NCT07544901

Brief Summary

The study will be randomised clinical trial. This study will be conducted at the University of Lahore Teaching Hospital, Lahore, Pakistan. A sample size of 48 will be randomly allocated into two experimental groups, (24 participants in each group), by using sealed envelope method. All the screened and willing participants were randomly allocated into two groups. Group A will be given navicular mobilization and group B will be given conventional therapy with navicular mobilization. Treatment will be given for 4 weeks 4 sessions/ week with total of 16 sessions. Assessment to be taken at baseline, 2nd week and 4th week. The participants randomly allocated in Group A will receive navicular mobilization. In navicular mobilization, Subject- prone lying, Therapist- standing on tested side. 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. Four sessions will be given per week for 4 weeks. The participants randomly allocated in Group B will receive conventional physical therapy with navicular mobilization. In navicular mobilization, Subject- prone lying, Therapist- standing on tested side. 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. In Conventional therapy, ultrasound with an output of 1.5 w/cm2 for 7 minutes using a continuous mode with a frequency of 3MHz, stretching of planter fascia, strengthening of medial arch and foot surround muscles such as calf and tibialis posterior will be done by doing exercises like arch lift, heel raise, towel pickup, toe lift, strengthening exercises for intrinsic foot muscles, standing toe curls, towel toe curls and Ice pack for 10 minutes .These exercises will be performed in a set of 3 with 12 repetitions in each set in one session. This treatment session will be of 30 minutes and will be give 4 session per week for 4 weeks.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

June 30, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
Last Updated

April 22, 2026

Status Verified

August 1, 2025

Enrollment Period

10 months

First QC Date

December 30, 2025

Last Update Submit

April 15, 2026

Conditions

Keywords

Planter FaciitisNavicular bone

Outcome Measures

Primary Outcomes (3)

  • 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. 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. During the initial administration of the questionnaire, Cronbach's alpha was determined to be = 0.78 for the FFI total score while the subscales ranged from 0.80 to 0.61

    Baseline, 3rd week, 6th week

  • Numeric Pain Rating Scale

    Numeric rating scales consist of a series of numbers rating pain intensity, typically from 0 to 10 or with 0 being "no pain" and 10 "the worst pain imaginable."

    Baseline, 3rd week, 6th week

  • 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. All testers' measurements of showed high levels of intra- and inter-rater reliability (ICC = 0.83 to 0.95) of navicular drop test.

    Baseline, 3rd week, 6th week

Study Arms (2)

Navicular Mobilization

EXPERIMENTAL

In navicular mobilization, Subject- prone lying, Therapist- standing on tested side. 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.

Other: Navicular MobilizationOther: Conventional physical therapy

Conventional physical therapy + Navicular Mobilization

EXPERIMENTAL

In Conventional therapy, ultrasound with an output of 1.5 w/cm2 for 7 minutes using a continuous mode with a frequency of 3MHz, stretching of planter fascia, strengthening of medial arch and foot surround muscles such as calf and tibialis posterior will be done by doing exercises like arch lift, heel raise, towel pickup, toe lift, strengthening exercises for intrinsic foot muscles, standing toe curls, towel toe curls and Ice pack for 10 minutes.In navicular mobilization, Subject- prone lying, Therapist- standing on tested side. 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.

Other: Navicular MobilizationOther: Conventional physical therapy

Interventions

In navicular mobilization, Subject- prone lying, Therapist- standing on tested side. 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.

Conventional physical therapy + Navicular MobilizationNavicular Mobilization

In Conventional therapy, ultrasound with an output of 1.5 w/cm2 for 7 minutes using a continuous mode with a frequency of 3MHz, stretching of planter fascia, strengthening of medial arch and foot surround muscles such as calf and tibialis posterior will be done by doing exercises like arch lift, heel raise, towel pickup, toe lift, strengthening exercises for intrinsic foot muscles, standing toe curls, towel toe curls and Ice pack for 10 minutes .

Conventional physical therapy + Navicular MobilizationNavicular Mobilization

Eligibility Criteria

Age18 Years - 32 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants between 18 to 32 years of age.
  • Plantar fasciitis with flat foot.
  • Positive Flat foot cases diagnosed with foot print measurement
  • Both males and females
  • 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)

University of Lahore Teaching Hospital

Lahore, Punjab Province, 55150, Pakistan

Location

Study Officials

  • Asim Arif, Phd scholar

    University of Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Study will be single and assessor blinded. Participants will be masked about other groups but they will know what treatment they will be receiving or what exercises they will be doing. Principal investigator would also not be masked or blinded because investigator would be applying the techniques on participants of both group. So participant and and principal investigator cannot be blinded. Only assessor will be blinded and he will take outcome measures without knowing the problem and treatment techniques.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2025

First Posted

April 22, 2026

Study Start

June 30, 2025

Primary Completion

April 15, 2026

Study Completion

April 15, 2026

Last Updated

April 22, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations