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Planter FasciitisNCT06493487

INIT Versus IASTM In Patients With Chronic PF

A study testing integrated neuromuscular inhibition technique, instrument assissted soft tissue mobilization and convential treatment in people with Planter Fasciitis, run by Cairo University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 60 years
Conditions the study is for
Planter Fasciitis
What is being tested?
integrated neuromuscular inhibition technique, instrument assissted soft tissue mobilization and convential treatment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
54 participants
Where
No sites listed yet
Study dates
1 Jul 2024to 1 Sep 2024
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 40 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

esraa khairy afify esmail, B.Sc contact

+2(02)01013982552

ekhairy851@gmail.com

About this study

Official title: Integrated Neuromuscular Inhibition Technique Versus Instrument Assissted Soft Tissue Mobilization In Patients With Chronic Planter Fasciitis

  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.
  6. 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.

Being tested
integrated neuromuscular inhibition technique, instrument assissted soft tissue mobilization, convential treatment
Keywords
planter fasciitis, integrated neuromuscular inhibition technique (INIT), Instrument-Assisted Soft Tissue Mobilization (IASTM)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • integrated neuromuscular inhibition techniqueOther

    integrated neuromuscular inhibition technique for gastrocniemus muscle

  • instrument assissted soft tissue mobilizationOther

    instrument assissted soft tissue mobilization for calf muscle

  • convential treatmentOther

    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).

Study groups in NCT06493487
Study groupRoleWhat they receive
integrated neuromuscular inhibition techniqueExperimentalintegrated neuromuscular inhibition in addition to conventional treatment
Receives: Other: integrated neuromuscular inhibition technique
instrument assisted soft tissue mobilizationExperimentalinstrument assisted soft tissue mobilization technique (IASTM) in addition to conventional treatment
Receives: Other: instrument assissted soft tissue mobilization
conventional treatmentPlacebo comparator(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).
Receives: Other: convential treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: change of general pain intensity through 4 weeks

Secondary outcomes (1)
  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2024
  2. Study start1 Jul 2024 (estimated)
  3. Primary completion1 Aug 2024 (estimated)
  4. Study completion1 Sep 2024 (estimated)

Resources

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
Double blind
Who is masked
Participant, Care provider
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06493487
Sponsor's protocol ID
INIT versus IASTM in PF
Status last verified
Jun 2024
First submitted
29 Jun 2024
Last updated
10 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing integrated neuromuscular inhibition technique, instrument assissted soft tissue mobilization and convential treatment in people with Planter Fasciitis, run by Cairo University.

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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact esraa khairy afify esmail, B.Sc (+2(02)01013982552, ekhairy851@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

general pain intensity (time frame: change of general pain intensity through 4 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 10 Jul 2024; AzTrials last refreshed its copy on 31 Oct 2026.

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