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Shock Wave Therapy Versus Low Level Laser Therapy in Patients With Plantar Fasciitis

Primary Purpose

Plantar Fascitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
conventional therapy
shock wave therapy
low level laser therapy
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 low level laser therapy, shock wave therapy, stretching exercises

Eligibility Criteria

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

Inclusion Criteria: Age ranges from 40-60 years old. Both genders will be included. Unilateral plantar fasciitis. Duration of symptoms more than 4 weeks. Positive Windlass test and negative Tinel and calcaneus squeeze tests. Patients will be classified according to their BMI (18.5 - 24.9) kg/m2 Exclusion Criteria: Open wound, infection in plantar surface of foot. History of foot surgery. History of trauma or fracture in foot or ankle. Neuropathic pain as diabetes mellitus. Peripheral vascular disease. Calcaneal stress fracture or show evidence of a foreign body or tumor of the affected heel. Previously suffered a rupture or surgery of the plantar fascia. Existing or prior osteomyelitis of the involved calcaneus.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Control group

    Experimental group 1

    Experimental group 2

    Arm Description

    conventional physical therapy program (Instructions, Ice application, Deep tissue massage, Stretching exercises, Joint mobilization and isometric exercises).

    Shock wave therapy + Conventional physical therapy.

    Low level laser therapy + Conventional physical therapy.

    Outcomes

    Primary Outcome Measures

    Assess the change in pain intensity level
    The visual analogue scale (VAS) is a widely utilized pain intensity level assessment instrument in patients with plantar fasciitis. The visual analogue scale (VAS) is typically composed of a horizontal line from zero (minimum value) to 10 (maximum value) where zero signifies (no pain) and 10 signifies (worst pain) one can imagine.
    Assess the change in pain pressure threshold
    Pressure algometry will be used to evaluate the pain pressure threshold for the two predetermined locations on the affected leg: gastrocnemius (middle point over the muscle belly) and soleus (center point of the muscle belly 10 cm above the Achilles tendon). The participant will speak up at the point where the pressure evoke a painful sensation. This process will be repeated 3 times in the same manner, and three measurements will be recorded at the same point on the plantar fascia. An average of the three readings will be recorded. Higher algometer scores indicate greater pressure threshold, therefore less tenderness. Lower algometer scores indicate less pressure threshold, thus more tenderness.
    Assess the change in range of ankle motion
    Ankle range of motion (ROM) will be measured by using digital goniometer (ankle dorsiflexion and plantarflexion ranges will be measured). It can monitor the progress of intervention.
    Assess the change in foot functional disability
    Foot functional disability will be assessed by foot and ankle ability measure questionnaire (FAAM). Higher scores on the questionnaire indicate a higher level of physical functioning and lower scores on the questionnaire indicate a lower level of physical functioning.
    Assess the change in ankle stability
    The Human Assessment Computer (HUMAC) Balance System will be used in the current study to assess limits of stability of ankle joint.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 29, 2023
    Last Updated
    August 29, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05867888
    Brief Title
    Shock Wave Therapy Versus Low Level Laser Therapy in Patients With Plantar Fasciitis
    Official Title
    Effect of Shock Wave Therapy Versus Low Level Laser Therapy in Patients With Plantar Fasciitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    October 2023 (Anticipated)
    Study Completion Date
    November 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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Both shock wave therapy and low level laser therapy in plantar fasciitis are effective in improvement of such cases without any side effects but there are no previously published studies on the use of shock wave therapy versus low level laser therapy in plantar fasciitis and, hence, evidence of its acceptability and effectiveness compared with each other remains to be established.
    Detailed Description
    Plantar fasciitis is a result of degenerative irritation of the plantar fascia origin at the medial calcaneal tuberosity of the heel as well as the surrounding perifascial structures, it is a common problem accounting for approximately one million patient visits per year, it is often an overuse injury. As a result tight gastrocnemius, soleus, and/or other posterior leg muscles have also been commonly found in patients with this condition. Shock wave therapy is thought to provide long lasting analgesia and stimulate the healing process, Low level laser therapy has been used to relieve pain caused by plantar fasciitis, also stretching of the shortened and contracted plantar flexors may positively influence an individual's functional activities of daily living and decrease the risk of injury.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Plantar Fascitis
    Keywords
    low level laser therapy, shock wave therapy, stretching exercises

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    75 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    conventional physical therapy program (Instructions, Ice application, Deep tissue massage, Stretching exercises, Joint mobilization and isometric exercises).
    Arm Title
    Experimental group 1
    Arm Type
    Experimental
    Arm Description
    Shock wave therapy + Conventional physical therapy.
    Arm Title
    Experimental group 2
    Arm Type
    Experimental
    Arm Description
    Low level laser therapy + Conventional physical therapy.
    Intervention Type
    Other
    Intervention Name(s)
    conventional therapy
    Intervention Description
    conventional therapy ( instructions, ice application, deep tissue massage, stretching exercises, joint mobilization and isometric exercises )
    Intervention Type
    Other
    Intervention Name(s)
    shock wave therapy
    Intervention Description
    Acoustic waves (shock waves) that can carry energy and can propagate through tissues promote healing effects.
    Intervention Type
    Other
    Intervention Name(s)
    low level laser therapy
    Intervention Description
    The application of light to a biologic system to promote tissue regeneration, reduce inflammation and relieve pain.
    Primary Outcome Measure Information:
    Title
    Assess the change in pain intensity level
    Description
    The visual analogue scale (VAS) is a widely utilized pain intensity level assessment instrument in patients with plantar fasciitis. The visual analogue scale (VAS) is typically composed of a horizontal line from zero (minimum value) to 10 (maximum value) where zero signifies (no pain) and 10 signifies (worst pain) one can imagine.
    Time Frame
    Before treatment and after 6 weeks treatment
    Title
    Assess the change in pain pressure threshold
    Description
    Pressure algometry will be used to evaluate the pain pressure threshold for the two predetermined locations on the affected leg: gastrocnemius (middle point over the muscle belly) and soleus (center point of the muscle belly 10 cm above the Achilles tendon). The participant will speak up at the point where the pressure evoke a painful sensation. This process will be repeated 3 times in the same manner, and three measurements will be recorded at the same point on the plantar fascia. An average of the three readings will be recorded. Higher algometer scores indicate greater pressure threshold, therefore less tenderness. Lower algometer scores indicate less pressure threshold, thus more tenderness.
    Time Frame
    Before treatment and after 6 weeks treatment
    Title
    Assess the change in range of ankle motion
    Description
    Ankle range of motion (ROM) will be measured by using digital goniometer (ankle dorsiflexion and plantarflexion ranges will be measured). It can monitor the progress of intervention.
    Time Frame
    Before treatment and after 6 weeks treatment
    Title
    Assess the change in foot functional disability
    Description
    Foot functional disability will be assessed by foot and ankle ability measure questionnaire (FAAM). Higher scores on the questionnaire indicate a higher level of physical functioning and lower scores on the questionnaire indicate a lower level of physical functioning.
    Time Frame
    Before treatment and after 6 weeks treatment
    Title
    Assess the change in ankle stability
    Description
    The Human Assessment Computer (HUMAC) Balance System will be used in the current study to assess limits of stability of ankle joint.
    Time Frame
    Before treatment and after 6 weeks treatment

    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: Age ranges from 40-60 years old. Both genders will be included. Unilateral plantar fasciitis. Duration of symptoms more than 4 weeks. Positive Windlass test and negative Tinel and calcaneus squeeze tests. Patients will be classified according to their BMI (18.5 - 24.9) kg/m2 Exclusion Criteria: Open wound, infection in plantar surface of foot. History of foot surgery. History of trauma or fracture in foot or ankle. Neuropathic pain as diabetes mellitus. Peripheral vascular disease. Calcaneal stress fracture or show evidence of a foreign body or tumor of the affected heel. Previously suffered a rupture or surgery of the plantar fascia. Existing or prior osteomyelitis of the involved calcaneus.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Reham M Lotfy, Msc
    Phone
    01063251724
    Email
    mnabilbebo@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fatma S Amin, Professor
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Rania N Karkousha, Ass.prof
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Mohamed I Abd Elhay, Lecturer
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Ashraf N Moharram, Professor
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Shock Wave Therapy Versus Low Level Laser Therapy in Patients With Plantar Fasciitis

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