Hallux ValgusHALLPRESSNCT07043439
Comparison of the Immediate Effects of Mobilization and Manipulation Versus Sham Manipulation on Plantar Pressure in Patients With Hallux Valgus
A study testing Mobilization and High-Velocity Low-Amplitude (HVLA) Manipulation in people with Hallux Valgus and Foot Deformities, run by SEFA HAKTAN HATIK at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hallux Valgus, Foot Deformities, Musculoskeletal Manipulations
- What is being tested?
- Mobilization and High-Velocity Low-Amplitude (HVLA) Manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jun 2025to 25 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Having undergone surgery on the foot or ankle area within the last 6 months
- Having any neurological or psychiatric problems
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Sinop University
Sinop
SEFA H HATIK, Asst. Prof., +905058761553, haktanhtk@gmail.com
SEFA H HATIK, Asst. Prof.
About this study
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.
Read the 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.
- Conditions
- Hallux Valgus, Foot Deformities, Musculoskeletal Manipulations, Plantar Pressure, Manuel Therapy, Chiropractic
- Being tested
- Mobilization, High-Velocity Low-Amplitude (HVLA) Manipulation, Sham Manipulation
- Keywords
- Hallux Valgus, First Metatarsal Mobilization, HVLA Manipulation, Sham Manipulation, Plantar Pressure Analysis, Pedobarography, Manual Therapy, Chiropractic Mobilization, Pain, Quality of Life
- Medical subject headings
- Hallux Valgus, Foot Deformities, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MobilizationOther
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) ManipulationOther
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 ManipulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and immediately after the intervention (within the same session)
Secondary outcomes (5)
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.
Measured: Baseline and immediately after the intervention (within the same session)
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.
Measured: Baseline and immediately after the intervention
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.
Measured: Baseline and immediately after the intervention
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.
Measured: Baseline and immediately after the intervention
SF-36 Short Form Health Survey
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.
Measured: Baseline and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start25 Jun 2025 (estimated)
- Primary completion25 Jul 2025 (estimated)
- Study completion25 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SEFA HAKTAN HATIK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, SEFA HAKTAN HATIK, Sinop University
- Investigators
- SEFA H HATIK, Asst. Prof., Principal investigator, Sinop University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043439
- Sponsor's protocol ID
- CMT0009
- Acronym
- HALLPRESS
- Status last verified
- Jun 2025
- First submitted
- 20 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Immediate Effects of Mobilization and Manipulation Versus Sham Manipulation on Plantar Pressure in Patients With Hallux Valgus
- ClinicalTrials.gov ID
- NCT07043439
- Acronym / sponsor ID
- HALLPRESS / CMT0009
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- SEFA HAKTAN HATIKUniversity, hospital or other
- Study start
- 25 Jun 2025 (estimated)
- Primary completion
- 25 Jul 2025 (estimated)
- Study completion
- 25 Aug 2025 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobilization and Manipulation Group (MMG) | Experimental | Other: Mobilization, Other: High-Velocity Low-Amplitude (HVLA) ManipulationParticipants 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. |
| Control Group (CG) | Sham comparator | Other: Sham ManipulationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Having undergone surgery on the foot or ankle area within the last 6 months
- Having any neurological or psychiatric problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MobilizationParticipants 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 | Mobilization and Manipulation Group (MMG) |
| High-Velocity Low-Amplitude (HVLA) ManipulationThis 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 | Mobilization and Manipulation Group (MMG) |
| Sham ManipulationParticipants 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. | Other | Control Group (CG) |
Primary outcome
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.
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
SEFA H HATIK, Asst. Prof. principal investigator
Sinop University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobilization and High-Velocity Low-Amplitude (HVLA) Manipulation in people with Hallux Valgus and Foot Deformities, run by SEFA HAKTAN HATIK at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SEFA H HATIK, Asst. Prof. (+905058761553, haktanhtk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pedobarographic Analysis (time frame: Baseline and immediately after the intervention (within the same session)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.