Effect of Low-level Laser Therapy Versus Shock Wave Therapy on Pain and Function in Patients With Chronic Non-specific Low Back Pain

Effect of Low-level Laser Therapy Versus Shock Wave Therapy on Pain and Function in Patients With Chronic Non-specific Low Back Pain: a Randomized Controlled Clinical Trial

A significant global source of disability is low back pain. Maladaptive variations in the level of activity in the lumbar musculature are one thing that could possibly contribute to persistent pain.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Low-level laser therapy; Other: Shock wave Therapy

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 11742
    • October 6 University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. All patients will suffer from mechanical low back pain
2. Age will range from 20 to 40 years
3. All patients will have BMI range from 20-24

Exclusion Criteria:

1. History of radicular pain
2. Lumbar disc prolapse.
3. Visual problems
4. History of previous lumbar surgery
5. BMI more than 24

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Twenty patients will receive low-level laser therapy 3 times per week for a month	Other: Low-level laser therapy; Is a form of medicine that applies low-level (low-power) lasers that relieve pain.The effects appear to be limited to a specified set of wavelengths
Experimental: Group B; Twenty patients will receive shock wave therapy 3 times per week for a month	Other: Shock wave Therapy; is a non-invasive treatment that stimulates the body's natural healing process. It can relieve pain and promote healing of injured tendons, ligaments, and other soft tissues

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry low back disability questionnaire	The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome toolsFor each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. If all 10 sections are completed the score is calculated as follows: Example: 16 (total scored) 50 (total possible score) x 100 = 32% If one section is missed or not applicable the score is calculated: 16 (total scored) 45 (total possible score) x 100 = 35.5% Minimum detectable change (90% confidence): 10% points (change of less than this may be attributable to error in the measurement)	30 minutes
Back pain functional scale	The Back Pain Functional Scale (BPFS) is a subjective scale used to measure the patient's physical function after low back painThis scale consists of a total score of 60. Moreover, the patient's score can be measured from the responses obtained on the Likert scale (0 to 5), and accordingly, a total score is summed up out of 60. Furthermore, the maximum score obtained indicates the maximum physical abilities of the patients. In addition, this scale also has an 'Adjusted score' ranging from 0 (0%)-unable to perform any activity to 60 (100%)-no difficulty in any activity	20 minutes
Visual analogue scale	Visual analogue scale (VAS) is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. Visual analogue scale (VAS) is most commonly a straight 100-mm line, without demarcation, that has the words "no pain" at the left-most end and "worst pain imaginable" (or something similar) at the right-most end.48 Patients are instructed to place a mark on the line indicating the amount of pain that they feel at the time of the evaluation. The distance of this mark from the left end is then measured, and this number is used as a numeric representation of the severity of the patient's pain	5 minutes

Collaborators and Investigators

• Sponsor: October 6 University

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2024
• Primary Completion (Actual): October 20, 2024
• Study Completion (Actual): January 20, 2025

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Function; Low-level laser therapy; Shock wave therapy; Chronic Non-Specific Low Back Pain
• Additional Relevant MeSH Terms: Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Low Back Pain; Therapeutics; Physical Therapy Modalities; Rehabilitation; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Laser Therapy; Phototherapy; Extracorporeal Shockwave Therapy; Low-Level Light Therapy
• Other Study ID Numbers: 2024 (Other Grant/Funding Number: Rome Foundation)

Drug and device information, study documents

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