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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSEFA HAKTAN HATIK

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

Having undergone surgery on the foot or ankle area within the last 6 months

Having any neurological or psychiatric problems

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mobilization

    Other intervention

    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 intervention

    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 intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Mobilization and Manipulation Group (MMG)Experimental treatment 2 interventions
Group B: Control Group (CG)Sham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pedobarographic Analysis

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.

Time frame
Baseline and immediately after the intervention (within the same session)
2

Goniometric Measurement of 1st MTP Joint Range of Motion

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.

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

Secondary outcomes

1

Numeric Pain Rating Scale (NPRS)

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.

Time frame
Baseline and immediately after the intervention (within the same session)
2

Manchester-Oxford Foot Questionnaire (MOXFQ)

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.

Time frame
Baseline and immediately after the intervention
3

Manchester Scale for Hallux Valgus Severity

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.

Time frame
Baseline and immediately after the intervention
4

Multidimensional Nil Hallux Valgus Scale

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

Time frame
Baseline and immediately after the intervention

Other outcomes

Sponsors and contacts

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SEFA HAKTAN HATIK

Lead sponsor

Sinop University

Sponsor institution

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