- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06305507
Differents Laser Applications on Plantar Fasciitis (FASLaser)
Effects of Differents Laser Applications on Plantar Fasciitis
The objective of this randomized controlled clinical trial (RCT) with a double-blind technique and longitudinal chronology, is to evaluate and compare the effectiveness of High intensity laser therapy (HILT) in static mode versus scanning mode in the reduction of pain associated with plantar fasciitis.
The main questions it seeks to answer are:
- What is the comparative effectiveness between low-level laser therapy in local spot mode and sweep mode in reducing pain in patients with plantar fasciitis?
- What are the optimal therapeutic parameters (session duration, frequency and power) for LLLT in both modes, maximizing pain reduction in patients with plantar fasciitis?
Participants in this study will perform the following tasks:
- Undergo HILT sessions or scanning mode.
- Comply with the instructions on the duration and frequency of the sessions.
- Record the pain levels experienced before and after each session.
The investigators will compare the group this differents laser to evaluate whether there are significant differences in pain reduction effects.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This randomized controlled clinical trial, titled 'Effect of Different Laser Applications on Plantar Fasciitis', aims to specifically address the effectiveness of static mode versus scanning mode (HILT) in the treatment of pain associated with plantar fasciitis. Using a rigorous methodology that includes double-blind masking and a longitudinal chronology, the study focuses on comparing two modes of laser application.
The main objective is to evaluate and compare the pain reduction between these two modes of application of LLLT. To achieve this, key questions are asked, such as the relative effectiveness of each mode and the identification of optimal therapeutic parameters, including session duration, frequency and power, that maximize benefits in patients with plantar fasciitis.
Participants in this study will undergo low-level laser therapy sessions, following the protocols established for each mode of application. Additionally, they will be asked to record their pain levels before and after each session, providing valuable information about the effectiveness of the therapy.
In the case of a comparison group, a detailed evaluation will be carried out comparing the results obtained between the group treated with static in local spot mode and the group treated in scanning mode. This approach will allow researchers to determine if there are significant differences in the pain reduction effects between the two modes of laser application.
With a solid experimental design and specific objectives, this study seeks to contribute significantly to the understanding of laser applications in the treatment of plantar fasciitis, providing valuable information for the optimization of therapy and thus improving the quality of life of patients. . affected.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Seville, Spain, 41009
- Fasciitis
-
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Andalusia
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Seville, Andalusia, Spain, 41004
- Área Clínica de Podología
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Study Population
Description
Inclusion Criteria:
- Confirmed Diagnosis of Plantar Fasciitis (at least 8 weeks), adults,
Exclusion Criteria:
- Additional Serious Medical Conditions, Not receiving treatment at the time of the study for plantar fasciitis, neither, serious disease, a score of >3 on the DN4 questionnaire neuropathic pain, neither Pregnancy or lactation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: HILT Static mode
Hilt Scanning mode
|
The intervention involves the precise and focused application of HILT on specific areas related to plantar fasciitis.
The static mode technique is characterized by directing the laser directly to the painful point, seeking optimal stimulation in the affected region.The Scanning Mode technique is characterized by applying the HILT through a continuous, sweeping movement of the handpiece over the target area
|
|
Active Comparator: Shower laser application
laser application in shower or sweep mode
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The Scanning Mode technique is characterized by applying the HILT through a continuous, sweeping movement of the handpiece over the target area (the plantar fascia and adjacent tender regions). This application ensures a more uniform energy distribution across a larger tissue area, potentially addressing inflammation and pain in a broader region than the static mode. The total dose is distributed over the area treated with a continuous motion.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual pain analogic scale
Time Frame: 1,2 and 4 months
|
Visual pain scale from 0 minimum (best) to 10 maximum (worse)
|
1,2 and 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ultrasound image of thickness
Time Frame: 1,2 and 4 months
|
fascia thickness measured by ultrasound from minumum of 3 (Best) to maximum of 6 mm (Worse)
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1,2 and 4 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aurora Castro Mendez, PhD, University of Seville
Publications and helpful links
General Publications
- Guimaraes JS, Arcanjo FL, Leporace G, Metsavaht LF, Sena C, Moreno MVMG, Marcal Vieira TE, Gomes Neto M. Effect of low-level laser therapy on pain and disability in patients with plantar fasciitis: A systematic review and meta-analysis. Musculoskelet Sci Pract. 2022 Feb;57:102478. doi: 10.1016/j.msksp.2021.102478. Epub 2021 Nov 16.
- Takla MKN, Rezk SSR. Clinical effectiveness of multi-wavelength photobiomodulation therapy as an adjunct to extracorporeal shock wave therapy in the management of plantar fasciitis: a randomized controlled trial. Lasers Med Sci. 2019 Apr;34(3):583-593. doi: 10.1007/s10103-018-2632-4. Epub 2018 Sep 7.
- Kiritsi O, Tsitas K, Malliaropoulos N, Mikroulis G. Ultrasonographic evaluation of plantar fasciitis after low-level laser therapy: results of a double-blind, randomized, placebo-controlled trial. Lasers Med Sci. 2010 Mar;25(2):275-81. doi: 10.1007/s10103-009-0737-5.
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 30923-N
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
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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