NCT06377800

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2024

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2024

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

April 18, 2024

Last Update Submit

July 22, 2024

Conditions

Keywords

Planter FasciitisFoot Navicular boneMobilization,Flat Foot

Outcome Measures

Primary Outcomes (4)

  • 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

    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.

    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.

    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).

    four weeks

Study Arms (2)

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.

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

Other: conventional therapy

Interventions

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.

navicular mobilization along with conventional therapy.

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

conventional therapy

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DHQ Hospital

Faisalābad, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • maria Khalid, MSOMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2024

First Posted

April 22, 2024

Study Start

April 2, 2024

Primary Completion

June 10, 2024

Study Completion

July 1, 2024

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations