Cairo university
Cairo, Cairo Governorate, 11311, Egypt
NCT Number: NCT07480876
Does phonophoresis with glyceryl trinitrate gel have an effect in treatment of planter fasciitis patients?
Trial opening soon.
Get Notified18 year–44 year
All sexes
Interventional
Not applicable
Cairo, Cairo Governorate, 11311, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: From enrollment to the end of treatment at 5 weeks
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
Time frame: From enrollment to the end of treatment at 5 weeks
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.
Time frame: From enrollment to the end of treatment at 5 weeks
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
Time frame: From enrollment to the end of treatment at 5 weeks
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.
Contact information is provided by the study sponsor or research team.
Doaa Rafat Al azab, PhD
CONTACT
01005591580 ext. +20
Fouad Sherin Fouad, PhD
CONTACT
01014411419 ext. +20
Cairo University
Other
Effect of Glyceryl Trinitrate Gel Phonophoresis in Treatment of Plantar Fasciitis: A Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07480967
Planter Fasciitis
Dhaka, Bangladesh
View Trial DetailsNCT07079566
Planter Fasciitis
Peshawar, KPK, Pakistan
View Trial DetailsNCT07669831
Effectiveness, Extracoropral Shock Wave Therapy
Cairo, Menofyia, Egypt
View Trial DetailsNCT07588776
Bone Diseases, Exostoses
Lahore, Punjab Province, Pakistan
View Trial Details