AzTrials
AzTrials

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.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

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.

menna ali mohammed tolba, B.sc. In Physicaltherapy contact

02201003654140

mennatolba89@gmail.com

About this study

  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. To compare effect of high power pain threshold ultrasound versus myofascial release technique on pain intensity in treating of chronic planter fasciitis patients.
  3. To compare effect of high power pain threshold ultrasound versus myofascial release technique on ankle disability function in treating of chronic planter fasciitis patients.
  4. 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.
  5. 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.

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 groups in NCT05827367
Study groupRoleWhat they receive
high power pain thershold ultrasoundExperimentalPatients will reseiv high power pain ultrasound ,intrinsic muscle strength and plantar fascia streatching
Receives: Device: Ultrasound; Other: Strength and stretching
myofascial releaseExperimentalPlantar 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 armPlacebo comparatorPlantar 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.

  1. 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)
  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.

  1. First posted25 Apr 2023
  2. Study startJul 2023 (estimated)
  3. Primary completionAug 2023 (estimated)
  4. Study completionSep 2023 (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
60 participants (estimated)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in