NCT06456944

Brief Summary

This study will be done to investigate the effect of the selected rehabilitation program for PF on plantar fascia thickness, clinical outcomes such as pain, foot function, dorsiflexion ROM and pressure pain threshold and alignment such as rearfoot eversion angle and foot posture index in patients with PF.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

June 15, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

9 months

First QC Date

June 8, 2024

Last Update Submit

July 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessing the change in pain intensity

    VAS is typically composed of a 100 mm horizontal line attached to two opposed labels, the left end marked "no pain" and the right end marked "worst possible pain. Patients were marked a score on the scale by a vertical line that exactly refer to their pain

    At baseline and following 8 weeks

Secondary Outcomes (6)

  • Assessing the change in foot posture

    At baseline and following 8 weeks

  • Assessing the change in foot function

    At baseline and following 8 weeks

  • Assessing the change in plantar fascia thickness

    At baseline and following 8 weeks

  • Assessing the change in rear foot angle

    At baseline and following 8 weeks

  • Assessing the change in range of motion

    At baseline and following 8 weeks

  • +1 more secondary outcomes

Study Arms (2)

selected rehabilitation program

EXPERIMENTAL

involves 24 patients and will be given the selected rehabilitation program involving (self-stretching exercise, mobilization of the ankle and subtalar, rigid tape and unilateral heel raising exercise 3 times per week for 8 weeks.

Other: stretching exercisesOther: rigid tapeOther: mobilizationOther: strengthening exercise

traditional program

EXPERIMENTAL

involves 24 patients and will be given the traditional program involving (self-stretching exercise, mobilization of the ankle and subtalar, plantar fascial release and ultrasonic therapy 3 times per week for 8 weeks.

Other: stretching exercisesDevice: ultrasoundOther: mobilizationOther: myofascial release

Interventions

stretching exercises of the plantar fascia, gastrocnemius and soleus

selected rehabilitation programtraditional program

therapeutic ultrasound upon the most painful point on the medial calcaneal tubercle. The parameters involved a pulsed mode (duty cycle 50%) using an intensity of 1.5 W/cm2 and a 1 MHz of frequency for 5 minutes

traditional program

low-dye tapping will be done to provide mechanical correction to plantar fascia and medial longitudinal arch

selected rehabilitation program

mobilization techniques for the talocrural joint in weight bearing and non-bearing positions and subtalar joint

selected rehabilitation programtraditional program

deep tissue release of the plantar fascia and flexor hallucis longus in a stretched position of the plantar fascia

traditional program

strengthening exercise of the plantar intrinsic muscles using short foot exercise and strengthening of the Achilles tendon and windlass mechanism using unilateral heel raise exercises

selected rehabilitation program

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Plantar medial heel pain: most noticeable with initial steps after a period of inactivity, but also worse following prolonged weight-bearing
  • Pain with palpation of the proximal insertion of the plantar fascia
  • Positive windlass test
  • flat foot posture utilizing the foot posture index
  • age range from 40 to 60 years

You may not qualify if:

  • tarsal tunnel syndrome
  • atrophy of the fat pad.
  • diabetic patients or patients with rheumatoid arthritis
  • corticosteroid injection over the last sex months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Outpatient clinic, Faculty of Physical Therapy, Horus University, Egypt

Damietta, 34518, Egypt

Location

out-patient clinic, Faculty of Physical Therapy, Horus university

Damietta, Egypt

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Muscle Stretching ExercisesUltrasonographyMyofascial Release Therapy

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisMassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary Therapies

Study Officials

  • Mohamed Ramadan Ibraheem, Assistant lecturer

    Horus University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
double blinded randomized controlled trial (participants blinded to the intervention and statistician blinded to group assignment)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

June 8, 2024

First Posted

June 13, 2024

Study Start

June 15, 2024

Primary Completion

March 15, 2025

Study Completion

April 15, 2025

Last Updated

July 22, 2025

Record last verified: 2025-07

Locations