Plantar FascitisNCT06377800
Effects Of Navicular Mobilization In Patients With Planter Fasciitis
A study testing navicular mobilization along conventional therapy. and conventional therapy in people with Plantar Fascitis, run by Riphah International University at 1 site in Pakistan.
Trial summary
The significance of studying the effects of navicular mobilization in patients suffering from plantar fasciitis lies in its potential to provide valuable insights into non-invasive treatment approaches for a common and debilitating foot condition such as flat foot. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- navicular mobilization along conventional therapy. and conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Apr 2024to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Plantar fasciitis with flat foot.
- Positive Flat foot cases diagnosed with foot print measurement.
- Unilateral or bilateral involvement with chronic plantar fasciitis
- Diagnosed case of plantar fasciitis will be taken with navicular drop.
- Navicular Drop (ND) of > 10mm
Who cannot join
- Patients with Peripheral vascular diseases.
- Patients with History of fractures in the lower limb
- Patients with Skin infections and wounds on the foot
- Patients with any neurological deficit involving foot.
- Patients with a history of foot or ankle surgery.
Trial locations and contacts
1 site in 1 country.
About this study
The significance of studying the effects of navicular mobilization in patients suffering from plantar fasciitis lies in its potential to provide valuable insights into non-invasive treatment approaches for a common and debilitating foot condition such as flat foot. Understanding how this therapy impacts navicular height, pain and disability of the foot can lead to improved clinical outcomes and a better understanding of the biomechanical factors contributing to plantar fasciitis. Ultimately, this research may help refine treatment strategies and enhance the quality of life for individuals suffering from this condition
Read the detailed description
The foot is a complex structure comprising numerous bones, muscles, and ligaments that work together to provide support and facilitate movement. It is supported by three arches: the medial longitudinal arch, the lateral longitudinal arch, and the transverse arch. The medial longitudinal arch plays a crucial role in absorbing weight, but issues like ligament laxity and muscle weakness can cause it to shorten, leading to conditions like plantar fasciitis. Plantar fasciitis, a common overuse injury, occurs when the plantar fascia, a fibrous tissue that supports the arch of the foot, becomes inflamed due to repetitive strain, especially during activities that increase its stretch, such as barefoot walking or stair climbing. People with flat feet are more susceptible to plantar fasciitis due to the overstretching of the plantar fascia caused by the lack of arch support.
Navicular drop, a measure of the navicular bone height, also plays a significant role in foot biomechanics and the development of plantar fasciitis. High navicular height leads to increased foot pronation and tension on the plantar fascia, while low navicular height causes overpronation and arch collapse, both of which can result in inflammation of the plantar fascia. Physiotherapists use techniques like navicular mobilization to address issues related to the navicular bone and improve blood circulation, healing, and pain relief in cases of plantar fasciitis. By understanding the biomechanics of the foot and employing targeted interventions, healthcare professionals can help manage and prevent conditions like plantar fasciitis, allowing individuals to maintain optimal foot health and functionality.
- Conditions
- Plantar Fascitis
- Being tested
- navicular mobilization along conventional therapy., conventional therapy
- Keywords
- Planter Fasciitis, Foot Navicular bone, Mobilization,, Flat Foot
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
navicular mobilization along conventional therapy.Other
In the prone position, when the foot is stabilized by a towel underneath, navicular mobilization is administered. The therapist's fixing hand wraps the calcaneus, grasps the talus bone, and fixes it.
By placing the thumb on the plantar surface of the foot and pushing with the thumb of the other hand in a dorsal direction, navicular mobilization is provided.
This dorsal glide will be given with 2 sets of 5 minutes. Each session will be of 30 minutes.
conventional therapyOther
ultrasound therapy at 1.5 w/cm2 for 7 minutes in continuous mode at a 3MHz frequency. Stretching targets the medial arch and surrounding muscles like calf and tibialis posterior with exercises such as arch lift, heel raise, towel pickup, and toe lift. Additionally, strengthening exercises for intrinsic foot muscles like standing toe curls and towel toe curls are included. Ice pack application for 10 minutes follows
| Study group | Role | What they receive |
|---|---|---|
| navicular mobilization along with conventional therapy. | Experimental | In the prone position, when the foot is stabilized by a towel underneath, navicular mobilization is administered. The therapist's fixing hand wraps the calcaneus, grasps the talus bone, and fixes it.
By placing the thumb on the plantar surface of the foot and pushing with the thumb of the other hand in a dorsal direction, navicular mobilization is provided.
This dorsal glide will be given with 2 sets of 5 minutes. Each session will be of 30 minutes. Receives: Other: navicular mobilization along conventional therapy. |
| conventional therapy | Other | ultrasound therapy at 1.5 w/cm2 for 7 minutes in continuous mode at a 3MHz frequency. Stretching targets the medial arch and surrounding muscles like calf and tibialis posterior with exercises such as arch lift, heel raise, towel pickup, and toe lift. Additionally, strengthening exercises for intrinsic foot muscles like standing toe curls and towel toe curls are included. Ice pack application for 10 minutes follows Receives: Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). According to researches NPRS shows excellent reliability (0.97 and 0.99, respectively) for the measurement of musculoskeletal pain
Measured: four weeks
(Foot Function Index)
Foot function index is a questionnaire used to assess pathological impact on foot with respect to disability, limitations of activity and pain. It consists of 23 questions which are sub divided into three sub scales. These three sub scales are pain, activity limitation and disability.(19) It's scoring is done by adding these scales which range is from 0 to 100. Minimum score is 0 and maximum is 100. Where 0 shows no pain and 100 shows worst pain.
Measured: four weeks
Navicular drop test
Navicular drop test is used to measure static foot assessment in Sagittal plane of navicular tuberosity in neutral state. The tuberosity of the navicular bone is measured in neutral position, relaxed and stance position. Supinated foot showed less than 5mm, neutral foot shows range from 6 to 8mm or 5 to 9mm and pronated foot shows reading from greater than 10 to 15 or greater than 9mm.
Measured: four weeks
Foot print analysis
In this technique, participants created footprints on paper while standing, submerged clean feet a normal foot, while SPI > 1.15 denotes a flat foot. (22) The correlation test and intraclass correlation coefficient showed that I was a valid and reliable in diagnosing flatfoot (0.427, 0.446).
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start2 Apr 2024
- Primary completion10 Jun 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FascitisStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- maria Khalid, MSOMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377800
- Sponsor's protocol ID
- REC 01801 Kainat Fatima
- Status last verified
- Jul 2024
- First submitted
- 18 Apr 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Navicular Mobilization In Patients With Planter Fasciitis
- ClinicalTrials.gov ID
- NCT06377800
- Acronym / sponsor ID
- REC 01801 Kainat Fatima
- Conditions
- Plantar Fascitis
- Keywords
- Planter Fasciitis, Foot Navicular bone, Mobilization,, Flat Foot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 22 Apr 2024 (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 significance of studying the effects of navicular mobilization in patients suffering from plantar fasciitis lies in its potential to provide valuable insights into non-invasive treatment approaches for a common and debilitating foot condition such as flat foot. Understanding how this therapy impacts navicular height, pain and disability of the foot can lead to improved clinical outcomes and a better understanding of the biomechanical factors contributing to plantar fasciitis. Ultimately, this research may help refine treatment strategies and enhance the quality of life for individuals suffering from this condition
Detailed description
The foot is a complex structure comprising numerous bones, muscles, and ligaments that work together to provide support and facilitate movement. It is supported by three arches: the medial longitudinal arch, the lateral longitudinal arch, and the transverse arch. The medial longitudinal arch plays a crucial role in absorbing weight, but issues like ligament laxity and muscle weakness can cause it to shorten, leading to conditions like plantar fasciitis. Plantar fasciitis, a common overuse injury, occurs when the plantar fascia, a fibrous tissue that supports the arch of the foot, becomes inflamed due to repetitive strain, especially during activities that increase its stretch, such as barefoot walking or stair climbing. People with flat feet are more susceptible to plantar fasciitis due to the overstretching of the plantar fascia caused by the lack of arch support.
Navicular drop, a measure of the navicular bone height, also plays a significant role in foot biomechanics and the development of plantar fasciitis. High navicular height leads to increased foot pronation and tension on the plantar fascia, while low navicular height causes overpronation and arch collapse, both of which can result in inflammation of the plantar fascia. Physiotherapists use techniques like navicular mobilization to address issues related to the navicular bone and improve blood circulation, healing, and pain relief in cases of plantar fasciitis. By understanding the biomechanics of the foot and employing targeted interventions, healthcare professionals can help manage and prevent conditions like plantar fasciitis, allowing individuals to maintain optimal foot health and functionality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| navicular mobilization along with conventional therapy. | Experimental | Other: navicular mobilization along conventional therapy.In the prone position, when the foot is stabilized by a towel underneath, navicular mobilization is administered. The therapist's fixing hand wraps the calcaneus, grasps the talus bone, and fixes it. By placing the thumb on the plantar surface of the foot and pushing with the thumb of the other hand in a dorsal direction, navicular mobilization is provided. This dorsal glide will be given with 2 sets of 5 minutes. Each session will be of 30 minutes. |
| conventional therapy | Other | Other: conventional therapyultrasound therapy at 1.5 w/cm2 for 7 minutes in continuous mode at a 3MHz frequency. Stretching targets the medial arch and surrounding muscles like calf and tibialis posterior with exercises such as arch lift, heel raise, towel pickup, and toe lift. Additionally, strengthening exercises for intrinsic foot muscles like standing toe curls and towel toe curls are included. Ice pack application for 10 minutes follows |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Plantar fasciitis with flat foot.
- Positive Flat foot cases diagnosed with foot print measurement.
- Unilateral or bilateral involvement with chronic plantar fasciitis
- Diagnosed case of plantar fasciitis will be taken with navicular drop.
- Navicular Drop (ND) of > 10mm
Key exclusion criteria (5 listed)
- Patients with Peripheral vascular diseases.
- Patients with History of fractures in the lower limb
- Patients with Skin infections and wounds on the foot
- Patients with any neurological deficit involving foot.
- Patients with a history of foot or ankle surgery.
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 |
|---|---|---|
| navicular mobilization along conventional therapy.In the prone position, when the foot is stabilized by a towel underneath, navicular mobilization is administered. The therapist's fixing hand wraps the calcaneus, grasps the talus bone, and fixes it. By placing the thumb on the plantar surface of the foot and pushing with the thumb of the other hand in a dorsal direction, navicular mobilization is provided. This dorsal glide will be given with 2 sets of 5 minutes. Each session will be of 30 minutes. | Other | navicular mobilization along with conventional therapy. |
| conventional therapyultrasound therapy at 1.5 w/cm2 for 7 minutes in continuous mode at a 3MHz frequency. Stretching targets the medial arch and surrounding muscles like calf and tibialis posterior with exercises such as arch lift, heel raise, towel pickup, and toe lift. Additionally, strengthening exercises for intrinsic foot muscles like standing toe curls and towel toe curls are included. Ice pack application for 10 minutes follows | Other | conventional therapy |
Primary outcome
Numeric Pain Rating Scale
Time frame: four weeks
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). According to researches NPRS shows excellent reliability (0.97 and 0.99, respectively) for the measurement of musculoskeletal pain
(Foot Function Index)
Time frame: four weeks
Foot function index is a questionnaire used to assess pathological impact on foot with respect to disability, limitations of activity and pain. It consists of 23 questions which are sub divided into three sub scales. These three sub scales are pain, activity limitation and disability.(19) It's scoring is done by adding these scales which range is from 0 to 100. Minimum score is 0 and maximum is 100. Where 0 shows no pain and 100 shows worst pain.
Navicular drop test
Time frame: four weeks
Navicular drop test is used to measure static foot assessment in Sagittal plane of navicular tuberosity in neutral state. The tuberosity of the navicular bone is measured in neutral position, relaxed and stance position. Supinated foot showed less than 5mm, neutral foot shows range from 6 to 8mm or 5 to 9mm and pronated foot shows reading from greater than 10 to 15 or greater than 9mm.
Foot print analysis
Time frame: four weeks
In this technique, participants created footprints on paper while standing, submerged clean feet a normal foot, while SPI > 1.15 denotes a flat foot. (22) The correlation test and intraclass correlation coefficient showed that I was a valid and reliable in diagnosing flatfoot (0.427, 0.446).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Plantar Fascitis
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Active Release Technique vs. Dynamic Soft Tissue Mobilization for Plantar Pain
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Hip Muscle Strengthening and Calf Myofascial Release in Females With Chronic Plantar Fasciitis
Chronic Planter Fascitis
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F-18 Sodium Fluoride PET/CT-Guided Pain Palliation in Chronic Plantar Fasciitis: A Comparative Study of ¹⁷⁷Lutetium-Corticosteroid-Local Anaesthetic Injection vs Corticosteroid-Local Anaesthetic Injection
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Radial vs Focused Shockwave Therapy for Plantar Fasciitis
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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. This study is not recruiting at the moment.
maria Khalid, MSOMPT principal investigator
Riphah International 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 navicular mobilization along conventional therapy. and conventional therapy in people with Plantar Fascitis, run by Riphah International University at 1 site in Pakistan.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 23 Jul 2024. 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 Pakistan. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: four weeks). The study lists 4 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 23 Jul 2024.