Evaluation Of Clinical Data And Literature Review Low .

2y ago
24 Views
2 Downloads
460.33 KB
22 Pages
Last View : 15d ago
Last Download : 2m ago
Upload by : Ronan Orellana
Transcription

Evaluation Of Clinical Data and Literature Review Low Level Laser Therapy forB-CURE LASER LLLT808 0f GOOD ENERGIESPrepared by:Arnon D. Cohen, MD, MPH, PhD17/2 Yehoshua Bin-Nun St.Hod Hasharon 45236ISRAELe-mail: arcohen@clalit.org.ilTel: 972-50-6263848Fax: 972-3-7608612ForB-Cure Laser - LLLT 808Erika-Carmel LTD.www.gd-energies.comMonday , November 16,2009

Evaluation Of Clinical Data and Literature ReviewLow Level Laser TherapyB-CURE LASER LLLT808 0f GOOD ENERGIESPage 2 of 22Abstract B-CURE LASER (LLLT808 of GOOD ENERGIES) is a powerful hand heldsoft-laser medical device, with a peak power of 250 mW at wavelength of 808nm. In the following document we present evidence for the clinical use of the lowlevel laser therapy the following diseases: carpal tunnel syndrome,fibromyalgia, myofascial pain syndromes (e.g knee pain, low back pain,neck/upper back pain, muscle pain etc.), joint disorders/arthritis (e.gachilles tendinitis, tennis elbow etc.), medical skin conditions (e.g acne,vitiligo,herpes simplex, lymphedema, wound healing, fresh and old surgicalwounds or scars, skin wounds, burns etc.), cosmetic skin conditions (e.g.post-pregnancy stretch marks (striae gravidarum), skin rejuvenation, wrinklesand skin aging, skin sensitivity, etc.), inflammation, hemorrhoids,headache and dental diseases. A literature review has demonstrated the beneficial effect of LLLT in highquality clinical studies in all the above mentioned indications. B-Cure Laser is approved by the Standards Institution of Israel and by theIsraeli Ministry of Health. B-Cure Laser is being used in major hospitals and medical centers inIsrael as will be shown in the manuscript. Several other LLLT devices with similar technical specification have aCE mark (Timelas Vital, Mo-dulas Handy CW100, EKKy Lite and PowerLaser 105) as will be shown in the manuscript. The current application of B-Cure Laser device has superior power of 250mW as compared to lower power applied by the other CE approved devicescited above.

Evaluation Of Clinical Data and Literature ReviewLow Level Laser TherapyB-CURE LASER LLLT808 0f GOOD ENERGIESPage 3 of 22IndexCover page . .1Abstract . 2Index . 3Introduction . 4LLLT Devices . 4Therapeutic Mechanisms of LLLT . 4Indications for LLLT Use . 5B-Cure Laser – Product Description . 6B-Cure Laser – Technical Specifications . 7B-Cure Laser – Safety . 7Experience in B-Cure Laser Clinical Use in Israel . 9Literature review of the Indications for LLLT Use . .11CONCLUSION .11Reference List. 12Appendix 1: Table summarizing literature search . 16

Evaluation Of Clinical Data and Literature ReviewLow Level Laser TherapyB-CURE LASER LLLT808 0f GOOD ENERGIESPage 4 of 22IntroductionLow level laser therapy (LLLT), also called "cold laser therapy" and "low-power lasertherapy" (LPLT) is a light source treatment that generates a coherent light of a singlewavelength. LLLT uses red-beam or near-infrared lasers with a wavelength between600 and 1,000 nanometers (nm) and from 5 to 500 milliwatts. LLLT emits no heat,sound, or vibration. Instead of producing a thermal effect, LLLT acts byphotochemical reactions in the cells (bio-stimulation).LLLT DevicesThere are 2 kinds of LLLT devices:1. Point Lasers – with a treatment area of approximately 0.5 cm2.2. Clusters (shower type lasers) with generally 3 – 8 diodes covering largerareas, irradiating an area of 0.5 cm2 times the number of laser diodesLLLT devices include the following laser types:1. Gallium arsenide (GaAs) laser2. Gallium aluminum arsenide infrared semiconductor (GaAlAs) laser3. Helium neon (HeNe) laserTherapeutic Mechanisms of LLLTLLLT promotes healing and reduces pain through several therapeutic mechanisms:1. Stimulation of collagen production2. Alteration of DNA synthesis3. Improves the function of damaged neurological tissue4. Increased ATP production by the mitochondria and increased oxygenconsumption on the cellular level, which may result in muscle relaxation5. Increased serotonin and increased endorphins6. Increased anti-inflammatory effects through reduced prostaglandin synthesis7. Improved blood circulation to the skin in cases like neuralgia and diabetesmellitus8. Decreases permeability of the membrane of the nerve cells for Na/K causinghyperpolarisation9. Increased lymphatic flow and decreased edema

Evaluation Of Clinical Data and Literature ReviewLow Level Laser TherapyB-CURE LASER LLLT808 0f GOOD ENERGIESPage 5 of 22Indications for LLLT UseThe literature review supports the following indications for LLLT use (page 10,appendix 1)1. Carpal tunnel syndrome2. Fibromyalgia3. Myofascial pain syndromesa. Knee painb. Low back painc. Neck/upper back paind. Muscle pain4. Joint disorders (Arthritis)a. Achilles Tendinitisb. Tennis elbow5. Skin – Medical conditionsa. Acneb. Vitiligoc. Herpes simplexd. Lymphedemae. Wound healingf.Fresh and old surgical wounds or scarsg. Skin woundsh. Burns6. Skin – Cosmetic conditionsa. Post-pregnancy stretch marks (striae garvidarum)b. Skin rejuvenationc. Wrinkles and skin agingd. Skin sensitivity7. Inflammation8. Hemorrhoids9. Headache10. Dental diseases

Evaluation Of Clinical Data and Literature ReviewLow Level Laser TherapyB-CURE LASER LLLT808 0f GOOD ENERGIESPage 6 of 22B-Cure Laser – Product DescriptionThe LLLT device LLLT808 (Good Energies, B-Cure Laser) is a powerful portable(hand held) soft-laser medical device, with a peak power of 250 mW. B-Cure Laser808 wavelength is 808 nm, which is within the range of wavelengths known for besttissue penetration ability 800 – 830 nm.An innovative electro-optical mechanism, restricted to B-Cure Laser enables theproduction of an effective, homogenous, and very large coherent laser beam – withthe area of 4.5 cm2 (Patent Pending).The combination of the relatively high power with the wavelength of 808 nm, and theunique treatment area of 4.5 cm2, enables high quality and fast recovery in shorterindividual treatment times.In order to enable the device to treat the different kind of indications, two operationmethods were developed, unique to B-Cure Laser.1.Open wounds, burns, acne etc.: Pressing the treatment start button enables tooperate B-Cure Laser device without touching the skin. This method is indicated forlesions without direct contact of the treated area.2. Articular or muscle pain etc.: Pressing the device directly onto the skin ortreatment area for a deeper effective treatment

Evaluation Of Clinical Data and Literature ReviewLow Level Laser TherapyB-CURE LASER LLLT808 0f GOOD ENERGIESPage 7 of 22B-Cure Laser – Technical SpecificationsGaAlAs Infra-RedLaserOptical powerWavelength: 808 nm (810nm max)Laser IndicatorGreen Color LEDBeam Size45 mm x 5 mm ( Effective Beam Area )Beam DivergencePulse TimeDuty CycleLCD Display TimerPower SupplyPowerDimension /- 3.0 degree20 micro second25%30 min Timer with 30 second interval settingAC/DC Adaptor for charging (115/230VAC, 60 / 50Hz)Output 9V, 500mA3x 1.2V AAA Rechargeable batteries (Metal HybridNiCd or NiMH)Standby 32,768HzActive 2.0 MHzMax. 3.2W200 x 70 x 40 mmWeight650 gBatteryFrequency250 mW (Peak)B-Cure Laser – SafetyLaser Safety: The LLLT 808 is certified as CLASS 1 LASER PRODUCT by StandardInstitution of Israel (Certificate no.: 8412320697 Rev.1, Date of issue: 19/06/2008)according to the requirements of the standard: IEC 60825-1 "Safety of laserproducts" Part 1: "Equipment classification, Requirements and user's guide" Ed. 1.2;2001.Electromagnetic Compatibility: Positive Test Report # 200SJ 10·30-107026 ofShanghai Institute of Measurement and Testing Technology EMC Lab (NVLAP LabCode: 200632-0) according to the following standards: EN 55011:1998 A1:1999A2:2002 Information technology equipment – Radio disturbance characteristics Limits and methods of measurement; IEC 61000-4-2:2001 Electromagneticcompatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostaticdischarge immunity lest; IEC 61000-4-3: 2006 Electromagnetic compatibility (EMC) Part 4-3: Testing and measurement techniques · Radiated, radio-frequency,electromagnetic field immunity test; Refer to: IEC 60601-1-2:2001/A1:2004 Medical

Evaluation Of Clinical Data and Literature ReviewLow Level Laser TherapyB-CURE LASER LLLT808 0f GOOD ENERGIESPage 8 of 22Electrical Equipment - Part 1-2: General Requirements for Safety - Collateralstandard: Electromagnetic Compatibility Requirements and Tests (with Amendment1:2004).General safety: According to the standard: IEC/EN 60601-1 (1988) A1 (1991) A2(1995) Medical electrical equipment - Part 1-1: General requirements for safety Collateral standard: Safety requirements for medical electrical systems (tested byElectronics & Telematics Laboratory of Standards Institution of Israel):Class II medical equipment while connected with AC/DC AdaptorInternally powered equipment while not connected with AC/DC AdaptorApplied part BF

Evaluation Of Clinical Data and Literature ReviewLow Level Laser TherapyB-CURE LASER LLLT808 0f GOOD ENERGIESPage 9 of 22Experience in B-Cure Laser Clinical Use in IsraelB-Cure Laser is approved by the Standards Institution of Israel, and by the IsraeliMinistry of Health. B-Cure Laser is being used in 4 major hospitals in Israel: Tel-AvivMedical Center, Hadassah Medical Center, Rambam Medical Center, and ShebaMedical Center. The following table describes the clinical use of B-Cure Laser in themedical centers in Israel, having applied it for 6 minutes per treatment.NameTitle/Hospital/CityDiseaseNumber ofpatientsResultsDr. Ana sajinSpecialist inRehabilitation andPhysical MedicalHadassa Jerusalem40Prof. ElonEisenbergDr. V.ShabshayevitzDirector of the painclinic. A Dr. in the painClinic.Rambam/ HaifaSub-acute articularPains, Carpal TunnelSyndrome, MCI inPatients W/ subacute Inflammation.Acute and chronicneck pain, low backpain knee and otherArticular pains.Dr. Ittay GurAriehDirector, unit for paintreatment. ShebaHospital Tel-AvivPresident of the IsraeliPain Association.Articular pains andperipheral nervepains – occipitalneuralgia.50Rachel TiktinskyMPTThe directors ofHemophilia Center.Sheba Medical Center.Tel AvivHemophilia A Severeand Willebrandt type38Owns a private clinic, amember of the ALDAcademy of laserdentistry, a reviewer ofdental Journals.NetanyaPeriodontal disease,insertion of implants,surgical procedureswith stitches.8"The treatments for all thementioned indications werevery successful; The reductionof pain was very significant"."Nonegative side effects"."The apparatus exerted apositive effect on a substantialnumber of treated patients. It isour Intention to continue usingthis equipment in the RambamPain Clinic."There was a significant painreduction in the majority ofpatients treated with theapparatus (pain reduction by30% is consideredsignificant)"."No negative sideeffects occurred."Reduced pain on the VASScale from 9-10 to 5-6.Reduced swelling in the kneeby 0.5-2.5 cm. A substantialrange of motionimprovement."The laser isalmost an exclusive modalitythat is allowed to be used on ajoint that has undergonearthroplasty."There were no illside effects reported." "Thelaser adds a huge step forwardfor these patients; no otherreported modality has shownimprovement in so manymusculoskeletal areas in such ashort time frame.""Normally, a day after surgicalprocedure such as implants,Periimplantitis, epicoectomy,surgical extraction,, periodontalsurgery etc. the patientpresents swelling and pain.With the use of the GoodEnergies B-CURE laser, 6Prof. MichaelHeim400Prof. UriMartinowitzDr. AviReyhanian

Evaluation Of Clinical Data and Literature ReviewLow Level Laser TherapyB-CURE LASER LLLT808 0f GOOD ENERGIESNameDr. Le-OnGileadTitle/Hospital/CityHead of wound clinicCertified Dermatologistand MOHSSurgeon.Dpt. OfDermatology,Hadassah universityHospital / JerusalemDiseaseChondrodermatitishelicis nodularisPage 10 of 22Number ofpatients15Resultsminutes before and after and aday after, there was a positiveinfluence on the healingprocess of the hard and softtissue, in the mean of less painless swelling and the healingprocess was better and faster""No side effects." There washardly a need for pain killers.After the positive results – thefinal report relates to one caseonly: a 56 years old lady. "Iperformed surgery andremoved the involved skin andCartilage. The wound's healingprocess got very long despitesystemic and local antibiotictreatment. After noimprovement for weeks," Idecided to treat her with LLLT808. Within a number of days –two treatments a day, there wasa substantial improvement.After two weeks there was atleast 50% retreat in rednessand pain, and a week later itwas all gone – a completehealing and no sensitivity. Infour month follow up – anaffliction did not return."Inlight of the long procedure andthe condition of patient at thebeginning of treatment I haveno doubt that the recovery isonly due to the treatment withthe device."

Evaluation Of Clinical Data and Literature ReviewLow Level Laser TherapyB-CURE LASER LLLT808 0f GOOD ENERGIESPage 11 of 22Literature review of the Indications for LLLT UseThe strategy of literature review is as follows: PubMed (PubMed [Internet]. Bethesda(MD): National Library of Medicine. Available from: http://www.pubmed.gov/) wassearched for publications relevant to LLT use using the following terms: lasertherapy, low-level laser [MeSH], lasers, LLLT, randomized controlled trial, clinical trialand all the following clinical possible indications: carpal tunnel syndrome,fibromyalgia, myofascial pain, knee pain, low back pain, neck pain, upper back pain,muscle pain, arthritis, achilles tendinitis, tennis elbow, acne, vitiligo, herpes simplex,lymphedema, wound healing, surgical wounds, surgical scars, skin wounds, burns,post-pregnancy stretch marks, striae gravidarum, skin rejuvenation, wrinkles, skinaging, skin sensitivity, inflammation, hemorrhoids, headache and dental diseases.According the literature review, the beneficial effect of LLLT has been demonstratedin high quality clinical studies, in all the above mentioned indications. The results ofthe literature review appear in Appendix 1.Conclusion: The above mentioned literature review provide evidence basewhich indicates that B-Cure Laser LLLT 808 treatment is clinically effective inthe treatment of the following diseases: carpal tunnel syndrome, fibromyalgia,myofascial pain syndromes (e.g knee pain, low back pain, neck/upper backpain, muscle pain etc.), joint disorders/arthritis (e.g achilles tendinitis, tenniselbow etc.), medical skin conditions (e.g acne, vitiligo, herpes simplex,lymphedema, wound healing, fresh and old surgical wounds or scars, skinwounds, burns etc.), cosmetic skin conditions (e.g. post-pregnancy stretchmarks (striae gravidarum), skin rejuvenation, wrinkles and skin aging, skinsensitivity, etc.), inflammation, hemorrhoids, headache and dental diseases.

Evaluation Of Clinical Data and Literature ReviewLow Level Laser TherapyB-CURE LASER LLLT808 0f GOOD ENERGIESPage 12 of 22Reference List1. Altan L, Bingol U, Aykac M, Yurtkuran M. Investigation of the effect of GaAslaser therapy on cervical myofascial pain syndrome. Rheumatol Int 2005;25(1):23-27.2. Amorim JC, de Sousa GR, de Barros SL, Prates RA, Pinotti M, Ribeiro MS.Clinical study of the gingiva healing after gingivectomy and low-level lasertherapy. Photomed Laser Surg 2006; 24(5):588-594.3. Bakhtiary AH, Rashidy-Pour A. Ultrasound and laser therapy in the treatmentof carpal tunnel syndrome. Aust J Physiother 2004; 50(3):147-151.4. Basford JR, Sheffield CG, Harmsen WS. Laser therapy: a randomized,controlled trial of the effects of low-intensity Nd:YAG laser irradiation onmusculoskeletal back pain. Arch Phys Med Rehabil 1999; 80(6):647-652.5. Bayat M, Azari A, Golmohammadi MG. Effects of 780-nm Low-level LaserTherapy with a Pulsed Gallium Aluminum Arsenide Laser on the Healing of aSurgically Induced Open Skin Wound of Rat. Photomed Laser Surg 2009.6. Bingol U, Altan L, Yurtkuran M. Low-power laser treatment for shoulder pain.Photomed Laser Surg 2005; 23(5):459-464.7. Bjordal JM, Lopes-Martins RA, Iversen VV. A randomised, placebo controlledtrial of low level laser therapy for activated Achilles tendinitis withmicrodialysis measurement of peritendinous prostaglandin E2 concentrations.Br J Sports Med 2006; 40(1):76-80.8. Bjordal JM. Re: "low-level laser therapy and lateral epicondylitis" Maher S.Phys Ther. 2006;86:1161-1167. Phys Ther 2007; 87(2):224-225.9. Bjordal JM, Lopes-Martins RA, Joensen J et al. A systematic review withprocedural assessments and meta-analysis of low level laser therapy inlateral elbow tendinopathy (tennis elbow). BMC Musculoskelet Disord 2008;9:75.10. Brosseau L, Welch V, Wells G et al. Low level laser therapy for osteoarthritisand rheumatoid arthritis: a metaanalysis. J Rheumatol 2000; 27(8):19611969.11. Brosseau L, Welch V, Wells G et al. Low level laser therapy (Classes I, II andIII) for treating osteoarthritis. Cochrane Database Syst Rev2004;(3):CD002046.12. Brosseau L, Wells G, Marchand S et al. Randomized controlled trial on lowlevel laser therapy (LLLT) in the treatment of osteoarthritis (OA) of the hand.Lasers Surg Med 2005; 36(3):210-219.13. Brosseau L, Wells G, Marchand S et al. Randomized controlled trial on lowlevel laser therapy (LLLT) in the treatment of osteoarthritis (OA) of the hand.Lasers Surg Med 2005; 36(3):210-219.

Evaluation Of Clinical Data and Literature ReviewLow Level Laser TherapyB-CURE LASER LLLT808 0f GOOD ENERGIESPage 13 of 2214. Brosseau L, Robinson V, Wells G et al. Low level laser therapy (Classes I, IIand III) for treating rheumatoid arthritis. Cochrane Database Syst Rev2005;(4):CD002049.15. Carati CJ, Anderson SN, Gannon BJ, Piller NB. Treatment of postmastectomylymphedema with low-level laser therapy: a double blind, placebo-controlledtrial. Cancer 2003; 98(6):1114-1122.16. Chang WD, Wu JH, Jiang JA, Yeh CY, Tsai CT. Carpal tunnel syndrometreated with a diode laser: a controlled treatment of the transverse carpalligament. Photomed Laser Surg 2008; 26(6):551-557.17. Chow RT, Heller GZ, Barnsley L. The effect of 300 mW, 830 nm laser onchronic neck pain: a double-blind, randomized, placebo-controlled study. Pain2006; 124(1-2):201-210.18. de Bie RA, de Vet HC, Lenssen TF, van den Wildenberg FA, Kootstra G,Knipschild PG. Low-level laser therapy in ankle sprains: a randomized clinicaltrial. Arch Phys Med Rehabil 1998; 79(11):1415-1420.19. de Paiva Carvalho RL, Alcantara PS, Kamamoto F, Cressoni MD, CasarottoRA. Effects of Low-Level Laser Therapy on Pain and Scar Formation afterInguinal Herniation Surgery: A Randomized Controlled Single-Blind Study.Photomed Laser Surg 2009.20. Djavid GE, Mehrdad R, Ghasemi M, Hasan-Zadeh H, Sotoodeh-Manesh A,Pouryaghoub G. In chronic low back pain, low level laser therapy combinedwith exercise is more beneficial than exercise alone in the long term: arandomised trial. Aust J Physiother 2007; 53(3):155-160.21. Dundar U, Evcik D, Samli F, Pusak H, Kavuncu V. The effect of galliumarsenide aluminum laser therapy in the management of cervical myofascialpain syndr

Ministry of Health. B-Cure Laser is being used in 4 major hospitals in Israel: Tel-Aviv Medical Center, Hadassah Medical Center, Rambam Medical Center, and Sheba Medical Center. The following table describes the clinical use of B-Cure Laser in the medical centers in Israel, having applied i

Related Documents:

must include a clinical evaluation in accordance with Annex X. MDD 93/42/EEC clinical evaluation: not a one-time isolated activity Clinical evaluation is defined as the assessment and analysis of clinical data pertaining to a medical device in order to verify its clinical safety and performance when used as intended. Two key elementsFile Size: 864KB

clinical data and clinical evaluation Devices may be at different points in their lifecycle (design and development, CE marking, maintenance of CE mark), with some requiring initial clinical evaluation and others clinical evaluation update May be difficult to ha

The Clinical Program is administered by the Clinical Training Committee (CTC) under the leadership of the Director of Clinical Training (DCT) and the Associate Director of Clinical Training (ADCT). The program consists of three APA defined Major Areas of Study: Clinical Psychology (CP), Clinical Child Psychology (CCP), Clinical Neuropsychology .

The Clinical Laboratory Evaluation Program The Clinical Laboratory Evaluation Program (CLEP) administers the activities of the Clinical Laboratory Reference System and provides the oversight of over 1,000 clinical laboratories and blood banks, including out-of-state facilities that accept clinical specimens collected in New York State.

Clinical Investigation of Medical Devices for Human Subjects Good Clinical Practice NB-MED/2.7/Rec 3 (1999) Notified Bodies’ Recommendations on the Evaluation of Clinical Data MEDDEV 2.7.1 Rev 3 (December 2009) European Commissions Guidelines on Medical Devices: Evaluation of Clinical

Annex X, Clinical Evaluation, Section 1.1b-1.1c “The clinical evaluation and its outcome shall be documented. This documentation shall be included and/or fully referenced in the technical documentation of the device.” “The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance.File Size: 1MB

MEDDEV 2.7.1 is the key document for the clinical evaluation of medical devices Context of Clinical Evaluation according to guideline 93/42/ECC Aim of the MEDDEV 2.7.1: Assistance for manufacturers concerning the evaluation of clinical data Notified Bodies concer

Title: ER/Studio Data Architect 8.5.3 Evaluation Guide, 2nd Edition Author: Embarcadero Technologies, Inc. Keywords: CA ERwin data model software Data Modeler data modeler tools data modelers data modeling data modeling software data modeling tool data modeling tools data modeling with erwin data modelings data modeller data modelling software data modelling tool data modelling