- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07672327
Efficacy of Short Wave and Laser Therapy in Patients With Plantar Fasciitis (Blind assessor)
Efficacy of Extracorporeal Shock Wave Therapy Versus High-intensity Laser Therapy in Patients With Plantar Fasciitis
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Mecca Region
-
Mecca, Mecca Region, Saudi Arabia, 24211
- Mecca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
1. Patients will be included according to the diagnostic criteria for plantar fasciitis of the American physical therapy association (APTA) (Martin et al., 2014). This criterion includes pain in medial sole and heel of foot: most pronounced in initial steps after a period of inactivity, it also worsens after prolonged weight bearing, pain during palpation and compression of proximal plantar fascia, limited range of motion in active and passive ankle dorsiflexion, positive windlass test.
2. Patients will be referred from an orthopedic surgeon with confirmed diagnosis of plantar fasciitis (Bidoki et al., 2024).
3. Patients with chronic plantar fasciitis (Duration of patient's symptoms will be more than three months) (Riaz et al., 2023).
4. Patients' age will range from 18 to 45 years (Bidoki et al., 2024). 5. Both genders (Riaz et al., 2023). 6. Localized non radiating foot pain with an NPRS more than 5 on the first step in the morning (Riaz et al., 2023).
Exclusion Criteria:
Patients will be excluded if they present any of the following criteria
- History of previous surgery of plantar fasciitis (Riaz et al., 2023).
- History of previous corticosteroid injections (Bidoki et al., 2024).
- History of heel pain due to previous trauma or calcaneus stress fracture in the last 3 months (Bidoki et al., 2024).
- History of previous lumbar spine surgery (Bidoki et al., 2024).
- History of rheumatologic disease (rheumatoid arthritis, diffuse idiopathic skeletal hyperostosis, systemic lupus erythematosus, gout, Sjogren disease, enthesopathy, etc…) (Bidoki et al., 2024).
- Pregnancy, pacemaker fitted or bleeding disorders (Bidoki et al., 2024).
- Wounds, infections or tumors in the treatment area (Bidoki et al., 2024).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control group
Group (A)
|
exercise
|
|
Experimental: Extracorporeal shock wave therapy
Group (B)
|
ESWT
|
|
Experimental: High-intensity laser therapy
Group (C)
|
HILT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hand held dynamometer
Time Frame: 6 weeks
|
Hand held dynamometer is a portable device, characterized as a low-cost and convenience to assess muscle strength in a clinical setting
|
6 weeks
|
|
Ultrasonography
Time Frame: 6 weeks
|
Ultrasonography is a type of medical imaging device that uses high-frequency sound (ultrasound) waves to produce images of internal organs and other tissues such as tendons, muscles, joints, blood vessels, and internal organs, to measure some characteristics
|
6 weeks
|
|
Arabic version of foot function index (FFI-Ar)
Time Frame: 6 weeks
|
Foot functional index is a self-administered index consisting of 23 items divided into 3 subcategories on the basis of: pain, disability and activity limitation.
|
6 weeks
|
|
Arabic version of numerical pain rating scale (NPRS-Ar)
Time Frame: 6 weeks
|
The Numerical Rating Scale is an 11-point (0-10) Scale that measures pain intensity, it is considered a very sensitive pain assessment scale.
|
6 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/006509
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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