Differents Laser Applications on Plantar Fasciitis

Fasciitis, Plantar Clinical Trial

Official title:

Effects of Differents Laser Applications on Plantar Fasciitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06305507
• Other study ID #: 30923-N
• Status: Recruiting
• Start date: June 2024
• Est. completion date: July 2024

Study information

• Verified date: June 2024
• Source: University of Seville
• Contact: Aurora Castro, PhD
• Phone: +34 677 60 89 57
• Email: auroracastro[@]us.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this randomized controlled clinical trial (RCT) with a double-blind technique and longitudinal chronology, entitled "Effect of different laser applications on Plantar Fasciitis", is to evaluate and compare the effectiveness of laser therapy low-level (LLLT) in local spot mode versus sweep 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 low-level laser therapy sessions in local spot mode or sweep 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 undergoing local spot mode low-level laser therapy with the group undergoing sweeping mode low-level laser therapy to evaluate whether there are significant differences in pain reduction effects.

Description:

This randomized controlled clinical trial, titled 'Effect of Different Laser Applications on Plantar Fasciitis', aims to specifically address the effectiveness of low-level laser therapy (LLLT) 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: local spot mode and sweep mode.

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 LLLT in local spot mode and the group treated in swept 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Confirmed Diagnosis of Plantar Fasciitis

Exclusion Criteria:

• Additional Serious Medical Conditions

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar

Intervention

Other:
• Focussed laser therapy
Others: Spot laser therapy Other names: Spot laser therapy "Low Level Laser Therapy (LLLT) - Local Spot" The intervention involves the precise and focused application of low-power laser on specific areas related to plantar fasciitis. The local point technique is characterized by directing the laser directly to the painful point, seeking optimal stimulation in the affected region. This approach allows for targeted delivery of treatment to the area where pain is experienced, with the goal of maximizing the effectiveness of the therapy in reducing the symptoms associated with plantar fasciitis.
• Shower laser therapy
Laser Therapy Sweeping The intervention involves constantly moving the low-power laser over the areas affected by plantar fasciitis in a sweeping pattern. The sweeping technique seeks to cover a greater extent of the painful area during each treatment session. This approach differs by providing broader stimulation across the affected area, exploring the possibility of additional benefits compared to the local spot technique.

Locations

Country	Name	City	State
Spain	Área Clínica de Podología	Sevilla	Andalucía
Spain	Fasciitis	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

References & 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 — View Citation

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 — View Citation

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. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual pain analogic scale	Visual pain scale from 0 minimum (best) to 10 maximum (worse)	1,2 and 4 months
Secondary	Ultrasound image of thickness	fascia thickness measured by ultrasound from minumum of 3 (Best) to maximum of 6 mm (Worse)	1,2 and 4 months