The Effect of High Intensity Laser on Muscle Quality and Pain in Those With Low Back Pain

October 10, 2022 updated by: University of Central Florida

The Effects of CureWave Laser on Paraspinal Muscle Oxygenation, Pressure Pain Thresholds, Muscle Edema, Muscle Quality, and Perceived Outcomes in Patients With Chronic Low Back Pain.

The purpose of this study is to evaluate the effects of CureWave laser on paraspinal muscle oxygenation, pressure pain thresholds, muscle edema, and quality, and perceived outcomes in patients with chronic low back pain.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Low back pain (LBP) contributes to disability and has a significant economic impact. High intensity laser devices are class 4 producing > 40 W of power at longer wavelengths, thereby allowing deeper tissue penetration. Currently, there is little evidence to demonstrate the effectiveness of high intensity laser treatment in those with chronic LBP. Optimal dosing strategies are still unknown as well as patient response based on chronicity of symptoms. Therefore, our study seeks to evaluate the effectives of high intensity laser therapy using CureWave in those with LBP of a duration longer than 3 months and with a dosing strategy of two times/week for three weeks.

Hypothesis

  1. CureWave laser therapy will increase total oxygenated hemoglobin and muscle blood flow in patients with chronic LBP.
  2. CureWave laser therapy will reduce inflammation as assessed by muscle edema in patients with chronic LBP.
  3. CureWave laser therapy will improve paraspinal echogenicity (muscle quality) following treatment in patients with chronic LBP.
  4. CureWave laser therapy will decrease muscle sensitivity in patients with chronic LBP
  5. CureWave laser therapy will demonstrate improve patient reported outcomes, including decreased pain, reduced disability and improved function in patients with chronic LBP.
  6. CureWave laser therapy will increase muscle activation during maximal strength testing.
  7. CureWave laser therapy will decrease performance fatigability as assessed by maximal muscle activation and force production.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-65
  • Self-reported history of low back pain (5 episodes in lifetime or 3 in last three years which altered activities of daily living)13

Exclusion Criteria:

  • Self-reported pregnancy
  • Inability to complete all required meeting sessions
  • Known cardiovascular, pulmonary, metabolic, muscular, and/or coronary heart disease
  • Regularly uses prescription medication
  • Seeking medical care for the current episode of low back pain
  • Report average symptoms greater than 8/10
  • Inability to perceive light touch.
  • Verbal reports of known cardiovascular, pulmonary, metabolic, muscular, and/or coronary heart disease
  • Verbal reports of known skin sensitivity to gels or adhesives.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CureWave High Intensity Laser
The participant will lie prone and the HILT will be administered in two preliminary test locations. In order to evaluate any possible adverse reactions, the initial treatment location will be delivered at a decreased intensity at two separate locations above the target treatment areas. The Power for these two locations will be at a half dose (22 W) for one minute each. The initial, half dose treatment area is indicated by the Blue circles in the image below. Upon conclusion of the initial test treatments (at half dose), the skin with be evaluated for excessive redness or any other changes in skin appearance. Also, the participant will be asked about any discomfort. Should no unanticipated changes in skin appearance occur and the participant reports no discomfort, the treatment will be administered. The process of applying the laser at half dosage will occur prior to each treatment.
Device: CureWave High Intensity Laser

  • The participant will lie prone and the HILT will be administered in 9 symmetrical positions which cover the lumbosacral region. Dose will be 1minute per position. The dose will include:

    • Power (44 Watts)
    • Mode (continues wave)
    • Time on (60000 ms)
    • Time off (1 ms)
    • Repeats (9)
  • Distance of electrode from skin will begin 10" from skin surface. The participant may or may not feel mild warmth. Should the subject report excessive warmth or discomfort the probe distance will be increased in 2" intervals until it is comfortable. The entire process will take approximately 10 minutes.
  • The participant will lie prone and the Placebo treatment will consist of positioning the HILT probe over the 9 symmetrical positions for 1 minutes each however the no laser will be admitted.
Placebo Comparator: Control
The participant will lie prone and the Placebo HILT will be administered is the same capacity as the treatment group however no Laser treatment will be administered. Upon conclusion of the placebo treatment, the skin with be evaluated for excessive redness or any other changes in skin appearance. Also, the participant will be asked about any discomfort.
Other: Placebo

The participant will lie prone and the NON ACTIVE HILT will be administered in 9 symmetrical positions which cover the lumbosacral region. Dose will be 1minute per position. THE LASER WILL NOT BE ACTIVE.

o Distance of electrode from skin will begin 10" from skin surface. The entire process will take approximately 10 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CHANGE in EMG activity of the lumbar paraspinal muscles
Time Frame: Baseline; 24-48 hours after baseline; 4 weeks after baseline
EMG will be recorded during all submaximal and maximal strength testing. EMG will be assessed using wireless Bluetooth electrodes that will be attached using double-sided adhesive stickers. All submaximal and maximal strength testing will be performed using a hand-held dynamometer (Microfet 2 Manual Muscle Tester). Subjects will be stabilized using a nylon strap, the same material and mechanism as a seat belt, when necessary to eliminate accessory or compensatory motion during strength testing. This will be placed on their anterior and/or medial thigh with padding to eliminate any discomfort where the strap contacts the skin.
Baseline; 24-48 hours after baseline; 4 weeks after baseline
CHANGE in total hemoglobin
Time Frame: Baseline; 24-48 hours after baseline; 4 weeks after baseline
Change in total hemoglobin will be used as an index of change in regional blood volume.will be assessed using near-infrared spectroscopy (NIRS) (Portamon, Artinis Medical Systems, Arnhem, The Netherlands).
Baseline; 24-48 hours after baseline; 4 weeks after baseline
CHANGE in Muscle Edema
Time Frame: Baseline; 24-48 hours after baseline; 4 weeks after baseline
Muscle edema will be assessed via ultrasound using the echo intensity function. Ultrasound images will be obtained using a portable brightness mode (B-mode) ultrasound-imaging device (GE Logiqe, USA) and a multi-frequency linear-array probe (12L-Rs; 5-13MHz; 38.4 mm field-of-view). Ultrasound images will be analyzed using ImageJ software (Version 1.47v., National Institutes of Health, Bethesda, MD, USA). Echo intensity, as assessed by gray-scale analysis (0 arbitrary units [AU], corresponds to black image, 255 AU corresponds to white image) will be performed using the histogram function and will be determined from the same region of interest as muscle thickness.
Baseline; 24-48 hours after baseline; 4 weeks after baseline
CHANGE in Muscle sensitivity
Time Frame: Baseline; 24-48 hours after baseline; 4 weeks after baseline
Muscle sensitivity will be measured with a handheld digital algometer (Wagner FDX-25 pressure algometer- Wagner Instruments, Greenwich, CT) and be applied at a right angle to the skin surface with the subject lying in prone position at 3 locations on the Paravertebral muscles, Quadratus lumborum, and Piriformis. Pressure will be applied at a rate of 30 kPa/s, which corresponds to 3 N/s.
Baseline; 24-48 hours after baseline; 4 weeks after baseline
CHANGE in Numeric Pain Rating Scale
Time Frame: Baseline; 24-48 hours after baseline; 4 weeks after baseline
Quantity of perceived Pain will be evaluated via a likert scale between 0 (no pain) to 10 (the worst imaginable pain)
Baseline; 24-48 hours after baseline; 4 weeks after baseline
CHANGE in Muscle Oxygenation
Time Frame: Baseline; 24-48 hours after baseline; 4 weeks after baseline
Muscle oxygenation will be assessed using near-infrared spectroscopy (NIRS) (Portamon, Artinis Medical Systems, Arnhem, The Netherlands). Changes in muscle tissue oxygenation and deoxyhemoglobin will be examined across time using the optical densities from two continuous wavelengths (760 and 850 nm)
Baseline; 24-48 hours after baseline; 4 weeks after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CHANGE in Oswestry Disability Index
Time Frame: Baseline; 24-48 hours after baseline; 4 weeks after baseline
Measure self reported perceived disability via a standardized survey form that can report a raw score between 0 and 50 points.
Baseline; 24-48 hours after baseline; 4 weeks after baseline
CHANGE in Patients Specific Functional Scale
Time Frame: Baseline; 24-48 hours after baseline; 4 weeks after baseline
Measure self reported functional abilities based on a survey form which identifies 5 individual functional tasks that the participant struggles with. These are rated 0 (no difficulty) to 10 (unable to perform task).
Baseline; 24-48 hours after baseline; 4 weeks after baseline
CHANGE in Global Rating of Change
Time Frame: Baseline; 24-48 hours after baseline; 4 weeks after baseline
Measure overall change in condition via a survey questionnaire which rates change in symptoms between -7 (quite a bit worse) to 0 (no change) to +7 (quite a bit better).
Baseline; 24-48 hours after baseline; 4 weeks after baseline
CHANGE in Sleep disturbance (short form 8a)
Time Frame: Baseline; 24-48 hours after baseline; 4 weeks after baseline
Measure self reported measures of sleep quality via a survey questionnaire that evaluates quality and quantity of sleep.
Baseline; 24-48 hours after baseline; 4 weeks after baseline
CHANGE in International Physical Activity Questionnaire (IPAQ)
Time Frame: Baseline; 24-48 hours after baseline; 4 weeks after baseline
Measure of self reported physical activity via a survey questionnaire that reports level of physical activity.
Baseline; 24-48 hours after baseline; 4 weeks after baseline
CHANGE in McGill Pain Questionnaire
Time Frame: Baseline; 24-48 hours after baseline; 4 weeks after baseline
Measure of pain quality via a survey questionnaire the measures qualitative aspects of perceived pain.
Baseline; 24-48 hours after baseline; 4 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Central Florida

Collaborators

Curewave Laser, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2022

Primary Completion (Actual)

August 30, 2022

Study Completion (Actual)

August 30, 2022

Study Registration Dates

First Submitted

March 4, 2021

First Submitted That Met QC Criteria

March 17, 2021

First Posted (Actual)

March 22, 2021

Study Record Updates

Last Update Posted (Actual)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 10, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001355

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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