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

Overview

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.

Interventions

• 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 resista
• 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
• 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

Primary outcome measures

• Pedobarographic Analysis [Time frame: Baseline and immediately after the intervention (within the same session)]
• Goniometric Measurement of 1st MTP Joint Range of Motion [Time frame: Baseline and immediately after the intervention (within the same session)]

Secondary outcome measures (5)

• Numeric Pain Rating Scale (NPRS) [Time frame: Baseline and immediately after the intervention (within the same session)]
• Manchester-Oxford Foot Questionnaire (MOXFQ) [Time frame: Baseline and immediately after the intervention]
• Manchester Scale for Hallux Valgus Severity [Time frame: Baseline and immediately after the intervention]
• Multidimensional Nil Hallux Valgus Scale [Time frame: Baseline and immediately after the intervention]
• SF-36 Short Form Health Survey [Time frame: Baseline and immediately after the intervention]

Eligibility criteria

Inclusion criteria

• 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)

Exclusion criteria

• Having undergone surgery on the foot or ankle area within the last 6 months
• Having any neurological or psychiatric problems

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Sinop University — Sinop

Identifiers

NCT: NCT07043439 · CMT0009

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗