Shockwave and Laser for Spinal and Neck Pain

Research Review: Shockwave Therapy and High-Intensity Laser Therapy for Spinal and Neck Pain

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TABLE OF CONTENTS

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Level of evidence for intervention

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Mechanism of action of shockwave therapy

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Shockwave indications

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Laser therapy mechanisms of action

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Product portfolio

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About Enovis™

This guide reviews the mechanisms of action and new evidence supporting the clinical efficacy of shockwave and high-intensity laser therapy (HILT).

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LEVEL OF EVIDENCE FOR INTERVENTION

What does evidence based practice (EBP) mean? The chart below outlines the different levels of evidence.

Level 1a, Systematic Reviews A systematic review is the strongest level of scientific evidence. Investigators thoroughly evaluate multiple studies on a specific topic assessing their quality, outcomes, and potential bias. Level 1b, Randomized Controlled Trials These are research studies designed usually with an experimental group and a control group with the intent to determine the effectiveness of an intervention while minimizing the risk of bias. Level 2, Cohort Studies Observational research of a group of people who share similar characteristics. Level 3, Case Control Studies A retrospective study comparing two groups of people, those with a certain condition and those without it, to learn more about the condition. Level 4, Case Report/ Case Series These are detailed accounts of a specific patient’s treatment and are usually written to share lessons learned.

Level 1a

Level 1b

Level 2

Level 3

Level 4

Level 5 , Expert Opinion/Animal and In Vitro Studies

Inside this Guide The highest levels of evidence are systematic reviews and randomized controlled trials. The evidence presented in this guide for Shockwave Therapy and HILT is focused on systematic reviews and randomized controlled trials.

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MECHANISMS OF ACTION OF SHOCKWAVES

Radial Shockwave (RSW), sometimes referred to as Radial Pressure Wave (RPW) or Extracorporeal Activation Therapy (EPAT), is a non-invasive treatment option to aid in the activation of muscle and connective issue, facilitating pain relief. During treatment with RSW, high-energy sound waves are transmitted into the tissue propagating radially and creating a therapeutic effect on the impacted areas.

These high energy waves create a phenomenon referred to as mechanotransduction. In simple terms, it is the process of imparting brief, physical deformation to cells that lead to biochemical changes. These changes have the potential to positively impact pain and tissue repair. 1 In some instances, the negative pressure created during the tensile phase of a shockwave creates cavitation bubbles within cells. 2 If intense enough, it can lead to disruption of damaged cells which is why shockwave can be classified as a proinflammatory modality. Disruption of cells can lead to cell death (apoptosis) which triggers a low-level inflammatory response that benefits the process of removal and replacement of damaged tissue. This is another way that shockwave therapy can uniquely assist in treating chronic soft tissue problems.

Radial shockwave energy delivery is modified by the following:

• The volume of shocks provided. Most studies, and Chattanooga, recommend 2000 pulses per location when treating tendon dysfunction. Trigger points may require fewer shocks. Patient biofeedback will dictate length and intensity of treatment over an area. • The rate at which the shocks are provided (Hz). Some patients will subjectively prefer higher frequency treatments. Treating at higher rates will also shorten treatment times. • The bar pressure of the machine which dictates the intensity of the radial pressure wave. Deeper tissue dysfunction requires higher bar settings in most cases. • The applicator used. Softer materials transmit less energy and are useful for superficial tissues/ sensitive areas. Harder metals (steel and titanium) are used to treat deeper tissues as they transmit more energy into the tissue. Examples of different applicators are listed on page 5.

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SHOCKWAVE INDICATIONS

Intelect RPW2 RPW units are typically pneumatic and deploy air behind a pellet that travels through a tube and makes contact with the head of the treatment applicator. The transducer sends energy into the tissue. Different types of treatment heads are available to optimize treatments based on the presenting condition.

The Intelect RPW2 device is used to aid in the activation of muscle and connective tissue, facilitating pain relief, and temporarily increase blood flow. 8

F15 White soft transmitter 15mm for superficial pain regions, muscles of mastication, cervical spine

Penetration depth 0-30mm Intensity level: Very Low

Indications include:

Ro40 15mm Energy beam transmitter with concave coupling surface, best for pain zones near the skin surface Penetration depth 0-35mm Intensity level: Medium

Achilles Tendinopathy

DI15 Golden Depth 15mm Deep Impact ® transmitter for deep target areas, chronic disorder, local trigger points Penetration depth 0-60mm Intensity level: High

Disorders of Tendon Insertions

Myofascial Trigger Points

D20-S Standard Oscillator, 20mm transmitter for muscle and connective tissue Penetration depth 0-50mm Intensity level: Medium

Plantar Fasciitis

C15 CERAma-x ® Ceramic Energy 15mm transmitter for

Pulse Vibration Massage

any type of tendinopathies Penetration depth 0-35mm Intensity level: High

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SHOCKWAVE BACK PAIN RESEARCH

Extracorporeal shock wave therapy for low back pain: A systematic review and meta-analysis. Wu Z, Zhou T, Ai S. College of Health and Rehabilitation, Chengdu University of Traditional Chinese Medicine, Chengdu, China

Read the full study at pubmed.ncbi.nlm.nih.gov/38206739/

This study aimed to systematically evaluate the effectiveness and safety of ESWT for low back pain (LBP) by meta-analysis to judge the quality of evidence objectively and rigorously and to provide high quality evidence for LBP.

Study design & methods Systematic review and meta-analysis. Methods: • Randomised controlled trials comparing the effect of ESWT or ESWT combined with other modalities with standard treatment or sham were included in the computerized search. Outcomes: • Primary outcomes were pain, dysfunction and psychological conditions • Secondary outcomes included adverse reactions and valid cases • Meta-analysis was completed using Revman 5.4 and Stata 15 software, and GRADEpro software quantitated rate the evidence and assigned a recommendation strength.

At the 3-month follow-up, • The VAS and ODI remained lower; adverse reactions were less, and the valid cases were more. Sensitivity analyses revealed that the results were stable and robust. ESWT for LBP has efficacy and safety in improving pain, dysfunction, and psychological conditions compared to other therapies. • ESWT has shown advantages in terms of long-term efficacy. • Conclusion • Randomized controlled trials with larger sample sizes and more objective outcomes are required.

Results •

This meta-analysis included 22 Random Controlled Trails (RCTs) involving 1749 patients. 13 studies used RPW and 9 used FSW.

Key message ESWT was shown to improve pain and function in low back pain patients

After treatment, patients in the ESWT group had, • Significantly lower scores in the visual analog scale (VAS) ,Oswestry disability index (ODI) and Beck depression inventory; • Significantly shorter finger-floor distance • Significantly higher Japanese orthopedic association (JOA) scores

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LASER THERAPY MECHANISMS OF ACTION

Laser therapy uses an induced emission of electromagnetic radiation to transfer energy to biological cells to stimulate photobiomodulation. For those photons to produce a biological response, they must be absorbed by the tissue. Chromophores absorb the light, which produces biological reactions.

• High-intensity laser therapy, also known as Photobiomodulation therapy (PBMT) can result in beneficial therapeutic outcomes such as the alleviation of pain, increased blood flow, muscle relaxation, and relief from joint stiffness. 3-4 Relieving pain and increasing muscle relaxation allows patients suffering from back and neck conditions to get more out of their therapy program which can lead to improved outcomes and an accelerated recovery. • PBMT is a form of light therapy based on the photochemical process called photobiomodulation (PBM). In PBMT, a light source is placed near or in contact with the skin. The light energy penetrates the skin, reaching the cell’s mitochondria and creating a cascade of biological responses. PBM-Mechanisms of Action The application of a therapeutic dose of light to impaired or dysfunctional tissue leads to a cellular response mediated by mitochondrial mechanisms involved in pain relief and tissue repair processes. 4 The primary target for the process is the cytochrome c complex which is found in the inner membrane of the cell mitochondria. Cytochrome c is a vital component of the electron transport chain that drives cellular metabolism. As light is absorbed, cytochrome c is stimulated, leading to increased production of adenosine triphosphate (ATP), the molecule that facilitates energy transfer within the cell.

In addition to ATP, laser stimulation also produces free nitric oxide and reactive oxygen species. Nitric oxide is a powerful vasodilator and an important cellular signaling molecule involved in many physiological processes. Reactive oxygen species have been shown to affect many important physiological signaling pathways including the inflammatory response. In concert, these molecules have been shown to increase growth factor production and promote extracellular matrix deposition. The resultant increase in cell proliferation and motility leads to pro-survival pathways for the cell. 4-6 Many electrotherapy interventions claim to influence pain but only a few have direct influence on nociceptors. LightForce Therapy is one of those and can provide both immediacy and long term pain relief. 7

The Thermal Effect of HILT Melanin, hair follicles, chromophores, and other superficial absorbers attract and absorb light during photobiomodulation treatments. The heat produced by class IV lasers is considered superficial heat. It will increase skin temperature, thus producing an additional analgesic effect. The thermal effect provides additional value to the biological process of photobiomodulation.

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HILT NECK PAIN RESEARCH Immediate effects of high-intensity laser therapy for nonspecific neck pain (NNP): a double-blind randomized controlled trial. Xie Y, Diao Y, Wu D, Liao M, Liao L. Rehabilitation Medicine Center, The First Dongguan Affiliated Hospital, Guangdong Medical University, Dongguan, China.

Read the full study at pubmed.ncbi.nlm.nih.gov/40313543/

Study design & methods Double-blinded Randomized Controlled Trial. (Patients and assessor blinding) Subjects: 28 patients diagnosed with NNP. Methods: subjects were allocated to either • HILT group (HILT+ exercise, n= 14), or • Placebo group (placebo-laser therapy+ exercise, n=14)

Results Upon initial comparison at baseline, no significant differences (p > 0.05) were observed between the two groups. • After treatment, both groups showed notable improvements in all outcome measures compared to baseline (p < 0.05) • The HILT group demonstrated greater efficacy compared to the placebo group in terms of VAS scores, cervical lateral flexion and neck muscle shear modulus • No statistically significant differences (p > 0.05) were identified between the groups in cervical flexion, extension, rotation, neck fascia stiffness and NDI scores.

HILT protocol: One treatment session Power: 8W

Mode: 2x 2 min resp. fast and slow scanning of the para vertebral region of both cervical vertebrae, interscapular region, trapezius, stemocleidomastoid, and pain trigger points ( 100 cm2); 6x 15 sec trigger point treatment on 6 TPs Total dose: 2x 1,025 J during scanning; 6x 125J during TP treatment Fluence: scanning: 10.25 J/cm2 Treatment time: total 6 min Outcomes: all participants underwent assessments both before treatment and 2 h after treatment Primary Pain intensity via the visual analogue scale (VAS O - 100)

Pain VAS

P = 0.001

54.64

53.57

43.57

29.64

POST

PRE

HILT

Placebo

Conclusion HILT has immediate efficacy for NNP and may be considered as one of the alternative interventions for NNP. Note: patient received only one treatment session and only the immediate effects were assessed. Key message This RCT showed that HILT was significantly more effective for immediate pain relief than placebo when added to exercise therapy.

Secondary •

Cervical active ROM

• Stiffness of neck muscles (splenius capitis, semispinalis capitis, and neck fascia), measured by Shear Wave Elastography (Ultrasound) • Functional disability via the neck disability index (NDI). Statistical evaluations were carried out using SPSS version 25.0, with a significance threshold established at p < 0.05.

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HILT NECK PAIN RESEARCH A systematic review and meta-analysis of randomized controlled trials on the effectiveness of high-intensity laser therapy in the management of neck pain

Hernán Andrés de la Barra Ortiz, Mariana Arias, Richard Eloin Liebano

Read the full study at pubmed.ncbi.nlm.nih.gov/38709332/

The authors conducted a systematic review and meta-analysis of 20 clinical trials that used high-intensity laser therapy (HILT) to treat neck pain.

Summary of outcome measures: •

Pain: Patients treated with HILT had a clinically significant reduction in pain after treatment when compared to patients treated with other physical therapy techniques. In studies where HILT was used in combination with other techniques such as exercise, transcutaneous electrical nerve stimulation, or ultrasound, a more significant analgesic effect was seen. The population experiencing the best results were those with chronic neck pain and myofascial pain.

• Range of Motion: Patients treated with HILT had a clinically significant improvement in their neck extension.

• Disability: Neck disability was significantly improved in patients that received treatment with HILT.

Take Home Message: • This extensive review concludes that HILT is effective at relieving neck pain and improving disability.

• HILT is effective when used alone. However, better outcomes may be achieved when using HILT in combination with stretching and exercise.

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Contact Enovis™ for more information about our portfolio of products for back and neck pain relief.

LightForce Therapy Lasers

LightForce XLi Therapy Laser | 40W

LightForce XPi Therapy Laser | 25W

LightForce FXi Therapy Laser | 15W

Chattanooga Shockwave Devices

Intelect® Mobile 2 RPW

Intelect® RPW2

Intelect® Focus Shockwave

Request a demonstration of a Chattanooga and Lightforce product at learn.chattanoogarehab.com/request-a-quote-ebook

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BETTER IS

CREATING THE NEXT GENERATION OF POSSIBLE. TOGETHER.

ABOUT ENOVIS™ Enovis™ (NYSE: ENOV) is a medical technology company focused on developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows.

Powered by a culture of continuous improvement, extraordinary talent and innovation, we ‘create better together’ by partnering with healthcare professionals. Our extensive range of products, services and integrated technologies fuel active lifestyles.

EGX is our unique business system that guides the way we operate. It provides the tools, techniques, and values that ensure we are continuously improving our ability to meet or exceed customer requirements each and every day.

ASSOCIATES 7,000+

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2022 REVENUE $1.6B

WE ARE UNIQUELY POSITIONED ACROSS THE ORTHOPEDIC CARE CONTINUUM

PREVENTION

REPAIR

RECOVERY

PERFORMAMCE • Athletic Braces • Muscle Stimulation

PREVENTION • Off-loading Braces

SURGICAL • Shoulder • Knees • Hips • Foot / Ankle

RECOVERY • Post-op Braces • Walker Boots • Cold Therapy

REHAB • Electrotherapy • Laser Therapy • Heat / Cold Therapy • Traction Devices

• Back Braces • Cold Therapy

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THANK YOU FOR READING

Request a demonstration of a Chattanooga product at learn.chattanoogarehab.com/request-a-quote-ebook

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Individual results may vary. Neither Enovis, DJO, LLC or any of their subsidiaries dispense medical advice. The contents of this document do not constitute medical, legal, or any other type of professional advice. Rather, please consult your healthcare professional for information on the courses of treatment, if any, which may be appropriate for you. MKT- 9401310114-EN – Rev A Copyright © 2025 DJO, LLC, a subsidiary of Enovis Corporation

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References: 1. d’Agostino MC, Craig K, Tibalt E, Respizzi S. Shock wave as biological therapeutic tool: From mechanical stimulation to recovery and healing, through mechanotransduction. Int J Surg. 2015;24(Pt B):147-153. doi:10.1016/j.ijsu.2015.11.030 2. Fuchs J. Stable vs. Transient Cavitation. CTG Technical Blog. Published January 17, 2019. Accessed December 18, 2023. https://techblog.ctgclean. com/2019/01/stable-vs-transientcavitation/#:~:text=Basically%2C%20the%20cavity%20is%20created%20but%20the%20contents 3. Anders JJ, Lanzafame RJ, Arany PR. Low-level light/laser therapy versus photobiomodulation therapy. Photomed Laser Surg. 2015;33(4):183-184. 4. Karu TI. Low power laser therapy. In: Vo-Dinh T, ed. Biomedical Photonics Handbook. 2nd ed. Boca Raton,FL: CRC Press; 2003: 48-1-48-25. 5. Hamblin MR, Demidova TN. Mechanisms of low level light therapy. Proc. of SPIE Photonics. 2006; 6140: 614001-01-12. 6. Chung H, Dai T, Sharma SK, Huang Y-Y, Carroll JD, Hamblin MR. The nuts and bolts of low-level laser (light) therapy. Ann Biomed Eng. 2012; 40(2): 516-533. 7. Zupin L, Ottaviani G, Rupel K, Biasotto M, Zacchigna S, Crovella S, Celsi F. (2019), Analgesic effect of Photobiomodulation Therapy: An in vitro and in

vivo study. J Biophotonics. Oct;12(10) 8. Data on file ENOVIS-S-INP-0007

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