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Integrative Approaches to Spine Pain Carolyn E. Keeler, DO, FAAPMR Physical Medicine & Rehabilitation Assistant Professor Division of Neurosurgery Duke University Medical Center
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“Complementary” vs. “Alternative” Complementary medicine is used alongside conventional medicine. Alternative medicine is used in place of conventional medicine. Integrative medicine combines conventional and CAM treatments for which there is evidence of safety and effectiveness. National Institute of Health Center for Complementary and Alternative Medicine
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Integrative Medicine Philosophy: neither rejects conventional medicine nor accepts alternative medicine uncritically Recognition that good medicine should be inquiry driven, based in good science and open to new paradigms
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Complementary and Alternative Treatment Use 2007 National Health Interview Survey Information collected: 23,000+ adults aged 18 years or older 9,000+ children aged 17 years and under.
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CAM Therapies Included in the 2007 NHIS Acupuncture Ayurveda Biofeedback Chelation therapy Manipulation/ Manual medicine Energy healing therapy/Reiki Movement therapies Naturopathy Traditional healers Hypnosis Massage
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CAM Therapies Included in the 2007 NHIS Deep breathing exercises Progressive relaxation Qi gong Tai chi Diet-based therapies Meditation Yoga Guided imagery Homeopathic treatment Natural products
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Reasons patients don’t tell us about CAM use "It wasn't important for the doctor to know" (61%) "The doctor never asked" (60%) "It was none of the doctor's business" (31%) "The doctor would not understand" (20%) “The doctor would disapprove” (14%) Respondents felt CAM therapies to be more helpful for the treatment of headache and neck and back conditions, but considered conventional care to be more helpful for treatment of hypertension. Eisenberg DM. Ann Int Med 2001;135(5):344-51
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Treatment of Back and Neck Pain: Range of Evidence Diet/Nutrition Supplements Botanicals Acupuncture Spinal manipulation Yoga Mind-body interventions
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American College of Physicians/American Pain Society 2007 clinical guidelines: Low back pain Promising, beneficial Acupuncture Massage Spinal manipulation CBT Exercise Progressive relaxation Intensive interdisciplinary rehabilitation Yoga Limited, mixed, or none Herbal therapies Prolotherapy “Doctors and patients should consider the following nondrug treatments for patients who do not respond to self-care: rehabilitation, spinal manipulation, exercise therapy, massage, acupuncture, yoga, progressive relaxation, or cognitive-behavioral therapy.” Ann Intern Med. 2 October 2007;147(7):I- 45
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American College of Physicians/American Pain Society 2007 clinical guidelines: Neck pain Mixed evidence Manual therapy (manipulation and mobilization) Acupuncture Chronic tension-type or cervicogenic headaches: possible benefit. No overall consensus, need for additional research
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Problems with research Difficulty blinding practitioner Difficulty blinding participants Issues with sham treatments Individualized treatments Standardization of botanicals Placebo Spine pain subgroups
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"No illness which can be treated by the diet should be treated by any other means." ~ Moses Maimonides (1135-1204) DIET
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Dietary Basics Spinal structures require proper nutrition to function property Lean meats, fish, legumes Vitamin B12 Calcium, vitamin D, and magnesium
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Anti-inflammatory Diet http://www.drweil.com/drw/u/ART02995/Dr-Weil-Anti-Inflammatory- Food-Pyramid.html
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Mediterranean Diet http://oldwayspt.org/resources/heritage-pyramids
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Dietary Supplement Fact Sheet: Calcium Recommended Dietary Allowances (RDAs) for Calcium AgeMaleFemalePregnantLactating 0–6 months*200 mg 7–12 months*260 mg 1–3 years700 mg 4–8 years1,000 mg 9–13 years1,300 mg 14–18 years1,300 mg 19–50 years1,000 mg 51–70 years1,000 mg1,200 mg 71+ years1,200 mg *adequate intake ods.od.nih.gov/factsheets/Calcium-HealthProfessional/
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Calcium Deficiency risk factors Women Vegan Lactose-intolerance Amenorrhea Medication affecting absorption/excretion Corticosteroids Aromatase inhibitors, Anticonvulsants Thiazide-type diuretics Tetracycline Aluminum or magnesium- containing antacids
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Calcium and Vitamin D FDA authorized health claim for food and supplements related to osteoporosis: 1993: Calcium and balanced diet 2010: Calcium + vitamin D Calcium absorption can be enhanced by increased vitamin D intake from food or through sunlight exposure Wimalawansa SJ. Annals of the New York Academy of Sciences, 2011
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Dietary Resources http://www.choosemyplate.gov /index.html http://www.mayoclinic.com/hea lth/nutrition-facts/ http://health.gov/dietaryguidelines/
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DIETARY SUPPLEMENTS
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Regulation Dietary Supplement Health Education Act in 1994 FDA Current Good Manufacturing Practices in 2007
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Supplement Labels DSHEA and previous food labeling laws: three types of claims permitted by the FDA 1.Nutrient content claims 2.Health claims (that a substance has impact on a disease) 3.Structure/function claims
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Quality and Safety United States Pharmacopeia (USP) United States Pharmacopeia National Sanitation Foundation (NSF International) National Sanitation Foundation Consumer Labs
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Botanicals History: Ancient Egypt, Greece, Rome, India, China and the Middle East Rich oral traditions of Africa and the Americas Current US (2007) Rising popularity $15 billion USD
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Botanicals Adverse Effects Systematic review of complementary and alternative therapies Most reported adverse effects were associated with herbal medicines when compared to other CAM therapies Ernst E. Serious adverse effects of unconventional therapies for children and adolescents: a systematic review of recent evidence. European journal of pediatrics 2003
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Safety of Botanicals Adulterated or contaminated ingredients Inappropriate use Pregnancy, nursing, children or elderly More concentrated products Safety Quality Herb-drug interactions http://reference.medscape.com/drug- interactionchecker
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Efficacy: Research challenges Systematic Reviews & Meta-Analyses of Botanicals Biological & Pharmaceutical Equivalence Single Herb vs. Formulation Individualization Dose Mechanism of Action
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Common Supplements used for Pain and/or Arthritis Fish oil (Omega-3 FA) Vitamin D ASUs SAM-e Glucosamine & Chondroitin Devil’s Claw Bromelain Turmeric Willow Ginger Rhodiola Topicals Arnica, Capsaicin, Comfrey
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Omega-3 Fatty Acids EPA and DHA Enhance the conversion of COX to prostaglandin E2 competitive inhibition of AA Inhibition of inflammatory cytokines Inhibit conversion of AA to inflammatory leukotrienes
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Omega-3 Fatty Acids 250 patients with cervical and lumbar disc disease taking NSAIDs 59% were able to discontinue NSAIDs 60% reported improvement in pain Dosage 1200-2400mg of EPA and DHA per day Maroon JC, Bost JW. Omega-3 fatty acids (fish oil) as an antiinflammatory: An alternative to nonsteroidal anti-inflammatory drugs for discogenic pain. Surg Neurol. 2006.
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Avocado Soybean Unsaponafiables Inhibit IL-1 synthesis Anti-inflammatory effect Articular chondrocytes ASU 300 mg vs. placebo in hip and knee OA Decreased pain Reduced NSAID use Ernst, E. Avocado-soybean unsaponifiables (ASU) for osteoarthritis - a systematic review. Clin Rheumatol. 2003
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SAM-e S-adenosyl-L-methionine From essential AA methionine Methyl donor in various biochemical pathways Synthesis linked to vitamin B12, folate Initially studied in depression found improvement in arthritis pain
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SAM-e Meta-analysis conducted by the AHRQ Several randomized clinical trials More effective than placebo and comparable to NSAIDs in reducing osteoarthritis pain S-Adenosyl-L-Methionine (SAMe) for Depression, Osteoarthritis, and Liver Disease. Rockville, MD: Agency for Healthcare Research and Quality August 2002
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SAM-e SAMe 1,200 mg/d vs. celecoxib 200 mg per day Celecoxib more effective than SAM-e in reducing pain during the first month of treatment After two months of use, no difference in pain relief was noted between the two agents Najm WI, Reinsch S, Hoehler F, Tobis JS, Harvey PW. S-adenosyl methionine (SAMe) versus celecoxib for the treatment of osteoarthritis symptoms: a double-blind cross- over trial. BMC musculoskeletal disorders 56 Feb, 2004
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Vitamin D Osteoporosis Long-term effect of deficiency Older adults Non-ambulatory individuals who have difficulty exercising Postmenopausal women Chronic steroid therapy http://ods.od.nih.gov/factsheets/VitaminD-QuickFacts/
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Vitamin D 360 people, low back pain >6 months, age 15 to 52 83% had an abnormally low level of vitamin D before treatment with vitamin D supplements. After treatment, clinical improvement in symptoms was seen in all the groups with low level of vitamin D. Vitamin D deficiency is a contributor to chronic low back pain in areas where vitamin D deficiency is endemic. Al Faraj S, Al Mutairi K. Vitamin D deficiency and chronic low back pain in Saudi Arabia. Spine. 2003 Jan 15; 28(2):177-9.
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Devil’s Claw Harpagophytum procumbens Native to Southern Africa Back pain specific studies, also OA Side effects: GI upset Avoid in PUD
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Devil’s Claw: Systematic Review Harpagophytum procumbens for osteoarthritis and low back pain: a systematic review. Gagnier JJ, Chrubasik S, Manheimer E. BMC Complement Altern Med. 2004 12 trials, 4 studied low back pain Moderate evidence of effectiveness Aqueous extract 100 mg harpagoside/day in the treatment of acute exacerbations of chronic non-specific LBP 60 mg was equivocal to 12.5 mg rofecoxib per day for chronic non-specific low-back pain (short term) Strong evidence: 50 mg / day for acute exacerbations of chronic low back pain.
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Willow Bark Salix alba Among many salicin- containing plants Salicin levels vary widely across species Not everyone can convert to salicylic acid Studies provide mixed results Poor methodology Likely safe: less inhibition of platelet aggregation than 100mg ASA
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Willow Bark Salix alba Two moderate-quality trials utilizing Salix alba (White willow bark) Moderate evidence for short-term improvement in pain and rescue medication use Daily doses standardized to 120 mg or 240 mg Salicin with an additional trial demonstrating relative equivalence to 12.5 mg per day of rofecoxib Herbal medicine for low back pain: a Cochrane review. Spine (Phila Pa 1976). 2007 Jan 1 ;32(1):82-92.
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Turmeric Curcuma longa Flowering plant- Ginger family Common spice Ayurveda, TCM Anti-inflammatory, antioxidant effects Ongoing clinical trials, emerging data
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Turmeric SAFETY Safe for most adults Indigestion, nausea, diarrhea Liver disease (animal studies) Gallbladder disease Use: Standardized turmeric powder 400–600 three times/day Caution: Anticoagulants or high doses of NSAIDS May be used in combination with lower doses of NSAIDs
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Turmeric Curcuma longa Standardized turmeric powder 400–600 three times/day Side effects: GI upset, gastric ulcers (high doses). Caution: anticoagulants or high doses of NSAIDS. May be used in combination with lower doses of NSAIDs
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Specific Safety Concerns: Interventional Procedures & Surgery ANTICOAGULATION Devil’s claw Ginger Turmeric Ginseng Garlic Ginkgo Omega-3 fatty acids Chamomile Feverfew Others STEROIDS Ginseng (potentiates) Echinacea (decreased effect)
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Acupuncture Yellow emperor’s classic of internal medicine >2300 years ago Qi Meridians Sir William Osler 19 th century France 1950s
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Acupuncture 1971- US Appendectomy under acupuncture anesthesia in China 1997 NIH consensus
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Mechanisms Augmentation of Immunity Theory Endorphin Theory Neurotransmitter Theory Circulatory Theory Gate Control Theory
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Complications Pneumothorax Organ injury Vascular injury Infection Bleeding/bruising
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Contraindications Electro acupuncture -> pacemakers/ implantable defibrillators. Bleeding disorders? Infection Recent total joint arthoplasty
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Research challenges Many clinical trials for spinal pain Double-blind and sham controlled trials difficult to design and to perform Meta-analyses show conflicting results ? Expectations
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Acupuncture and neck pain Moderate evidence: More effective for pain relief than sham controls, (measured immediately post-treatment) More effective than sham treatments measured immediately post-treatment and at short-term follow-up Chronic neck disorders with radicular symptoms: acupuncture was more effective than a wait-list control at short-term follow-up Trinh K, Graham N, Gross A, Goldsmith C, Wang E, Cameron I, Kay T. Acupuncture for neck disorders. Spine 2007 Jan 15 ;32(2):236-43.
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Acupuncture and back pain Moderate evidence - more effective than no treatment Strong evidence No significant difference between acupuncture and sham acupuncture (short-term) Useful supplement to other forms of conventional therapy for nonspecific LBP Yuan J, Purepong N, Kerr DP, Park J, Bradbury I, McDonough S. Effectiveness of acupuncture for low back pain: a systematic review. Spine 2008 Nov 1; 33(23):E887- 900.
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Acupuncture and back pain Chronic low back pain: pain relief and functional improvement for acupuncture compared to no treatment or sham (post-treatment, short-term follow-up) Acupuncture + conventional therapies: pain relief and functional improvement superior to conventional therapies alone (small effect) Dry-needling - useful adjunct to other therapies for chronic low back pain. Acupuncture and dry-needling for low back pain: an updated systematic review within the framework of the Cochrane collaboration. Furlan AD, van Tulder M, Cherkin D, Tsukayama H, Lao L, Koes B, Berman B. Spine (Phila Pa 1976). 2005 Apr 15; 30(8):944- 63.
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Agency for Healthcare Research and Quality (US) Agency for Healthcare Research and Quality (US) Acupuncture: lower pain intensity than placebo but only immediately post-treatment Sham acupuncture studies: negative results Compared with placebo or other treatment Furlan AD, Yazdi F, Tsertsvadze A, et al. Complementary and Alternative Therapies for Back Pain II. Rockville (MD): Agency for Healthcare Research and Quality (US); 2010 Oct. Systematic review: acupuncture, spinal manipulation, mobilization, and massage spinal pain. 265 RCTs and 5 non-RCTs Systematic review: acupuncture, spinal manipulation, mobilization, and massage spinal pain. 265 RCTs and 5 non-RCTs
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Barriers Insurance coverage? Out of pocket cost
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Nonresponders Possible factors Chronicity Opioid use Other…
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SPINAL MANIPULATION Osteopathy Chiropractic Physical Therapy Massage Therapy Ultimate goal -> correct imbalances in the musculoskeletal system to improve health and function
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Spinal Manipulation: Credentialing Osteopathic Certificate of Special Proficiency in Osteopathic Manipulative Medicine Board Certification in Neuromusculoskeletal Medicine American Academy of Osteopathy Chiropractic Licensure by state Variation from state to state Scope of practice: generally limited to neuromusculoskeletal system diagnosis, treatment Massage Therapy 500 hours State licensure AMTA
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Contraindications: Manipulation Fracture DVT Systemic anticoagulation treatment Vertebrobasilar disease or insufficiency Ligamentous joint instability or laxity Aseptic necrosis Local aneurysm Osteoporosis, osteomalacia Malignancy Acute disk herniation
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Complications Reporting inconsistent Soreness or bleeding on the site of application after acupuncture Worsening of pain after manipulation or massage Cervical manipulation (HVLA): significantly associated with vertebral artery dissection or vertebrobasilar stroke
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Research Unique challenges Double-blinded placebo-controlled trials Random selection and random assignment Patient preference trial Clinical effectiveness vs. mechanism Heterogeneity Natural history
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Efficacy of Manipulation Low back pain Mix of acute and chronic LBP similar or superior pain outcomes in the short and long term when compared with placebo and with other conventional treatments Bronfort G, Haas M, Evans RL, Bouter LM. Efficacy of spinal manipulation and mobilization for low back pain and neck pain: a systematic review and best evidence synthesis. Spine J. 2004 May-Jun ;4(3):335-56.
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Efficacy of Manipulation Chronic low back pain Moderate evidence: Similar efficacy to NSAIDs Effective in the short term when compared with placebo and general practitioner care, and in the long term compared to physical therapy. Bronfort G, Haas M, Evans RL, Bouter LM. Efficacy of spinal manipulation and mobilization for low back pain and neck pain: a systematic review and best evidence synthesis. Spine J. 2004 May-Jun ;4(3):335-56.
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Efficacy of Manipulation and Mobilization Neck pain Acute: Few studies, inconclusive evidence Chronic: Moderate evidence that manipulation/mobilization is superior to general practitioner management for short- term pain reduction Manipulation offers at most similar pain relief to rehabilitation exercises (short and long term) Bronfort G, Haas M, Evans RL, Bouter LM. Efficacy of spinal manipulation and mobilization for low back pain and neck pain: a systematic review and best evidence synthesis. Spine J. 2004 May-Jun ;4(3):335-56.
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Manipulation Low back and neck: superior to placebo or no treatment in reducing pain immediately or short-term Chronic nonspecific low back pain: Manipulation appeared effective in improving pain and function Furlan AD, Yazdi F, Tsertsvadze A, et al. Complementary and Alternative Therapies for Back Pain II. Rockville (MD): Agency for Healthcare Research and Quality (US); 2010 Oct.
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Issues Evidence was of poor to moderate grade Most studies: chronic nonspecific pain Subgroup effects: insufficient data The benefit of CAM treatments was mostly evident immediately or shortly after the end of the treatment and then faded with time. Long-term outcomes? Methodological and clinical diversity Furlan AD, Yazdi F, Tsertsvadze A, et al. Complementary and Alternative Therapies for Back Pain II. Rockville (MD): Agency for Healthcare Research and Quality (US); 2010 Oct.
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YOGA
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Yoga Styles Hatha yoga Iyengar Vinyasa Ashtanga Power yoga Bikram yoga Viniyoga
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Yoga Clinically significant improvement in functional outcomes in mild-moderate LBP and fibromyalgia Trend to improvement in kyphosis Improved pain in OA, RA and mild-severe LBP Psychosocial outcomes were significantly improved in mild-to-moderate LBP and OA Meta-analysis: moderate treatment effect for yoga Yoga for Functional Ability, Pain and Psychosocial Outcomes in Musculoskeletal Conditions: A Systematic Review and Meta-Analysis. Musculoskeletal Care. 2013 Jan 9.
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Yoga Systematic review, chronic LBP 10 trials, 967 patients Outcomes: pain, back-specific and general disability, QOL Strong evidence for long-term effect on pain Moderate evidence for long-term effect on back-specific disability Cramer H, Lauche R, Haller H, Dobos G. A Systematic Review and Meta- analysis of Yoga for Low Back Pain. Clin J Pain. 2012 Dec 14.
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MIND-BODY
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Mindfulness-Based Stress Reduction Chronic low back pain 3 RCTs, 117 chronic low back pain patients FBSS: significant and clinically important short- term improvements in pain intensity and disability for MBSR compared to no treatment Older adults with chronic specific or non-specific SBP: no improvements in pain or disability for MBSR compared to no treatment or health education Larger short-term improvements of pain acceptance for MBSR compared to no treatment. Cramer H, Haller H, Lauche R, Dobos G. Mindfulness-based stress reduction for low back pain. A systematic review. BMC Complement Altern Med. 2012; 12: 162.
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Cognitive-Behavioral Therapy Systematic review, 46 studies included CBT -> beneficial treatment for chronic back pain, especially when compared to wait-list controls/treatment as usual. Sveinsdottir et al. Assessing the role of cognitive behavioral therapy in the management of chronic nonspecific back pain. J Pain Res. 2012
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Current NCCAM Funded Research Chronic low-back pain: acupuncture, massage, spinal manipulation, yoga Osteoarthritis pain: prolotherapy, tai chi, and yoga Chronic neck pain: massage Chronic headaches: acupuncture, spinal manipulation Fibromyalgia pain: acupuncture, tai chi
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Future research Valid experimental design Pretesting and post-testing Appropriate sample sizes and statistical analysis methods Reliable and valid measurement Standardization of duration and frequency of treatment Attempt to control placebo
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RESOURCES NIH National Center for Complementary and Alternative Medicine http://nccam.nih.gov/ http://nccam.nih.gov/ Agency for Healthcare Research and Quality http://www.ahrq.gov/clinic/epcindex.htm http://www.ahrq.gov/clinic/epcindex.htm Consumer Lab www.consumerlab.comwww.consumerlab.com Natural Medicines Comprehensive Database www.naturaldatabase.com www.naturaldatabase.com The Natural Standard www.naturalstandard.comwww.naturalstandard.com NIH Office of Dietary Supplements http://ods.od.nih.gov/http://ods.od.nih.gov/ Memorial Sloan Kettering Cancer Center: Herbs and supplements www.mskcc.org/cancer-care/integrative-medicine www.mskcc.org/cancer-care/integrative-medicine My Plate http://www.choosemyplate.gov/index.htmlhttp://www.choosemyplate.gov/index.html American Academy of Medical Acupuncture www.medicalacupuncture.org www.medicalacupuncture.org
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References Barnes PM, Bloom B, Nahin R. CDC National Health Statistics Report #12. Complementary and Alternative Medicine Use Among Adults and Children: United States, 2007. December 10, 2008 Eisenberg et. al. Perceptions about complementary therapies relative to conventional therapies among adults who use both: results from a national survey. Ann Intern Med. 2001 Sep 4 ;135(5):344-51. Chou R, Huffman LH: Nonpharmacologic therapies for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med 2007:147(7):492-505 Chou R, Qaseem A, Snow V, Casey D, Cross JT, Shekelle P, Owens DK Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med 2007 147(7)478-91 Ernst E. Serious adverse effects of unconventional therapies for children and adolescents: a systematic review of recent evidence. European journal of pediatrics 2003 Wimalawansa SJ. Vitamin D: an essential component for skeletal health. Annals of the New York Academy of Sciences 1240E1-12 Dec, 2011 Cramer et. al.,. S-Adenosyl-L-Methionine (SAMe) for Depression, Osteoarthritis, and Liver Disease. Rockville, MD: Agency for Healthcare Research and Quality August 2002 Ernst, E. Avocado-soybean unsaponifiables (ASU) for osteoarthritis - a systematic review. Clin Rheumatol. 2003 Oct ;22(4-5):285-8. Najm WI, Reinsch S, Hoehler F, Tobis JS, Harvey PW. S-adenosyl methionine (SAMe) versus celecoxib for the treatment of osteoarthritis symptoms: a double-blind cross-over trial. BMC Musculoskelet Disord. 2004 Feb 26 ;5:6. Al Faraj S, Al Mutairi K. Vitamin D deficiency and chronic low back pain in Saudi Arabia. Spine. 2003 Jan 15; 28(2):177-9.
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Gagnier JJ, Chrubasik S, Manheimer E. Harpagophytum procumbens for osteoarthritis and low back pain: a systematic review. BMC Complement Altern Med. 2004 Sep 15; 4:13. Epub 2004 Sep 15. Hurwitz EL, Aker PD, Adams AH, Meeker WC, Shekelle PG. Manipulation and mobilization of the cervical spine: a systematic review of the literature. Spine 1996;21:1746-1760 Curtis CL, Rees SG, Little CB, Flannery CR, Hughes CE, Wilson C, et al. Pathologic indicators of degradation and inflammation in human osteoarthritic cartilage are abrogated by exposure to n-3 fatty acids. Arthritis Rheum. 2002;46:1544–53. Maroon JC, Bost JW. Omega-3 fatty acids (fish oil) as an anti-inflammatory: an alternative to nonsteroidal anti-inflammatory drugs for discogenic pain. Surg Neurol. 2006 Apr; 65(4):326-31. Furlan AD, Yazdi F, Tsertsvadze A, et al. Complementary and Alternative Therapies for Back Pain II. Rockville (MD): Agency for Healthcare Research and Quality (US); 2010 Oct. Trinh K, Graham N, Gross A, Goldsmith C, Wang E, Cameron I, Kay T. Acupuncture for neck disorders. Spine 2007 Jan 15 ;32(2):236-43. Yoga for Functional Ability, Pain and Psychosocial Outcomes in Musculoskeletal Conditions: A Systematic Review and Meta-Analysis. Musculoskeletal Care. 2013 Jan 9. Cramer H, Lauche R, Haller H, Dobos G. A Systematic Review and Meta-analysis of Yoga for Low Back Pain. Clin J Pain. 2012 Dec 14. Mindfulness-based stress reduction for low back pain. A systematic review. BMC Complement Altern Med. 2012 Sep 25 ;12:162. doi: 10.1186/1472-6882-12-162. Cramer H, Haller H, Lauche R, Dobos G. Mindfulness-based stress reduction for low back pain. A systematic review. BMC Complement Altern Med. 2012; 12: 162. Sveinsdottir et al. Assessing the role of cognitive behavioral therapy in the management of chronic nonspecific back pain. J Pain Res. 2012
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Thank you! carolyn.keeler@duke.edu
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