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High-power Pain Thershold Ultrasound Versus Myofascial Release in Patients With Chronic Plantar Fasciitis

Primary Purpose

Plantar Fascitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound
Myofascial release technique
Strength and stretching
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fascitis focused on measuring high power pain thershold ultrasound, Planter fasciitis, Myofascial release

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    high power pain thershold ultrasound

    myofascial release

    control arm

    Arm Description

    Patients will reseiv high power pain ultrasound ,intrinsic muscle strength and plantar fascia streatching

    Plantar fascia myofascial release,gastrocnmias Myofascial release ,soluse myofascial release,foot interstice muscle strength and plantar fascia streatching

    Plantar fascia stretching and foot interstice muscle strength

    Outcomes

    Primary Outcome Measures

    pain pressure threshold
    pain pressure threshold over the medial calcaneal tuberosity of the involved heel will be measured by pressure algometer.

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    February 27, 2023
    Last Updated
    May 1, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05827367
    Brief Title
    High-power Pain Thershold Ultrasound Versus Myofascial Release in Patients With Chronic Plantar Fasciitis
    Official Title
    High-power Pain Thershold Ultrasound Versus Myofascial Release in Patients With Chronic Plantar Fasciitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    August 2023 (Anticipated)
    Study Completion Date
    September 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Plantar Fascitis
    Keywords
    high power pain thershold ultrasound, Planter fasciitis, Myofascial release

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    high power pain thershold ultrasound
    Arm Type
    Experimental
    Arm Description
    Patients will reseiv high power pain ultrasound ,intrinsic muscle strength and plantar fascia streatching
    Arm Title
    myofascial release
    Arm Type
    Experimental
    Arm Description
    Plantar fascia myofascial release,gastrocnmias Myofascial release ,soluse myofascial release,foot interstice muscle strength and plantar fascia streatching
    Arm Title
    control arm
    Arm Type
    Placebo Comparator
    Arm Description
    Plantar fascia stretching and foot interstice muscle strength
    Intervention Type
    Device
    Intervention Name(s)
    Ultrasound
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Myofascial release technique
    Intervention Description
    Plantar fascia myofascial release Soluse muscle myofascial release Gastrocnmias muscle myofascial release
    Intervention Type
    Other
    Intervention Name(s)
    Strength and stretching
    Intervention Description
    Plantar fascia stretching Interstice foot muscles strengthing
    Primary Outcome Measure Information:
    Title
    pain pressure threshold
    Description
    pain pressure threshold over the medial calcaneal tuberosity of the involved heel will be measured by pressure algometer.
    Time Frame
    Change at pain pressure thershold through 4 weeks
    Secondary Outcome Measure Information:
    Title
    Pain intensity at first step after prolonged setting
    Description
    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
    Time Frame
    Change at pain intensity through 4 weeks
    Other Pre-specified Outcome Measures:
    Title
    Disability function of ankle joint
    Description
    Disability function of ankle joint will be measured by Arabic version of foot function index scale.that consist of 23 question each one score range from 0 it mean no pain to 10 that means worst pain
    Time Frame
    Change at disability function of ankle through 4 weeks
    Title
    Ankle joint dorsi flexion
    Description
    Ankle joint dorsi flexion will be measured by manual goniometer
    Time Frame
    Change at ankle dorsi flexion through 4 weeks
    Title
    Walk endurance
    Description
    Walk endurance will be measured by 6-min walk test
    Time Frame
    Change at walk endurance through 4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    menna ali mohammed tolba, B.sc. In Physicaltherapy
    Phone
    02201003654140
    Email
    mennatolba89@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    doaa rafat, Lecturer
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    amaal hassan, Professor
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    mohammed kaddah, Professor
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    High-power Pain Thershold Ultrasound Versus Myofascial Release in Patients With Chronic Plantar Fasciitis

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