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

NCT07043439 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-06-29

No results posted yet for this study

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.

Conditions

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

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 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.

Sponsors & Collaborators

  • SEFA HAKTAN HATIK

    lead OTHER

Principal Investigators

  • SEFA H HATIK, Asst. Prof. · Sinop University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-25
Primary Completion
2025-07-25
Completion
2025-08-25

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07043439 on ClinicalTrials.gov