Glyceryl Trinitrate Gel Phonophoresis on Planter Fasciiatis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-44
SponsorCairo University

About this trial

Does phonophoresis with glyceryl trinitrate gel have an effect in treatment of planter fasciitis patients?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Phonophoresis group

    Other intervention

    1. 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

  • ultrasound only and Therapeutic exercises

    Other intervention

    1. 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Phonophoresis groupExperimental treatment 1 intervention
Group B: ultrasound only and Therapeutic exercisesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to the end of treatment at 5 weeks

Secondary outcomes

1

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

Time frame
From enrollment to the end of treatment at 5 weeks
2

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.

Time frame
From enrollment to the end of treatment at 5 weeks
3

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

Time frame
From enrollment to the end of treatment at 5 weeks
4

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.

Time frame
From enrollment to the end of treatment at 5 weeks

Other outcomes

Sponsors and contacts

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Cairo University

Lead sponsor

Port Said University

Sponsor institution

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