Plantar FasciitisNCT07043699
Effect of Phonophoresis Versus Iontophoresis in the Treatment of Perimenopausal Plantar Fasciitis
A study testing Phonophoresis and Iontophoresis in people with Plantar Fasciitis, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study was to investigate the effect of phonophoresis versus iontophoresis on plantar fasciitis in perimenopausal women. Read more about this study
- Who is it for?
- Ages 50 to 51 years, women only
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Phonophoresis and Iontophoresis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 16 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 51 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study was to investigate the effect of phonophoresis versus iontophoresis on plantar fasciitis in perimenopausal women.
Read the 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
- Being tested
- Phonophoresis, Iontophoresis
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhonophoresisOther
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.
IontophoresisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Phonophoresis | Experimental | It consisted of 21 perimenopausal women. Each patient in this group received phonophoresis, 3 times per week, for 8 weeks. Receives: Other: Phonophoresis |
| Iontophoresis | Experimental | It consisted of 21 perimenopausal women. Each patient in this group received iontophoresis, 3 times per week, for 8 weeks. Receives: Other: Iontophoresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 8 weeks
Secondary outcomes (2)
Measurement of the level of disability
Foot function was measured before and after the treatment program using the Foot Function Index (FFI), a self-reported, foot-specific tool used for over 20 years to assess pain and disability. The FFI consisted of 23 items divided into three subscales: pain, disability, and activity limitation. Scores were interpreted on a scale from 0% to 100% for each subscale and for the overall index. Higher scores indicated poorer foot health and reduced foot-related quality of life.
Measured: 8 weeks
Assessment of Dorsi flexion Range of Motion (ROM)
Dorsiflexion ROM was measured using an inclinometer placed at the tibial tuberosity and distal tibia. Participants performed a knee-bent stance facing a wall, with the dominant foot stepped back and toes forward. They bent the dominant knee forward while keeping the foot flat and used the wall for balance if needed. The examiner measured dorsiflexion once full foot contact could no longer be maintained. The inclinometer was calibrated before each session, and values were recorded to the nearest degree. Three consistent trials within ±5° or ±10% were required, with up to six attempts allowed.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Dec 2024
- Primary completion1 Jun 2025
- Study completion16 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mereet Mokhles Zaref Farid, Cairo University
- Investigators
- Hala Mohamed Hanfi Emara, PhD, Study chair, Professor, Cairo universityHossam Eldin Hossam Eldin Hussein Kamel, PhD, Study director, Professor, Al-Azhar university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043699
- Sponsor's protocol ID
- P.T.REC/012/005763
- Status last verified
- Jun 2025
- First submitted
- 20 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Phonophoresis Versus Iontophoresis in the Treatment of Perimenopausal Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT07043699
- Acronym / sponsor ID
- P.T.REC/012/005763
- Conditions
- Plantar Fasciitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phonophoresis | Experimental | Other: PhonophoresisIt consisted of 21 perimenopausal women. Each patient in this group received phonophoresis, 3 times per week, for 8 weeks. |
| Iontophoresis | Experimental | Other: IontophoresisIt consisted of 21 perimenopausal women. Each patient in this group received iontophoresis, 3 times per week, for 8 weeks. |
Who may qualify
- Ages
- 50 to 51 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhonophoresisEach 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. | Other | Phonophoresis |
| IontophoresisEach 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. | Other | Iontophoresis |
Primary outcome
Assessment of pain
Time frame: 8 weeks
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)
2 secondary outcomes
Measurement of the level of disability
Time frame: 8 weeks
Assessment of Dorsi flexion Range of Motion (ROM)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hala Mohamed Hanfi Emara, PhD study chair
Professor, Cairo university
Hossam Eldin Hossam Eldin Hussein Kamel, PhD study director
Professor, Al-Azhar university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phonophoresis and Iontophoresis in people with Plantar Fasciitis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pain (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.