NCT07043439

Comparison of the Immediate Effects of Mobilization and Manipulation Versus Sham Manipulation on Plantar Pressure in Patients With Hallux Valgus

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: SEFA HAKTAN HATIK · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Hallux Valgus
• Foot Deformities
• Musculoskeletal Manipulations
• Plantar Pressure
• Manuel Therapy
• Chiropractic

Interventions

Type	Name	Description
OTHER	Mobilization	Participants receiving this intervention will undergo Grade 3 joint mobilization targeting the first metatarsophalangeal (1st MTP) joint. The technique will be administered by a licensed physiotherapist with the participant lying in the prone position and the foot in a neutral position. Mobilization will be performed according to the Maitland concept, which defines Grade 3 as large-amplitude, rhythmic oscillatory movements applied within the range of motion but up to the limit of tissue resistance, without entering the paraphysiological space. The goal of this technique will be to increase joint play and mobility, reduce stiffness, and potentially improve biomechanical alignment. The mobilization will last approximately 5 minutes, and outcome measures will be collected before and immediately after the session.
OTHER	High-Velocity Low-Amplitude (HVLA) Manipulation	This intervention will involve the application of a high-velocity, low-amplitude (HVLA) thrust manipulation to the first metatarsophalangeal (1st MTP) joint. A licensed physiotherapist will perform the procedure with the participant positioned prone and the foot placed in a neutral alignment. The therapist will stabilize the 1st metatarsal bone with one hand and apply a quick, controlled thrust to the proximal phalanx of the hallux in a dorsal direction using the other hand. The technique will be delivered with minimal amplitude and maximal speed, aiming to restore joint motion, reduce soft tissue tension, and stimulate neuromechanical reflexes. The manipulation procedure will take approximately 2-3 minutes, including setup and execution. Pre- and post-intervention outcome measures will be used to assess its immediate effects.
OTHER	Sham Manipulation	Participants in the control group will receive a sham (placebo) intervention designed to mimic the real treatment in setup and duration, without applying any therapeutic mechanical stimulus. The sham procedure will be conducted by the same physiotherapist with participants lying prone and their foot in a neutral position. The physiotherapist will place their hands around the 1st MTP joint as if a manipulation were to be performed and will maintain static contact for the same duration as in the experimental group. However, no thrust, traction, or mobilization force will be applied. The sham intervention will also last approximately 10 minutes, ensuring consistency across groups. All assessments will be conducted immediately before and after the intervention to evaluate potential placebo effects.

Timeline

• Start date: 2025-06-25
• Primary completion: 2025-07-25
• Completion: 2025-08-25
• First posted: 2025-06-29
• Last updated: 2025-06-29

Locations

1 site across 1 country: Turkey (Türkiye)