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

University of Central Florida

Status: Withdrawn

Conditions: Low Back Pain

Treatments: Device: CureWave High Intensity Laser; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04808492

STUDY00001355

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

CureWave High Intensity Laser

Experimental group

Description:

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.

Treatment:

Device: CureWave High Intensity Laser

Control

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo