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
About this trial
This is an interventional treatment trial for Low Back Pain, Mechanical
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.
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
NCT ID
NCT05257421
First Posted
February 16, 2022
Last Updated
February 25, 2022
Sponsor
University of Sharjah
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
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