Differents Laser Applications on Plantar Fasciitis

NCT06305507 | Completed DMC

• 1 other identifier: 30923-N
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Fasciitis, Plantar

Keywords

Fascitis Plantar; Focused laser therapy; Randomized Clinical trial; Doubled blinded; Longitudinal; Pain reduction; Therapeutic; Session duration; Comparision group

Outcome Measures

Primary Outcomes (1)

• Visual pain analogic scale

  Visual pain scale from 0 minimum (best) to 10 maximum (worse)

  1,2 and 4 months

Secondary Outcomes (1)

• Ultrasound image of thickness

  1,2 and 4 months

Study Arms (2)

HILT Static mode

OTHER

Hilt Scanning mode

Other: Static therapy

Shower laser application

ACTIVE COMPARATOR

laser application in shower or sweep mode

Other: Static Mode

Interventions

Static Mode OTHER

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.

Also known as: Sweeping laser therapy

Shower laser application

Static therapy OTHER

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

HILT Static mode

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed Diagnosis of Plantar Fasciitis (at least 8 weeks), adults,

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Seville: lead

Study Sites (2)

Área Clínica de Podología

Seville, Andalusia, 41004, Spain

Location

Fasciitis

Seville, 41009, Spain

Location

Related Publications (3)

• 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.

  PMID: 34847470 RESULT

• 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.

  PMID: 30194553 RESULT

• 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.

  PMID: 19841862 RESULT

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Magnetic Field Therapy

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Aurora Castro Mendez, PhD

  University of Seville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor Titular Doctor

Model Details: 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.

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 12, 2024
• Study Start: January 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: September 23, 2024
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)