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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Low Back Pain, Mechanical
• Intervention / Treatment: Device: shockwave machine; Other: leg and back exercises; Combination product: shockwave and exercises

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: maram makki; Phone Number: +971567288781; Email: mmarram95@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: shockwave group	Device: shockwave machine; 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
Active Comparator: exercise group	Other: leg and back exercises; 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.
Active Comparator: combined group	Combination product: shockwave and exercises; both types of interventions will be applied for the patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pressure-pain threshold	Algometry device will be used to measure three thresholds' values: Tenderness threshold.; Referred pain threshold.; Pain tolerance threshold.	45 hour session
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	45 minutes session
Numerical pain scale	0-10 the lower the better	45 minutes session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ROM of the back	an electrical goniometer will be used to measure the change in the back ROM	45 minutes session

Collaborators and Investigators

• Sponsor: University of Sharjah

Publications and helpful links

General Publications

• Epidemiological features of chronic low-back pain
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: February 16, 2022
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 14, 2022
• Last Update Submitted That Met QC Criteria: February 25, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: ESWTQLRCT2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No