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.
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.
About this study
Official title: Integrated Neuromuscular Inhibition Technique Versus Instrument Assissted Soft Tissue Mobilization In Patients With Chronic Planter Fasciitis
- To investigate integrated neuromuscular inhibition versus Instrument assisted soft tissue mobilization on general pain intensity in patient with chronic plantar fasciitis.
- To investigate integrated neuromuscular inhibition versus Instrument assisted soft tissue mobilization on pain intensity at initial morning step in patient with chronic plantar fasciitis.
- To investigate integrated neuromuscular inhibition versus Instrument assisted soft tissue mobilization on pain pressure threshold in patient with chronic plantar fasciitis.
- To investigate integrated neuromuscular inhibition versus Instrument assisted soft tissue mobilization on active dorsiflexion ROM in patient with chronic plantar fasciitis.
- To investigate integrated neuromuscular inhibition versus Instrument assisted soft tissue mobilization on functional disability in patient chronic plantar fasciitis.
- 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.
- Conditions
- Planter Fasciitis
- 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 group | Role | What they receive |
|---|---|---|
| integrated neuromuscular inhibition technique | Experimental | integrated neuromuscular inhibition in addition to conventional treatment Receives: Other: integrated neuromuscular inhibition technique |
| instrument assisted soft tissue mobilization | Experimental | instrument assisted soft tissue mobilization technique (IASTM) in addition to conventional treatment Receives: Other: instrument assissted soft tissue mobilization |
| conventional treatment | Placebo 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.
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)
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.
- First posted10 Jul 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Planter FasciitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, esraa khairy afify esmail, Cairo University
- Investigators
- magda zahran, Ass.Prof, Study director, faculty of physical therapyFatma Amin, Professor, Study director, faculty of physical therapymohammed kaddah, professor, Study director, Cairo University
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Neuromuscular Inhibition Technique Versus Instrument Assissted Soft Tissue Mobilization In Patients With Chronic Planter Fasciitis
- ClinicalTrials.gov ID
- NCT06493487
- Acronym / sponsor ID
- INIT versus IASTM in PF
- Conditions
- Planter Fasciitis
- Keywords
- planter fasciitis, integrated neuromuscular inhibition technique (INIT), Instrument-Assisted Soft Tissue Mobilization (IASTM)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To investigate integrated neuromuscular inhibition versus Instrument assisted soft tissue mobilization on general pain intensity in patient with chronic plantar fasciitis.
- To investigate integrated neuromuscular inhibition versus Instrument assisted soft tissue mobilization on pain intensity at initial morning step in patient with chronic plantar fasciitis.
- To investigate integrated neuromuscular inhibition versus Instrument assisted soft tissue mobilization on pain pressure threshold in patient with chronic plantar fasciitis.
- To investigate integrated neuromuscular inhibition versus Instrument assisted soft tissue mobilization on active dorsiflexion ROM in patient with chronic plantar fasciitis.
- To investigate integrated neuromuscular inhibition versus Instrument assisted soft tissue mobilization on functional disability in patient chronic plantar fasciitis.
- Investigate integrated neuromuscular inhibition versus Instrument assisted soft tissue mobilization on functional disability in patient chronic plantar fasciitis.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| integrated neuromuscular inhibition technique | Experimental | Other: integrated neuromuscular inhibition techniqueintegrated neuromuscular inhibition in addition to conventional treatment |
| instrument assisted soft tissue mobilization | Experimental | Other: instrument assissted soft tissue mobilizationinstrument assisted soft tissue mobilization technique (IASTM) in addition to conventional treatment |
| conventional treatment | Placebo comparator | Other: 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). |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| integrated neuromuscular inhibition techniqueintegrated neuromuscular inhibition technique for gastrocniemus muscle | Other | integrated neuromuscular inhibition technique |
| instrument assissted soft tissue mobilizationinstrument assissted soft tissue mobilization for calf muscle | Other | instrument assisted soft tissue mobilization |
| convential treatmentconvential 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 | conventional treatment |
Primary outcome
general pain intensity
Time frame: change of general pain intensity through 4 weeks
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.
1 secondary outcome
pain intensity in morning initial step
Time frame: change of pain intensity in morning initial step through 4 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
Related trials for Planter Fasciitis
Active, not recruiting
Comparison of Platelet-Rich Plasma and Prolotherapy for Plantar Fasciitis
Planter Fasciitis
Recruiting
Cognitive Training for Pain , Balance and Foot Function in Plantar Fasciitis
Planter Fasciitis
Active, not recruiting
Navicular Mobilization in Patients of Planter Fasciitis
Planter Fasciitis, Navicular Bone
Not yet recruiting
Effect of Primal Reflex Release Technique on Pain and Function in Plantar Fasciitis Patients
Planter Fasciitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
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.