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1.  Establishing key components of yoga interventions for musculoskeletal conditions: a Delphi survey 
Background
Evidence suggests yoga is a safe and effective intervention for the management of physical and psychosocial symptoms associated with musculoskeletal conditions. However, heterogeneity in the components and reporting of clinical yoga trials impedes both the generalization of study results and the replication of study protocols. The aim of this Delphi survey was to address these issues of heterogeneity, by developing a list of recommendations of key components for the design and reporting of yoga interventions for musculoskeletal conditions.
Methods
Recognised experts involved in the design, conduct, and teaching of yoga for musculoskeletal conditions were identified from a systematic review, and invited to contribute to the Delphi survey. Forty-one of the 58 experts contacted, representing six countries, agreed to participate. A three-round Delphi was conducted via electronic surveys. Round 1 presented an open-ended question, allowing panellists to individually identify components they considered key to the design and reporting of yoga interventions for musculoskeletal conditions. Thematic analysis of Round 1 identified items for quantitative rating in Round 2; items not reaching consensus were forwarded to Round 3 for re-rating.
Results
Thirty-six panellists (36/41; 88%) completed the three rounds of the Delphi survey. Panellists provided 348 comments to the Round 1 question. These comments were reduced to 49 items, grouped under five themes, for rating in subsequent rounds. A priori group consensus of ≥80% was reached on 28 items related to five themes concerning defining the yoga intervention, types of yoga practices to include in an intervention, delivery of the yoga protocol, domains of outcome measures, and reporting of yoga interventions for musculoskeletal conditions. Additionally, a priori consensus of ≥50% was reached on five items relating to minimum values for intervention parameters.
Conclusions
Expert consensus has provided a non-prescriptive reference list for the design and reporting of yoga interventions for musculoskeletal conditions. It is anticipated future research incorporating the Delphi guidelines will facilitate high quality international research in this field, increase homogeneity of intervention components and parameters, and enhance the comparison and reproducibility of research into the use of yoga for the management of musculoskeletal conditions.
doi:10.1186/1472-6882-14-196
PMCID: PMC4081491  PMID: 24942270
Yoga; Musculoskeletal conditions; Clinical trials; Guidelines; Delphi
2.  Cognitive interviews guide design of a new CAM patient expectations questionnaire 
Background
No consistent relationship exists between pre-treatment expectations and therapeutic benefit from various complementary and alternative medicine (CAM) therapies in clinical trials. However, many different expectancy measures have been used in those studies, with no validated questionnaires clearly focused on CAM and pain. We undertook cognitive interviews as part of a process to develop and validate such a questionnaire.
Methods
We reviewed questions about expectations of benefits of acupuncture, chiropractic, massage, or yoga for pain. Components of the questions – verbs, nouns, response options, terms and phrases describing back pain – were identified. Using seven different cognitive interview scripts, we conducted 39 interviews to evaluate how individuals with chronic low back pain understood these individual components in the context of expectancy questions for a therapy they had not yet received. Chosen items were those with the greatest agreement and least confusion among participants, and were closest to the meanings intended by the investigators.
Results
The questionnaire drafted for psychometric evaluation had 18 items covering various domains of expectancy. “Back pain” was the most consistently interpreted descriptor for this condition. The most understandable response options were 0-10 scales, a structure used throughout the questionnaire, with 0 always indicating no change, and 10 anchored with an absolute descriptor such as “complete relief”. The use of words to describe midpoints was found to be confusing. The word “expect” held different and shifting meanings for participants. Thus paired items comparing “hope” and “realistically expect” were chosen to evaluate 5 different aspects of treatment expectations (back pain; back dysfunction and global effects; impact of back pain on specific areas of life; sleep, mood, and energy; coping). “Impact of back pain” on various areas of life was found to be a consistently meaningful concept, and more global than “interference”.
Conclusions
Cognitive interviews identified wordings with considerable agreement among both participants and investigators. Some items widely used in clinical studies had different meanings to participants than investigators, or were confusing to participants. The final 18-item questionnaire is undergoing psychometric evaluation with goals of streamlining as well as identifying best items for use when questionnaire length is constrained.
doi:10.1186/1472-6882-14-39
PMCID: PMC3906834  PMID: 24460709
Cognitive interviews; Questionnaires; Expectations; Low back pain; Acupuncture; Chiropractic; Massage therapy; Yoga
3.  Complementary and alternative medicine (CAM) providers’ views of chronic low back pain patients’ expectations of CAM therapies: a qualitative study 
Background
Some researchers think that patients with higher expectations for CAM therapies experience better outcomes and that enthusiastic providers can enhance treatment outcomes. This is in contrast to evidence suggesting conventional medical providers often reorient patient expectations to better match what providers believe to be realistic. However, there is a paucity of research on CAM providers’ views of their patients’ expectations regarding CAM therapy and the role of these expectations in patient outcomes.
Methods
To better understand how CAM providers view and respond to their patients’ expectations of a particular therapy, we conducted 32 semi-structured, qualitative interviews with acupuncturists, chiropractors, massage therapists and yoga instructors identified through convenience sampling. Interviews were recorded, transcribed and analyzed thematically using Atlas ti version 6.1.
Results
CAM providers reported that they attempt to ensure that their patients’ expectations are realistic. Providers indicated they manage their patients’ expectations in a number of domains— roles and responsibilities of providers and patients, treatment outcomes, timeframe for improvement, and treatment experience. Providers reported that patients’ expectations change over time and that they need to continually manage these expectations to enhance patient engagement and satisfaction with treatment.
Conclusions
Providers of four types of CAM therapies viewed patients’ expectations as an important component of their experiences with CAM therapy and indicated that they try to align patient expectations with reality. These findings suggest that CAM providers are similar in this respect to conventional medical providers.
doi:10.1186/1472-6882-12-234
PMCID: PMC3533863  PMID: 23186539
Expectations; Providers; Qualitative research; Chiropractic; Massage; Acupuncture; Yoga; Complementary medicine; Alternative medicine
4.  Dosing study of massage for chronic neck pain: protocol for the dose response evaluation and analysis of massage [DREAM] trial 
Background
Despite the growing popularity of massage, its effectiveness for treating neck pain remains unclear, largely because of the poor quality of research. A major deficiency of previous studies has been their use of low “doses” of massage that massage therapists consider inadequate. Unfortunately, the number of minutes per massage session, sessions per week, or weeks of treatment necessary for massage to have beneficial or optimal effects are not known. This study is designed to address these gaps in our knowledge by determining, for persons with chronic neck pain: 1) the optimal combination of number of treatments per week and length of individual treatment session, and 2) the optimal number of weeks of treatment.
Methods/design
In this study, 228 persons with chronic non-specific neck pain will be recruited from primary health care clinics in a large health care system in the Seattle area. Participants will be randomized to a wait list control group or 4 weeks of treatment with one of 5 different dosing combinations (2 or 3 30-min treatments per week or 1, 2, or 3 60-min treatments per week). At the end of this 4-week primary treatment period, participants initially receiving each of the 5 dosing combinations will be randomized to a secondary treatment period of either no additional treatment or 6 weekly 60-min massages. The primary outcomes, neck-related dysfunction and pain, will be assessed by blinded telephone interviewers 5, 12, and 26 weeks post-randomization. To better characterize the trajectory of treatment effects, these interview data will be supplemented with outcomes data collected by internet questionnaire at 10, 16, 20 and 39 weeks. Comparisons of outcomes for the 6 groups during the primary treatment period will identify the optimal weekly dose, while comparisons of outcomes during the secondary treatment period will determine if 10 weeks of treatment is superior to 4 weeks.
Discussion
A broad dosing schedule was included in this trial. If adherence to any of these doses is poor, those doses will be discontinued.
Trial registration
This trial is registered in ClinicalTrials.gov, with the ID number of NCT01122836
doi:10.1186/1472-6882-12-158
PMCID: PMC3546891  PMID: 22985134
Therapeutic massage; Optimal dose; Chronic neck pain
5.  Adjunctive naturopathic care for type 2 diabetes: patient-reported and clinical outcomes after one year 
Background
Several small, uncontrolled studies have found improvements in self-care behaviors and reductions in clinical risk in persons with type 2 diabetes who received care from licensed naturopathic physicians. To extend these findings and determine the feasibility and promise of a randomized clinical trial, we conducted a prospective study to measure the effects of adjunctive naturopathic care (ANC) in primary care patients with inadequately controlled type 2 diabetes.
Methods
Forty patients with type 2 diabetes were invited from a large integrated health care system to receive up to eight ANC visits for up to one year. Participants were required to have hemoglobin A1c (HbA1c) values between 7.5-9.5 % and at least one additional cardiovascular risk factor (i.e., hypertension, hyperlipidemia or overweight). Standardized instruments were administered by telephone to collect outcome data on self-care, self-efficacy, diabetes problem areas, perceived stress, motivation, and mood. Changes from baseline scores were calculated at 6- and 12-months after entry into the study. Six and 12-month changes in clinical risk factors (i.e., HbA1c, lipid and blood pressure) were calculated for the ANC cohort, and compared to changes in a cohort of 329 eligible, non-participating patients constructed using electronic medical records data. Between-cohort comparisons were adjusted for age, gender, baseline HbA1c, and diabetes medications. Six months was pre-specified as the primary endpoint for outcome assessment.
Results
Participants made 3.9 ANC visits on average during the year, 78 % of which occurred within six months of entry into the study. At 6-months, significant improvements were found in most patient-reported measures, including glucose testing (P = 0.001), diet (P = 0.001), physical activity (P = 0.02), mood (P = 0.001), self-efficacy (P = 0.0001) and motivation to change lifestyle (P = 0.003). Improvements in glucose testing, mood, self-efficacy and motivation to change lifestyle persisted at 12-months (all P < 0.005). For clinical outcomes, mean HbA1c decreased by −0.90 % (P = 0.02) in the ANC cohort at 6-months, a −0.51 % mean difference compared to usual care (P = 0.07). Reductions at 12-months were not statistically significant (−0.34 % in the ANC cohort, P = 0.14; -0.37 % difference compared to the usual care cohort, P = 0.12).
Conclusions
Improvements were noted in self-monitoring of glucose, diet, self-efficacy, motivation and mood following initiation of ANC for patients with inadequately controlled type 2 diabetes. Study participants also experienced reductions in blood glucose that exceeded those for similar patients who did not receive ANC. Randomized clinical trials will be necessary to determine if ANC was responsible for these benefits.
doi:10.1186/1472-6882-12-44
PMCID: PMC3403984  PMID: 22512949
6.  Survey of CAM interest, self-care, and satisfaction with health care for type 2 diabetes at group health cooperative 
Background
Very little research has explored the factors that influence interest in complementary and alternative medicine (CAM) treatments. We surveyed persons with sub-optimally controlled type 2 diabetes to evaluate potential relationships between interest in complementary and alternative medicine (CAM) treatments, current self-care practices, motivation to improve self-care practices and satisfaction with current health care for diabetes.
Methods
321 patients from a large integrated healthcare system with type 2 diabetes, who were not using insulin and had hemoglobin A1c values between 7.5-9.5%, were telephoned between 2009-2010 and asked about their self-care behaviors, motivation to change, satisfaction with current health care and interest in trying naturopathic (ND) care for their diabetes. Responses from patients most interested in trying ND care were compared with those from patients with less interest.
Results
219 (68.5%) patients completed the survey. Nearly half (48%) stated they would be very likely to try ND care for their diabetes if covered by their insurance. Interest in trying ND care was not related to patient demographics, health history, clinical status, or self-care behaviors. Patients with greater interest in trying ND care rated their current healthcare as less effective for controlling their blood sugar (mean response 5.9 +/- 1.9 vs. 6.6 +/- 1.5, p = 0.003), and were more determined to succeed in self-care (p = 0.007). Current CAM use for diabetes was also greater in ND interested patients.
Conclusions
Patients with sub-optimally controlled type 2 diabetes expressed a high level of interest in trying ND care. Those patients with the greatest interest were less satisfied with their diabetes care, more motivated to engage in self-care, and more likely to use other CAM therapies for their diabetes.
doi:10.1186/1472-6882-11-121
PMCID: PMC3280939  PMID: 22132687
7.  Development of a taxonomy to describe massage treatments for musculoskeletal pain 
Background
One of the challenges in conducting research in the field of massage and bodywork is the lack of consistent terminology for describing the treatments given by massage therapists. The objective of this study was to develop a taxonomy to describe what massage therapists actually do when giving a massage to patients with musculoskeletal pain.
Methods
After conducting a review of the massage treatment literature for musculoskeletal pain, a list of candidate techniques was generated for possible inclusion in the taxonomy. This list was modified after discussions with a senior massage therapist educator and seven experienced massage therapists participating in a study of massage for neck pain.
Results
The taxonomy was conceptualized as a three level classification system, principal goals of treatment, styles, and techniques. Four categories described the principal goal of treatment (i.e., relaxation massage, clinical massage, movement re-education and energy work). Each principal goal of treatment could be met using a number of different styles, with each style consisting of a number of specific techniques. A total of 36 distinct techniques were identified and described, many of which could be included in multiple styles.
Conclusion
A new classification system is presented whereby practitioners using different styles of massage can describe the techniques they employ using consistent terminology. This system could help facilitate standardized reporting of massage interventions.
doi:10.1186/1472-6882-6-24
PMCID: PMC1544351  PMID: 16796753
8.  A survey of training and practice patterns of massage therapists in two US states 
Background
Despite the growing popularity of therapeutic massage in the US, little is known about the training or practice characteristics of massage therapists. The objective of this study was to describe these characteristics.
Methods
As part of a study of random samples of complementary and alternative medicine (CAM) practitioners, we interviewed 226 massage therapists licensed in Connecticut and Washington state by telephone in 1998 and 1999 (85% of those contacted) and then asked a sample of them to record information on 20 consecutive visits to their practices (total of 2005 consecutive visits).
Results
Most massage therapists were women (85%), white (95%), and had completed some continuing education training (79% in Connecticut and 52% in Washington). They treated a limited number of conditions, most commonly musculoskeletal (59% and 63%) (especially back, neck, and shoulder problems), wellness care (20% and 19%), and psychological complaints (9% and 6%) (especially anxiety and depression). Practitioners commonly used one or more assessment techniques (67% and 74%) and gave a massage emphasizing Swedish (81% and 77%), deep tissue (63% and 65%), and trigger/pressure point techniques (52% and 46%). Self-care recommendations, including increasing water intake, body awareness, and specific forms of movement, were made as part of more than 80% of visits. Although most patients self-referred to massage, more than one-quarter were receiving concomitant care for the same problem from a physician. Massage therapists rarely communicated with these physicians.
Conclusion
This study provides new information about licensed massage therapists that should be useful to physicians and other healthcare providers interested in learning about massage therapy in order to advise their patients about this popular CAM therapy.
doi:10.1186/1472-6882-5-13
PMCID: PMC1182347  PMID: 15955245
9.  Practice patterns of naturopathic physicians: results from a random survey of licensed practitioners in two US States 
Background
Despite the growing use of complementary and alternative medicine (CAM) by consumers in the U.S., little is known about the practice of CAM providers. The objective of this study was to describe and compare the practice patterns of naturopathic physicians in Washington State and Connecticut.
Methods
Telephone interviews were conducted with state-wide random samples of licensed naturopathic physicians and data were collected on consecutive patient visits in 1998 and 1999. The main outcome measures were: Sociodemographic, training and practice characteristics of naturopathic physicians; and demographics, reasons for visit, types of treatments, payment source and visit duration for patients.
Result
One hundred and seventy practitioners were interviewed and 99 recorded data on a total of 1817 patient visits. Naturopathic physicians in Washington and Connecticut had similar demographic and practice characteristics. Both the practitioners and their patients were primarily White and female. Almost 75% of all naturopathic visits were for chronic complaints, most frequently fatigue, headache, and back symptoms. Complete blood counts, serum chemistries, lipids panels and stool analyses were ordered for 4% to 10% of visits. All other diagnostic tests were ordered less frequently. The most commonly prescribed naturopathic therapeutics were: botanical medicines (51% of visits in Connecticut, 43% in Washington), vitamins (41% and 43%), minerals (35% and 39%), homeopathy (29% and 19%) and allergy treatments (11% and 13%). The mean visit length was about 40 minutes. Approximately half the visits were paid directly by the patient.
Conclusion
This study provides information that will help other health care providers, patients and policy makers better understand the nature of naturopathic care.
doi:10.1186/1472-6882-4-14
PMCID: PMC529271  PMID: 15496231
10.  Complementary and alternative medical therapies for chronic low back pain: What treatments are patients willing to try? 
Background
Although back pain is the most common reason patients use complementary and alternative medical (CAM) therapies, little is known about the willingness of primary care back pain patients to try these therapies. As part of an effort to refine recruitment strategies for clinical trials, we sought to determine if back pain patients are willing to try acupuncture, chiropractic, massage, meditation, and t'ai chi and to learn about their knowledge of, experience with, and perceptions about each of these therapies.
Methods
We identified English-speaking patients with diagnoses consistent with chronic low back pain using automated visit data from one health care organization in Boston and another in Seattle. We were able to confirm the eligibility status (i.e., current low back pain that had lasted at least 3 months) of 70% of the patients with such diagnoses and all eligible respondents were interviewed.
Results
Except for chiropractic, knowledge about these therapies was low. Chiropractic and massage had been used by the largest fractions of respondents (54% and 38%, respectively), mostly for back pain (45% and 24%, respectively). Among prior users of specific CAM therapies for back pain, massage was rated most helpful. Users of chiropractic reported treatment-related "significant discomfort, pain or harm" more often (23%) than users of other therapies (5–16%). Respondents expected massage would be most helpful (median of 7 on a 0 to 10 scale) and meditation least helpful (median of 3) in relieving their current pain. Most respondents indicated they would be "very likely" to try acupuncture, massage, or chiropractic for their back pain if they did not have to pay out of pocket and their physician thought it was a reasonable treatment option.
Conclusions
Most patients with chronic back pain in our sample were interested in trying therapeutic options that lie outside the conventional medical spectrum. This highlights the need for additional studies evaluating their effectiveness and suggests that researchers conducting clinical trials of these therapies may not have difficulties recruiting patients.
doi:10.1186/1472-6882-4-9
PMCID: PMC503394  PMID: 15260884
acupuncture; chiropractic; massage; meditation; t'ai chi; low back pain

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