NCT07070245

Brief Summary

Chronic plantar fasciitis (CPF) is the most common cause of chronic heel pain in adults, affecting both young active patients and older, more sedentary individuals. It results from chronic overload of the plantar fascia. This overload may be due to overuse, as seen in runners and military personnel, or due to excessive loading in individuals with obesity (body mass index \>30), sedentary lifestyles, or occupations that require prolonged standing.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

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
enrolling by invitation

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 22, 2025

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 17, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2025

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

July 5, 2025

Last Update Submit

July 15, 2025

Conditions

Keywords

Instrument assisted soft tissue mobilizationChronic plantar fasciitisPositional release technique

Outcome Measures

Primary Outcomes (2)

  • Pain intensity level assessed by Numeric Pain Rating Scale (NPRS)

    Pain intensity level assessed by Numeric Pain Rating Scale. A scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.

    Baseline and after 8 sessions (approximately 4 weeks)

  • Range of motion

    A digital goniometer is used for the assessment of ankle dorsiflexion, plantar flexion range of motion, and knee flexion range of motion.

    Baseline and after 8 sessions (approximately 4 weeks)

Study Arms (3)

Positional release technique

EXPERIMENTAL

Positional release technique in addition to exercises in form of stretching exercises for plantar fascia, gastrocnemius, soleus muscles, and short foot exercise (study group) The treatment protocol will be two sessions. given per week for 4 weeks.

Procedure: Positional release

Traditional exercises (control group)

EXPERIMENTAL

Traditional exercises (control group), traditional exercises in form of stretching exercises for plantar fascia, gastrocnemius, soleus muscles, and short foot exercise The treatment protocol will be two sessions. given per week for 4 weeks.

Procedure: Exercises

Instrument assisted soft tissue mobilization

EXPERIMENTAL

Instrument-assisted soft tissue mobilization in addition to exercises (study group) in form of stretching exercises for plantar fascia, gastrocnemius, soleus muscles, and short foot exercise

Procedure: Instrument assisted soft tissue mobilization

Interventions

The treatment protocol will be two sessions. given per week for 4 weeks.

Instrument assisted soft tissue mobilization

The treatment protocol will be two sessions. given per week for 4 weeks.

Positional release technique
ExercisesPROCEDURE

The treatment protocol will be two sessions. given per week for 4 weeks.

Traditional exercises (control group)

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinically diagnosed cases of plantar fasciitis not less than 3 months.
  • Heel pain felt maximally over plantar aspect of heel.
  • Pain in the heel on the first step in the morning.
  • Their age ranging from 30 to 50 years

You may not qualify if:

  • Subjects can't tolerate close physical contact (Kotwalkar et al., 2019).
  • Athletes.
  • Subjects with skin infections (Kotwalkar et al., 2019).
  • Subjects with recent fracture with incomplete bony union (Rowlett et al., 2018).
  • Subjects with acute inflammatory or infectious process (Rowlett et al., 2018).
  • Subjects with hematoma (Rowlett et al., 2018).
  • Subjects with osteoporosis (Looney et al., 2011).
  • Subjects with foot deformity (Kotwalkar et al., 2019).
  • Subjects that take medications that may increase blood clotting (Kotwalkar et al., 2019).
  • Surgery to the ankle or foot (Looney et al., 2011).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Port Said, Port Said Governorate, Egypt

Location

Related Publications (1)

  • Neufeld SK, Cerrato R. Plantar fasciitis: evaluation and treatment. J Am Acad Orthop Surg. 2008 Jun;16(6):338-46. doi: 10.5435/00124635-200806000-00006.

    PMID: 18524985BACKGROUND

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Exercise

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

July 5, 2025

First Posted

July 17, 2025

Study Start

June 22, 2025

Primary Completion

September 22, 2025

Study Completion

October 1, 2025

Last Updated

July 17, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to privacy concerns and limitations in data-sharing agreements.

Locations