Planter FasciitisNCT07480876
Glyceryl Trinitrate Gel Phonophoresis on Planter Fasciitis
A study testing Phonophoresis group and ultrasound only and Therapeutic exercises in people with Planter Fasciitis, run by Cairo University at 1 site in Egypt.
Trial summary
Does phonophoresis with glyceryl trinitrate gel have an effect in treatment of planter fasciitis patients? Read more about this study
- Who is it for?
- Ages 18 to 44 years
- Conditions the study is for
- Planter Fasciitis
- What is being tested?
- Phonophoresis group and ultrasound only and Therapeutic exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2026to 2 Oct 2026
- 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 18 to 44 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18-44 years .
- Patients BMI less than 35 kg/m2..
- The diagnosis of PF appear clinically according to the history and physical - examination findings of point tenderness at or near the medial calcaneal insertion of the plantar fascia .
- Diagnosis of plantar fasciitis, with plantar fascia of more than 4 mm thickness as evaluated by ultrasonography.
- Painful symptoms lasting three months or more .
Who cannot join
- Diabetes mellitus, peripheral neuropathy, vasculitis and vasculopathy.
- Any pathology in ankle/foot (instability, arthritis, malignancy, acute infection, and skin disorders) .
- Pregnancy or lactation, coronary artery disease, hypertension, renal diseases and anemia .
- Atrophy/ scar or skin ulcers at the site of intervention.
- Patients with allergy to nitrates.
- Heart pacemaker use .
- Anticoagulant use and absence of coagulation disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Glyceryl Trinitrate Gel Phonophoresis in Treatment of Plantar Fasciitis: A Randomized Controlled Trial
Does phonophoresis with glyceryl trinitrate gel have an effect in treatment of planter fasciitis patients?
Read the detailed description
Plantar fasciitis (PF), considered the most common cause of sub-calcaneal pain, was first described in 1812, related to painful sensation in the calcaneus, resulting from degeneration of the plantar fascia. Some reported cases are the result of biomechanical failure that provides tension along the plantar fascia. It is a common dysfunction in runners, due to the high loads they exert on the plantar fascia, but other risk factors are also worth mentioning, such as increased planter flexion, high body mass and high body mass index phonophoresis emerges as a valuable and versatile modality within physiotherapy, demonstrating clinical efficacy across a spectrum of musculoskeletal and inflammatory conditions. The combination of topically applied gel or cream-based medications with ultrasound therapy, operating within specific frequency and intensity ranges, enhances percutaneous absorption of pharmacological agents.
Glyceryl trinitrate can directly relax vascular smooth muscles, especially the smooth muscle of small blood vessels, thus dilating blood vessels and improving the microcirculation. In addition, nitroglycerin interacts with intracellular sulfhydryl to release nitric oxide (NO). NO, as endothelial relaxing factor, activates guanylate cyclase to transform into cyclic guanosine monophosphate (cGMP), which increases cGMP in smooth muscles and other tissues, thereby causing dephosphorylation of myosin light chain, regulating the contractile state of smooth muscles, relaxing smooth muscles, and dilating blood vessels gap in literature about the effect of glyceryl trinitrate gel in treatment of plantar fasciitis. So the aim of this study is to investigate the effect of glyceryl trinitrate gel in treatment of plantar fasciitis.
- Conditions
- Planter Fasciitis
- Being tested
- Phonophoresis group, ultrasound only and Therapeutic exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phonophoresis groupOther
- Patients will receive Phonophoresis with topical glyceryl trinitrate gel. Using pulsed ultrasound (2:1) with the frequency of 0.8 MHz and intensity of 1.5 W/CM for 10 minutes was dynamically administered for the patients in 10 every other day sessions.
- Therapeutic exercises
- Tibialis anterior strengthening (four sets of ten repetitions, with weights of 3 to 5 kg)
- Plantar fascia stretching the patient was comfortably sitting on chair with tennis ball under his foot. Then he rolls the ball by moving his foot in forward and backward direction.
- Stretching of the gastrocnemius and gastro soleus muscles by standing (standing calf stretch exercise, standing soleus muscle stretch exercise), the Achilles tendon by sitting (towel stretch exercise) , and the plantar fascia on a step (plantar fascia stretch exercise) . Patients were asked to do the exercises for four weeks, 10 times each morning and evening by counting up to 30
ultrasound only and Therapeutic exercisesOther
- Patients will receive ultrasound at a frequency of 1.0 Hz and intensity of 1.2 watts/cm². Ten sessions were undertaken at a frequency of two sessions per week.
- therapeutic exercises.
| Study group | Role | What they receive |
|---|---|---|
| Phonophoresis group | Experimental | Ultrasound will be used in addition to topical glyceryl trinitrate gel and therapeutic exercises. Receives: Other: Phonophoresis group |
| ultrasound only and Therapeutic exercises | Active comparator | Not described Receives: Other: ultrasound only and Therapeutic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonography
Patients with plantar fasciitis also typically have a thickened fascia. This change could be related to the reparative process of microtears, fiber degeneration, or edema.
The average thickness of the plantar fascia in healthy individuals is between 2.2 and 3.6 mm. In patients with plantar fasciitis, it ranges from 4.6 to 6.1 mm. In general, individuals with a plantar fascia thicker than 4 mm are considered to have plantar fasciitis.
Measured: From enrollment to the end of treatment at 5 weeks
Secondary outcomes (4)
visual analogue scale
This scale is the most valid pain rating system and is achieved through the use of a 10-cm horizontal ruler with one end being 0 (no pain) and the other end being 10 (the most severe pain). The ruler has 2 qualitative and quantitative procedures. The patient was asked to mark the qualitative side of the ruler given the extent of their pain. The researcher then returned the ruler and recorded that point as a number. The resulting number is considered as the patient's pain level
Measured: From enrollment to the end of treatment at 5 weeks
6-Minu Walk Test
It is a sub-maximal exercise test used to assess walk endurance. How much time patient walked before feeling pain at sole of foot was used as the outcome by which to compare changes in performance capacity pre and post treatment.
The 6MWT will be performed along a minimally trafficked flat, straight corridor ideally 30 m in length to be consistent with established reference equations. Reference equations exist for shorter tracks, including 20- and 10-m lengths, Procedural Guidelines for 6-Minute Walk Test reflect space limitations in practice. Continuous walks in various shapes (circular, oval, or square) layouts resulted in greater walk distances than non-continuous.
Measured: From enrollment to the end of treatment at 5 weeks
Smartphone apps
The examiner was positioned lateral to the participant's pathologic ankle. The phone was positioned such that the bottom corner (toward the home button) of the phone was centered on the participant's lateral malleolus with the side edge of the phone parallel to the longitudinal axis of the participant's fifth metatarsal . Once neutral position was attained, the examiner selected the "Start" button on the app, which recorded the angle of this neutral position. Then, as the participant plantar flexed or dorsiflexed, the examiner rotated the phone's position such that the side edge of the phone was repositioned to be parallel to the longitudinal axis of the participant's fifth metatarsal, with the bottom corner of the phone still centered on the participant's lateral malleolus. At this point, the examiner selected the "End" button, and the recorder documented the measured angle of plantarflexion and dorsiflexion displayed on the screen
Measured: From enrollment to the end of treatment at 5 weeks
Arabic version of modified foot function index (FFI)
The modified foot function index (FFI) consists of 17 items scored on a VAS scale with a straight line of 10-cm. It was split into three subscales: pain (5 items), disability (9 items), and activity limitation (3 items).
The items were rated on a Visual Analogue Scale (VAS), from 0 to 10. The answers lie between "no pain" and "worst pain imaginable" (pain), "no difficulty" and "so difficult as to be unable" (disability), and "none of the time" and "all of the time" (limitations). A score is calculated for every subgroup of items, and the final score is then calculated by adding the subscale scores and dividing the result by 170. The final percentage score is between 0% (best outcome) and 100% (worst outcome) .
The patient is asked to mark the horizontal line at the spot that best corresponds to the effect of the foot complaints.
Measured: From enrollment to the end of treatment at 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start30 Apr 2026
- Primary completion30 Sep 2026
- Study completion2 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Planter 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fouad Sherin Fouad Ahmed, Port Said University
- Investigators
- abeer Abdrahman Mohamed, Phd, Principal investigator, Faculty of physical therapy, Cairo university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480876
- Sponsor's protocol ID
- P.T.REC/012/005852
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Glyceryl Trinitrate Gel Phonophoresis in Treatment of Plantar Fasciitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07480876
- Acronym / sponsor ID
- P.T.REC/012/005852
- Conditions
- Planter Fasciitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 2 Oct 2026 (actual)
- First posted
- 18 Mar 2026 (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.
Does phonophoresis with glyceryl trinitrate gel have an effect in treatment of planter fasciitis patients?
Detailed description
Plantar fasciitis (PF), considered the most common cause of sub-calcaneal pain, was first described in 1812, related to painful sensation in the calcaneus, resulting from degeneration of the plantar fascia. Some reported cases are the result of biomechanical failure that provides tension along the plantar fascia. It is a common dysfunction in runners, due to the high loads they exert on the plantar fascia, but other risk factors are also worth mentioning, such as increased planter flexion, high body mass and high body mass index phonophoresis emerges as a valuable and versatile modality within physiotherapy, demonstrating clinical efficacy across a spectrum of musculoskeletal and inflammatory conditions. The combination of topically applied gel or cream-based medications with ultrasound therapy, operating within specific frequency and intensity ranges, enhances percutaneous absorption of pharmacological agents.
Glyceryl trinitrate can directly relax vascular smooth muscles, especially the smooth muscle of small blood vessels, thus dilating blood vessels and improving the microcirculation. In addition, nitroglycerin interacts with intracellular sulfhydryl to release nitric oxide (NO). NO, as endothelial relaxing factor, activates guanylate cyclase to transform into cyclic guanosine monophosphate (cGMP), which increases cGMP in smooth muscles and other tissues, thereby causing dephosphorylation of myosin light chain, regulating the contractile state of smooth muscles, relaxing smooth muscles, and dilating blood vessels gap in literature about the effect of glyceryl trinitrate gel in treatment of plantar fasciitis. So the aim of this study is to investigate the effect of glyceryl trinitrate gel in treatment of plantar fasciitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phonophoresis group | Experimental | Other: Phonophoresis groupUltrasound will be used in addition to topical glyceryl trinitrate gel and therapeutic exercises. |
| ultrasound only and Therapeutic exercises | Active comparator | Other: ultrasound only and Therapeutic exercises |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18-44 years .
- Patients BMI less than 35 kg/m2..
- The diagnosis of PF appear clinically according to the history and physical - examination findings of point tenderness at or near the medial calcaneal insertion of the plantar fascia .
- Diagnosis of plantar fasciitis, with plantar fascia of more than 4 mm thickness as evaluated by ultrasonography.
- Painful symptoms lasting three months or more .
Key exclusion criteria (7 listed)
- Diabetes mellitus, peripheral neuropathy, vasculitis and vasculopathy.
- Any pathology in ankle/foot (instability, arthritis, malignancy, acute infection, and skin disorders) .
- Pregnancy or lactation, coronary artery disease, hypertension, renal diseases and anemia .
- Atrophy/ scar or skin ulcers at the site of intervention.
- Patients with allergy to nitrates.
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 |
|---|---|---|
| Phonophoresis group1. Patients will receive Phonophoresis with topical glyceryl trinitrate gel. Using pulsed ultrasound (2:1) with the frequency of 0.8 MHz and intensity of 1.5 W/CM for 10 minutes was dynamically administered for the patients in 10 every other day sessions. 2. Therapeutic exercises * Tibialis anterior strengthening (four sets of ten repetitions, with weights of 3 to 5 kg) * Plantar fascia stretching the patient was comfortably sitting on chair with tennis ball under his foot. Then he rolls the ball by moving his foot in forward and backward direction. * Stretching of the gastrocnemius and gastro soleus muscles by standing (standing calf stretch exercise, standing soleus muscle stretch exercise), the Achilles tendon by sitting (towel stretch exercise) , and the plantar fascia on a step (plantar fascia stretch exercise) . Patients were asked to do the exercises for four weeks, 10 times each morning and evening by counting up to 30 | Other | Phonophoresis group |
| ultrasound only and Therapeutic exercises1. Patients will receive ultrasound at a frequency of 1.0 Hz and intensity of 1.2 watts/cm². Ten sessions were undertaken at a frequency of two sessions per week. 2. therapeutic exercises. | Other | ultrasound only and Therapeutic exercises |
Primary outcome
Ultrasonography
Time frame: From enrollment to the end of treatment at 5 weeks
Patients with plantar fasciitis also typically have a thickened fascia. This change could be related to the reparative process of microtears, fiber degeneration, or edema. The average thickness of the plantar fascia in healthy individuals is between 2.2 and 3.6 mm. In patients with plantar fasciitis, it ranges from 4.6 to 6.1 mm. In general, individuals with a plantar fascia thicker than 4 mm are considered to have plantar fasciitis.
4 secondary outcomes
visual analogue scale
Time frame: From enrollment to the end of treatment at 5 weeks
6-Minu Walk Test
Time frame: From enrollment to the end of treatment at 5 weeks
Smartphone apps
Time frame: From enrollment to the end of treatment at 5 weeks
Arabic version of modified foot function index (FFI)
Time frame: From enrollment to the end of treatment at 5 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 14 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Planter Fasciitis
Not yet recruiting
Hip Muscle Strengthening and Calf Myofascial Release in Females With Chronic Plantar Fasciitis
Chronic Planter Fascitis
Active, not recruiting
Comparison of Platelet-Rich Plasma and Prolotherapy for Plantar Fasciitis
Planter Fasciitis
Recruiting
Cognitive Training for Pain , Balance and Foot Function in Plantar Fasciitis
Planter Fasciitis
Active, not recruiting
Navicular Mobilization in Patients of Planter Fasciitis
Planter Fasciitis, Navicular Bone
Not yet recruiting
Calcaneal Osteotomy for Recalcitrant Planter Fasciosis
Plantar Fascitis
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.
abeer Abdrahman Mohamed, Phd principal investigator
Faculty of physical therapy, Cairo university, Egypt
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 group and ultrasound only and Therapeutic exercises in people with Planter 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 5 inclusion and 7 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 14 Oct 2026. 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?
Ultrasonography (time frame: From enrollment to the end of treatment at 5 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 14 Oct 2026.