The Effect of High Intensity Laser on Muscle Quality and Pain in Those With Low Back Pain
NCT ID: NCT04808492
Last Updated: 2022-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2022-01-31
2022-08-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
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.
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Curewave Laser, LLC
UNKNOWN
University of Central Florida
OTHER
Responsible Party
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Principal Investigators
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William J Hanney, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Central Florida
References
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Santamato A, Solfrizzi V, Panza F, Tondi G, Frisardi V, Leggin BG, Ranieri M, Fiore P. Short-term effects of high-intensity laser therapy versus ultrasound therapy in the treatment of people with subacromial impingement syndrome: a randomized clinical trial. Phys Ther. 2009 Jul;89(7):643-52. doi: 10.2522/ptj.20080139. Epub 2009 May 29.
Nakamura T, Ebihara S, Ohkuni I, Izukura H, Harada T, Ushigome N, Ohshiro T, Musha Y, Takahashi H, Tsuchiya K, Kubota A. Low Level Laser Therapy for chronic knee joint pain patients. Laser Ther. 2014 Dec 27;23(4):273-7. doi: 10.5978/islsm.14-OR-21.
Alghadir A, Omar MT, Al-Askar AB, Al-Muteri NK. Effect of low-level laser therapy in patients with chronic knee osteoarthritis: a single-blinded randomized clinical study. Lasers Med Sci. 2014 Mar;29(2):749-55. doi: 10.1007/s10103-013-1393-3. Epub 2013 Aug 3.
Fukuda VO, Fukuda TY, Guimaraes M, Shiwa S, de Lima Bdel C, Martins RA, Casarotto RA, Alfredo PP, Bjordal JM, Fucs PM. SHORT-TERM EFFICACY OF LOW-LEVEL LASER THERAPY IN PATIENTS WITH KNEE OSTEOARTHRITIS: A RANDOMIZED PLACEBO-CONTROLLED, DOUBLE-BLIND CLINICAL TRIAL. Rev Bras Ortop. 2015 Dec 6;46(5):526-33. doi: 10.1016/S2255-4971(15)30407-9. eCollection 2011 Sep-Oct.
Alayat MS, Elsodany AM, El Fiky AA. Efficacy of high and low level laser therapy in the treatment of Bell's palsy: a randomized double blind placebo-controlled trial. Lasers Med Sci. 2014 Jan;29(1):335-42. doi: 10.1007/s10103-013-1352-z. Epub 2013 May 26.
Kim SH, Kim YH, Lee HR, Choi YE. Short-term effects of high-intensity laser therapy on frozen shoulder: A prospective randomized control study. Man Ther. 2015 Dec;20(6):751-7. doi: 10.1016/j.math.2015.02.009. Epub 2015 Mar 2.
de Freitas LF, Hamblin MR. Proposed Mechanisms of Photobiomodulation or Low-Level Light Therapy. IEEE J Sel Top Quantum Electron. 2016 May-Jun;22(3):7000417. doi: 10.1109/JSTQE.2016.2561201.
Karlekar A, Bharati S, Saxena R, Mehta K. Assessment of feasibility and efficacy of Class IV laser therapy for postoperative pain relief in off-pump coronary artery bypass surgery patients: A pilot study. Ann Card Anaesth. 2015 Jul-Sep;18(3):317-22. doi: 10.4103/0971-9784.159800.
Chow R, Armati P, Laakso EL, Bjordal JM, Baxter GD. Inhibitory effects of laser irradiation on peripheral mammalian nerves and relevance to analgesic effects: a systematic review. Photomed Laser Surg. 2011 Jun;29(6):365-81. doi: 10.1089/pho.2010.2928. Epub 2011 Apr 1.
Basford JR, Sheffield CG, Harmsen WS. Laser therapy: a randomized, controlled trial of the effects of low-intensity Nd:YAG laser irradiation on musculoskeletal back pain. Arch Phys Med Rehabil. 1999 Jun;80(6):647-52. doi: 10.1016/s0003-9993(99)90167-3.
Ay S, Dogan SK, Evcik D. Is low-level laser therapy effective in acute or chronic low back pain? Clin Rheumatol. 2010 Aug;29(8):905-10. doi: 10.1007/s10067-010-1460-0. Epub 2010 Apr 23.
Fiore P, Panza F, Cassatella G, Russo A, Frisardi V, Solfrizzi V, Ranieri M, Di Teo L, Santamato A. Short-term effects of high-intensity laser therapy versus ultrasound therapy in the treatment of low back pain: a randomized controlled trial. Eur J Phys Rehabil Med. 2011 Sep;47(3):367-73. Epub 2011 Jun 8.
Hart JM, Fritz JM, Kerrigan DC, Saliba EN, Gansneder BM, Ingersoll CD. Quadriceps inhibition after repetitive lumbar extension exercise in persons with a history of low back pain. J Athl Train. 2006 Jul-Sep;41(3):264-9.
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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STUDY00001355
Identifier Type: -
Identifier Source: org_study_id
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