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

NCT04808492 | Withdrawn DMC

• 1 other identifier: STUDY00001355
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Low Back Pain

Keywords

low back pain; Laser; Perceived Pain; Perceived Disability

Outcome Measures

Primary Outcomes (6)

• CHANGE in EMG activity of the lumbar paraspinal muscles

  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

  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

  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

  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

  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

  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 Outcomes (6)

• CHANGE in Oswestry Disability Index

  Baseline; 24-48 hours after baseline; 4 weeks after baseline

• CHANGE in Patients Specific Functional Scale

  Baseline; 24-48 hours after baseline; 4 weeks after baseline

• CHANGE in Global Rating of Change

  Baseline; 24-48 hours after baseline; 4 weeks after baseline

• CHANGE in Sleep disturbance (short form 8a)

  Baseline; 24-48 hours after baseline; 4 weeks after baseline

• CHANGE in International Physical Activity Questionnaire (IPAQ)

  Baseline; 24-48 hours after baseline; 4 weeks after baseline

Study Arms (2)

CureWave High Intensity Laser

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

CureWave High Intensity Laser DEVICE

* 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.

CureWave High Intensity Laser

Placebo OTHER

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.

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Central Florida: lead
• Curewave Laser, LLC: collaborator

Related Publications (14)

• 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.

  PMID: 19482902 BACKGROUND

• 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.

  PMID: 25705083 BACKGROUND

• 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.

  PMID: 23912778 BACKGROUND

• 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.

  PMID: 27027049 BACKGROUND

• 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.

  PMID: 23709010 BACKGROUND

• 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.

  PMID: 25770420 BACKGROUND

• 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.

  PMID: 28070154 BACKGROUND

• 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.

  PMID: 26139735 BACKGROUND

• 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.

  PMID: 21456946 BACKGROUND

• 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.

  PMID: 10378490 BACKGROUND

• 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.

  PMID: 20414695 BACKGROUND

• 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.

  PMID: 21654616 BACKGROUND

• 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.

  PMID: 17043693 BACKGROUND

• 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.

  PMID: 17695343 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• William J Hanney, PhD

  University of Central Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participating subjects will be blinded to group assignment. Also, the outcomes assessor analyzing the data will be blinded to group assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 22, 2021
• Study Start: January 1, 2022
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share