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

Low Back Pain, Mechanical Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05257421
• Other study ID #: ESWTQLRCT2022
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2022
• Est. completion date: August 2022

Study information

• Verified date: February 2022
• Source: University of Sharjah
• Contact: maram makki
• Phone: +971567288781
• Email: mmarram95[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 78
• Est. completion date: August 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Low Back Pain, Mechanical

Intervention

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

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.

Combination Product:
• shockwave and exercises
both types of interventions will be applied for the patient

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sharjah

References & Publications (3)

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.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pressure-pain threshold	Algometry device will be used to measure three thresholds' values: Tenderness threshold.; Referred pain threshold.; Pain tolerance threshold.	45 hour session
Primary	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
Primary	Numerical pain scale	0-10 the lower the better	45 minutes session
Secondary	ROM of the back	an electrical goniometer will be used to measure the change in the back ROM	45 minutes session