Acupuncture for chronic low back pain in older adults: Design and protocol for the BackInAction pragmatic clinical trial.

BACKGROUND: Back pain prevalence and burden increase with age; approximately one-third of U.S. adults 65 years of age and older experience lower back pain (LBP). For chronic low back pain (cLBP), typically defined as lasting three months or longer, many treatments for younger adults may be inappropriate for older adults given their greater prevalence of comorbidities with attendant polypharmacy. While acupuncture has been demonstrated to be safe and effective for cLBP in adults overall, few studies of acupuncture have either included or focused on adults ≥65 years old. METHODS: The BackInAction study is a pragmatic, multi-site, three-arm, parallel-groups randomized controlled trial designed to test the effectiveness of acupuncture needling for improving back pain-related disability among 807 older adults ≥65 years old with cLBP. Participants are randomized to standard acupuncture (SA; up to 15 treatment sessions across 12 weeks), enhanced acupuncture (EA; SA during first 12 weeks and up to 6 additional sessions across the following 12 weeks), and usual medical care (UMC) alone. Participants are followed for 12 months with study outcomes assessed monthly with the primary outcome timepoint at 6 months. DISCUSSION: The BackInAction study offers an opportunity to further understand the effectiveness, dose-dependence, and safety of acupuncture in a Medicare population. Additionally, study results may encourage broader adoption of more effective, safer, and more satisfactory options to the continuing over-reliance on opioid- and invasive medical treatments for cLBP among older adults. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04982315. Clinical trial registration date: July 29, 2021.

Interest in Mindfulness Training for Chronic Low-Back Pain: Results from a Vignette-driven, Web-based Survey of Patients.

Objectives: Mindfulness-based stress reduction (MBSR) has been found effective for improving chronic low-back pain (cLBP). However, little data exist regarding how attractive this technique is to Americans as a therapy for cLBP. Design: Survey of randomly selected persons with cLBP. Settings/Location: Respondents were recruited from Kaiser Permanente Washington and one-time surveys were completed online. Patients: Adults 18-80 years of age with cLBP. Surveys: The study was conducted between December 2019 and August 2020. Outcome measures: The survey described an evidence-based classic MBSR course and then asked respondents about their sociodemographic characteristics, their current back pain, previous back pain treatments, behavioral risk factors for back pain, and four outcomes indicative of intention to engage in MBSR. Results: Four-hundred fifty-seven respondents completed the survey. Respondents were primarily women, white, educated, and with back pain for more than 5 years. About half had previously used a mind-body therapy for their pain. Overall, they reported moderate to high intention to try mindfulness classes and practice at home (median of 5 with 50% of the observations between 4 and 6, and 5.7, 50% of the observations between 4.3 and 6.3, respectively, on a 7-point scale). They reported a willingness to spend a median of 3 h/week learning mindfulness and 3.5 h/week practicing mindfulness techniques (for both outcomes, 50% of the respondents reported between 2 and 5 h). Few patient characteristics predicted intention to engage in MBSR, with no variable predicting all outcomes. The magnitude of the effect associated with significant predictors was small. Conclusion: Classic MBSR appealed to many survey respondents, in that they reported high interest in learning MBSR and intention to practice at home. The amount of time they reported being willing to spend learning MBSR and practicing at home is consistent with the time commitment in the original course.

Social Risk Factors and Desire for Assistance Among Patients Receiving Subsidized Health Care Insurance in a US-Based Integrated Delivery System.

PURPOSE: Because social conditions such as food insecurity and housing instability shape health outcomes, health systems are increasingly screening for and addressing patients' social risks. This study documented the prevalence of social risks and examined the desire for assistance in addressing those risks in a US-based integrated delivery system. METHODS: A survey was administered to Kaiser Permanente members on subsidized exchange health insurance plans (2018-2019). The survey included questions about 4 domains of social risks, desire for help, and attitudes. We conducted a descriptive analysis and estimated multivariate modified Poisson regression models. RESULTS: Of 438 participants, 212 (48%) reported at least 1 social risk factor. Housing instability was the most common (70%) factor reported. Members with social risks reported more discomfort being screened for social risks (14.2% vs 5.4%; P = .002) than those without risks, although 90% of participants believed that health systems should assist in addressing social risks. Among those with 1-2 social risks, however, only 27% desired assistance. Non-Hispanic Black participants who reported a social risk were more than twice as likely to desire assistance compared with non-Hispanic White participants (adjusted relative risk [RR] 2.2; 95% CI, 1.3-3.8). CONCLUSIONS: Athough most survey participants believed health systems have a role in addressing social risks, a minority of those reporting a risk wanted assistance and reported more discomfort being screened for risk factors than those without risks. Health systems should work to increase the comfort of patients in reporting risks, explore how to successfully assist them when desired, and offer resources to address these risks outside the health care sector.VISUAL ABSTRACT.

T'ai Chi for Chronic Low Back Pain in Older Adults: A Feasibility Trial.

Objectives: T'ai chi (TC) has been found effective for improving chronic low back pain (cLBP). However, such studies did not include adults over 65 years of age. This study was designed to evaluate the feasibility and acceptability of TC in this population compared with Health Education (HE) and with Usual Care (UC). Design: Feasibility randomized controlled trial. Settings/Location: Participants were recruited from Kaiser Permanente Washington and classes took place in a Kaiser facility. Patients: Adults 65 years of age and older with cLBP. Interventions: Twenty-eight participants were randomized to 12 weeks of TC followed by a 24-week tapered TC program, 12 were assigned to a 12-week HE intervention and 17 were assigned to UC only. Outcome Measures: Feasibility and acceptability were determined by recruitment, retention and 12-, 26-, and 52-week follow-up rates, instructor adherence to protocol, class attendance, TC home practice, class satisfaction, and adverse events. Results: Fifty-seven participants were enrolled in two cohorts of 28 and 29 during two 4-month recruitment periods. Questionnaire follow-up completion rates ranged between 88% and 93%. Two major class protocol deviations were noted in TC and none in HE. Sixty-two percent of TC participants versus 50% of HE participants attended at least 70% of the classes during the 12-week initial intervention period. Weekly rates of TC home practice were high among class attendees (median of 4.2 days) at 12 weeks, with fewer people practicing at 26 and 52 weeks. By 52 weeks, 70% of TC participants reported practicing the week before, with a median of 3 days per week and 15 min/session. TC participants rated the helpfulness of their classes significantly higher than did HE participants, but the groups were similarly likely to recommend the classes. Conclusion: The TC intervention is feasible in this population, while the HE group requires modifications in delivery.

Randomized clinical trial assessing whether additional massage treatments for chronic neck pain improve 12- and 26-week outcomes.

BACKGROUND CONTEXT: This is the first study to systematically evaluate the value of a longer treatment period for massage. We provide a framework of how to conceptualize an optimal dose in this challenging setting of nonpharmacologic treatments. PURPOSE: The aim was to determine the optimal dose of massage for neck pain. STUDY DESIGN/SETTING: Two-phase randomized trial for persons with chronic nonspecific neck pain. Primary randomization to one of five groups receiving 4 weeks of massage (30 minutes 2x/or 3x/wk or 60 minutes 1x, 2x, or 3x/wk). Booster randomization of participants to receive an additional six massages, 60 minutes 1x/wk, or no additional massage. PATIENT SAMPLE: A total of 179 participants from Group Health and the general population of Seattle, WA, USA recruited between June 2010 and August 2011 were included. OUTCOME MEASURES: Primary outcomes self-reported neck-related dysfunction (Neck Disability Index) and pain (0-10 scale) were assessed at baseline, 12, and 26 weeks. Clinically meaningful improvement was defined as greater than or equal to 5-point decrease in dysfunction and greater than or equal to 30% decrease in pain from baseline. METHODS: Clinically meaningful improvement for each primary outcome with both follow-up times was analyzed using adjusted modified Poisson generalized estimating equations (GEEs). Secondary analyses for the continuous outcomes used linear GEEs. RESULTS: There were no observed differences by primary treatment group at 12 or 26 weeks. Those receiving booster dose had improvements in both dysfunction and pain at 12 weeks (dysfunction: relative risk [RR]=1.56 [1.08-2.25], p=.018; pain: RR=1.25 [0.98-1.61], p=.077), but those were nonsignificant at 26 weeks (dysfunction: RR=1.22 [0.85-1.74]; pain: RR=1.09 [0.82-1.43]). Subgroup analysis by primary and booster treatments found the booster dose only effective among those initially randomized to one of the 60-minute massage groups. CONCLUSIONS: "Booster" doses for those initially receiving 60 minutes of massage should be incorporated into future trials of massage for chronic neck pain.

Five-week outcomes from a dosing trial of therapeutic massage for chronic neck pain.

PURPOSE: This trial was designed to evaluate the optimal dose of massage for individuals with chronic neck pain. METHODS: We recruited 228 individuals with chronic nonspecific neck pain from an integrated health care system and the general population, and randomized them to 5 groups receiving various doses of massage (a 4-week course consisting of 30-minute visits 2 or 3 times weekly or 60-minute visits 1, 2, or 3 times weekly) or to a single control group (a 4-week period on a wait list). We assessed neck-related dysfunction with the Neck Disability Index (range, 0-50 points) and pain intensity with a numerical rating scale (range, 0-10 points) at baseline and 5 weeks. We used log-linear regression to assess the likelihood of clinically meaningful improvement in neck-related dysfunction (≥5 points on Neck Disability Index) or pain intensity (≥30% improvement) by treatment group. RESULTS: After adjustment for baseline age, outcome measures, and imbalanced covariates, 30-minute treatments were not significantly better than the wait list control condition in terms of achieving a clinically meaningful improvement in neck dysfunction or pain, regardless of the frequency of treatments. In contrast, 60-minute treatments 2 and 3 times weekly significantly increased the likelihood of such improvement compared with the control condition in terms of both neck dysfunction (relative risk = 3.41 and 4.98, P = .04 and .005, respectively) and pain intensity (relative risk = 2.30 and 2.73; P = .007 and .001, respectively). CONCLUSIONS: After 4 weeks of treatment, we found multiple 60-minute massages per week more effective than fewer or shorter sessions for individuals with chronic neck pain. Clinicians recommending massage and researchers studying this therapy should ensure that patients receive a likely effective dose of treatment.

Mediators of yoga and stretching for chronic low back pain.

Although yoga is an effective treatment for chronic low back pain, little is known about the mechanisms responsible for its benefits. In a trial comparing yoga to intensive stretching and self-care, we explored whether physical (hours of back exercise/week), cognitive (fear avoidance, body awareness, and self-efficacy), affective (psychological distress, perceived stress, positive states of mind, and sleep), and physiological factors (cortisol, DHEA) mediated the effects of yoga or stretching on back-related dysfunction (Roland-Morris Disability Scale (RDQ)). For yoga, 36% of the effect on 12-week RDQ was mediated by increased self-efficacy, 18% by sleep disturbance, 9% by hours of back exercise, and 61% by the best combination of all possible mediators (6 mediators). For stretching, 23% of the effect was mediated by increased self-efficacy, 14% by days of back exercise, and 50% by the best combination of all possible mediators (7 mediators). In open-ended questions, ≥20% of participants noted the following treatment benefits: learning new exercises (both groups), relaxation, increased awareness, and the benefits of breathing (yoga), benefits of regular practice (stretching). Although both self-efficacy and hours of back exercise were the strongest mediators for each intervention, compared to self-care, qualitative data suggest that they may exert their benefits through partially distinct mechanisms.

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

Validity of eight integrated healthcare delivery organizations' administrative clinical data to capture breast cancer chemotherapy exposure.

BACKGROUND: Cancer Research Network (CRN) sites use administrative data to populate their Virtual Data Warehouse (VDW). However, information on VDW chemotherapy data validity is limited. The purpose of this study was to assess the validity of VDW chemotherapy data. METHODS: This was a retrospective cohort study of women ≥18 years with incident, invasive breast cancer diagnosed between January 1999 and December 2007. Pharmacy and procedure chemotherapy data were extracted from each site's VDW. Random samples of 50 patients stratified on trastuzumab, anthracyclines, and no chemotherapy exposure was selected from each site for detailed chart abstraction. Weighted sensitivities and specificities of VDW compared with abstracted data were calculated. Cumulative doses calculated from VDW data were compared with doses obtained from the medical chart review. RESULTS: The cohort included 13,497 patients with 6,456 (48%) chart review eligible. Patients in the sample (N = 400) had a mean age of 65 years. Trastuzumab, anthracycline, and other chemotherapy weighted sensitivities were 95%, 97%, and 100%, respectively; specificities were 99%, 99%, and 93%, respectively; positive predictive values were 96%, 99%, and 55%, respectively; and negative predictive values were 99%, 96%, and 100%. Trastuzumab and anthracyclines VDW mean doses were 873 and 386 mg, respectively, whereas abstracted mean doses were 1,734 and 369 mgs, respectively (R(2) = 0.14, P < 0.01 and R(2) = 0.05, P = 0.03, respectively). CONCLUSIONS: Sensitivities and specificities for CRN chemotherapy VDW data were high and dosages were correlated with chart information. IMPACT: The findings support the use of CRN data in evaluating chemotherapy exposures and related outcomes.

A randomized trial comparing yoga, stretching, and a self-care book for chronic low back pain.

BACKGROUND: Chronic low back pain is a common problem lacking highly effective treatment options. Small trials suggest that yoga may have benefits for this condition. This trial was designed to determine whether yoga is more effective than conventional stretching exercises or a self-care book for primary care patients with chronic low back pain. METHODS: A total of 228 adults with chronic low back pain were randomized to 12 weekly classes of yoga (92 patients) or conventional stretching exercises (91 patients) or a self-care book (45 patients). Back-related functional status (modified Roland Disability Questionnaire, a 23-point scale) and bothersomeness of pain (an 11-point numerical scale) at 12 weeks were the primary outcomes. Outcomes were assessed at baseline, 6, 12, and 26 weeks by interviewers unaware of treatment group. RESULTS: After adjustment for baseline values, 12-week outcomes for the yoga group were superior to those for the self-care group (mean difference for function, -2.5 [95% CI, -3.7 to -1.3]; P < .001; mean difference for symptoms, -1.1 [95% CI, -1.7 to -0.4]; P < .001). At 26 weeks, function for the yoga group remained superior (mean difference, -1.8 [95% CI, -3.1 to -0.5]; P < .001). Yoga was not superior to conventional stretching exercises at any time point. CONCLUSION: Yoga classes were more effective than a self-care book, but not more effective than stretching classes, in improving function and reducing symptoms due to chronic low back pain, with benefits lasting at least several months. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00447668.

A comparison of the effects of 2 types of massage and usual care on chronic low back pain: a randomized, controlled trial.

BACKGROUND: Few studies have evaluated the effectiveness of massage for chronic low back pain. OBJECTIVE: To compare the effectiveness of 2 types of massage and usual care for chronic back pain. DESIGN: Parallel-group randomized, controlled trial. Randomization was computer-generated, with centralized allocation concealment. Participants were blinded to massage type but not to assignment to massage versus usual care. Massage therapists were unblinded. The study personnel who assessed outcomes were blinded to treatment assignment. (ClinicalTrials.gov registration number: NCT00371384) SETTING: An integrated health care delivery system in the Seattle area. PATIENTS: 401 persons 20 to 65 years of age with nonspecific chronic low back pain. INTERVENTION: Structural massage (n = 132), relaxation massage (n = 136), or usual care (n = 133). MEASUREMENTS: Roland Disability Questionnaire (RDQ) and symptom bothersomeness scores at 10 weeks (primary outcome) and at 26 and 52 weeks (secondary outcomes). Mean group differences of at least 2 points on the RDQ and at least 1.5 points on the symptom bothersomeness scale were considered clinically meaningful. RESULTS: The massage groups had similar functional outcomes at 10 weeks. The adjusted mean RDQ score was 2.9 points (95% CI, 1.8 to 4.0 points) lower in the relaxation group and 2.5 points (CI, 1.4 to 3.5 points) lower in the structural massage group than in the usual care group, and adjusted mean symptom bothersomeness scores were 1.7 points (CI, 1.2 to 2.2 points) lower with relaxation massage and 1.4 points (CI, 0.8 to 1.9 points) lower with structural massage. The beneficial effects of relaxation massage on function (but not on symptom reduction) persisted at 52 weeks but were small. LIMITATION: Participants were not blinded to treatment. CONCLUSION: Massage therapy may be effective for treatment of chronic back pain, with benefits lasting at least 6 months. No clinically meaningful difference between relaxation and structural massage was observed in terms of relieving disability or symptoms. PRIMARY FUNDING SOURCE: National Center for Complementary and Alternative Medicine.

Comparison of yoga versus stretching for chronic low back pain: protocol for the Yoga Exercise Self-care (YES) trial.

BACKGROUND: Back pain, one of the most prevalent conditions afflicting American adults, is the leading reason for using complementary and alternative medicine (CAM) therapies. Yoga is an increasingly popular "mind-body" CAM therapy often used for relieving back pain and several small studies have found yoga effective for this condition. This study will assess whether yoga is effective for treating chronic low back pain compared with self care and exercise and will explore the mechanisms responsible for any observed benefits. METHODS/DESIGN: A total of 210 participants with low back pain lasting at least 3 months will be recruited from primary care clinics of a large healthcare system based in Seattle. They will be randomized in a 2:2:1 ratio to receive 12 weekly yoga classes, 12 weekly conventional therapeutic exercise classes of comparable physical exertion, or a self-care book. Interviewers masked to participants' treatment group will assess outcomes at baseline and 6, 12 and 26 weeks after randomization. Primary outcomes will be back-related dysfunction and symptom bothersomeness. In addition, data will be collected on physical measurements (e.g., flexion) at baseline and 12 weeks and saliva samples will be obtained at baseline, 6 and 12 weeks. Information will be collected on specific physical, psychological, and physiological factors to allow exploration of possible mechanisms of action through which yoga could relieve back pain and dysfunction. The effectiveness of yoga will be assessed using analysis of covariance (using general estimating equations - GEE) within an intention-to-treat context. If yoga is found effective, further analyses will explore whether yoga's benefits are attributable to physical, psychological and/or physiological factors. CONCLUSIONS: This study will provide the clearest evidence to date about the value of yoga as a therapeutic option for treating chronic back pain, and if the results are positive, will help focus future, more in-depth, research on the most promising potential mechanisms of action identified by this study.

Susceptibility to nicotine dependence: the Development and Assessment of Nicotine Dependence in Youth 2 study.

OBJECTIVES: The purpose of this work was to identify characteristics that predict progression from the first inhalation of a cigarette to dependence. We studied a cohort of 1246 public school 6th-graders in 6 Massachusetts communities (mean age at baseline: 12.2 years). METHODS: We conducted a 4-year prospective study using 11 interviews. We assessed 45 risk factors and measured diminished autonomy over tobacco with the Hooked on Nicotine Checklist and evaluated tobacco dependence according to the International Classification of Diseases, 10th Revision. Cox proportional-hazards models were used. RESULTS: Among 217 youths who had inhaled from a cigarette, the loss of autonomy over tobacco was predicted by feeling relaxed the first time inhaling from a cigarette and depressed mood. Tobacco dependence was predicted by feeling relaxed, familiarity with Joe Camel, novelty seeking, and depressed mood. CONCLUSIONS: Once exposure to nicotine had occurred, remarkably few risk factors for smoking consistently contributed to individual differences in susceptibility to the development of dependence or loss of autonomy. An experience of relaxation in response to the first dose of nicotine was the strongest predictor of both dependence and lost autonomy. This association was not explained by trait anxiety or any of the other measured psychosocial factors. These results are discussed in relation to the theory that the process of dependence is initiated by the first dose of nicotine.