Plantar FascitisNCT05827367
High-power Pain Thershold Ultrasound Versus Myofascial Release in Patients With Chronic Plantar Fasciitis
A study testing Ultrasound, Myofascial release technique and Strength and stretching in people with Plantar Fascitis, run by Cairo University.
Trial summary
1. To compare effect of high power pain threshold ultrasound versus myofascial release technique on pain pressure threshold over the medial calcaneal tuberosity of the involved heel in treating of chronic planter fasciitis patients 2. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- Ultrasound, Myofascial release technique and Strength and stretching
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Sep 2023
- 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
- Patients with history of plantar fasciitis more than three months ago
- Patient's age ranged between 40-60 years old
- Patients with body mass index (MBI)<30kg/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 disorders
Trial locations and contacts
No sites are listed yet.
About this study
- To compare effect of high power pain threshold ultrasound versus myofascial release technique on pain pressure threshold over the medial calcaneal tuberosity of the involved heel in treating of chronic planter fasciitis patients
- To compare effect of high power pain threshold ultrasound versus myofascial release technique on pain intensity in treating of chronic planter fasciitis patients.
- To compare effect of high power pain threshold ultrasound versus myofascial release technique on ankle disability function in treating of chronic planter fasciitis patients.
- To compare effect of high power pain threshold ultrasound versus myofascial release technique on ankle active dorsiflexion range of motionin treating of chronic planter fasciitis patients.
- To compare effect of high power pain threshold ultrasound versus myofascial release technique on walk endurance. In treating of chronic planter fasciitis patients.
Read the detailed description
Plantar fasciitis (PF) is The most common cause of plantar heel pain(PHP) is a degeneration of the plantar fascia as a result of repetitive micro tears of the fascia that lead to an inflammatory reaction, and is not a primary inflammatory process that most believe it to be the cause of plantar fasciitis is unknown but is believed to be multifactorial, with abnormal biomechanics. It is the most common cause of heel pain about 4% to 7% of the population suffer from it. There are many risk factors for plantar fasciitis include excessive foot pronation or flat feet (pesplanus), high arches (pescavus), tight Achilles tendon or gastrocnemius muscle (equinus), tight intrinsic foot muscles, limb length discrepancy, obesity, running, prolonged standing or walking, poor-fitting shoes, and improper gait. Many patients complain of heel pain in the morning or after rising from prolonged sitting, with relief upon initiation of movement. Physical examination will reveal pain to palpation of the medial plantar calcaneal region, pain with dorsiflexion, and tightness of the Achilles tendon or the gastrocnemius muscle ,.
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.
The high-power pain threshold ultrasound (HPPTUS) technique is one of the therapeutic ultrasound modifications used to treat myofascial pain syndrome.
HPPTUS is considered as an effective treatment for Myofascial pain syndrome which be applied in continuous mode with intensity from 0.5 to 2 watt/cm to elicit pain threshold the US probe was kept motionless, and the intensity progressively increased until the maximum level of pain patient can endure was selected, it was maintained on this level for 3 to 4 seconds and then decreased to half intensity for 15 seconds the treatment process was repeated three times.
performed clinical study to compare (HPPTUS) technique with the traditional ultrasound technique in patients with myofascial pain syndrome. The results showed that HPPTUS was much more effective than the traditional technique, pain reduction and improvement of range of motion (ROM) were significant in a smaller number of sessions.
Myofascial release (MFR) is the application of a low load, long duration stretch to the myofascial complex, intended to restore optimal length, decrease pain, and improve function .MFR effect on (PF) by decreasing in tension over the plantar fascia and decrease of risk factors, such as tightness of the gastrocnemii and soleus muscles and restricted ankle dorsiflexion Several treatment methods are available to relieve symptoms associated with plantar fasciitis. These include stretching, manual therapy, dry needling, shockwave therapy, physical agents (electrotherapy, low-level laser therapy, phonophoresis, and ultrasound), lifestyle counseling, anti-inflammatory injections, and mechanical treatments such as taping, rocker shoes, and ankle-foot orthoses including night splints. Mechanical treatments are promising due to the low risk of complications, good accessibility, and high capacity to relieve the mechanical load on the plantar fascia during functional tasks of daily life. The effectiveness of mechanical treatment on plantar fasciitis has previously been investigated.
- Conditions
- Plantar Fascitis
- Being tested
- Ultrasound, Myofascial release technique, Strength and stretching
- Keywords
- high power pain thershold ultrasound, Planter fasciitis, Myofascial release
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
The high-power pain threshold ultrasound (HPPTUS) In this technique, "which be applied in continuous mode with intensity from t0.5 to 2 watt/cm to elicit pain threshold the US probe was kept motionless, and the intensity progressively increased until the maximum level of pain patient can endure was selected, it was maintained on this level for 3 to 4 seconds and then decreased to half intensity for 15 seconds the treatment process was repeated three times.
Myofascial release techniqueOther
Plantar fascia myofascial release Soluse muscle myofascial release Gastrocnmias muscle myofascial release
Strength and stretchingOther
Plantar fascia stretching Interstice foot muscles strengthing
| Study group | Role | What they receive |
|---|---|---|
| high power pain thershold ultrasound | Experimental | Patients will reseiv high power pain ultrasound
,intrinsic muscle strength and plantar fascia streatching Receives: Device: Ultrasound; Other: Strength and stretching |
| myofascial release | Experimental | Plantar fascia myofascial release,gastrocnmias Myofascial release ,soluse myofascial release,foot interstice muscle strength and plantar fascia streatching Receives: Other: Myofascial release technique; Other: Strength and stretching |
| control arm | Placebo comparator | Plantar fascia stretching and foot interstice muscle strength Receives: Other: Strength and stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain pressure threshold
pain pressure threshold over the medial calcaneal tuberosity of the involved heel will be measured by pressure algometer.
Measured: Change at pain pressure thershold through 4 weeks
Secondary outcomes (1)
Pain intensity at first step after prolonged setting
Pain intensity at first step after prolonged setting will be measured by numerical pain rating scale it rang from 0 that means no pain and 10 that means the worst pain ever
Measured: Change at pain intensity 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 posted25 Apr 2023
- Study startJul 2023 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FascitisStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menna Ali mohammed tolba, Cairo University
- Investigators
- doaa rafat, Lecturer, Study director, Cairo Universityamaal hassan, Professor, Study director, Cairo Universitymohammed kaddah, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827367
- Sponsor's protocol ID
- HPPTUS versus MFR IN PF
- Status last verified
- May 2023
- First submitted
- 27 Feb 2023
- Last updated
- 3 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-power Pain Thershold Ultrasound Versus Myofascial Release in Patients With Chronic Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT05827367
- Acronym / sponsor ID
- HPPTUS versus MFR IN PF
- Conditions
- Plantar Fascitis
- Keywords
- high power pain thershold ultrasound, Planter fasciitis, Myofascial release
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 25 Apr 2023 (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 compare effect of high power pain threshold ultrasound versus myofascial release technique on pain pressure threshold over the medial calcaneal tuberosity of the involved heel in treating of chronic planter fasciitis patients
- To compare effect of high power pain threshold ultrasound versus myofascial release technique on pain intensity in treating of chronic planter fasciitis patients.
- To compare effect of high power pain threshold ultrasound versus myofascial release technique on ankle disability function in treating of chronic planter fasciitis patients.
- To compare effect of high power pain threshold ultrasound versus myofascial release technique on ankle active dorsiflexion range of motionin treating of chronic planter fasciitis patients.
- To compare effect of high power pain threshold ultrasound versus myofascial release technique on walk endurance. In treating of chronic planter fasciitis patients.
Detailed description
Plantar fasciitis (PF) is The most common cause of plantar heel pain(PHP) is a degeneration of the plantar fascia as a result of repetitive micro tears of the fascia that lead to an inflammatory reaction, and is not a primary inflammatory process that most believe it to be the cause of plantar fasciitis is unknown but is believed to be multifactorial, with abnormal biomechanics. It is the most common cause of heel pain about 4% to 7% of the population suffer from it. There are many risk factors for plantar fasciitis include excessive foot pronation or flat feet (pesplanus), high arches (pescavus), tight Achilles tendon or gastrocnemius muscle (equinus), tight intrinsic foot muscles, limb length discrepancy, obesity, running, prolonged standing or walking, poor-fitting shoes, and improper gait. Many patients complain of heel pain in the morning or after rising from prolonged sitting, with relief upon initiation of movement. Physical examination will reveal pain to palpation of the medial plantar calcaneal region, pain with dorsiflexion, and tightness of the Achilles tendon or the gastrocnemius muscle ,.
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.
The high-power pain threshold ultrasound (HPPTUS) technique is one of the therapeutic ultrasound modifications used to treat myofascial pain syndrome.
HPPTUS is considered as an effective treatment for Myofascial pain syndrome which be applied in continuous mode with intensity from 0.5 to 2 watt/cm to elicit pain threshold the US probe was kept motionless, and the intensity progressively increased until the maximum level of pain patient can endure was selected, it was maintained on this level for 3 to 4 seconds and then decreased to half intensity for 15 seconds the treatment process was repeated three times.
performed clinical study to compare (HPPTUS) technique with the traditional ultrasound technique in patients with myofascial pain syndrome. The results showed that HPPTUS was much more effective than the traditional technique, pain reduction and improvement of range of motion (ROM) were significant in a smaller number of sessions.
Myofascial release (MFR) is the application of a low load, long duration stretch to the myofascial complex, intended to restore optimal length, decrease pain, and improve function .MFR effect on (PF) by decreasing in tension over the plantar fascia and decrease of risk factors, such as tightness of the gastrocnemii and soleus muscles and restricted ankle dorsiflexion Several treatment methods are available to relieve symptoms associated with plantar fasciitis. These include stretching, manual therapy, dry needling, shockwave therapy, physical agents (electrotherapy, low-level laser therapy, phonophoresis, and ultrasound), lifestyle counseling, anti-inflammatory injections, and mechanical treatments such as taping, rocker shoes, and ankle-foot orthoses including night splints. Mechanical treatments are promising due to the low risk of complications, good accessibility, and high capacity to relieve the mechanical load on the plantar fascia during functional tasks of daily life. The effectiveness of mechanical treatment on plantar fasciitis has previously been investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| high power pain thershold ultrasound | Experimental | Device: Ultrasound, Other: Strength and stretchingPatients will reseiv high power pain ultrasound ,intrinsic muscle strength and plantar fascia streatching |
| myofascial release | Experimental | Other: Myofascial release technique, Other: Strength and stretchingPlantar fascia myofascial release,gastrocnmias Myofascial release ,soluse myofascial release,foot interstice muscle strength and plantar fascia streatching |
| control arm | Placebo comparator | Other: Strength and stretchingPlantar fascia stretching and foot interstice muscle strength |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with history of plantar fasciitis more than three months ago
- Patient's age ranged between 40-60 years old
- Patients with body mass index (MBI)<30kg/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 disorders
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 |
|---|---|---|
| UltrasoundThe high-power pain threshold ultrasound (HPPTUS) In this technique, "which be applied in continuous mode with intensity from t0.5 to 2 watt/cm to elicit pain threshold the US probe was kept motionless, and the intensity progressively increased until the maximum level of pain patient can endure was selected, it was maintained on this level for 3 to 4 seconds and then decreased to half intensity for 15 seconds the treatment process was repeated three times. | Device | high power pain thershold ultrasound |
| Myofascial release techniquePlantar fascia myofascial release Soluse muscle myofascial release Gastrocnmias muscle myofascial release | Other | myofascial release |
| Strength and stretchingPlantar fascia stretching Interstice foot muscles strengthing | Other | control arm, high power pain thershold ultrasound, myofascial release |
Primary outcome
pain pressure threshold
Time frame: Change at pain pressure thershold through 4 weeks
pain pressure threshold over the medial calcaneal tuberosity of the involved heel will be measured by pressure algometer.
1 secondary outcome
Pain intensity at first step after prolonged setting
Time frame: Change at pain intensity 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 3 May 2023.
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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
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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.
doaa rafat, Lecturer study director
Cairo University
amaal hassan, Professor study director
Cairo University
mohammed kaddah, Professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound, Myofascial release technique and Strength and stretching in people with Plantar Fascitis, 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 3 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 3 May 2023. 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 menna ali mohammed tolba, B.sc. In Physicaltherapy (02201003654140, mennatolba89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain pressure threshold (time frame: Change at pain pressure thershold 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 3 May 2023.