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Completed

NCT Number: NCT07669831

Effectiveness of Extracorporeal Shockwave 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.

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Key information

Conditions

Planter Fasciitis Effectiveness Extracoropral Shock Wave Therapy Observational Cohort Study

Age range

25 year–59 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Al-Kasr Al-Ani Hospitals

Cairo, Menofyia, 11432, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Pressure Pain Threshold

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

    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.

  2. American Orthopedic Foot and Ankle Society Scale (AOFAS)

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

    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.

Secondary outcomes

  1. Visual Analogue Scale

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

    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)

  2. Arabic version of the foot function index (FFI)

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

    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

Sponsors and collaborators

Lead sponsor

Adly A Adam

Other

Registry information

Official study title

Effectiveness of Extracorporeal Shockwave on Gait Parameters and Quality of Life in Planter Fasciitis

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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