Effectiveness, Extracoropral Shock Wave Therapy, Observational Cohort Study, Planter Fasciitis
Conditions
Keywords
planter fasciitis, Quality of life, Extracorporeal Shock Wave Therapy, Effectiveness, Observational Cohort Study
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.
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.
Interventions
None listed
Sponsors
Adly A Adam
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
25 Years to 59 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pressure Pain Threshold | 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. |
| American Orthopedic Foot and Ankle Society Scale (AOFAS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale | 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) |
| Arabic version of the foot function index (FFI) | 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 |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORAdnan AA Gharib
GOTHI
Outcome results
None listed