11/12/2016. Pain Management: Why Is This Important? A Global Health Problem. Pain Management An Epidemic Opioid Problem in the US

Transcription

1 World Massage Conference Presents: Findings from the Largest Research Review in Massage History with Ruth Werner & Jerrilyn Cambron Pain Management: Why Is This Important? A Global Health Problem 1:5 in pain, 1:10 with chronic pain diagnosis/year million people with chronic pain 2 $560-$635 billion in annual costs 2 1 WHO, 2014, 2 Institute of Medicine, 2011 Pain Management An Epidemic Opioid Problem in the US Drug overdose deaths (United States, ) Pain and Pain Drug Use Medication often 50% appropriate and required 44% Opioid prescriptions increased 60% ( ) 1 40% 30% 26% Patients often disappointed 47,055 deaths with biomedical treatment 2 20% 15.1% 10% Prolonged use can worsen 4% symptoms 3 15 million addicted 4 0% 200% increase Military Civilian Chronic Pain Opiod Use 1 *SDI s Vector One : National (VONA); 2 Center Berman, for 2003; Behavioral 3 Fulton-Kehoe, Statistics and 2015, Quality, 4 WHO, Substance 2014 Abuse and Mental Health Services Administration, Treatment Episode Data Set. Data received through

2 Pain Management Challenges and Complexities Physical Mental Chronic Pain Spiritual Emotional Pain is complex and multidimensional Approaches must address the whole person Failure to adequately treat escalates other problems 1 1 IOM, 2011 Purpose of the review What is the state of the science regarding the impact of massage therapy for populations living with pain? Massage Therapy Foundation The practice of massage therapy is evidenceinformed and accessible to everyone. *Funding for this project provided by Massage Therapy Foundation, through the generous support of the American Massage Therapy Association. 2

3 S A M U E L I I N S T I T U T E S M I S S I O N To create a flourishing society through the scientific exploration of wellness and whole person healing. HEALTH AND WELLBEING T H R O U G H RESEARCH INNOVATION EDUCATION Methods 1. Assemble Working Group 2. Develop research question 3. Search literature 4. Screen literature 5. Review literature Assess methodological quality Extract data STRICT-M 6. Synthesize data Meta-analysis GRADE analysis Assemble Working Group Steering Committee Members Jerrilyn Cambron, LMT, DC, PhD Ruth Werner, BCTMB Jan Schwartz, MA, BCTMB Pete Whitridge, BA, LMT Christopher Deery, LMT Chester Buckenmeier III, MD, COL (ret) USA Pam Buckenmeier, RN, LMT Paul Pasquina, MD, COL (ret) Eric Schoomaker, MD, PhD, LTG (ret) USA Review Team Cindy Crawford Courtney Boyd Charmagne Paat Ashley Price Lea Xenakis Weimin Zhang 3

4 Develop Research Question What is the state of the science regarding the impact of massage therapy on function for those experiencing pain? Research Question - PICOS Population: patients experiencing pain An unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage. Pain is always subjective. Pain can be acute or chronic. Research Question - PICOS Population: patients experiencing pain Intervention: An unpleasant massage sensory therapy and emotional experience associated with The actual systematic or potential manipulation tissue damage of soft or tissue described with the in terms hands of that such positively damage. affects Pain is and always promotes subjective. healing, Pain reduces can be acute stress, or enhances chronic. muscle relaxation, improves local circulation and creates a sense of well-being 1. General pain populations (e.g., musculoskeletal pain) 2. Cancer pain Manual 3. Surgical/operative forces Oscillating pain Vibration Soft-tissue deformation Gliding Torsion Shearing Elongation Touch Compression Gliding Percussion Friction Kneading Movement Positioning Stretching Holding 4

5 Research Question - PICOS Population: patients experiencing pain Intervention: An unpleasant massage sensory therapy and emotional experience associated with The actual systematic or potential manipulation tissue damage of soft or tissue described with the in terms hands of that such Control/Comparison: damage. Pain always sham, subjective. no treatment, Pain can or be active acute or comparators positively affects and promotes healing, reduces stress, enhances chronic. muscle relaxation, improves local circulation and creates a sense of well-being 1. General pain populations (e.g., musculoskeletal pain) 2. Cancer pain Manual 3. Surgical/operative forces Oscillating pain Vibration Soft-tissue deformation Gliding Torsion Shearing Elongation Touch Compression Gliding Percussion Friction Kneading Movement Positioning Stretching Holding Research Question - PICOS Population: patients experiencing pain Intervention: An unpleasant massage sensory therapy and emotional experience associated with The actual systematic or potential manipulation tissue damage of soft or tissue described with the in terms hands of that such Control/Comparison: damage. Pain always sham, subjective. no treatment, Pain can or be active acute or comparators positively affects and promotes healing, reduces stress, enhances chronic. Outcome(s): muscle relaxation, function improves local circulation and creates a sense of well-being 1. General pain populations (e.g., musculoskeletal pain) 2. Pain Cancer pain Pain Manual 3. Activity Surgical/operative forces Oscillating pain Vibration Soft-tissue Sleep deformation Touch Kneading Limits function Limits function Gliding Mood Compression Movement Torsion Gliding Positioning Stress Shearing Percussion Increases Stretching pain Elongation Health-related quality Friction of life Holding responses Physiological outcomes Research Question - PICOS Population: patients experiencing pain Intervention: An unpleasant massage sensory therapy and emotional experience associated with The actual systematic or potential manipulation tissue damage of soft or tissue described with the in terms hands of that such Control/Comparison: damage. Pain always sham, subjective. no treatment, Pain can or be active acute or comparators positively affects and promotes healing, reduces stress, enhances chronic. Outcome(s): muscle relaxation, function improves local circulation and creates a sense of well-being 1. General pain populations (e.g., musculoskeletal pain) 2. Cancer pain Pain Study Design: Pain Randomized clinical trials, English language Manual 3. Activity Surgical/operative forces Oscillating pain Vibration Soft-tissue Sleep deformation Touch Kneading Limits function Limits function Gliding Mood Compression Movement Torsion Gliding Positioning Stress Shearing Percussion Increases Stretching pain Elongation Health-related quality Friction of life Holding responses Physiological outcomes 5

6 Review the Literature Quality Assessment Internal Validity: SIGN 50 Checklist External Validity: EVAT Data Extraction Information related to PICO Gaps in reporting helped to form STRICT-M Population Review the Literature: Data Extraction Pain condition Sample entered/completed Intervention Comparator Outcome Results Main conclusions Population Review the Literature: Data Extraction Pain condition Sample entered/completed Intervention Comparator STRICT-M Standards of Reporting Interventions of Clinical Trials of Massage Outcome Results Main conclusions 6

7 Review the Literature: Data Extraction STRICT-M Population Components Massage Rationale Pain condition Reasoning for treatment provided Sample Extent to which entered/completed treatment varied Details of Massage Technique Intervention Name and description Details of intervention using terms Location of massage Time spent massaging each location Comparator Description of pressure Response sought Outcome Treatment Regimen Related to Dosing Results Total number of treatment sessions Time frame (total duration) Main Treatment conclusions frequency/duration Other Components of Treatment Details of related interventions Massage equipment Setting STRICT-M Practitioner Background Type of practitioner Standards Qualifications of Reporting Interventions of Clinical Trials of Massage Control or Comparator Interventions Rationale for control Name and description Total number of control sessions Time frame (total duration) Frequency/duration Synthesizing the Data Meta-analyses Statistically combine results of similar studies to understand overall picture Group by: Population General Pain, Cancer Pain, Surgical Pain Outcome Pain, Activity, Stress, Mood, Quality of Life, Sleep, Pain Pressure Threshold, Physiological Comparator Active Comparator, No Treatment, Sham Synthesizing the Data GRADE Analyses Make recommendations based on findings Strongly in favor of/against massage therapy Weakly in favor of/against massage therapy No recommendation for massage therapy 7

8 The Results Results Results Methodological Quality QUALITY ALL POPULATIONS CANCER SURGERY High (++) Acceptable (+) Low (0) High (++) Acceptable (+) Low (0) High (++) Acceptable (+) Low (0) 8

9 Results Methodological Quality QUALITY ALL POPULATIONS CANCER SURGERY High (++) Acceptable (+) Low (0) High (++) Acceptable (+) Low (0) High (++) Acceptable (+) Low (0) SIGN 50 Appropriate and clearly focused question Randomization Allocation concealment Percentage of dropouts Baseline similarities Group differences Outcome reliability/validity Intention-to-treat analyses Multi-site similarities EVAT Recruitment Participation Model validity Results STRICT-M Analyses Massage Rationale Reasoning for treatment provided Extent to which treatment varied Details of Massage Technique Name and description of massage technique Details of intervention using terms Location of massage Amount of time spent massage each location Description of pressure Response sought Treatment Regimen Related to Dosing Number of treatment sessions over what time Time frame (total duration) Frequency Duration of each treatment Other Components of Treatment Details of massage-related interventions Massage equipment Setting Practitioner Background Type of practitioner Qualifications Control or Comparator Interventions Rationale for control Name and description of control Number of control sessions Time frame (total duration) Frequency Duration of each treatment Results What is the efficacy of massage for treating General (Musculoskeletal Pain) Populations Pain, compared to an active comparator? Sham? No treatment? Activity, compared to an active comparator? Sham? Anxiety, compared to an active comparator? Quality of life, compared to an active comparator? Surgery Populations Pain, compared to an active comparator? Anxiety, compared to an active comparator? Cancer Populations Pain, compared to an active comparator? No treatment/sham? Sleep, compared to an active comparator? Anxiety, compared to an active comparator? 9

10 Results Interpreting Meta-analyses Forest plots Look for the center line Look for the diamond Combined Result Better 0 Worse Results: Meta-Analysis General Population What is the efficacy of massage for treating pain... compared to an to active no to treatment? sham? comparator? Results: Meta-Analysis General Population What is the efficacy of massage for treating pain... compared compared to an active to sham? comparator? 10

11 Results: Meta-Analysis General Population What is the efficacy of massage for treating pain... compared to an active comparator?? Strong Weak None Weak Strong Strength of Recommendation Population Healthcare Workers Policy Makers Weak/Conditional Recommendation Many, but not all, would want massage therapy Help people make decisions consistent with their own values Need for substantial debate and to involve stakeholders Strong Recommendation Majority would want massage therapy Advise people to receive massage therapy Adopt as policy Results: GRADE Analysis General Pain Population Number of Confidence in Reported Outcome/ participants the Estimate of Effect Size Studies Safety Comparison completed (n) the Effect GRADE (n) PAIN (95% CI, -0.84, vs. Sham 655 (9) -0.05), 5 studies (95% CI, -1.94, vs. No Treatment 245 (4) -0.35), 4 studies (95% CI, -0.53, vs. Active Comparator 3557 (34) 0.003), 24 studies ACTIVITY 0.36 (95% CI, -0.53, 1.25), vs. Sham 584 (7) 3 studies (95% CI, -0.50, 0.05), vs. Active Comparator 3063 (25) 7 studies MOOD, HEALTH-RELATED QUALITY OF LIFE vs. Active Comparator 2527 (21) Mood: (95% CI, , -0.09), 6 studies Strength of the Recommendation Health-related quality of life: 0.14 (95% CI, -0.09, 0.36), 4 studies 11

12 Results: GRADE Analysis General Pain Population Number of Confidence in Reported Outcome/ Strength of the participants the Estimate of Effect Size Studies Safety Comparison Recommendation completed (n) the Effect GRADE (n) PAIN (95% CI, -0.84, vs. Sham 655 (9) Moderate +2 (3) Weak, in favor -0.05), 5 studies (95% CI, -1.94, vs. No Treatment 245 (4) High +2 (2) Strong, in favor -0.35), 4 studies (95% CI, -0.53, vs. Active Comparator 3557 (34) Moderate +1 (14) Weak, in favor 0.003), 24 studies ACTIVITY 0.36 (95% CI, -0.53, 1.25), vs. Sham 584 (7) Moderate +2 (2) No recommendation 3 studies (95% CI, -0.50, 0.05), vs. Active Comparator 3063 (25) Moderate +1 (12) No recommendation 7 studies MOOD, HEALTH-RELATED QUALITY OF LIFE vs. Active Comparator 2527 (21) Moderate Mood: (95% CI, - +1 (11) Weak, in favor 1.06, -0.09), 6 studies Moderate Health-related quality of life: 0.14 (95% CI, -0.09, 0.36), 4 studies Weak, in favor Results: GRADE Analysis Cancer Pain Population Outcome/ Comparison PAIN vs. No Treatment 167 (3) vs. Active Comparator 708 (10) SLEEP vs. Active Comparator 539 (6) Confidence Number of in the participants Estimate of completed (n) the Effect STRESS, MOOD, HEALTH-RELATED QUALITY OF LIFE vs. Active Comparator 620 (8) Effect Size (95% CI, -0.99, 0.59), 3 studies (95% CI, -1.23, 0.14), 6 studies Fatigue: (95% CI, -2.18, 0.05), 3 studies Mood: (95% CI, -2.44, ), 3 studies Reported Studies Safety GRADE (n) Strength of the Recommendation Results: GRADE Analysis Cancer Pain Population Confidence Number of in the Outcome/ Comparison participants Estimate of completed (n) the Effect PAIN vs. No Treatment 167 (3) Low vs. Active Comparator 708 (10) Low SLEEP vs. Active Comparator 539 (6) Low STRESS, MOOD, HEALTH-RELATED QUALITY OF LIFE vs. Active Comparator 620 (8) Low Effect Size (95% CI, -0.99, 0.59), 3 studies (95% CI, -1.23, 0.14), 6 studies Fatigue: (95% CI, -2.18, 0.05), 3 studies Mood: (95% CI, -2.44, ), 3 studies Reported Studies Safety GRADE (n) +2 (1) Strength of the Recommendation No recommendation +2 (5) Weak, in favor +2 (4) Weak, in favor +2 (4) Weak, in favor 12

13 Results: GRADE Analysis Surgical Pain Population Outcome/ Comparison PAIN Number of participants completed (n) vs. Active Comparator 2270 (14) Confidence in the Estimate of the Effect STRESS, MOOD, HEALTH-RELATED QUALITY OF LIFE vs. Active Comparator 2150 (12) Effect Size (95% CI, -1.36, -0.23), 7 studies Mood: (95% CI, -1.15, 0.01), 7 studies Reported Studies Strength of the Safety Recommendation GRADE (n) Results: GRADE Analysis Surgical Pain Population Outcome/ Comparison Number of participants completed (n) Confidence in the Estimate of the Effect Effect Size Reported Studies Strength of the Safety Recommendation GRADE (n) PAIN vs. Active Comparator 2270 (14) Moderate STRESS, MOOD, HEALTH-RELATED QUALITY OF LIFE vs. Active Comparator 2150 (12) Moderate (95% CI, -1.36, -0.23), 7 studies Mood: (95% CI, -1.15, 0.01), 7 studies +2 (4) Weak, in favor +2 (4) Weak, in favor Takeaway Messages: Outcomes Overall, massage therapy decreases pain and improves function Pain Activity Sleep (Fatigue) Mood (Anxiety) Quality of Life Musculoskeletal Pain Cancer Pain Surgical Pain 13

14 Takeaway Messages Researchers Use STRICT-M, PROMIS reporting guidelines Work for more consistent descriptions of functional outcomes Specific gaps, as described in articles Especially for multi-site consistency, allocation concealment, intention to treat Takeaway Messages Practitioners No recipes! Relatively Inconsistent safe definitions Pain Inconsistent multidimensional techniques, application locations Application Address Inconsistent symptoms in different doses from settings whole-person perspective Policy-making Understand Military Under-reported relationship doses between pain and function Credentials are necessary What Under-reported Cancer Access to take care is key: settings, home financial, to practitioner hospitals clients geographic characteristics Patient-centered Qualifications/training bio-psycho-social especially important approach to pain and Variable Modifications patient populations function Only Intake studies questions that are measured critical functional outcomes Integrated Incorporate care education, for pain settings movement, well-being Access Communication Team approach Massage therapy is the evidence-based new thinking that will, with other integrative, nonpharmacologic approaches, help pain medicine overcome the current opioid-focused old thinking that has devastated so many lives. 14

15 More Information Publications General Pain Populations Cancer Pain Populations Surgical Pain Populations Database Houses all of the extracted data Search, filter, sort functions More Information Publications General Pain Populations Cancer Pain Populations Surgical Pain Populations Database Houses all of the extracted data Search, filter, sort functions Samueli Institute Acknowledgements Massage Therapy Foundation American Massage Therapy Association Steering Committee 15

16 More Information Publications- Can be found on General Population Cancer Population Surgical Population Questions? Jerrilyn Cambron, Ruth Werner, 16