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

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Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

high power laser acupuncture (HPLA)

conventional treatment

Sham laser

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Subjects will be included in this study will be having all of the following criteria: Age over 18 years of age. Both genders (males and females). Normal BMI ranges between 18.5:24.9 kg/m2. 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: History of any surgical procedure in the back or the lower extremities. 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). Patient with lumbar instability including spondylolisthesis. Red flags (e.g. fever, unexplained weight loss, progressive weakness, radiation to lower limb, bowel and bladder dysfunction). Pregnancy.

Sites / Locations

Outpatient clinic faculty of physical therapy cairo university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High power laser acupuncture group

Conventional treatment group

Arm Description

This group will receive high power laser acupuncture (HPLA) +conventional therapy

This group will receive sham laser and The first line of chronic nonspecific low back pain treatment is the conventional treatment.

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05970419

First Posted

July 24, 2023

Last Updated

July 24, 2023

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT05970419

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

August 10, 2023 (Anticipated)

Primary Completion Date

October 30, 2023 (Anticipated)

Study Completion Date

November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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?

Detailed Description

The aims of this study are: To investigate the effect of high power laser acupuncture on pain in chronic nonspecific low back pain patients 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. To investigate the effect of high power laser acupuncture on function in chronic nonspecific low back pain patients. To investigate the effect of high power laser acupuncture on quality of life in chronic nonspecific low back pain patients. To investigate the effect of high power laser acupuncture on back muscle fatigue in chronic nonspecific low back pain patients. To investigate the effect of high power laser acupuncture on level of satisfaction in chronic nonspecific low back pain patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

High power laser acupuncture group

Arm Type

Experimental

Arm Description

This group will receive high power laser acupuncture (HPLA) +conventional therapy

Arm Title

Conventional treatment group

Arm Type

Active Comparator

Arm Description

This group will receive sham laser and The first line of chronic nonspecific low back pain treatment is the conventional treatment.

Intervention Type

Other

Intervention Name(s)

high power laser acupuncture (HPLA)

Intervention Description

HPLA will be provided in Wave length 1064 (nm) Energy Density (0.510-0.1780 J/cm 2) Power Average (3000 W) pulsed Time per Point (14s) for acupoints. Although a maximum power of 8000 W was reported in two studies, the average power of the lasers used in t

Intervention Type

Other

Intervention Name(s)

conventional treatment

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Sham laser

Intervention Description

sham laser (Not active)

Primary Outcome Measure Information:

Title

Assessing the change in intensity of pain

Description

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.

Time Frame