Examining the Effectiveness of Multiwave Locked System Laser Treatment in Chronic Low Back Pain

Patients who come to Tavşanlı Assoc. Prof. Dr. Mustafa Kalemli State Hospital, Physical Therapy, and Rehabilitation Department who have been diagnosed with Chronic Low Back Pain by a physician will be included. Patients will be divided into two groups by the physician: conservative treatment and patients whose treatment program is determined as multi-wave locked system laser treatment in addition to conservative treatment. Pain intensity will be measured with a numerical pain rating scale. The Roland-Morris disability questionnaire will be used to evaluate the functionality of the participants, and the esthesiometer will be used to assess tactile acuity. Pressure pain threshold will be evaluated with the MicroFET 2 device. The Turkish Form of the SF-12 Quality of Life Scale will be used to assess the participants' quality of life. Pittsburgh's sleep quality index will be used to evaluate sleep quality. Patient satisfaction will be evaluated with a numerical rating scale.

Study Overview

• Status: Withdrawn
• Conditions: Low Back Pain
• Intervention / Treatment: Other: conventional treatment; Other: Conventional treatment + multi-wave locked system laser treatment

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Kütahya, Turkey (Türkiye), 43100
    • Kutahya Health Sciences University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Being between the ages of 18-65
• Volunteering to participate in the study
• Having low back pain that has persisted for at least 3 months

Exclusion Criteria:

• History of surgery in the waist area
• Discopathy at a different level of the spine (Modic Type 3)
• Presence of tumor in the spine
• Infection in the discs
• Having an inflammatory disease
• Presence of neurological involvement
• Fracture
• Spondylosis
• Spinal Stenosis
• Spondylolisthesis
• Radiculopathy
• Having received treatment for low back pain in the last 3 months

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional treatment group; In conventional treatment, Hot Pack, TENS, therapeutic ultrasound and exercise program will be given by the hospital staff.	Other: conventional treatment; Hot Pack, TENS, therapeutic ultrasound, and exercise
Experimental: Conventional treatment + Multiwave Locked System Laser treatment group; Multiwave-locked system laser treatment will be applied by the hospital staff to the group in addition to conventional treatment.	Other: conventional treatment; Hot Pack, TENS, therapeutic ultrasound, and exercise; Other: Conventional treatment + multi-wave locked system laser treatment; Hot Pack, TENS, therapeutic ultrasound, and exercise + multi-wave locked system laser treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain intensity	Numerical Pain Rating Scale: Ratings from 0 to 10 range from no pain to the highest pain level imaginable. Studies show that a 2-point change in the evaluation made with this scale indicates a clinically significant change beyond the limits of measurement error.Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functionality	The Roland-Morris Disability Questionnaire: This survey contains 24 questions about the impact of low back pain on a person's functionality. The yes answer given by the people is evaluated as 1 point, the no answer is evaluated as 0 points, and a total score between 0 and 24 is received.The score ranges from 0 (no disability) to 24 (max. disability) depending on the questionnaire used.	Through study completion, an average of 1 year
Tactile Acuity	Esthesiometer: Measurements will be taken by moving horizontally from the midline where the spinous process of the 3rd lumbar vertebra is located to the dominant part of the person. The evaluation will start from the position where the distance between two points is 0 mm, and the distance will be increased until the person can distinguish between two points. Around this determined threshold, 5 increasing and decreasing evaluations will be made and the average of the evaluation will be taken.	Through study completion, an average of 1 year
Pressure Pain Thereshold	MicroFET 2: Measurements will be taken 5 centimeters to the right and left of the spinous processes of the 3rd and 5th Lumbal vertebrae, which will be marked before. Two more points (on the tibialis anterior muscle of the right and left legs, 5 centimeters lateral to the tuberosity tibia) will be marked and used for control. The probe will be applied perpendicular to the skin, and the pressure will be gradually increased, starting from the point where no pressure is applied at first. At the point when the feeling of pressure turns into pain, participants will be instructed to call this point. This value will be recorded during the application, and after waiting the required time, additional measurements will be taken to calculate the pressure pain threshold.	Through study completion, an average of 1 year
Assessment of Quality of life	SF 12: The SF-12 health survey is a self-reported outcome measure designed for use among the general population. It is a 12-item short-form health survey that assesses the same eight health domains as the SF-36 Health Survey. Each health domain score contributes to the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.	Through study completion, an average of 1 year
Sleep Quality	Pittsburgh Sleep Quality Index: 19 out of 24 questions are self-answered questions. While other questions include questions to get information from a roommate or bed partner, some questions in the index are included in the scoring. There are 7 components and the total score varies between 0 and 21. If the total PSQI score is below 5, sleep quality is considered good, and if it is above 5, sleep quality is considered poor.	Through study completion, an average of 1 year
Patient Satisfaction	Numerical Rating Scale: Participants will score their satisfaction between 0 and 10, with higher scores indicating a higher level of satisfaction.	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Kutahya Health Sciences University
• Investigators: Study Director: Meltem Işıntaş, Kutahya Health Sciences University

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2024
• Primary Completion (Actual): December 9, 2025
• Study Completion (Actual): August 10, 2026

Study Registration Dates

• First Submitted: July 31, 2024
• First Submitted That Met QC Criteria: September 10, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 12, 2026
• Last Update Submitted That Met QC Criteria: August 10, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Low Back Pain
• Other Study ID Numbers: 2024/09-36

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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