Glyceryl Trinitrate Gel Phonophoresis on Planter Fasciiatis

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Planter Fasciitis
• Intervention / Treatment: Other: Phonophoresis group; Other: ultrasound only and Therapeutic exercises

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fouad sherin fouad, Phd; Phone Number: +20 01014411419; Email: fouadshrin2@gmail.com
• Study Contact Backup: Name: Doaa Rafat Al azab, PhD; Phone Number: +20 01005591580; Email: doaa.rafat@pt.cu.edu.eg

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 11311
      • Cairo University
      • Contact: Fouad sherin fouad, Phd; Phone Number: +20 01014411419; Email: fouadshrin2@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 18-44 years .
• Patients BMI 18.5 to 24.9 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 .

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phonophoresis group; Ultrasound will be used in addition to topical glyceryl trinitrate gel and therapeutic exercises.	Other: Phonophoresis group; 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 exercisesTibialis 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
Active Comparator: ultrasound only and Therapeutic exercises	Other: ultrasound only and Therapeutic exercises; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of treatment at 5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	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.	From enrollment to the end of treatment at 5 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: abeer Abdrahman Mohamed, Phd, Faculty of Physical Therapy, Cairo University, Egypt

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: March 14, 2026
• First Submitted That Met QC Criteria: March 14, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Physical Therapy Modalities; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Exercise Therapy
• Other Study ID Numbers: P.T.REC/012/005852

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No