NCT04808492

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

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.

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Central Florida · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2022-01-01
• Primary completion: 2022-08-30
• Completion: 2022-08-30
• First posted: 2021-03-22
• Last updated: 2022-10-13