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Low Back PainNCT04808492

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

A study testing CureWave High Intensity Laser in people with Low Back Pain, run by University of Central Florida.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Low Back Pain
What is being tested?
CureWave High Intensity Laser
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2022to 30 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

About this study

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.

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.

Read the 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
Being tested
CureWave High Intensity Laser, Placebo
Keywords
low back pain, Laser, Perceived Pain, Perceived Disability
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CureWave High Intensity LaserDevice

    • 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.

  • PlaceboOther

    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.

    • Distance of electrode from skin will begin 10" from skin surface. The entire process will take approximately 10 minutes.
Study groups in NCT04808492
Study groupRoleWhat they receive
CureWave High Intensity LaserExperimentalThe 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.
Receives: Device: CureWave High Intensity Laser
ControlPlacebo comparatorThe 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.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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).

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

  3. 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.

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

  4. 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.

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

  5. 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)

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

  6. 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)

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

Secondary outcomes (6)

  1. CHANGE in Oswestry Disability Index

    Measure self reported perceived disability via a standardized survey form that can report a raw score between 0 and 50 points.

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

  2. CHANGE in Patients Specific Functional Scale

    Measure self reported functional abilities based on a survey form which identifies 5 individual functional tasks that the participant struggles with. These are rated 0 (no difficulty) to 10 (unable to perform task).

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

  3. CHANGE in Global Rating of Change

    Measure overall change in condition via a survey questionnaire which rates change in symptoms between -7 (quite a bit worse) to 0 (no change) to +7 (quite a bit better).

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

  4. CHANGE in Sleep disturbance (short form 8a)

    Measure self reported measures of sleep quality via a survey questionnaire that evaluates quality and quantity of sleep.

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

  5. CHANGE in International Physical Activity Questionnaire (IPAQ)

    Measure of self reported physical activity via a survey questionnaire that reports level of physical activity.

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

  6. CHANGE in McGill Pain Questionnaire

    Measure of pain quality via a survey questionnaire the measures qualitative aspects of perceived pain.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2021
  2. Study startJan 2022 (estimated)
  3. Primary completion30 Aug 2022
  4. Study completion30 Aug 2022

Why it stopped: Funding unavailable

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Clinical Trial
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04808492
Sponsor's protocol ID
STUDY00001355
Status last verified
Oct 2022
First submitted
4 Mar 2021
Last updated
13 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19482902

  • 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.

    PubMed 25705083

  • 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.

    PubMed 23912778

  • 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.

    PubMed 27027049

  • 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.

    PubMed 23709010

  • 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.

    PubMed 25770420

  • 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.

    PubMed 28070154

  • 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.

    PubMed 26139735

  • 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.

    PubMed 21456946

  • 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.

    PubMed 10378490

  • 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.

    PubMed 20414695

  • 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.

    PubMed 21654616

  • 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.

    PubMed 17043693

  • 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.

    PubMed 17695343

Questions about this trial

What is this clinical trial studying?

A study testing CureWave High Intensity Laser in people with Low Back Pain, run by University of Central Florida.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CHANGE in EMG activity of the lumbar paraspinal muscles (time frame: Baseline; 24-48 hours after baseline; 4 weeks after baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04808492, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.

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