Fasciitis, PlantarFASLaserNCT06305507
Differents Laser Applications on Plantar Fasciitis
A study testing Static therapy and Static Mode in people with Fasciitis, Plantar, run by University of Seville at 2 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fasciitis, Plantar
- What is being tested?
- Static therapy and Static Mode
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jan 2024to 23 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed Diagnosis of Plantar Fasciitis (at least 8 weeks), adults,
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Área Clínica de Podología
Seville, Andalusia, 41004
Fasciitis
Seville, 41009
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Fasciitis, Plantar
- Being tested
- Static therapy, Static Mode
- Keywords
- Fascitis Plantar, Focused laser therapy, Randomized Clinical trial, Doubled blinded, Longitudinal, Pain reduction, Therapeutic, Session duration, Comparision group
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static therapyOther
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
Static ModeOther
Also called Sweeping laser therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| HILT Static mode | Other | Hilt Scanning mode Receives: Other: Static therapy |
| Shower laser application | Active comparator | laser application in shower or sweep mode Receives: Other: Static Mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual pain analogic scale
Visual pain scale from 0 minimum (best) to 10 maximum (worse)
Measured: 1,2 and 4 months
Secondary outcomes (1)
Ultrasound image of thickness
fascia thickness measured by ultrasound from minumum of 3 (Best) to maximum of 6 mm (Worse)
Measured: 1,2 and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Jan 2024
- Primary completion30 Jun 2024
- Study completion23 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fasciitis, PlantarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Pilot Study with Two Parallel Groups. Participants were randomly assigned to one of two experimental groups (High-Intensity Laser Therapy in Static Mode or High-Intensity Laser Therapy in Scanning Mode) to receive 12 treatment sessions over a 40-day period. This is a single-blind design, where participants were blinded to the type of laser application received.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aurora Castro Mendez, University of Seville
- Investigators
- Aurora Castro Mendez, PhD, Principal investigator, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305507
- Sponsor's protocol ID
- 30923-N
- Acronym
- FASLaser
- Status last verified
- Dec 2025
- First submitted
- 22 Feb 2024
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34847470Takla 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.
PubMed 30194553Kiritsi 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.
PubMed 19841862
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Differents Laser Applications on Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT06305507
- Acronym / sponsor ID
- FASLaser / 30923-N
- Conditions
- Fasciitis, Plantar
- Keywords
- Fascitis Plantar, Focused laser therapy, Randomized Clinical trial, Doubled blinded, Longitudinal, Pain reduction, Therapeutic, Session duration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 23 Sep 2024 (actual)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Pilot Study with Two Parallel Groups. Participants were randomly assigned to one of two experimental groups (High-Intensity Laser Therapy in Static Mode or High-Intensity Laser Therapy in Scanning Mode) to receive 12 treatment sessions over a 40-day period. This is a single-blind design, where participants were blinded to the type of laser application received.
| Arm | Type | Receives |
|---|---|---|
| HILT Static mode | Other | Other: Static therapyHilt Scanning mode |
| Shower laser application | Active comparator | Other: Static Modelaser application in shower or sweep mode |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Confirmed Diagnosis of Plantar Fasciitis (at least 8 weeks), adults,
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Static therapyThe 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 | Other | HILT Static mode |
| Static ModeAlso: Sweeping laser therapyThe 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 | Shower laser application |
Primary outcome
Visual pain analogic scale
Time frame: 1,2 and 4 months
Visual pain scale from 0 minimum (best) to 10 maximum (worse)
1 secondary outcome
Ultrasound image of thickness
Time frame: 1,2 and 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Results publication: PubMed 34847470Guimaraes 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.
- Results publication: PubMed 30194553Takla 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.
- Results publication: PubMed 19841862Kiritsi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurora Castro Mendez, PhD principal investigator
University of Seville
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static therapy and Static Mode in people with Fasciitis, Plantar, run by University of Seville at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual pain analogic scale (time frame: 1,2 and 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06305507, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.