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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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,
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| Name | Affiliation | Role |
|---|---|---|
| Adnan AA Gharib | GOTHI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-Kasr Al-Ani Hospitals | Cairo | Menofyia | 11432 | Egypt |
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| 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 | 1- At Baseline, 2- Post-Treatment, 3- After 6 months as long-term follow-up |