- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07669831
Effectiveness of Extracorporeal Shockwave in Planter Fasciitis
Effectiveness of Extracorporeal Shockwave on Gait Parameters and Quality of Life in Planter Fasciitis
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Menofyia
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Cairo, Menofyia, Egypt, 11432
- Al-Kasr Al-Ani Hospitals
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pressure Pain Threshold
Time Frame: 1- At Baseline, 2- Post-Treatment, 3- After 6 months as long-term follow-up
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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.
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1- At Baseline, 2- Post-Treatment, 3- After 6 months as long-term follow-up
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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.
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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.
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1- At baseline, 2- Post-treatment, 3- After 6 months as long-term follow-up.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Visual Analogue Scale
Time Frame: 1- At Baseline, 2- Post-Treatment, 3- After 6 months as long-term follow-up
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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) |
1- At Baseline, 2- Post-Treatment, 3- After 6 months as long-term follow-up
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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
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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
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1- At Baseline, 2- Post-Treatment, 3- After 6 months as long-term follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Adnan AA Gharib, GOTHI
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HSH00071
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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