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Effect of Shockwave Versus LLL Therapy on Sacroiliac Joint Pain in Postnatal Women

Primary Purpose

Sacroiliac Joint Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Shockwave
Sponsored by
Samar Mimi Mohamed Okby
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sacroiliac Joint Pain

Eligibility Criteria

25 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • postnatal women suffering from sacroiliac joint pain for at least 3 months.
  • They should have moderate to severe pain .
  • They should have positive findings in at least 3 of 5 provocation sacroiliac joint tests

Exclusion Criteria:

  • lumber or hip joint pathology
  • Acute pelvic bacterial or viral infection .
  • Receiving corticosteroid injections within the previous 6 weeks

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    shock wave group

    low level laser group

    Arm Description

    Group A will receive shockwave therapy 2 session per week for 6 weeks

    Group B will receive low level laser therapy 2 session per week for 6 weeks

    Outcomes

    Primary Outcome Measures

    Sacroiliac joint pain
    •Pain intensity: it will by measure by VAS it's presented as 10 cm horizontal line on which the patient pain intensity is point between no pain at zero score to extreme pain at 10 score .
    Functional disability
    •Functional disability :it will be measure by oswestry disability index it is 10 point Patient reported outcome questionnaire which the higher score mean its the worst and the low score mean its the better outcome.
    Pain pressure threshold
    •Pain pressure threshold : it will be measure by a device Called pressure algometry

    Secondary Outcome Measures

    Full Information

    First Posted
    July 14, 2021
    Last Updated
    November 20, 2021
    Sponsor
    Samar Mimi Mohamed Okby
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05015413
    Brief Title
    Effect of Shockwave Versus LLL Therapy on Sacroiliac Joint Pain in Postnatal Women
    Official Title
    Effect of Shockwave Versus Low Level Laser Therapy on Sacroiliac Joint Pain in Postnatal Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 25, 2021 (Anticipated)
    Primary Completion Date
    December 3, 2021 (Anticipated)
    Study Completion Date
    December 29, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Samar Mimi Mohamed Okby

    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
    Sacroiliac joint pain is the most causes of back pain In pregnancy caused ligament laxity in sacroiliac joint so cause pain and this pain continue after natal Shock wave is new conservative treatment used in physical therapy Shock wave is most effective for sacroiliac joint pain Low level laser is a most effective pain relive and effective on sacroiliac joint pain
    Detailed Description
    The study is to determine if there is any difference between the effect of shockwave and low level laser therapy on sacroiliac joint pain in postnatal women This study will be randomly distributed into two equal group Group A consisted of 25 postpartum women complaining from sacroiliac joint pain . They will receive shockwave therapy 2 session per week for 6 weeks Group B consisted of 25 postpartum women complaining from sacroiliac joint pain . They will receive low level laser therapy 2 session per week for 6 weeks Evaluation procedures History taking recording in recording data sheet Weight and height measurement by calculate BMI Disability assessment by OWDI Pain assessment by VAS scale Assessment of pressure of pain threshold by pressure algometry

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sacroiliac Joint Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Group A will receive shock wave therapy Group B will receive low level laser therapy
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    shock wave group
    Arm Type
    Experimental
    Arm Description
    Group A will receive shockwave therapy 2 session per week for 6 weeks
    Arm Title
    low level laser group
    Arm Type
    Experimental
    Arm Description
    Group B will receive low level laser therapy 2 session per week for 6 weeks
    Intervention Type
    Device
    Intervention Name(s)
    Shockwave
    Intervention Description
    Shock wave master 500 Germany
    Primary Outcome Measure Information:
    Title
    Sacroiliac joint pain
    Description
    •Pain intensity: it will by measure by VAS it's presented as 10 cm horizontal line on which the patient pain intensity is point between no pain at zero score to extreme pain at 10 score .
    Time Frame
    About two months
    Title
    Functional disability
    Description
    •Functional disability :it will be measure by oswestry disability index it is 10 point Patient reported outcome questionnaire which the higher score mean its the worst and the low score mean its the better outcome.
    Time Frame
    About 2 month
    Title
    Pain pressure threshold
    Description
    •Pain pressure threshold : it will be measure by a device Called pressure algometry
    Time Frame
    About 2 month

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Postnatal women
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: postnatal women suffering from sacroiliac joint pain for at least 3 months. They should have moderate to severe pain . They should have positive findings in at least 3 of 5 provocation sacroiliac joint tests Exclusion Criteria: lumber or hip joint pathology Acute pelvic bacterial or viral infection . Receiving corticosteroid injections within the previous 6 weeks
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Manal Ahmed El shafei, Doctoral
    Phone
    201220664518
    Email
    Manalpt1989@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Effect of Shockwave Versus LLL Therapy on Sacroiliac Joint Pain in Postnatal Women

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