search
Back to results

The Immediate Effect Of Shockwave Therapy On the Quadratus Lumborum (QL) Muscle Trigger Points vs Regular Back Exercises in Chronic Nonspecific Low Back Pain

Primary Purpose

Low Back Pain, Mechanical

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
shockwave machine
leg and back exercises
shockwave and exercises
Sponsored by
University of Sharjah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain, Mechanical

Eligibility Criteria

20 Years - 40 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Only male patients will be included.
  • Age 20-40 years old.
  • Non-specific LBP for at least 3 months.
  • At least one local tenderness or active trigger point in the anatomical region of the QL muscle.
  • Pain intensity on numerical pain scale should be more than 4

Exclusion Criteria:

  • LBP due to a pathology or trauma.
  • Below 20 years of age.
  • Previous lumbar surgeries.
  • Malignancy.
  • Patients under medications or painkillers.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    shockwave group

    exercise group

    combined group

    Arm Description

    Outcomes

    Primary Outcome Measures

    pressure-pain threshold
    Algometry device will be used to measure three thresholds' values: Tenderness threshold. Referred pain threshold. Pain tolerance threshold.
    The Oswestry Disability Index
    is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability, scoring from 0 to 50, the lower score the better
    Numerical pain scale
    0-10 the lower the better

    Secondary Outcome Measures

    ROM of the back
    an electrical goniometer will be used to measure the change in the back ROM

    Full Information

    First Posted
    February 16, 2022
    Last Updated
    February 25, 2022
    Sponsor
    University of Sharjah
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05257421
    Brief Title
    The Immediate Effect Of Shockwave Therapy On the Quadratus Lumborum (QL) Muscle Trigger Points vs Regular Back Exercises in Chronic Nonspecific Low Back Pain
    Official Title
    The Immediate Effect Of Shockwave Therapy On the Quadratus Lumborum (QL) Muscle Trigger Points vs Regular Back Exercises in Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2022 (Anticipated)
    Primary Completion Date
    July 2022 (Anticipated)
    Study Completion Date
    August 2022 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    the study aims to compare the effect of regular back exercises with shockwave therapy by treating male patients with non-specific low back pain between the age of (20-40). Who will be devided into 3 groups, and will be treated by shockwave therapy , exercises or both combined. After signing a consent form, patients will be assigned to the groups blindly, so the patients will not know if they are in the experimental or control group. Hypothesis: The hypothesis of this study states that: o Research hypothesis: there will be a significant difference between the radial ESWT and back exercises in reducing LBP

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain, Mechanical

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    shockwave group
    Arm Type
    Experimental
    Arm Title
    exercise group
    Arm Type
    Active Comparator
    Arm Title
    combined group
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    shockwave machine
    Intervention Description
    shockwave therapy. 2000 impulses will be applied, 1000 on the TrPs and 1000 surrounding it, with Energy level up to 2,5 bars and frequency of 10Hz
    Intervention Type
    Other
    Intervention Name(s)
    leg and back exercises
    Intervention Description
    the exercise program will include 5 exercises that focuses on the back and lower limbs. These exercises are: Bridge Plank Squat Push-ups Back extension Each exercise will be done for 3-5 sets.
    Intervention Type
    Combination Product
    Intervention Name(s)
    shockwave and exercises
    Intervention Description
    both types of interventions will be applied for the patient
    Primary Outcome Measure Information:
    Title
    pressure-pain threshold
    Description
    Algometry device will be used to measure three thresholds' values: Tenderness threshold. Referred pain threshold. Pain tolerance threshold.
    Time Frame
    45 hour session
    Title
    The Oswestry Disability Index
    Description
    is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability, scoring from 0 to 50, the lower score the better
    Time Frame
    45 minutes session
    Title
    Numerical pain scale
    Description
    0-10 the lower the better
    Time Frame
    45 minutes session
    Secondary Outcome Measure Information:
    Title
    ROM of the back
    Description
    an electrical goniometer will be used to measure the change in the back ROM
    Time Frame
    45 minutes session

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Only male patients will be included. Age 20-40 years old. Non-specific LBP for at least 3 months. At least one local tenderness or active trigger point in the anatomical region of the QL muscle. Pain intensity on numerical pain scale should be more than 4 Exclusion Criteria: LBP due to a pathology or trauma. Below 20 years of age. Previous lumbar surgeries. Malignancy. Patients under medications or painkillers.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    maram makki
    Phone
    +971567288781
    Email
    mmarram95@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    Citation
    Epidemiological features of chronic low-back pain
    Results Reference
    background
    Citation
    Joshi S, Sheth M. Effect of extracorporeal shockwave therapy on myofascial pain syndrome of upper trapezius: A systematic review. Int J Med Sci Public Health. 2020;9(10):1.
    Results Reference
    background
    Citation
    Effect of Static Versus Dynamic Ultrasound on Pain in Subjects with Trigger Point in Quadratus Lumborum Having Non-Specific Chronic Low Back. 2020;10(December):263-9.
    Results Reference
    background

    Learn more about this trial

    The Immediate Effect Of Shockwave Therapy On the Quadratus Lumborum (QL) Muscle Trigger Points vs Regular Back Exercises in Chronic Nonspecific Low Back Pain

    We'll reach out to this number within 24 hrs