总结
The aim of this study is to examine the immediate effects of mobilization and manipulation versus sham manipulation on plantar pressure, quality of life, and pain in patients with hallux valgus. Participants will be assessed using a sociodemographic data form, the Manchester-Oxford Foot Questionnaire (MOXFQ), the Manchester Scale, goniometric measurements, the Multidimensional Nil Hallux Valgus Scale, the SF-36 Health Survey, the Numeric Pain Rating Scale (NPRS), and plantar pressure analysis via a pedobarographic device. The study will be conducted on a total of 60 feet, with 30 feet assigned to the manipulation group and 30 feet to the sham manipulation group.
详细描述
This is a single-center interventional study to be conducted at Diagenics R&D Technology Health Import and Export Co. Ltd., aiming to explore the biomechanical impact of manual therapy techniques in individuals with hallux valgus. The study focuses on the immediate effects of first metatarsal mobilization and high-velocity, low-amplitude (HVLA) chiropractic manipulation, compared to a sham procedure, on plantar pressure distribution.
In the intervention group, participants will receive both grade 3 mobilization and HVLA manipulation targeted at the first metatarsophalangeal joint. The procedures will be carried out by a physiotherapist with the participant in a prone position and the foot held in neutral alignment.
The control group will receive a sham manipulation applied under identical positioning and handling conditions, but without therapeutic force or joint cavitation. This approach is designed to mimic the procedure while avoiding any real biomechanical impact. To eliminate ethical concerns regarding withholding effective treatment, participants in the control group will be offered the actual intervention after all immediate post-intervention data are collected.
All interventions and assessments will be conducted on a single day. Pre- and post-intervention plantar pressure data will be captured using a pedobarographic system. Pain intensity, joint angles, and other self-reported outcomes will be recorded using validated tools, but their details are provided in the corresponding modules.
The study's novelty lies in its integration of pedobarography for objective quantification of plantar pressure changes following isolated manual interventions, which may offer new insight into the acute mechanical responses of the foot in hallux valgus cases.
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 (Outcomes Assessor)
盲法说明
This study will employ single masking. The outcomes assessor will be blinded to the group allocation of the participants (intervention vs. sham). Participants and therapists will not be blinded due to the nature of manual interventions, which require active therapist involvement and differ in technique between groups.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be over 18 years of age
- •Volunteer to participate in the study
- •Have hallux valgus (those with a hallux valgus angle greater than 15 and a Manchester Scale score of B or higher)
排除标准
- •Having undergone surgery on the foot or ankle area within the last 6 months
- •Having any neurological or psychiatric problems
研究组 & 干预措施
Mobilization and Manipulation Group (MMG)
Participants in this group underwent high-velocity, low-amplitude (HVLA) chiropractic manipulation of the first metatarsophalangeal (MTP) joint by an experienced physical therapist, followed by grade 3 accessory mobilization.
Participants were placed in the prone (face-down) position during the procedure, and the foot was stabilized in a neutral position.
Manipulation: The therapist stabilized the first metatarsal bone with one hand while applying a quick, short traction force to the proximal phalanx of the first toe with the other hand.
Mobilization: Following manipulation, grade 3 rhythmic oscillations were applied to the same joint in accordance with the Maitland technique to increase joint play.
The entire procedure was completed in a single session, with evaluations conducted immediately before and after the intervention.
干预措施: Mobilization (Other)
Mobilization and Manipulation Group (MMG)
Participants in this group underwent high-velocity, low-amplitude (HVLA) chiropractic manipulation of the first metatarsophalangeal (MTP) joint by an experienced physical therapist, followed by grade 3 accessory mobilization.
Participants were placed in the prone (face-down) position during the procedure, and the foot was stabilized in a neutral position.
Manipulation: The therapist stabilized the first metatarsal bone with one hand while applying a quick, short traction force to the proximal phalanx of the first toe with the other hand.
Mobilization: Following manipulation, grade 3 rhythmic oscillations were applied to the same joint in accordance with the Maitland technique to increase joint play.
The entire procedure was completed in a single session, with evaluations conducted immediately before and after the intervention.
干预措施: High-Velocity Low-Amplitude (HVLA) Manipulation (Other)
Control Group (CG)
The control group individuals underwent sham manipulation in the same position (prone and neutral foot) and for the same duration. During the sham application, the therapist assumed the manipulation position, placed his hands on the first metatarsal, and created the impression that the application was being performed. However, no traction, pushing, mobilization, or high-speed movement was applied during this process.
This application was performed in a way that would make the participant believe they were receiving treatment, but without creating any biomechanical or neurophysiological effects.
Since the purpose of the sham group was to control for the placebo effect, evaluations were also conducted on the individuals in this group before and immediately after the application.
For ethical reasons, the real treatment protocol was also applied to these participants after the evaluations.
干预措施: Sham Manipulation (Other)
结局指标
主要结局
Pedobarographic Analysis
时间窗: Baseline and immediately after the intervention (within the same session)
Dynamic plantar pressure distribution will be measured using a computerized pedobarography system. Key parameters will include peak pressure, pressure-time integral, and contact area under specific foot regions (e.g., forefoot, hallux). The goal is to evaluate the immediate biomechanical effects of the intervention.
Goniometric Measurement of 1st MTP Joint Range of Motion
时间窗: Baseline and immediately after the intervention (within the same session)
Passive range of motion (flexion and extension) of the first metatarsophalangeal joint will be assessed using a standard goniometer. Measurements will be taken to detect acute changes in joint mobility after intervention.
次要结局
- Numeric Pain Rating Scale (NPRS)(Baseline and immediately after the intervention (within the same session))
- Manchester-Oxford Foot Questionnaire (MOXFQ)(Baseline and immediately after the intervention)
- Manchester Scale for Hallux Valgus Severity(Baseline and immediately after the intervention)
- Multidimensional Nil Hallux Valgus Scale(Baseline and immediately after the intervention)
- SF-36 Short Form Health Survey(Baseline and immediately after the intervention)
研究者
SEFA HAKTAN HATIK
Asst. Professor
Sinop University