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Effect of Percussion Massage Gun on Hamstrings Flexibility.

Primary Purpose

Knee Osteoarthritis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Percussion massage gun
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

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

Inclusion Criteria: 1. Age - 40 years to 60 years patients of chronic knee OA (Culvenor et al., 2019). 2. Patients with BMI < 30 kg/m² (not being classified as obese) 3. Patients who are able to walk with painful knee OA without assistive devices. 4. Patients with knee pain intensity level at least >3 cm on a 10 cm VAS scale in activities such as going up-and downstairs, sitting and squatting. Exclusion Criteria: Radiated pain from low back pain. Patients with no radiographic evidence of knee OA or with mild OA (grade I according to K/L classification) or with severe OA (grade IV according to K/L classification). Loss of joint play in tibiofemoral and patellofemoral articulations. Lower extremity fracture and surgery or trauma to the knee joint. Neurological deficit or movement disorder related to lower limb. Those who were athletes or who had been treated with physiotherapy or medications during the previous 6 weeks -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    receive percussion massage gun and conventional physical therapy program

    receive conventional physical therapy program only for knee osteoarthrities

    Arm Description

    Outcomes

    Primary Outcome Measures

    hamstring flexibility
    measuring flexibility of hamstrings through sit and reach test and active knee extension

    Secondary Outcome Measures

    measuring pain
    through visual analogue scale .
    measuring Function
    through WOMAC questionnaire.

    Full Information

    First Posted
    July 30, 2023
    Last Updated
    August 4, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05988307
    Brief Title
    Effect of Percussion Massage Gun on Hamstrings Flexibility.
    Official Title
    Effect Of Percussion Massage Gun On Hamstrings Flexibility In Patients With Knee Osteoarthritis.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    May 1, 2024 (Anticipated)
    Study Completion Date
    June 2024 (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
    The purpose of this study would be to investigate: The effect of using percussion massage gun on Hamstring flexibility in patients with knee osteoarthritis. The effect of using percussion massage gun on pain in patients with knee osteoarthritis. The effect of using percussion massage gun on ROM in patients with knee osteoarthritis. The effect of using percussion massage gun on knee function in patients with knee osteoarthritis.
    Detailed Description
    Knee osteoarthritis (OA) is present in about 65% of people with knee pain aged 50 years or older. The condition is associated with knee pain and reduced function and those with progression of tibiofemoral OA. OA are at increased risk of both incidence and Approximately 11 percent of adults with knee osteoarthritis need help with personal care. Conservative treatment consists of medication and various forms of physiotherapy including heat, massage, electrotherapy and exercises.. The hamstring muscle group have tendency to shorten and the tightening results in increased patello-femoral compressive force, which may eventually lead to patello-femoral syndrome often associated with osteoarthritis . Percussion Therapy is a relatively new technique that uses a mechanical system, such as the massage gun, to provide percussion massage. The application of percussive massage gun activates the Golgi tendon organ, which triggers a relaxation response, improving circulation and nutrition to the tissue, and reducing tightness and improving flexibility, It also reduces pain perception through the pain gait theory process . Currently there are no evidence based clinical guidelines for the use of mechanical percussion devices. Further laboratory-based and clinical outcomes studies are needed to best guide clinical practice regarding these devices; however, research should also be informed based on how the devices are utilized by clinicians when providing care to patients. Understanding the knowledge and current trends in the use of mechanical percussion devices among health care professionals may help guide researchers in developing guidelines for research and/or practice. Thus, the purpose of this study was to document the knowledge, clinical application methods, and use of mechanical percussion devices.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    receive percussion massage gun and conventional physical therapy program
    Arm Type
    Experimental
    Arm Title
    receive conventional physical therapy program only for knee osteoarthrities
    Arm Type
    Other
    Intervention Type
    Device
    Intervention Name(s)
    Percussion massage gun
    Other Intervention Name(s)
    conventional physical therapy program
    Intervention Description
    Percussion massage gun on hamstrings flexibility in patients with knee Osteoarthritis.
    Primary Outcome Measure Information:
    Title
    hamstring flexibility
    Description
    measuring flexibility of hamstrings through sit and reach test and active knee extension
    Time Frame
    baseline (1 month )
    Secondary Outcome Measure Information:
    Title
    measuring pain
    Description
    through visual analogue scale .
    Time Frame
    baseline (1 month )
    Title
    measuring Function
    Description
    through WOMAC questionnaire.
    Time Frame
    baseline (1 month)

    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: 1. Age - 40 years to 60 years patients of chronic knee OA (Culvenor et al., 2019). 2. Patients with BMI < 30 kg/m² (not being classified as obese) 3. Patients who are able to walk with painful knee OA without assistive devices. 4. Patients with knee pain intensity level at least >3 cm on a 10 cm VAS scale in activities such as going up-and downstairs, sitting and squatting. Exclusion Criteria: Radiated pain from low back pain. Patients with no radiographic evidence of knee OA or with mild OA (grade I according to K/L classification) or with severe OA (grade IV according to K/L classification). Loss of joint play in tibiofemoral and patellofemoral articulations. Lower extremity fracture and surgery or trauma to the knee joint. Neurological deficit or movement disorder related to lower limb. Those who were athletes or who had been treated with physiotherapy or medications during the previous 6 weeks -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Heba Mohamed El-Berkawy, bachelor
    Phone
    1007955987
    Ext
    20
    Email
    hebaelberkawy2014@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Doaa raafat mohamed, PHD (lecturer)
    Phone
    1005591580
    Ext
    20
    Email
    doaa.rafat@pt.cu.edu.eg

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26066566
    Citation
    Alghadir A, Anwer S, Iqbal ZA, Alsanawi HA. Cross-cultural adaptation, reliability and validity of the Arabic version of the reduced Western Ontario and McMaster Universities Osteoarthritis index in patients with knee osteoarthritis. Disabil Rehabil. 2016;38(7):689-94. doi: 10.3109/09638288.2015.1055380. Epub 2015 Jun 11.
    Results Reference
    background
    Citation
    49. Lakhwani, M., & Phansopkar, P. (2021). Efficacy of Percussive Massage versus Calf Stretching on Pain, Range of Motion, Muscle Strength and Functional Outcomes in Patients with Plantar Fasciitis-A Research Protocol. Journal of Pharmaceutical Research International, 233(44B), 532-539.
    Results Reference
    background

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