Plantar FasciitisHILT - HPPTUSNCT07462169
High Intensity Laser VS High Power Pain Threshold Ultrasound in Treatment of Plantar Fasciitis
A study testing High intensity laser therapy, High power pain threshold ultrasound and Conventional treatment in people with Plantar Fasciitis, run by Cairo University at 2 sites in Egypt.
Trial summary
The purpose of the study is to 1. Investigate the Effect of High-intensity laser therapy versus High power pain threshold ultrasound on pain level in patients with plantar fasciitis. 2. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- High intensity laser therapy, High power pain threshold ultrasound and Conventional treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesEgypt
- Study dates
- 10 Mar 2026to 10 Jun 2026
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patient age ranged from 30 to 60 years.
- Plantar heel pain lasting for at least one month, mainly during the first few steps upon rising in the morning, which worsens with increased weight-bearing activity through the day.
- Tenderness at the insertion site of the plantar fascia on the calcaneus.
- Body mass index (MBI) <30 kg/m2
Who cannot join
- Medical red flag history (such as tumor, fracture, heterotrophic ossification, and acute inflammatory disease in the ankle-foot area.
- If the patient has history of recent trauma or foot surgery.
- Wounds, infections in the treatment area.
- Subjects with referred pain from sciatica and other neurological disorders.
- History of corticosteroid injection in the last 6 months.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Outpatient clinic of Faculty of Physical Therapy Benha National University.
Banhā
Faculty of Physical Therapy Benha National University.
Cairo
About this study
Official title: High Intensity Laser Versus High Power Pain Threshold Ultrasound in Treatment of Plantar Fasciitis
The purpose of the study is to
- Investigate the Effect of High-intensity laser therapy versus High power pain threshold ultrasound on pain level in patients with plantar fasciitis.
- Investigate the Effect of High intensity laser therapy versus High power pain threshold ultrasound on ROM in patients with plantar fasciitis.
Read the detailed description
Plantar fasciitis (PF) is one of the most prevalent musculoskeletal disorders of the foot, affecting individuals across different age groups and activity levels. It is clinically characterized by localized pain at the medial aspect of the heel, typically exacerbated during weight-bearing activities, with marked intensity upon the first steps in the morning or following periods of prolonged rest or non-weight bearing. Persistent symptoms may significantly impair functional mobility and quality of life.
Among contemporary conservative management strategies, laser therapy has emerged as a promising non-invasive modality for PF treatment. Recently, High-Intensity Laser Therapy (HILT) has been introduced as an advanced therapeutic option. Due to its high peak power and deeper tissue penetration capability, HILT can effectively stimulate large and deep fascial structures, potentially enhancing tissue repair, modulating inflammation, and reducing pain perception.
High-Power Pain Threshold Ultrasound (HPPTUS) represents a modified therapeutic ultrasound technique that delivers energy at intensities approaching the patient's pain threshold. This approach aims to maximize deep tissue stimulation while maintaining patient tolerance. HPPTUS has demonstrated superior clinical outcomes compared to conventional ultrasound techniques, particularly in the management of myofascial pain syndrome, with significant reductions in pain intensity and improvements in range of motion (ROM) achieved within fewer treatment sessions.
The study aims to Investigate the Effect of High intensity laser therapy versus High power pain threshold ultrasound in the treatment of plantar fasciitis.
- Conditions
- Plantar Fasciitis
- Being tested
- High intensity laser therapy, High power pain threshold ultrasound, Conventional treatment
- Keywords
- High power pain Threshold Ultrasound, High Intensity Laser therapy, plantar fasciitis (PF), HILT
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity laser therapyDevice
This group consists of 20 subjects will receive conventional treatment combined with High-intensity laser therapy, three times per week for one month
High power pain threshold ultrasoundDevice
this group consists of 20 subjects will receive conventional treatment combined with high power pain threshold ultrasound , three times per week for one month
Conventional treatmentOther
this group consists of 20 subjects will receive conventional treatment only, three times per week for one month
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 → High intensity laser therapy | Experimental | High Intensity Laser therapy this group consists of 20 subjects will receive conventional treatment combined with High-intensity laser therapy, three times per week for one month Receives: Device: High intensity laser therapy; Other: Conventional treatment |
| Arm 2 → High power pain threshold ultrasound | Experimental | High power pain threshold ultrasound this group consists of 20 subjects will receive conventional treatment combined with high power pain threshold ultrasound , three times per week for one month Receives: Device: High power pain threshold ultrasound; Other: Conventional treatment |
| Arm 3 → Conventional treatment | Active comparator | conventional treatment this group consists of 20 subjects will receive conventional treatment only, three times per week for one month
Interventions:
Conventional treatment Receives: Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of change of pain intensity
The Visual Analog Scale is a self-reported pain measurement scale with a 10-cm line labeling extreme pain levels. It is valid, reliable, and suitable for clinical practice. Studies have shown moderate to strong correlations for VAS validity in pain measurement.
Measured: At baseline and after 4 weeks of intervention
Secondary outcomes (3)
Assessment of change of pressure pain threshold
A pressure algometer is a reliable tool for determining local pressure pain threshold (PPT) in different pain syndromes. It is a force gauge calibrated in kg/cm2 and has a range of 0-10 kg/cm2. A manual pressure algometer will be used to measure pain threshold for heel, with repeated measurements to improve reliability.
Measured: At baseline and after 4 weeks of intervention
Assessment of change of Ankle Range of motion
Electronic goniometer will be used to differentiate changes in ROM. Electronic goniometer was used to evaluated ankle ROM in dorsiflexion and plantar flexion.
Measured: At baseline and after 4 weeks of Intervention
Assessment of foot pain and Functional Disability
The Foot Function Index (FFI) is a validated questionnaire used to evaluate foot pain and functional disability. It includes 23 items assessing pain, disability, and activity limitation. Each item is rated on a scale from 0 to 10, with higher scores indicating greater pain and functional limitation.
Measured: At baseline and after 4 weeks of Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start10 Mar 2026
- Primary completion5 May 2026
- Study completion10 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Khaled Attia Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462169
- Sponsor's protocol ID
- P.T.REC/012/006276
- Acronym
- HILT - HPPTUS
- Status last verified
- Jun 2026
- First submitted
- 5 Mar 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Laser Versus High Power Pain Threshold Ultrasound in Treatment of Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT07462169
- Acronym / sponsor ID
- HILT - HPPTUS / P.T.REC/012/006276
- Conditions
- Plantar Fasciitis
- Keywords
- High power pain Threshold Ultrasound, High Intensity Laser therapy, plantar fasciitis (PF), HILT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 5 May 2026 (actual)
- Study completion
- 10 Jun 2026 (actual)
- First posted
- 10 Mar 2026 (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.
The purpose of the study is to
- Investigate the Effect of High-intensity laser therapy versus High power pain threshold ultrasound on pain level in patients with plantar fasciitis.
- Investigate the Effect of High intensity laser therapy versus High power pain threshold ultrasound on ROM in patients with plantar fasciitis.
Detailed description
Plantar fasciitis (PF) is one of the most prevalent musculoskeletal disorders of the foot, affecting individuals across different age groups and activity levels. It is clinically characterized by localized pain at the medial aspect of the heel, typically exacerbated during weight-bearing activities, with marked intensity upon the first steps in the morning or following periods of prolonged rest or non-weight bearing. Persistent symptoms may significantly impair functional mobility and quality of life.
Among contemporary conservative management strategies, laser therapy has emerged as a promising non-invasive modality for PF treatment. Recently, High-Intensity Laser Therapy (HILT) has been introduced as an advanced therapeutic option. Due to its high peak power and deeper tissue penetration capability, HILT can effectively stimulate large and deep fascial structures, potentially enhancing tissue repair, modulating inflammation, and reducing pain perception.
High-Power Pain Threshold Ultrasound (HPPTUS) represents a modified therapeutic ultrasound technique that delivers energy at intensities approaching the patient's pain threshold. This approach aims to maximize deep tissue stimulation while maintaining patient tolerance. HPPTUS has demonstrated superior clinical outcomes compared to conventional ultrasound techniques, particularly in the management of myofascial pain syndrome, with significant reductions in pain intensity and improvements in range of motion (ROM) achieved within fewer treatment sessions.
The study aims to Investigate the Effect of High intensity laser therapy versus High power pain threshold ultrasound in the treatment of plantar fasciitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 → High intensity laser therapy | Experimental | Device: High intensity laser therapy, Other: Conventional treatmentHigh Intensity Laser therapy this group consists of 20 subjects will receive conventional treatment combined with High-intensity laser therapy, three times per week for one month |
| Arm 2 → High power pain threshold ultrasound | Experimental | Device: High power pain threshold ultrasound, Other: Conventional treatmentHigh power pain threshold ultrasound this group consists of 20 subjects will receive conventional treatment combined with high power pain threshold ultrasound , three times per week for one month |
| Arm 3 → Conventional treatment | Active comparator | Other: Conventional treatmentconventional treatment this group consists of 20 subjects will receive conventional treatment only, three times per week for one month Interventions: Conventional treatment |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The patient age ranged from 30 to 60 years.
- Plantar heel pain lasting for at least one month, mainly during the first few steps upon rising in the morning, which worsens with increased weight-bearing activity through the day.
- Tenderness at the insertion site of the plantar fascia on the calcaneus.
- Body mass index (MBI) <30 kg/m2
Key exclusion criteria (5 listed)
- Medical red flag history (such as tumor, fracture, heterotrophic ossification, and acute inflammatory disease in the ankle-foot area.
- If the patient has history of recent trauma or foot surgery.
- Wounds, infections in the treatment area.
- Subjects with referred pain from sciatica and other neurological disorders.
- History of corticosteroid injection in the last 6 months.
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 |
|---|---|---|
| High intensity laser therapyThis group consists of 20 subjects will receive conventional treatment combined with High-intensity laser therapy, three times per week for one month | Device | Arm 1 → High intensity laser therapy |
| High power pain threshold ultrasoundthis group consists of 20 subjects will receive conventional treatment combined with high power pain threshold ultrasound , three times per week for one month | Device | Arm 2 → High power pain threshold ultrasound |
| Conventional treatmentthis group consists of 20 subjects will receive conventional treatment only, three times per week for one month | Other | Arm 1 → High intensity laser therapy, Arm 2 → High power pain threshold ultrasound, Arm 3 → Conventional treatment |
Primary outcome
Assessment of change of pain intensity
Time frame: At baseline and after 4 weeks of intervention
The Visual Analog Scale is a self-reported pain measurement scale with a 10-cm line labeling extreme pain levels. It is valid, reliable, and suitable for clinical practice. Studies have shown moderate to strong correlations for VAS validity in pain measurement.
3 secondary outcomes
Assessment of change of pressure pain threshold
Time frame: At baseline and after 4 weeks of intervention
Assessment of change of Ankle Range of motion
Time frame: At baseline and after 4 weeks of Intervention
Assessment of foot pain and Functional Disability
Time frame: At baseline and after 4 weeks of Intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Plantar Fasciitis
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Active Release Technique vs. Dynamic Soft Tissue Mobilization for Plantar Pain
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Hip Muscle Strengthening and Calf Myofascial Release in Females With Chronic Plantar Fasciitis
Chronic Planter Fascitis
Recruiting
F-18 Sodium Fluoride PET/CT-Guided Pain Palliation in Chronic Plantar Fasciitis: A Comparative Study of ¹⁷⁷Lutetium-Corticosteroid-Local Anaesthetic Injection vs Corticosteroid-Local Anaesthetic Injection
Plantar Fascitis, Chronic Heel Pain
Not yet recruiting
Radial vs Focused Shockwave Therapy for Plantar Fasciitis
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity laser therapy, High power pain threshold ultrasound and Conventional treatment in people with Plantar Fasciitis, run by Cairo University at 2 sites in Egypt.
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 5 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: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of change of pain intensity (time frame: At baseline and after 4 weeks of intervention). 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 24 Jun 2026.