Plantar Pressures After Pressure Release of the Flexor Digitorum Brevis Muscle Versus a Non-emission Laser.

Plantar Pressures After Pressure Release of the Flexor Digitorum Brevis Muscle Versus a Non-emission Laser: Clinical Trial.

In this study we will test the effects of pressure release on the Flexor digitorum brevis muscle on the plantar pressures variables using a pressure platform.

Study Overview

• Status: Completed
• Conditions: Myofascial Pain Syndrome; Flat Foot; Manual Therapy; Foot
• Intervention / Treatment: Other: Pressure release; Other: Non emision Laser

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • San Sebastián De Los Reyes, Madrid, Spain, 28702
      • Mayuben Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

• Participants who came to the clinic presenting with pain in both heels and who were diagnosed with active or latent myofascial trigger point in bilateral flexor digitorum brevis muscles.
• Myofascila trigger points of flexor digitorum brevis were the only ones diagnosed in the foot.
• All participants with normal body mass, without obesity.

Exclusion criteria:

• Diagnosis of lower limb injury, such as plantar fasciitis, tendinopathy, bursitis, ligamentous injuries.
• History of previous lower limb surgery.
• Participants will not be subjected to ankle stretching or any other treatment.
• Diabetes due to possible elevation of plantar pressure.
• Toe deformities such as hammertoes and hallux valgus due to possible alteration of plantar pressure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pressure release; Application of pressure release as a trigger point treatment of the flexor digitorum brevis muscle. Performing 3 pressure cycles until the disappearance of the referred pain for a minimum of 90 seconds.	Other: Pressure release; Release of pre-pressure at the latent trigger point of flexor digitorum brevis
Sham Comparator: Non-emision Laser; Application of a non-emitting laser for 5 minutes.	Other: Non emision Laser; Non emision laser in Flexor digitorum brevis latent trigger point

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variables of plantar pressures with platform before non-emission laser	For 30 seconds we will record the plantar pressure variables in grams per square centimetre.	Through study completion, an average of 2 days
Variables of plantar pressures with platform before pressure release	For 30 seconds we will record the plantar pressure variables in grams per square centimetre.	Through study completion, an average of 2 days
Variable footprint planting surface with platform before non-emission laser	For 30 seconds we will record the area of the footprint in square centimetres.	Through study completion, an average of 2 days
Variable footprint plantar surface with platform before pressure release	For 30 seconds we will record the plantar pressure variables in grams per square centimetre.	Through study completion, an average of 2 days
Variables of plantar pressures with platform after non-emission laser	For 30 seconds we will record the plantar pressure variables in grams per square centimetre.	Through study completion, an average of 2 days
Variables of plantar pressures with platform after preassure release	For 30 seconds we will record the plantar pressure variables in grams per square centimetre.	Through study completion, an average of 2 days
Variable footprint planting surface with platform after non-emission laser	For 30 seconds we will record the area of the footprint in square centimetres.	Through study completion, an average of 2 days
Variable footprint planting surface with platform after pressure release	For 30 seconds we will record the area of the footprint in square centimetres.	Through study completion, an average of 2 days

Collaborators and Investigators

• Sponsor: Mayuben Private Clinic
• Investigators: Principal Investigator: Eva María Martínez-Jiménez, PhD, Universidad Complutense de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2024
• Primary Completion (Actual): July 28, 2024
• Study Completion (Actual): August 3, 2024

Study Registration Dates

• First Submitted: July 7, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 3, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Congenital Abnormalities; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Talipes; Fibromyalgia; Myofascial Pain Syndromes; Flatfoot
• Other Study ID Numbers: 1912202200923 B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No