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NCT Number: NCT07043439

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

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.

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Key information

Conditions

Hallux Valgus Chiropractic Foot Deformities Manuel Therapy Musculoskeletal Diseases Musculoskeletal Manipulations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Plantar Pressure Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sinop University

Sinop, Turkey (Türkiye)

Location contact

SEFA H HATIK, Asst. Prof.

CONTACT

[email protected]

+905058761553

SEFA H HATIK, Asst. Prof.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobilization

Other

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.

High-Velocity Low-Amplitude (HVLA) Manipulation

Other

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.

Sham Manipulation

Other

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.

Primary outcomes

  1. Pedobarographic Analysis

    Time frame: 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.

  2. Goniometric Measurement of 1st MTP Joint Range of Motion

    Time frame: 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.

Secondary outcomes

  1. Numeric Pain Rating Scale (NPRS)

    Time frame: Baseline and immediately after the intervention (within the same session)

    Participants will rate their perceived pain level during weight-bearing using a numeric scale from 0 (no pain) to 10 (worst possible pain). This will help assess any acute analgesic effects of the intervention.

  2. Manchester-Oxford Foot Questionnaire (MOXFQ)

    Time frame: Baseline and immediately after the intervention

    A validated self-reported questionnaire assessing foot-related pain, walking/standing difficulties, and social interaction limitations. Although designed for chronic use, it will be used to observe short-term perceptual changes.

  3. Manchester Scale for Hallux Valgus Severity

    Time frame: Baseline and immediately after the intervention

    A visual grading scale used to classify the severity of hallux valgus deformity. While structural changes are not expected in the short term, it will be used for documentation and potential perceptual variation.

  4. Multidimensional Nil Hallux Valgus Scale

    Time frame: Baseline and immediately after the intervention

    A multidimensional scale evaluating hallux valgus symptoms, appearance, shoe fit, and function. Will be used to assess changes in self-perception and functional symptoms.

  5. SF-36 Short Form Health Survey

    Time frame: Baseline and immediately after the intervention

    A general health-related quality of life questionnaire consisting of 8 domains. Although designed for long-term monitoring, it will be applied to explore immediate changes in perceived well-being.

Study contacts

Contact information is provided by the study sponsor or research team.

SEFA H HATIK, Asst. Prof.

CONTACT

[email protected]

+905058761553

ÖMER D KIZIL, PhD.

CONTACT

[email protected]

+905415233691

Sponsors and collaborators

Lead sponsor

SEFA HAKTAN HATIK

Other

Registry information

Acronym: HALLPRESS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 29, 2025
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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