Effect of Phonophoresis Versus Iontophoresis in the Treatment of Perimenopausal Plantar Fasciitis

NCT ID: NCT07043699

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-06-16

Brief Summary

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

Detailed Description

Collagen plays a critical role in determining the tensile strength of connective tissue. During the perimenopausal transition, the overall quantity of collagen decreases; however, there is a relative increase in type I collagen compared to type III collagen. This shift contributes to increased tissue stiffness. Research indicates that estrogen has a protective effect on muscles and fascia, preventing fibrogenesis. Consequently, as estrogen levels decline during perimenopause, fibrogenic activity may increase. In addition, reduced estrogen levels are associated with enhanced elastin degradation, leading to diminished tissue elasticity and reduced recoil capacity.

This degradation of connective tissue is considered a primary cause of plantar fasciitis, which results from collagen breakdown in the plantar fascia at its origin-the calcaneal tuberosity of the heel-and surrounding fascial structures.

When plantar fasciitis develops in perimenopausal women, it can significantly disrupt daily activities. Many women experience fallen arches and severe irritation, with pain affecting functions such as standing, walking, climbing stairs, and working. This functional impairment can lead to emotional consequences, including depression.

Given these challenges, there is a pressing need to identify new, alternative, and cost-effective methods for managing and treating this condition. This study examined the effectiveness of phonophoresis and iontophoresis in treating plantar fasciitis in perimenopausal women. The findings aimed to contribute valuable knowledge to the field of physical therapy and offer practical solutions for women suffering from this condition.

Conditions

Plantar Fasciitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phonophoresis

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

Group Type: EXPERIMENTAL

Phonophoresis

Intervention Type: OTHER

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.

Iontophoresis

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

Group Type: EXPERIMENTAL

Iontophoresis

Intervention Type: OTHER

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.

Interventions

Phonophoresis

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.

Intervention Type: OTHER

Iontophoresis

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 51 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mereet Mokhles Zaref Farid

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hala Mohamed Hanfi Emara, PhD

Role: STUDY_CHAIR

Professor, Cairo university

Hossam Eldin Hossam Eldin Hussein Kamel, PhD

Role: STUDY_DIRECTOR

Professor, Al-Azhar university

Locations

Cairo University

Giza, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/005763

Identifier Type: -

Identifier Source: org_study_id