K30 case study: innovative treatment approach to myofascial neck pain Marc Brodsky, MD UCLA Center...
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Transcript of K30 case study: innovative treatment approach to myofascial neck pain Marc Brodsky, MD UCLA Center...
K30 case study: innovative K30 case study: innovative treatment approach to treatment approach to myofascial neck painmyofascial neck pain
Marc Brodsky, MDMarc Brodsky, MD
UCLA Center for East-West MedicineUCLA Center for East-West Medicine
May 27, 2008May 27, 2008
Patient presentationPatient presentation
24 yo female medical 24 yo female medical student with a one-student with a one-year h/o neck pain that year h/o neck pain that began during a time of began during a time of intense stress during a intense stress during a visit with her parentsvisit with her parents
DyspepsiaDyspepsia Constipation Constipation DysmenorrheaDysmenorrhea Dry, red eyesDry, red eyes Cold intoleranceCold intolerance InsomniaInsomnia
Mechanistic (parts, Mechanistic (parts, objects, contents)objects, contents)
Problems in Problems in isolationisolation
Analytical thinkingAnalytical thinking
Treatment aims to Treatment aims to block, stimulate, or block, stimulate, or replacereplace
Holistic (whole, Holistic (whole, relationships, relationships, patterns)patterns)
Problems of the Problems of the systemsystem
Principles of Principles of organizationorganization
Treatment Treatment emphasizes self-emphasizes self-healing healing
How is CAM classified?How is CAM classified?
ttp://nccam.nhih.gov/
Integrative MedicineIntegrative Medicine
Healing oriented medicine that takes account of the whole Healing oriented medicine that takes account of the whole person (body, mind and spirit) including all aspects of lifestyle. It person (body, mind and spirit) including all aspects of lifestyle. It emphasizes the therapeutic relationship and makes use of all emphasizes the therapeutic relationship and makes use of all appropriate therapies, both conventional and alternative.appropriate therapies, both conventional and alternative.
Curriculum in Integrative Medicine: A Guide for Medical EducatorsCurriculum in Integrative Medicine: A Guide for Medical Educators. 2003, Consortium of Academic Health . 2003, Consortium of Academic Health Centers for Integrative MedicineCenters for Integrative Medicine
Hands-on physical examHands-on physical exam
Locally tender point Locally tender point in taut band of in taut band of musclemuscle
Characteristic Characteristic radiation of pain radiation of pain with pressurewith pressure
Pressure can Pressure can produce twitch produce twitch responseresponseTravell, J.G., and Simons, D.G., Myofascial pain and dysfunction: the trigger point manual. 1983: Baltimore.
Standard of care for myofascial painStandard of care for myofascial pain
Trigger point Trigger point injectioninjection
Physical therapyPhysical therapy Medications Medications
(muscle relaxant, (muscle relaxant, NSAID, botox)NSAID, botox)
Lifestyle changes to Lifestyle changes to address factors that address factors that contribute to trigger contribute to trigger pointspoints
http://www.emedicine.com/pmr/topic84.htmhttp://www.emedicine.com/pmr/topic84.htm
Wellness treatment Wellness treatment planplan
http://www.ehcca.com/presentations/hitsummit2/5_01_3.pdf
What is quality of lifeWhat is quality of life
The World Health The World Health Organization Organization defined "quality of defined "quality of life" in its life" in its constitution in constitution in 1948 to include 1948 to include physical, mental, physical, mental, and social well-and social well-being, and not just being, and not just the absence of the absence of disease or illness.disease or illness.
Physical Health
Physical function
(10)
Physical function
(10)
Role –physical
(4)
Role –physical
(4)Pain (2)Pain (2)
General Health
(5)
General Health
(5)
SF-36: Physical healthSF-36: Physical health
Mental Health
Emotional Well-
Being (5)
Emotional Well-
Being (5)
Role- emotional
(3)
Role- emotional
(3)
Energy/ fatigue (4)Energy/
fatigue (4)
Social function
(2)
Social function
(2)
SF-36: Mental healthSF-36: Mental health
Integrative approach Integrative approach to patients with neck to patients with neck painpain Pilot data from a Pilot data from a
cohort of 50 cohort of 50 consecutive patients consecutive patients with neck pain with neck pain recruited for 2000-recruited for 2000-2010 Neck Pain Task 2010 Neck Pain Task ForceForce
Compare change in Compare change in health-related quality health-related quality of life (HRQOL) at of life (HRQOL) at baseline and after 6 baseline and after 6 weeks of treatmentweeks of treatment
Change in SF-36 scoresChange in SF-36 scores
34
36
38
40
42
44
46
PF Role-P Pain Gen H Energy Social Role-E EWB
Baseline
Followup
Score
Multi-item scales
Statistical significanceStatistical significance
DeltaDelta t-testt-test prob.prob.
PF-10PF-10 2.62.6 2.212.21 .0334.0334
RP-4RP-4 3.43.4 2.802.80 .0081.0081
BP-2BP-2 2.82.8 3.093.09 .0038.0038
GH-5GH-5 1.91.9 2.282.28 .0287.0287
EN-4EN-4 3.33.3 2.762.76 .0090.0090
SF-2SF-2 2.32.3 1.541.54 .1324.1324
RE-3RE-3 1.51.5 0.820.82 .4152.4152
EWB-5EWB-5 2.72.7 2.032.03 .0500.0500
Research interest: is capsaicin Research interest: is capsaicin an effective biologic treatment an effective biologic treatment for myofascial pain?for myofascial pain? Capsaicin binds to a vanilloid Capsaicin binds to a vanilloid
type I receptor (VR1) on a type I receptor (VR1) on a trigeminal non-myelinated trigeminal non-myelinated group C fibergroup C fiber
Influx of sodium and calcium Influx of sodium and calcium ions results in depolarization, ions results in depolarization, which in turn opens voltage which in turn opens voltage gated sodium channels (VGSC) gated sodium channels (VGSC) and generates an action and generates an action potential along the nerve fiberpotential along the nerve fiber
Transmitter substances Transmitter substances including glutamate, including glutamate, Substance P (SP) und Substance P (SP) und Calcitonin Gene Related Calcitonin Gene Related Peptide (CGRP) transfers the Peptide (CGRP) transfers the signal to central neurons signal to central neurons responsible for the perception responsible for the perception of irritation and painof irritation and pain
Topical capsaicin and Topical capsaicin and analgesiaanalgesia
Diabetic and post-Diabetic and post-herpetic neuropathyherpetic neuropathy
OsteoarthritisOsteoarthritis Rheumatoid arthritisRheumatoid arthritis Post-mastectomy Post-mastectomy
pain pain
(Whittaker AL, Kennedy DT, Small (Whittaker AL, Kennedy DT, Small RE. Adjuvant agents for managing RE. Adjuvant agents for managing chronic pain. chronic pain. APS Bulletin.APS Bulletin. 1999:9) 1999:9)
What is a hydrogelWhat is a hydrogel
Polymer chains Polymer chains that are water-that are water-insolubleinsoluble
Can contain over Can contain over 99% water99% water
Natural or Natural or synthetic synthetic polymerspolymers
Capsaicin-containing Capsaicin-containing hydrogelhydrogel
Improve the Improve the permeability and permeability and patient compliance patient compliance of existing cream of existing cream dosage formsdosage forms
Hydrogels have Hydrogels have been investigated been investigated because of their because of their controlled-release controlled-release characterization and characterization and good tissue good tissue compatibilitycompatibility
Journal articleJournal article
Wang Y, Hong C, Chiu W, Fang Wang Y, Hong C, Chiu W, Fang J. In vitro and in vivo J. In vitro and in vivo evaluations of topically applied evaluations of topically applied capsaicin and nonivamide from capsaicin and nonivamide from hydrogels. International hydrogels. International Journal of Pharmaceutics 234 Journal of Pharmaceutics 234 (2001) 89-104.(2001) 89-104.
FDA guidelines to evaluate FDA guidelines to evaluate in vitro and in vivo in vitro and in vivo absorptionabsorption Permeation of Permeation of
stratum corneum stratum corneum (SC) is rate (SC) is rate limiting steplimiting step
Membrane to Membrane to assess in vitro assess in vitro release of drugrelease of drug
Dermato-Dermato-pharmacokinetics pharmacokinetics to assess in vivo to assess in vivo
Methods: in vitro skin Methods: in vitro skin permeationpermeation
Determined by Determined by Franz diffusion cellFranz diffusion cell
Skin of rat on a Skin of rat on a receptor receptor compartment with compartment with SC-side facing the SC-side facing the donor compartmentdonor compartment
Donor compartment Donor compartment filled with test drugfilled with test drug
In vitro permeation of In vitro permeation of capsaicin across rat capsaicin across rat skinskin
Capsaicin Capsaicin permeation permeation across rat skin across rat skin from study from study hydrogel is hydrogel is consistent with consistent with Dr. Fang’s Dr. Fang’s previous studies previous studies
Time (h)
0 10 20 30 40
Cumulative amount (
μ/g cm
2)
0
10
20
30
40
50
Methods: skin erythema Methods: skin erythema determinationdetermination
SC removedSC removed Mexemeter Mexemeter
placed on treated placed on treated skin surfaceskin surface
Result of Result of erythema was erythema was difference from difference from control value at control value at untreated siteuntreated site
Safety analysisSafety analysis
Skin condition Value ∆ Valuea
a* (skin erythema) -0.61±0.53
-1.28±2.13
Transepidermal water loss (g/m2/h)
13.19±2.42
1.23±2.47
a ∆ value indicates the value of patch-treated skin area minus the non-treated skin area (control).
Evaluation question and Evaluation question and standardstandard
Evaluation Evaluation QuestionQuestion
Does a topical Does a topical capsaicin 500 mcg capsaicin 500 mcg patch applied to 2 patch applied to 2 trigger points 12h trigger points 12h on and 12h off on and 12h off each day for 1 each day for 1 month improve month improve quality of life in quality of life in patients with patients with myofascial pain myofascial pain relative to a relative to a matched sample matched sample with placebowith placebo
StandardStandard
Statistically Statistically significant significant in in post-intervention post-intervention scores on quality scores on quality of life instrument of life instrument (global as well as (global as well as pain specific) and pain specific) and VAS relative to VAS relative to placeboplacebo
60 patients with chronic neck pain will be randomized into 2 groups of 30
Phase 1 Phase 2PLACEBO
TREATMENT
PLACEBO
TREATMENT
30 patients will apply gel without capsaicin 12h on 12h off x 4 weeks
30 patients will apply gel with capsaicin 12h on 12h off x 4 weeks
4- week wash out
30 patients will apply gel without capsaicin 12h on 12h off x 4 weeks
30 patients will apply gel with capsaicin 12h on 12h off x 4 weeks
McGill Pain Inventory, VAS, SF-36
McGill Pain Inventory, VAS, SF-36
McGill Pain Inventory, VAS, SF-36
McGill Pain Inventory, VAS, SF-36
Double-blinded, randomized controlled crossover design