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

NCT07043439 | Not Yet Recruiting

• 1 other identifier: CMT0009
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hallux Valgus; First Metatarsal Mobilization; HVLA Manipulation; Sham Manipulation; Plantar Pressure Analysis; Pedobarography; Manual Therapy; Chiropractic Mobilization; Pain; Quality of Life

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (5)

• Numeric Pain Rating Scale (NPRS)

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

• Manchester-Oxford Foot Questionnaire (MOXFQ)

  Baseline and immediately after the intervention

• Manchester Scale for Hallux Valgus Severity

  Baseline and immediately after the intervention

• Multidimensional Nil Hallux Valgus Scale

  Baseline and immediately after the intervention

• SF-36 Short Form Health Survey

  Baseline and immediately after the intervention

Study Arms (2)

Mobilization and Manipulation Group (MMG)

EXPERIMENTAL

Participants in this group underwent high-velocity, low-amplitude (HVLA) chiropractic manipulation of the first metatarsophalangeal (MTP) joint by an experienced physical therapist, followed by grade 3 accessory mobilization. Participants were placed in the prone (face-down) position during the procedure, and the foot was stabilized in a neutral position. Manipulation: The therapist stabilized the first metatarsal bone with one hand while applying a quick, short traction force to the proximal phalanx of the first toe with the other hand. Mobilization: Following manipulation, grade 3 rhythmic oscillations were applied to the same joint in accordance with the Maitland technique to increase joint play. The entire procedure was completed in a single session, with evaluations conducted immediately before and after the intervention.

Other: Mobilization; Other: High-Velocity Low-Amplitude (HVLA) Manipulation

Control Group (CG)

SHAM COMPARATOR

The control group individuals underwent sham manipulation in the same position (prone and neutral foot) and for the same duration. During the sham application, the therapist assumed the manipulation position, placed his hands on the first metatarsal, and created the impression that the application was being performed. However, no traction, pushing, mobilization, or high-speed movement was applied during this process. This application was performed in a way that would make the participant believe they were receiving treatment, but without creating any biomechanical or neurophysiological effects. Since the purpose of the sham group was to control for the placebo effect, evaluations were also conducted on the individuals in this group before and immediately after the application. For ethical reasons, the real treatment protocol was also applied to these participants after the evaluations.

Other: Sham Manipulation

Interventions

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.

Mobilization and Manipulation Group (MMG)

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.

Mobilization and Manipulation Group (MMG)

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.

Control Group (CG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• SEFA HAKTAN HATIK: lead

Study Sites (1)

Sinop University

Sinop, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hallux Valgus; Foot Deformities; Pain

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• SEFA H HATIK, Asst. Prof.

  Sinop University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SEFA H HATIK, Asst. Prof.

CONTACT

+905058761553; haktanhtk@gmail.com

ÖMER D KIZIL, PhD.

CONTACT

+905415233691; omerdiclekizil@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study will employ single masking. The outcomes assessor will be blinded to the group allocation of the participants (intervention vs. sham). Participants and therapists will not be blinded due to the nature of manual interventions, which require active therapist involvement and differ in technique between groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Asst. Professor

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: June 29, 2025
• Study Start: June 25, 2025
• Primary Completion: July 25, 2025
• Study Completion: August 25, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)