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

NCT ID: NCT05257421

Last Updated: 2022-03-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2022-08-31

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

Conditions

Low Back Pain, Mechanical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

shockwave group

Group Type: EXPERIMENTAL

shockwave machine

Intervention Type: DEVICE

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

exercise group

Group Type: ACTIVE_COMPARATOR

leg and back exercises

Intervention Type: OTHER

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.

combined group

Group Type: ACTIVE_COMPARATOR

shockwave and exercises

Intervention Type: COMBINATION_PRODUCT

both types of interventions will be applied for the patient

Interventions

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

Intervention Type: DEVICE

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.

Intervention Type: OTHER

shockwave and exercises

both types of interventions will be applied for the patient

Intervention Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Sharjah

OTHER

Sponsor Role: lead

Responsible Party

Maram Mohammed Taha Makki

physiotherapist / master student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

maram makki

Role: CONTACT

mmarram95@gmail.com

+971567288781

References

Epidemiological features of chronic low-back pain

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

Other Identifiers

ESWTQLRCT2022

Identifier Type: -

Identifier Source: org_study_id