Douglas Johnson, ATC, EES, CLS Vice President, Clinical and Scientific Affairs

1. Low Back Pain and MODALITIES Douglas Johnson, ATC, EES, CLS Vice President, Clinical and Scientific Affairs Multi Radiance Medical

2. Presenter: Douglas Johnson, ATC, EES, CLS Vice President, Clinical and Scientific Affairs Multi Radiance Medical

3. Does the Evidence Support What We Practice? • Discuss the quality of literature available for the use of modalities in spinal care • Compare various types of commonly used modalities • Introduce new modalities and treatment concepts • LAB: Demonstrate and administer protocols for low level laser therapy

4. Evidence Based Medicine: • Integration of: • Best Research Evidence • Clinical Expertise • Patient Values

5. Evidence Based Medicine: • Inherent Problems • Lack of sound evidence • Little or no clinical experience and/or expertise • Patient does not “want” it • Theory vs. Evidence

6. Philadelphia Panel - 2001 • Interventions • Massage • Thermal Therapy • Electrical Stimulation • EMG Biofeedback • TENS • Ultrasound • Therapeutic Exercise • Combination Therapy • Outcome Measures • Functional Status • Pain • Ability to Work • Patient Global Improvement • Patient Satisfaction • Quality of Life • Time Frames • Acute • Sub-Acute • Chronic • Post-Surgical

7. Philadelphia Panel - 2001 • Acute Low Back Pain (<4 weeks) • Ultrasound – 1 Non-randomized Controlled Trial • Continuous US vs. Placebo • No evidence to include or exclude alone • TENS – 1 RCT • 15 minutes of High Frequency, 15 minutes of AL TENS • No evidence to include or exclude alone • E-Stim, Massage, Thermotherapy, Biofeedback • Insufficient Data available • Sub-Acute Low Back Pain (4-12 weeks) • No data to evaluate effectiveness or efficacy of modalities

8. Philadelphia Panel - 2001 • Chronic Low Back Pain (>12 weeks) • Ultrasound – One RCT • Continuous US vs. placebo • No difference in pain improvement after 1 month • No other data reported • TENS – Four Controlled Clinical Trials • 2 trials used high frequency, 2 trials used low frequency • No difference in pain improvement at 1-month post therapy • No other data reported • Biofeedback – Five RCT’s • No effect on pain relief, functional status, or ROM after 1 month of therapy

9. Hurley, et al. Spine 2004 • RCT – Manipulative Therapy vs. Interferential Therapy vs. Combination for Acute LBP • 240 Subjects • Outcome Measures • Roland Morris Disability Questionnaire • VAS Pain Rating • SF-36 Questionnaire • Pain Medication Consumption • Methods • Manipulative Therapy vs. Pre-Modulated IFC vs. Combination Therapy • Average of 5 treatments over 5 weeks

10. Hurley, et al. Spine 2004 • Results • All subjects in all groups scored significantly “higher” at discharge, 6 months post-treatment, and 12 months post-treatment as compared with pre-treatment • No significant differences between groups at any data point post-treatment

11. Hurley, et al. Arch Phys Med Rehabil 2001 • RCT – IFT to painful area vs. IFT to Spinal Nerve vs. Control • 60 subjects with acute LBP • Outcome Measures • Pain Rating Index • Roland-Morris Disability Questionnaire • EuroQol • Methods • All subjects received educational material “The Back Book” • 3.85kHz carrier frequency, 140Hz “beat frequency” continuous, 30 minutes duration of treatment – altered method of application • Testing pre-treatment, at discharge, and at 3-months post-treatment

12. Hurley, et al. Arch Phys Med Rehabil 2001 • Results • All subjects displayed improvement at outcome measurement periods post-treatment • Subjects receiving spinal nerve IFT displayed statistically significant reduction in disability compared with painful area IFC and control

13. Hou, et al Arch Phys Med Rehabil 2002 • Large RCT • Various modalities for Cervical Myofascial Pain and Trigger Point Sensitivity • Multiple combinations of commonly used modalities/techniques • TENS 100Hz, 250μs, “strong but comfortable” 20 minutes • Results • Significant pain relief • TENS + ischemic compression • TENS + hot pack + AROM • IFC + hot pack + AROM

14. Moore, et al Arch Phys Med Rehabil 1997 • TENS vs. NMES vs. TENS + NMES for chronic back pain • TENS = 100Hz, 100μs “strong but comfortable” • NMES = 5sec on/15sec off, 70 Hz, 200μs • Alternated three 10 min periods of NMES with two 130min periods of no Rx • Combined TENS and NMES • Alternated one 10 minutes and two 20 minute periods of NMES with three periods of TENS • All three groups received 5 hours/day for 2 days • Subjects had 2 days between each modality • Results • Combined NMES/TENS produced best effects • Pain relief/reduction • TENS better than NMES alone for pain reduction

15. Treatment = + hot packs + EMS + ultrasound + massage + exercise + mobilization + cold packs + … Shotgun approach

16. Laser Therapy… • Over 3000 published articles on light therapy • Over 170 randomized, double blind studies • 200 studies are added each year to PubMed

17. Konstantinovic, et al Photomed Laser Surg 2010 Acute Low Back Pain with Radiculopathy: A Double-Blind, Randomized, Placebo-Controlled Study. • acute low back pain (LBP) with radiculopathy. • randomized, double-blind, placebo-controlled trial of 546 patients. • outcomes were VAS; lumbar movement, with a modified Schober test; Oswestry disability score; and SF-12 • Subjects were evaluated before and after treatment. • Statistically significant differences were found in all outcomes measured • The results of this study show better improvement in acute LBP treated with LLLT used as additional therapy.

18. TREATMENT OF NECK PAIN: NONINVASIVE INTERVENTIONSResults of the Bone and Joint Decade 2000–2010 Task Force on NeckPain and Its Associated Disorders Hurwitz and Carragee, Et All For WAD, educational videos, mobilization, and exercises appear more beneficial than usual care or physical modalities; for other neck pain, the evidence suggests that manual and supervised exercise interventions, low-level laser therapy, and perhaps acupuncture are more effective than no treatment, sham, or alternative interventions. However, none of the active treatments is clearly superior to any other in the short- or long-term.

19. Chow et al, The Lancet, 2009 • Efficacy of low-level laser therapy in the management of neck pain: a systematic review and meta-analysis of randomized placebo or active-treatment controlled trials • identified 16 randomized controlled trials including a total of 820 patients. • In acute neck pain, results of two trials showed a relative risk (RR) of 1·69 (95% CI 1·22—2·33) for pain improvement of LLLT versus placebo. Five trials of chronic neck pain reporting categorical data showed an RR for pain improvement of 4·05 (2·74—5·98) of LLLT. Patients in 11 trials reporting changes in visual analogue scale had pain intensity reduced by 19·86 mm (10·04—29·68). • Seven trials provided follow-up data for 1—22 weeks after completion of treatment, with short-term pain relief persisting in the medium term with a reduction of 22·07 mm (17·42—26·72). • Side-effects from LLLT were mild and not different from those of placebo. • LLLT reduces pain immediately after treatment in acute neck pain and up to 22 weeks after completion of treatment in patients with chronic neck pain.

20. Conclusions/Recommendation • Theory Vs. Evidence • While there may be inadequate evidence to support the use or non-use of a given modality, one must remember the theoretical model which caused one to consider the modality in the first place • Clinical Expertise vs. Best Research Evidence • If best evidence falls outside of clinical expertise, one must defer to the weaker or refer to the stronger • To Use or Not to Use • When in doubt, trust your clinical judgment over a single study

22. Understanding Laser Therapy and Other Modalities:

23. Understanding Laser Therapy and Other Modalities:

24. Understanding Laser Therapy and Other Modalities:

25. Oliveira et al Photomed Laser Surg 2009 • Assessment of cytoskeleton and endoplasmic reticulum of fibroblast cells subjected to low-level laser therapy and low-intensity pulsed ultrasound. • compare the effect of low-level laser therapy (LLLT) and low-intensity pulsed ultrasound (LIPUS) on the cytoskeleton and endoplasmic reticulum • Each group was irradiated at 24-h intervals, with the following post-treatment incubation times: 24, 48, and 72 h. • The effects were evaluated by the use of fluorescent probes and with fluorescence microscopy analysis. • both LLLT and LIPUS promote changes on the cellular level. • LIPUS revealed increased reticulum activity and increased protein synthesis • LLLT organized actin filaments better than LIPUS.

26. Dincer et al, Photomed Laser Surg. 2009 • The Effectiveness of Conservative Treatments of Carpal Tunnel Syndrome: Splinting, Ultrasound, and Low-Level Laser Therapies. • Abstract Objective: investigate the effectiveness of splinting, ultrasound (US), and low-level laser (LLL) in the management of CTS. • Materials and Methods: 100 hands of 50 women patients with bilateral CTS at 3 months post treatment, three groups, splinting only, splinting + US, and splinting + LLLT. Patients were assessed with the Boston Questionnaire, patient satisfaction inquiry, visual analogue scale for pain, and electroneuromyography. • Results and Conclusion: combinations of US or LLLT with splinting were more effective than splinting alone in treating CTS. However, LLLT + splinting was more advantageous than US + splinting, especially for the outcomes of lessening of symptom severity, pain alleviation, and increased patient satisfaction.

27. Cryotherapy Use laser therapy after due to vasoconstriction, it increases penetration Heat therapies (US- HP) Use laser therapy before, increased blood flow causes increased absorption of light by hemoglobin resulting in decreased penetration Electrical (EMS, TENS) Use laser therapy before (or during if LaserStim), increased blood flow causes increased absorption of light by hemoglobin Phono / Iontophoresis Use before steroid or anti-inflammatory agents, this modality lessens the cellular effects of laser therapy Manipulations May do before or after, depending on the specific goals of laser therapy Laser Therapy and Other Modalities:

28. Treat patients that other modalities can not: Pacemakers Implants - metal, joints, plastic Over boney prominences Peripheral vascular disease with decreased sensation When heat is contraindicated (if low level laser and super-pulsed only) Laser Therapy and Other Modalities:

29. Absolute Contraindications: Pregnancy Carcinoma Fever (body temperature higher than 38°c) Over hemorrhages Contraindications::North American Association of Laser TherapyMay, 2007; Tucson, Arizona, USA

30. Considerations: Anti-inflammatory medications Steroid Injections Photosensitive Patients Other Considerations: Wounds – ensure wound are completely cleaned from any topical applications and debrided prior to treatment Anticoagulants Tattoos Chronic musculoskeletal localized inflammation Considerations::North American Association of Laser TherapyMay, 2007; Tucson, Arizona, USA

31. Laser Therapy • What is Low Level Laser Therapy? • Understanding the parameters of laser therapy devices? • Optimal dosimetry for treatment of the spine

32. In 2003 North American Association of Laser Therapy (NAALT) adopted the terms Phototherapy or Photobiomodulation (PBM) PHOTOTHERAPY is: A therapeutic physical modality using photons of light from the visible red to the infrared spectrum for tissue healing and pain reduction, including five (5) different technologies: Low level lasers Non coherent narrow band light diodes Non coherent broad band light diodes Polarized light Photodynamic therapy Phototherapy:Definitions and Uses

33. Two Types of Lasers • High Powered Lasers • Heat tissue • Greater than 500 mW • Vaporize, coagulate and cut • Low Level Lasers • Minimal heating of tissue • Less than 500 mW of power • Photo-chemical and photo-physical effects TQ Solo Portable

34. Positive Results Use Appropriate: • Energy density • Wavelength • Schedule of treatments • Treatment technique • Dose Pro Sport Package

35. Webinars: • Misconceptions about Laser Therapy: How to improve clinical and business outcomes through New Hybrid Technology • Technology Advancements in Laser Therapy - Hybrid Solutions for Clinical Applications". • Energy density (Power) • Wavelength • Schedule of treatments http://www.multiradiance.com

36. Treatment Technique: “…applying a modality incorrectly is akin to not doing it at all…”

40. Divergence of Semiconductor Light, Photon Density and Target Distance:

44. Dosimetry: “…administering the optimal dose, each and every time, is the most difficult task of all…”

45. Treatment Protocols and Manuals:

46. General Treatment Strategies: • It should be noted that work by Dr. Tina Karu has shown that the biological response to laser stimulation can be significantly different according to the frequency in which different wavelengths are applied, and even non-existent if two or more continuous wavelengths are used simultaneously.

47. Dose Conversion:

48. OA of the Spine:

49. Spasm:

50. Lumbar Sprain: