NCT07043699

Brief Summary

The purpose of the study was to investigate the effect of phonophoresis versus iontophoresis on plantar fasciitis in perimenopausal women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 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

December 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2025

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 29, 2025

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

June 20, 2025

Last Update Submit

June 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of pain

    The Visual Analog Scale (VAS) was used to assess pain levels in each woman in both groups before and after the treatment program. Pain scores were determined by measuring the distance in millimeters on a 10-cm line between the "no pain" anchor and the patient's mark, yielding a score from 0 to 100. Higher scores indicated greater pain intensity. Recommended cut points were: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)

    8 weeks

Secondary Outcomes (2)

  • Measurement of the level of disability

    8 weeks

  • Assessment of Dorsi flexion Range of Motion (ROM)

    8 weeks

Study Arms (2)

Phonophoresis

EXPERIMENTAL

It consisted of 21 perimenopausal women. Each patient in this group received phonophoresis, 3 times per week, for 8 weeks.

Other: Phonophoresis

Iontophoresis

EXPERIMENTAL

It consisted of 21 perimenopausal women. Each patient in this group received iontophoresis, 3 times per week, for 8 weeks.

Other: Iontophoresis

Interventions

Each woman in the first group received phonophoresis treatment. The procedure was performed using diclofenac sodium gel. Treatment was administered three times per week over a period of eight weeks. Ultrasound was applied at an intensity of 1 W/cm² for 8 minutes using a pulsed mode at a frequency of 1 MHz.

Phonophoresis

Each woman in the second group received iontophoresis treatment using a diclofenac sodium solution (Voltaren ampoules). The solution was applied under the cathode (drug delivery electrode). The iontophoresis leads were connected, and the current intensity was adjusted based on individual tolerance, ranging between 1 and 4 mA, for a duration of 20 minutes. The negative electrode was placed on the medial side of the calcaneal tubercle (origin), while the positive electrode was positioned on the forefoot. Treatment was administered three times per week over a period of eight weeks.

Iontophoresis

Eligibility Criteria

Age50 Years - 51 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All participants were perimenopausal women who had been suffering from plantar fasciitis (PF) for at least one month.
  • Patients reported heel pain during the first step in the morning, while bearing weight, and after walking or running.
  • Diagnosis was confirmed using the Windlass test, Tarsal Tunnel test, and tenderness at the anterior medial heel.
  • Participants were aged between 50 and 51 years and experienced menstrual irregularities.
  • Their body mass index (BMI) was greater than 30 kg/m².
  • They had not received any medical treatment for plantar fascia pain or collagen supplements.
  • None of the participants were on hormonal therapy.

You may not qualify if:

  • Patients with a history of rheumatoid arthritis, diabetes mellitus, or hypertension.
  • Those diagnosed with neurological disorders.
  • Individuals who had undergone previous foot surgeries, experienced burns, or suffered severe foot trauma.
  • Participation in any other exercise training program during the study period.
  • History of skeletal deformities.
  • Presence of knee or ankle replacements.
  • Presence of ankle plates, screws, or nails.
  • Notable differences in lower limb length.
  • History of foot fractures that resulted in deformities.
  • Presence of infective foot conditions, dermatitis, or tumors.
  • Impaired circulation in the lower extremities.
  • Corticosteroid injection to the heel within the past year.
  • Congenital foot deformities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

PhonophoresisIontophoresis

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeuticsElectrophoresisElectrochemical TechniquesInvestigative Techniques

Study Officials

  • Hala Mohamed Hanfi Emara, PhD

    Professor, Cairo university

    STUDY CHAIR
  • Hossam Eldin Hossam Eldin Hussein Kamel, PhD

    Professor, Al-Azhar university

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 20, 2025

First Posted

June 29, 2025

Study Start

December 1, 2024

Primary Completion

June 1, 2025

Study Completion

June 16, 2025

Last Updated

June 29, 2025

Record last verified: 2025-06

Locations