NCT07669831

Brief Summary

Extracorporeal Shockwave (ESW) is a popular, non-invasive approach that arisen in line to stimulate healing via acoustic waves targeting lesion site i.e., planter fasciitis. Therefore, current clinical trial targets to determine the long-term effectiveness of ESW on Calcaneal spur in terms of quality of life, functional, and clinical manifestations, as well addressing real barriers for ESW approach among whom diagnosed with planter fasciitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
Last Updated

July 7, 2026

Status Verified

July 1, 2026

Enrollment Period

1.8 years

First QC Date

June 21, 2026

Last Update Submit

July 3, 2026

Conditions

Keywords

planter fasciitisQuality of lifeExtracorporeal Shock Wave TherapyEffectivenessObservational Cohort Study

Outcome Measures

Primary Outcomes (2)

  • Pressure Pain Threshold

    A valid, reliable Pressure Algometer device, that is calibrated per each evaluation, in line to identify well-addressed pressure pain threshold, that spread from the plantar calcaneal tuberosity for each participant.

    1- At Baseline, 2- Post-Treatment, 3- After 6 months as long-term follow-up

  • American Orthopedic Foot and Ankle Society Scale (AOFAS)

    a 9-item questionnaire classified into three subscales: 1) level of pain consists of 1 item and its score ranges from 0 to 40; 40 points = no pain and 0 points = severe pain; 2) function consists of 7 items (Activity limitations, support requirements, maximum continuous walking distance, walking surface, gait abnormalities, sagittal motion, hind foot motion, ankle hind-foot stability), and its score ranges from 0 (severe function impairment score) to 50 points (full function score); and 3) foot alignment consists of 1 item; its score ranges from 0 to 10 points; good alignment of ankle and foot equals 10 points and zero indicates severe malalignment, symptoms. It was used for measuring functional recovery after different foot and ankle problems. The total score of the scale ranged from 0 to 100 points; (0) indicates the worst, and (100) shows no symptoms or impairments.

    1- At baseline, 2- Post-treatment, 3- After 6 months as long-term follow-up.

Secondary Outcomes (2)

  • Visual Analogue Scale

    1- At Baseline, 2- Post-Treatment, 3- After 6 months as long-term follow-up

  • Arabic version of the foot function index (FFI)

    1- At Baseline, 2- Post-Treatment, 3- After 6 months as long-term follow-up

Study Arms (1)

Experimental Group

A 150 individuals with planter fasciitis whom received ESW intervention. Their age ranged between 25 to 59 years old, with well-organized full demographic data filling system, and evaluation for their clinical manifestations, plus service quality evaluation in line to address the long-term effectiveness of the received ESW therapeutic protocol, and identifying barriers they addressed.

Eligibility Criteria

Age25 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Current observational cohort trial involved participants diagnosed with planter fasciitis, whom age ranged between 25-59 years old, with nearby 3 months of clinical manifestations mainly heel pain. They had plantar medial heel pain: most noticeable with initial steps after a period of inactivity, but also worse following prolonged weight-bearing, * Whom had pain with palpation of the proximal insertion of the plantar fascia. * Whom had positive windlass test.

You may qualify if:

  • Individuals diagnosed with planter fasciitis, whom age ranged between 25-59 years old, with nearby 3 months of clinical manifestations mainly heel pain.
  • Whom have plantar medial heel pain: most noticeable with initial steps after a period of inactivity, but also worse following prolonged weight-bearing,
  • Whom had pain with palpation of the proximal insertion of the plantar fascia.
  • Whom had positive windlass test.

You may not qualify if:

  • Any individual whom underwent feet or ankle surgical interventions, received steroid injections within the past 3 months, also whom have deep venous thrombosis, or had a tarsal tunnel syndrome, diabetic neuropathies or any sort of tumors, lymphatic lesions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Kasr Al-Ani Hospitals

Cairo, Menofyia, 11432, Egypt

Location

Study Officials

  • Adnan AA Gharib

    GOTHI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physical Therapy Specialist

Study Record Dates

First Submitted

June 21, 2026

First Posted

June 25, 2026

Study Start

April 1, 2024

Primary Completion

January 1, 2026

Study Completion

May 30, 2026

Last Updated

July 7, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations