Planter FasciitisNCT07669831
Effectiveness of Extracorporeal Shockwave in Planter Fasciitis
An observational study of Planter Fasciitis and Observational Cohort Study, run by Adly A Adam at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 59 years
- Conditions the study is for
- Planter Fasciitis, Observational Cohort Study, Effectiveness
- How many people
- 175 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 30 May 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 59 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Extracorporeal Shockwave on Gait Parameters and Quality of Life in Planter Fasciitis
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.
Read the detailed description
Worldwide ESW protocol parameters' discrepancy still a research gap, mainly in terms of calcaneal spur i.e., sessions' number, applications' parameters. Therefore, current clinical trial was conducted to address the effectiveness of ESW on planter fasciitis on long-term, plus identifying the real barriers addressed by sufferers.
- Conditions
- Planter Fasciitis, Observational Cohort Study, Effectiveness, Extracoropral Shock Wave Therapy
- Keywords
- planter fasciitis, Quality of life, Extracorporeal Shock Wave Therapy, Effectiveness, Observational Cohort Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1- At baseline, 2- Post-treatment, 3- After 6 months as long-term follow-up.
Secondary outcomes (2)
Visual Analogue Scale
10-point, as 0 (no pain) to 10 (worst pain they can imagine). VAS scores
≤3.4 demarcated as mild pain, 3.5 to 7.4 as moderate pain, and ≥7.5 as severe pain. VAS is a simple, valid, as well as successful way to keep monitor of how a patient's pain is changing over time, and it has been utilized extensively in varied adult groups with a strong evidence of test-retest reliability (ICC= 0.99, 95%CI 0.989-0.992)
Measured: 1- At Baseline, 2- Post-Treatment, 3- After 6 months as long-term follow-up
Arabic version of the foot function index (FFI)
a widely used self-reporting measure used to assess the impact of foot pathology on pain, disability, and activity limitation. It is a reliable and sensitive outcome measure for patients with foot and ankle disorders. The FFI's subscale scores range from 0% to 100%, with higher scores indicating lower function and a poorer quality of life
Measured: 1- At Baseline, 2- Post-Treatment, 3- After 6 months as long-term follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Apr 2024
- Primary completion1 Jan 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Planter FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 175 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Adly A Adam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adly A Adam, Cairo University
- Investigators
- Adnan AA Gharib, Principal investigator, GOTHI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669831
- Sponsor's protocol ID
- HSH00071
- Status last verified
- Jul 2026
- First submitted
- 21 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No