NCT06677164

Brief Summary

Plantar heel pain is one of the most commonly encountered problems of the feet in adults \[1\]. It accounts for nearly 11%-15% of all foot symptoms, The purpose of this study was to investigate the effectiveness of high intensity laser therapy combined with gluteus Maximus strengthening exercise on pain, thickness of plantar fascia, and function of the foot.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2024

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2024

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

9 months

First QC Date

November 5, 2024

Last Update Submit

March 13, 2025

Conditions

Keywords

Plantar heel painobeselaser therapy

Outcome Measures

Primary Outcomes (2)

  • Pain assessment

    Pressure algometry (kg/cm2). Pressure algometry will be performed on both affected and healthy feet

    3 months

  • Plantar fascia thickness

    by using Ultrasonography, in a longitudinal view of the tendon in both affected and healthy feet (mm). the normal plantar fascia thickness is less than 4 mm

    3 months

Study Arms (2)

Experimental: High intensity laser therapy combined with Gluteus Maximus strengthening exercise

EXPERIMENTAL

patients will receive High intensity laser therapy combined with Gluteus Maximus strengthening exercise

Procedure: Gluteus Maximus strengthening exerciseDevice: high-intensity laser therapy

Active Comparator: High intensity laser therapy

ACTIVE COMPARATOR

patients will receive High intensity laser therapy.

Device: high-intensity laser therapy

Interventions

Maximus strengthening exercise for eight weeks using weight progression tools either elastic band or sand weight by assuming two modes of exercises (clamshell exercise, prone hip extension) with stretching exercise (hamstring, gastrocnemius, soleus, and plantar fascia) 2 sessions per week for 8 weeks

Experimental: High intensity laser therapy combined with Gluteus Maximus strengthening exercise

A 3-phase treatment program will be performed in each session on the plantar fascia area. Treatment of trigger points in phase 1 and 2 by using power of 9 watts, E2C mode for 6 minute of 2 phases. The draining and vascularization-promoting application involve the whole foot sole, starting from the heel area in phase three by using power of 9 watts, CW mode with energy of 100J/cm2.

Active Comparator: High intensity laser therapyExperimental: High intensity laser therapy combined with Gluteus Maximus strengthening exercise

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Unilateral plantar heel pain with or without calcaneal spur for more than 3 months.
  • Tenderness at the insertion of the plantar fascia
  • BMI index will be from 25 up to 30
  • Patient will wear silicone insole .
  • Diagnosis of PF based on orthopedic referral

You may not qualify if:

  • Patients with presence of foot deformity,
  • systemic inflammatory arthritis disease,
  • foot surgery, or
  • plantar heel pain due to trauma,
  • wound, or infection in the foot,
  • received oral corticosteroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deraya university

Minya, 05673, Egypt

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
single
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

November 5, 2024

First Posted

November 6, 2024

Study Start

March 10, 2024

Primary Completion

November 22, 2024

Study Completion

December 1, 2024

Last Updated

March 17, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations