Clinical trial NCT04808492: The Effect of High Intensity Laser on Muscle Quality and Pain in Those With Low Back Pain
Official title: 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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
Laser
Perceived Pain
Perceived Disability
Lead sponsor: University of Central Florida
Sponsor class: OTHER
Collaborators: name: Curewave Laser, LLC
First posted: 2021-03-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: CHANGE in EMG activity of the lumbar paraspinal muscles
timeFrame: Baseline; 24-48 hours after baseline; 4 weeks after baseline
measure: CHANGE in total hemoglobin
timeFrame: Baseline; 24-48 hours after baseline; 4 weeks after baseline
measure: CHANGE in Muscle Edema
timeFrame: Baseline; 24-48 hours after baseline; 4 weeks after baseline
measure: CHANGE in Muscle sensitivity
timeFrame: Baseline; 24-48 hours after baseline; 4 weeks after baseline
measure: CHANGE in Numeric Pain Rating Scale
timeFrame: Baseline; 24-48 hours after baseline; 4 weeks after baseline
measure: CHANGE in Muscle Oxygenation
timeFrame: Baseline; 24-48 hours after baseline; 4 weeks after baseline
Secondary outcomes:
measure: CHANGE in Oswestry Disability Index
timeFrame: Baseline; 24-48 hours after baseline; 4 weeks after baseline
measure: CHANGE in Patients Specific Functional Scale
timeFrame: Baseline; 24-48 hours after baseline; 4 weeks after baseline
measure: CHANGE in Global Rating of Change
timeFrame: Baseline; 24-48 hours after baseline; 4 weeks after baseline
measure: CHANGE in Sleep disturbance (short form 8a)
timeFrame: Baseline; 24-48 hours after baseline; 4 weeks after baseline
measure: CHANGE in International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline; 24-48 hours after baseline; 4 weeks after baseline
measure: CHANGE in McGill Pain Questionnaire
timeFrame: Baseline; 24-48 hours after baseline; 4 weeks after baseline
Other outcomes:
Locations:
Study officials:
affiliation: University of Central Florida
name: William J Hanney, PhD
role: PRINCIPAL_INVESTIGATOR
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