Efficacy Of Non-Invasive High Power Laser Acupuncture Stimulation In Chronic Non-Specific Low Back Pain

This study will be conducted to answer the following question: Does high power laser acupuncture has any effect on pain, back range of motion, function, quality of life, fatigue and level of satisfaction in chronic nonspecific low back pain patients?

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Other: conventional treatment; Other: Sham laser; Other: high power laser acupuncture (HPLA)

Detailed Description

The aims of this study are:

1. To investigate the effect of high power laser acupuncture on pain in chronic nonspecific low back pain patients
2. To investigate the effect of high power laser acupuncture on back range of motion (flexion, extension, side bending and rotation) in chronic nonspecific low back pain patients.
3. To investigate the effect of high power laser acupuncture on function in chronic nonspecific low back pain patients.
4. To investigate the effect of high power laser acupuncture on quality of life in chronic nonspecific low back pain patients.
5. To investigate the effect of high power laser acupuncture on back muscle fatigue in chronic nonspecific low back pain patients.
6. To investigate the effect of high power laser acupuncture on level of satisfaction in chronic nonspecific low back pain patients.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tasnim Mohamed; Phone Number: +20 106 800 3447; Email: eth.com@pt.cu.edu.eg

Study Locations

• Egypt
  • Dokki, Egypt
    • Recruiting
    • Outpatient clinic faculty of physical therapy cairo university
    • Contact: Outpatient CFOPTC university; Email: eth.com@pt.cu.edu.eg

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

Subjects will be included in this study will be having all of the following criteria:

1. Age over 18 years of age.
2. Both genders (males and females).
3. Normal BMI ranges between 18.5:24.9 kg/m2.
4. Patients will be referred from an orthopedist with diagnosis of chronic low back pain without underlying pathological causes. The patients with chronic nonspecific low back pain more than 3months. Minimum pain intensity of 30 mm on the visual analogue scale (VAS) for pain, which ranges from 0 to 100 mm.

6) CNSLBP patients will be diagnosed based on the standard criteria, including pain and tenderness on lower back and a negative result for all special tests for lumber neurological examination.

Exclusion Criteria:

1. History of any surgical procedure in the back or the lower extremities.
2. Back pain secondary to known specific pathology (e.g. infection, tumor, osteoporosis, fracture, structural deformity, inflammatory disorder (e.g. ankylosing spondylitis) or cauda equine syndrome).
3. Patient with lumbar instability including spondylolisthesis.
4. Red flags (e.g. fever, unexplained weight loss, progressive weakness, radiation to lower limb, bowel and bladder dysfunction).
5. Pregnancy.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High power laser acupuncture group; This group will receive high power laser acupuncture (HPLA) +conventional therapy	Other: conventional treatment; Superficial heat (hot packs). Will be applied 10 - 15 minutes. Guideline-endorsed treatment is to stay active, return to normal activity, and to exercise. Different exercise types are used in the treatment of CLBP such as strength and aerobic training on land as well as specific exercises such as motor control exercises (MCE). General exercises activating the extensor (paraspinals) and flexor (abdominals) muscle groups will be used.; Other: high power laser acupuncture (HPLA); High power laser therapy A Zimmer Opton pro, integrated High-power class IV laser device (serial N: 15200013306 & REF: 4682, made in Germany, manufactured by Zimmer Medizin System). It emits radiation in the infrared range to deliver topical heating and raise tissue temperature. The simultaneous application of two wavelengths of laser light (810 and 980nm) provides the user with a huge variety of therapy options. The laser probe - with the small spacer (3.1cm2) , with parameters of 3 watts, 5Hz, 50% duty cycle, 20 joule/ point for 13 seconds with 6.4 j/cm2 . Although a maximum power of 8000 W was reported in two studies, the average power of the lasers used in t
Active Comparator: Conventional treatment group; This group will receive sham laser and The first line of chronic nonspecific low back pain treatment is the conventional treatment.	Other: conventional treatment; Superficial heat (hot packs). Will be applied 10 - 15 minutes. Guideline-endorsed treatment is to stay active, return to normal activity, and to exercise. Different exercise types are used in the treatment of CLBP such as strength and aerobic training on land as well as specific exercises such as motor control exercises (MCE). General exercises activating the extensor (paraspinals) and flexor (abdominals) muscle groups will be used.; Other: Sham laser; sham laser (Not active)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing the change in intensity of pain	By using visual analoge scale (VAS). It is a valid and reliable measure to assess pain intensity level by patients by making a mark determining a decimal number from 0 to 100 (mm) on line with 'no pain' to the left and severe pain could be to the right. The subjects will rate their perception of pain by making a mark on the VAS line. The distance from the left to the mark will be measured and the accuracy will be adjusted to one decimal place.	at baseline and after 4 weeks of intervention
Assessing the change in Back Range of Motion	By using the Back Range of Motion Instrument (BROM). It is a valid and reliable measure to assess back range of motion (flexion, extension, side bending and rotation) The BROM is uses a patented inclinometer based instrument for measuring lateral side bend in the preferred upright position. The magnetic inclinometer and reference eliminate hip substitution errors. The BROM Basic includes two Universal Inclinometers for measuring flexion and extension of the lumbar spine.	at baseline and after 4 weeks of intervention
Assessing the change in Quality of Life	By using the short version of the WHO Quality of Life Instrument in Arabic. It will be used to assess quality of life. The World Health Organization Quality-of-Life Scale (WHOQOL-BREF) provides a reliable, valid, and brief assessment of quality-of-life. There will be a four-domain score. The four domain scores will denote an individual perception of quality of life in each particular domain. Domains scores are scaled in a positive direction higher score denote higher quality of life. The mean score of items within each domain is used to calculate the domain score. Mean scores are then multiplied by 4 in order to make domain scores comparable with the scores used in the WHOQOL-100.	at baseline and after 4 weeks of intervention
Assessing the change in endurance of the trunk extensor muscles	By using Biering-Sorensen test. The Sorensen test allows for a rapid, simple, and reproducible evaluation of the isometric endurance of the trunk extensor muscles. It discriminates between healthy individuals and patients with low back pain and may predict the occurrence of low back pain in the near future. The test consists in measuring the amount of time a person can hold the unsupported upper body in a horizontal prone position with the lower body fixed to the examining table. The Biering-Sørensen test for measuring back muscle fatigue is valid and provides reliable measures of position-holding time and can discriminate between subjects with and without nonspecific low back pain.	at baseline and after 4 weeks of intervention
Assessing the change in patient satisfaction	By using The MedRisk Instrument for Measuring Patient Satisfaction (MRPS). A Self-report measures that sample a variety of items provide clinicians with an array of information that may assist in assessing patient satisfaction. The MRPS questionnaire is valid and reliable for measuring patient satisfaction. It has a 2-factor structure: "internal," relating to the patient-therapist interaction, and "external," describing no therapist issues such as admissions and clinic environment.	at baseline and after 4 weeks of intervention

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Tasnim Mohamed, Cairo university

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: July 24, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 24, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: high-intensity laser therapy; chronic Low Back pain; high power laser acupuncture
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Tasnim Mohamed Elfeky

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