ClinicalTrials.gg
Status unknownNCT06493487Updated Jul 10, 2024

INIT Versus IASTM In Patients With Chronic PF

An interventional study of integrated neuromuscular inhibition technique and instrument assissted soft tissue mobilization in Planter Fasciitis, sponsored by Cairo University. Status unknown. Open to participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-07-10.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2024), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
40 Years to 60 Years
Sex
All
01

Study summary

  1. To investigate integrated neuromuscular inhibition versus Instrument assisted soft tissue mobilization on general pain intensity in patient with chronic plantar fasciitis.
  2. To investigate integrated neuromuscular inhibition versus Instrument assisted soft tissue mobilization on pain intensity at initial morning step in patient with chronic plantar fasciitis.
  3. To investigate integrated neuromuscular inhibition versus Instrument assisted soft tissue mobilization on pain pressure threshold in patient with chronic plantar fasciitis.
  4. To investigate integrated neuromuscular inhibition versus Instrument assisted soft tissue mobilization on active dorsiflexion ROM in patient with chronic plantar fasciitis.
  5. To investigate integrated neuromuscular inhibition versus Instrument assisted soft tissue mobilization on functional disability in patient chronic plantar fasciitis.

5) Investigate integrated neuromuscular inhibition versus Instrument assisted soft tissue mobilization on functional disability in patient chronic plantar fasciitis.

Read the detailed description

Plantar fasciitis (PF)is a degenerative syndrome of the plantar fascia resulting from repeated trauma at its origin on the calcaneus. Pain is generally caused by collagen degeneration at the origin of the plantar fascia at the medial tubercle of the calcaneus. It affects up to 10% of the general population. Functional risk factors include tightness in Gastrocnemius, soleus and weakness of intrinsic foot muscles because limited dorsiflexion of tight Achilles tendon strains the plantar fascia. Plantar fasciitis (PF), the most common cause of heel pain, it accounts for approximately 11% to 15% of foot symptoms presenting to physicians. The term plantar fasciitis implies an inflammatory condition. However, various lines of evidence indicate that this disorder is better classified as 'fasciosis' or 'fasciopathy' Plantar fasciitis. Main roles of plantar fascia are supporting longitudinal arch of the foot and providing shock absorption.if the tension on the plantar fascia exceeds the limits of the tissue, small tears can develop in the fascia. Repetitive tension and subsequent tearing can cause the fascia to become inflamed and painful. Plantar fasciitis is particularly common in runners, but is also noted among workers who stand for long periods.Any factor which is responsible for mechanical overloading of plantar fascia can be addressed as risk factors obesity, foot arch, decrease dorsiflexion ROM and tightness in calf muscles. One of the most common cause for limited ankle dorsiflexion range of motion (ADF)is gastrocnemius muscle tightness. The classic presentation of plantar fasciitis is pain on the sole of the foot at the inferior region of the heel. Pain is particularly bad with the first few steps taken on rising in the morning or after an extended refrain from weight-bearing activity. Often the pain diminishes after a few steps and through the course of the day, but returns if intense or prolonged weight bearing activity is carried out. Initially the heel pain may be diffuse or migratory; however, with time it usually focuses around the area of the medial tuberosity of calcaneum. Plantar heel pain is associated with impaired health-related quality of life including social isolation, a poor perception of health status and reduced functional capabilities.myofascial trigger points (MTrPs) in the calf muscle increase the stiffness and may reduce the dorsiflexion range of ankle joint which is one of the risk factor of plantar fasciitis.

Myofascial trigger points have the potential to create pain, limit ROM and restrict functional activities and should therefore be addressed as part of a comprehensive physical therapy program. Currently, a large variety of both manual and non-manual interventions exist for the deactivation of trigger points (TrPs). Manual approaches may include muscle energy techniques (METs), strain-counterstrain (SCS), myofascial release, proprioceptive neuromuscular facilitation, and ischemic compression.Integrated neuromuscular inhibition technique (INIT) is a method that includes three maneuvers in one. The three techniques are ischemic compression (IC) or trigger point release, strain counterstrain technique, and muscle energy technique (MET). In trigger point release, compression is given at the trigger point region and maintained for 15 seconds, while in strain counterstrain technique, the superficial fascia is stretched. MET works on the principle of reciprocal inhibition.Instrument-Assisted Soft Tissue Mobilization (IASTM) is uses specifically designed instruments to identify and treat myofascial restrictions. It is based off the principles of deep transverse friction massage. It is also known as Graston Technique. There are 6 stainless steel instruments which are specific for different regions and types of muscles which need to be targeted. It is designed to reduce fatigue of the clinician\'s hands and to detect lesions by amplifying the resonance felt through the instrument.

02

Conditions studied

  • Planter Fasciitis

Keywords

  • planter fasciitis
  • integrated neuromuscular inhibition technique (INIT)
  • Instrument-Assisted Soft Tissue Mobilization (IASTM)
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient with history of plantar fasciitis more than three months ago.
  • Plantar heel pain with first few steps upon walking in the morning and after prolonged rest.
  • Patient\'s Age between 40-60 years old.
  • Patient\'s Body mass index (BMI 18 to 29.9kg/m2).

Exclusion criteria

Exclusion Criteria:

  • Patients with any prior surgery to distal tibia, fibula, ankle joint or rear foot region.
  • Presence of any red flags i.e., tumor, fracture, and heterotrophic ossification and had acute inflammatory condition at ankle-foot region were excluded from the study.
  • Deformity of foot and ankle complex and subjects with referred pain due to sciatica and other neurological disorder.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
54 participants (estimated)

Study arms

  • Experimental
    integrated neuromuscular inhibition technique

    integrated neuromuscular inhibition in addition to conventional treatment

    Other: integrated neuromuscular inhibition technique

  • Experimental
    instrument assisted soft tissue mobilization

    instrument assisted soft tissue mobilization technique (IASTM) in addition to conventional treatment

    Other: instrument assissted soft tissue mobilization

  • Placebo comparator
    conventional treatment

    (home education program, therapeutic ultrasound, plantar fascia stretching, intrinsic muscle strengthening of foot, Self stretching of calf muscle using a towel and Ice Massage using frozen bottle).

    Other: convential treatment

Interventions

  • Otherintegrated neuromuscular inhibition technique

    integrated neuromuscular inhibition technique for gastrocniemus muscle

  • Otherinstrument assissted soft tissue mobilization

    instrument assissted soft tissue mobilization for calf muscle

  • Otherconvential treatment

    convential treatment (home education program, therapeutic ultrasound, plantar fascia stretching, intrinsic muscle strengthening of foot, Self stretching of calf muscle using a towel and Ice Massage using frozen bottle).

06

What researchers measure

Primary outcomes

  1. general pain intensity

    general pain intensity at planter aspect of foot will be measured by Visual analog scale (VAS): a horizontal line, 100 mm in length, anchored by word descriptors at each end (0 means no pain to 10 means worth pain). The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.

    Time frame: change of general pain intensity through 4 weeks

Secondary outcomes

  1. pain intensity in morning initial step

    pain intensity in morning initial step at planter aspect of foot will be measured by Visual analog scale (VAS): a horizontal line, 100 mm in length, anchored by word descriptors at each end.(0 means no pain to 10 means worse pain) The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks.

    Time frame: change of pain intensity in morning initial step through 4 weeks.

Other outcomes

  1. Disability function of ankle joint

    Disability function of ankle joint will be assisted by Arabic version of foot function index scale: The FFI (questionnaire) consists of 23 self-reported items divided into 3 subcategories on the basis of patient values: pain, disability and activity limitation. The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week. The pain subcategory consists of 9 items and measures foot pain in different situations, such as walking barefoot versus walking with shoes. The disability subcategory consists of 9 items and measures difficulty performing various functional activities because of foot problems, such as difficulty climbing stairs. The activity limitation subcategory consists of 5 items and measures limitations in activities because of foot problems, such as staying in bed all day.

    Time frame: change of disability function of ankle joint through 4 weeks

  2. pain pressure threshold

    Pain pressure threshold will be measured by Pressure algometer (FPX 25 Wagner Instruments, Greenwich, CT, USA) was use for the measurement of PPT. Used to assess Pressure pain threshold (tenderness) over the lower medial trigger point in gastrocnemius muscle of the involved heel.

    Time frame: change of pain pressure thershold through 4 weeks

  3. active ankle dorsiflexion range of motion

    active ankle dorsiflexion range of motion will be measured by Electro goniometer:Used to measure active ankle dorsiflexion range of motion.

    Time frame: change of active ankle dorsiflexion range of motion through 4 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06493487
Lead sponsor
Cairo University
Responsible party
esraa khairy afify esmail (Principal Investigator, Cairo University) — Principal investigator
First posted
Jul 10, 2024
Start date
Jul 1, 2024 (estimated)
Primary completion
Aug 1, 2024 (estimated)
Completion
Sep 1, 2024 (estimated)
Last update
Jul 10, 2024

Study contacts

esraa khairy afify esmail, B.Sc
Contact
ekhairy851@gmail.com
+2(02)01013982552
magda zahran, Ass.Prof
study director · faculty of physical therapy
Fatma Amin, Professor
study director · faculty of physical therapy
mohammed kaddah, professor
study director · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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