Identifying body awareness-related brain network changes after Spring Forest Qigong™ practice or P.Volve low-intensity exercise in adults with chronic low back pain: a feasibility Phase I Randomized Clinical Trial.

Background: Chronic low back pain (cLBP) affects the quality of life of 52 million Americans and leads to an enormous personal and economic burden. A multidisciplinary approach to cLBP management is recommended. Since medication has limited efficacy and there are mounting concerns about opioid addiction, the American College of Physicians and American Pain Society recommend non-pharmacological interventions, such as mind and body approaches (e.g., Qigong, yoga, Tai Chi) before prescribing medications. Of those, Qigong practice might be most accessible given its gentle movements and because it can be performed standing, sitting, or lying down. The three available Qigong studies in adults with cLBP showed that Qigong reduced pain more than waitlist and equally well than exercise. Yet, the duration and/or frequency of Qigong practice were low (<12 weeks or less than 3x/week). The objectives of this study were to investigate the feasibility of practicing Spring Forest Qigong™ or performing P.Volve low intensity exercises 3x/week for 12 weeks, feasibility of recruitment, data collection, delivery of the intervention as intended, as well as identify estimates of efficacy on brain function and behavioral outcomes after Qigong practice or exercise. To our knowledge, this is the first study investigating the feasibility of the potential effect of Qigong on brain function in adults with cLBP. Methods: We conducted a feasibility Phase I Randomized Clinical Trial. Of the 36 adults with cLBP recruited between January 2020 and June 2021, 32 were enrolled and randomized to either 12 weeks of remote Spring Forest Qigong™ practice or remote P.Volve low-intensity exercises. Participants practiced at least 3x/week for 41min/session with online videos. Our main outcome measures were the Numeric Pain Rating Scale (highest, average, and lowest cLBP pain intensity levels in the prior week), assessed weekly and fMRI data (resting-state and task-based fMRI tasks: pain imagery, kinesthetic imagery of a Qigong movement, and robot-guided shape discrimination). We compared baseline resting-state connectivity and brain activation during fMRI tasks in adults with cLBP with data from a healthy control group (n=28) acquired in a prior study. Secondary outcomes included measures of function, disability, body awareness, kinesiophobia, balance, self-efficacy, core muscle strength, and ankle proprioceptive acuity with a custom-build device. Results: Feasibility of the study design and methods was demonstrated with 30 participants completing the study (94% retention) and reporting high satisfaction with the programs; 96% adherence to P.Volve low-intensity exercises, and 128% of the required practice intensity for Spring Forest Qigong™ practice. Both groups saw promising reductions in low back pain (effect sizes Cohen's d =1.01-2.22) and in most other outcomes ( d =0.90-2.33). Markers of ankle proprioception were not significantly elevated in the cLBP group after the interventions. Brain imaging analysis showed weaker parietal operculum and insula network connectivity in adults with cLBP (n=26), compared to data from a healthy control group (n=28). The pain imagery task elicited lower brain activation of insula, parietal operculum, angular gyrus and supramarginal gyrus at baseline in adults with cLBP than in healthy adults. Adults with cLBP had lower precentral gyrus activation than healthy adults for the Qigong movement and robot task at baseline. Pre-post brain function changes showed individual variability: Six (out of 13) participants in the Qigong group showed increased activation in the parietal operculum, angular gyrus, supramarginal gyrus, and precentral gyrus during the Qigong fMRI task. Interpretation: Our data indicate the feasibility and acceptability of using Spring Forest Qigong™ practice or P.Volve low-intensity exercises for cLBP relief showing promising results in terms of pain relief and associated symptoms. Our brain imaging results indicated brain function improvements after 12 weeks of Qigong practice in some participants, pointing to the need for further investigation in larger studies. Trial registration number: ClinicalTrials.gov: NCT04164225 .

Multidisciplinary integrative care versus chiropractic care for low back pain: a randomized clinical trial.

BACKGROUND: Low back pain (LBP) is influenced by interrelated biological, psychological, and social factors, however current back pain management is largely dominated by one-size fits all unimodal treatments. Team based models with multiple provider types from complementary professional disciplines is one way of integrating therapies to address patients' needs more comprehensively. METHODS: This parallel group randomized clinical trial conducted from May 2007 to August 2010 aimed to evaluate the relative clinical effectiveness of 12 weeks of monodisciplinary chiropractic care (CC), versus multidisciplinary integrative care (IC), for adults with sub-acute and chronic LBP. The primary outcome was pain intensity and secondary outcomes were disability, improvement, medication use, quality of life, satisfaction, frequency of symptoms, missed work or reduced activities days, fear avoidance beliefs, self-efficacy, pain coping strategies and kinesiophobia measured at baseline and 4, 12, 26 and 52 weeks. Linear mixed models were used to analyze outcomes. RESULTS: 201 participants were enrolled. The largest reductions in pain intensity occurred at the end of treatment and were 43% for CC and 47% for IC. The primary analysis found IC to be significantly superior to CC over the 1-year period (P = 0.02). The long-term profile for pain intensity which included data from weeks 4 through 52, showed a significant advantage of 0.5 for IC over CC (95% CI 0.1 to 0.9; P = 0.02; 0 to 10 scale). The short-term profile (weeks 4 to 12) favored IC by 0.4, but was not statistically significant (95% CI - 0.02 to 0.9; P = 0.06). There was also a significant advantage over the long term for IC in some secondary measures (disability, improvement, satisfaction and low back symptom frequency), but not for others (medication use, quality of life, leg symptom frequency, fear avoidance beliefs, self-efficacy, active pain coping, and kinesiophobia). Importantly, no serious adverse events resulted from either of the interventions. CONCLUSIONS: Participants in the IC group tended to have better outcomes than the CC group, however the magnitude of the group differences was relatively small. Given the resources required to successfully implement multidisciplinary integrative care teams, they may not be worthwhile, compared to monodisciplinary approaches like chiropractic care, for treating LBP. Trial registration NCT00567333.

Learning to Apply Mindfulness to Pain (LAMP): Design for a Pragmatic Clinical Trial of Two Mindfulness-Based Interventions for Chronic Pain.

BACKGROUND: Mindfulness-based interventions (MBIs) are evidence-based nonpharmacological treatments for treating chronic pain. However, the predominant MBI, mindfulness-based stress reduction, has features that pose significant implementation barriers. OBJECTIVES: This study will test two approaches to delivering MBIs for improving Veterans' chronic pain and mental health comorbidities. These two approaches address key implementation barriers. METHODS: We will conduct a four-site, three-arm pragmatic randomized controlled trial, Learning to Apply Mindfulness to Pain (LAMP), to test the effectiveness of two MBIs at improving pain and mental health comorbidities. Mobile+Group LAMP consists of prerecorded modules presented by a mindfulness instructor that are viewed in an online group setting and interspersed with discussions led by a facilitator. Mobile LAMP consists of the same prerecorded modules but does not include a group component. We will test whether either of these MBIs will be more effective than usual care at improving chronic pain and whether the Mobile+Group LAMP will be more effective than Mobile LAMP at improving chronic pain. Comparisons for the primary hypotheses will be conducted with continuous outcomes (Brief Pain Inventory interference score) repeated at 10 weeks, 6 months, and 12 months. The secondary hypotheses are that Mobile+Group LAMP and Mobile LAMP will be more effective than usual care at improving secondary outcomes (e.g., post-traumatic stress disorder, depression). We will also confirm the comparisons for the primary and secondary hypotheses in gender-specific strata. IMPLICATIONS: This trial is expected to result in two approaches for delivering MBIs that will optimize engagement, adherence, and sustainability and be able to reach large numbers of Veterans.

Dose-response and efficacy of spinal manipulation for care of cervicogenic headache: a dual-center randomized controlled trial.

BACKGROUND CONTEXT: The optimal number of visits for the care of cervicogenic headache (CGH) with spinal manipulative therapy (SMT) is unknown. PURPOSE: The present study aimed to identify the dose-response relationship between visits for SMT and chronic CGH outcomes and to evaluate the efficacy of SMT by comparison with a light-massage control. STUDY DESIGN/SETTING: This is a two-site, open-label randomized controlled trial. PATIENT SAMPLE: Participants were 256 adults with chronic CGH. OUTCOME MEASURES: The primary outcome was days with CGH in the previous 4 weeks evaluated at the 12- and 24-week primary end points. Secondary outcomes included CGH days at remaining end points, pain intensity, disability, perceived improvement, medication use, and patient satisfaction. METHODS: Participants were randomized to four dose levels of chiropractic SMT: 0, 6, 12, or 18 sessions. They were treated three times per week for 6 weeks and received a focused light-massage control at sessions when SMT was not assigned. Linear dose effects and comparisons with the no-manipulation control group were evaluated at 6, 12, 24, 39, and 52 weeks. The present study was funded by the National Center for Complementary and Integrative Health (R01AT006330) and is registered at ClinicalTrials.gov (NCT01530321). The authors declare no conflicts of interest. RESULTS: A linear dose-response was observed for all follow-ups, a reduction of approximately 1 CGH day/4 weeks per additional 6 SMT visits (p<.05); a maximal effective dose could not be determined. Cervicogenic headache days/4 weeks were reduced from about 16 to 8 for the highest and most effective dose of 18 SMT visits. Mean differences in CGH days/4 weeks between 18 SMT visits and control were -3.3 (p=.004) and -2.9 (p=.017) at the primary end points, and were similar in magnitude at the remaining end points (p<.05). Differences between other SMT doses and control were smaller in magnitude (p>.05). Cervicogenic headache intensity showed no important improvement nor differed by dose. Other secondary outcomes were generally supportive of the primary outcome. CONCLUSIONS: There was a linear dose-response relationship between SMT visits and days with CGH. For the highest and most effective dose of 18 SMT visits, CGH days were reduced by half and about 3 more days per month than for the light-massage control.

Dose-response of spinal manipulation for cervicogenic headache: study protocol for a randomized controlled trial.

BACKGROUND: Cervicogenic headache is a prevalent and costly pain condition commonly treated by chiropractors. There is evidence to support the effectiveness for spinal manipulation, but the dose of treatment required to achieve maximal relief remains unknown. The purpose of this paper is to describe the methodology for a randomized controlled trial evaluating the dose-response of spinal manipulation for chronic cervicogenic headache in an adult population. METHODS/DESIGN: This is a mixed-methods, two-site, prospective, parallel groups, observer-blind, randomized controlled trial conducted at university-affiliated research clinics in the Portland, OR and Minneapolis, MN areas. The primary outcome is patient reported headache frequency. Other outcomes include self-reported headache intensity, disability, quality of life, improvement, neck pain intensity and frequency, satisfaction, medication use, outside care, cervical motion, pain pressure thresholds, health care utilization, health care costs, and lost productivity. Qualitative interviews are also conducted to evaluate patients' expectations of treatment. DISCUSSION: With growing concerns regarding the costs and side effects of commonly used conventional treatments, greater numbers of headache sufferers are seeking other approaches to care. This is the first full-scale randomized controlled trial assessing the dose-response of spinal manipulation therapy on outcomes for cervicogenic headache. The results of this study will provide important evidence for the management of cervicogenic headache in adults. TRIAL REGISTRATION: ClinicalTrials.gov (Identifier: NCT01530321).

Cost-effectiveness of spinal manipulative therapy, supervised exercise, and home exercise for older adults with chronic neck pain.

BACKGROUND CONTEXT: Chronic neck pain is a prevalent and disabling condition among older adults. Despite the large burden of neck pain, little is known regarding the cost-effectiveness of commonly used treatments. PURPOSE: This study aimed to estimate the cost-effectiveness of home exercise and advice (HEA), spinal manipulative therapy (SMT) plus HEA, and supervised rehabilitative exercise (SRE) plus HEA. STUDY DESIGN/SETTING: Cost-effectiveness analysis conducted alongside a randomized clinical trial (RCT) was performed. PATIENT SAMPLE: A total of 241 older adults (≥65 years) with chronic mechanical neck pain comprised the patient sample. OUTCOME MEASURES: The outcome measures were direct and indirect costs, neck pain, neck disability, SF-6D-derived quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) over a 1-year time horizon. METHODS: This work was supported by grants from the National Center for Complementary and Integrative Health (#F32AT007507), National Institute of Arthritis and Musculoskeletal and Skin Diseases (#P60AR062799), and Health Resources and Services Administration (#R18HP01425). The RCT is registered at ClinicalTrials.gov (#NCT00269308). A societal perspective was adopted for the primary analysis. A healthcare perspective was adopted as a sensitivity analysis. Cost-effectivenesswas a secondary aim of the RCT which was not powered for differences in costs or QALYs. Differences in costs and clinical outcomes were estimated using generalized estimating equations and linear mixed models, respectively. Cost-effectiveness acceptability curves were calculated to assess the uncertainty surrounding cost-effectiveness estimates. RESULTS: Total costs for SMT+HEA were 5% lower than HEA (mean difference: -$111; 95% confidence interval [CI] -$1,354 to $899) and 47% lower than SRE+HEA (mean difference: -$1,932; 95% CI -$2,796 to -$1,097). SMT+HEA also resulted in a greater reduction of neck pain over the year relative to HEA (0.57; 95% CI 0.23 to 0.92) and SRE+HEA (0.41; 95% CI 0.05 to 0.76). Differences in disability and QALYs favored SMT+HEA. The probability that adding SMT to HEA is cost-effective at willingness to pay thresholds of $50,000 to $200,000 per QALY gained ranges from 0.75 to 0.81. If adopting a health-care perspective, costs for SMT+HEA were 66% higher than HEA (mean difference: $515; 95% CI $225 to $1,094), resulting in an ICER of $55,975 per QALY gained. CONCLUSION: On average, SMT+HEA resulted in better clinical outcomes and lower total societal costs relative to SRE+HEA and HEA alone, with a 0.75 to 0.81 probability of cost-effectiveness for willingness to pay thresholds of $50,000 to $200,000 per QALY.

Manipulation and mobilisation for neck pain contrasted against an inactive control or another active treatment.

BACKGROUND: Manipulation and mobilisation are commonly used to treat neck pain. This is an update of a Cochrane review first published in 2003, and previously updated in 2010. OBJECTIVES: To assess the effects of manipulation or mobilisation alone compared wiith those of an inactive control or another active treatment on pain, function, disability, patient satisfaction, quality of life and global perceived effect in adults experiencing neck pain with or without radicular symptoms and cervicogenic headache (CGH) at immediate- to long-term follow-up. When appropriate, to assess the influence of treatment characteristics (i.e. technique, dosage), methodological quality, symptom duration and subtypes of neck disorder on treatment outcomes. SEARCH METHODS: Review authors searched the following computerised databases to November 2014 to identify additional studies: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and the Cumulative Index to Nursing and Allied Health Literature (CINAHL). We also searched ClinicalTrials.gov, checked references, searched citations and contacted study authors to find relevant studies. We updated this search in June 2015, but these results have not yet been incorporated. SELECTION CRITERIA: Randomised controlled trials (RCTs) undertaken to assess whether manipulation or mobilisation improves clinical outcomes for adults with acute/subacute/chronic neck pain. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, abstracted data, assessed risk of bias and applied Grades of Recommendation, Assessment, Development and Evaluation (GRADE) methods (very low, low, moderate, high quality). We calculated pooled risk ratios (RRs) and standardised mean differences (SMDs). MAIN RESULTS: We included 51 trials (2920 participants, 18 trials of manipulation/mobilisation versus control; 34 trials of manipulation/mobilisation versus another treatment, 1 trial had two comparisons). Cervical manipulation versus inactive control: For subacute and chronic neck pain, a single manipulation (three trials, no meta-analysis, 154 participants, ranged from very low to low quality) relieved pain at immediate- but not short-term follow-up. Cervical manipulation versus another active treatment: For acute and chronic neck pain, multiple sessions of cervical manipulation (two trials, 446 participants, ranged from moderate to high quality) produced similar changes in pain, function, quality of life (QoL), global perceived effect (GPE) and patient satisfaction when compared with multiple sessions of cervical mobilisation at immediate-, short- and intermediate-term follow-up. For acute and subacute neck pain, multiple sessions of cervical manipulation were more effective than certain medications in improving pain and function at immediate- (one trial, 182 participants, moderate quality) and long-term follow-up (one trial, 181 participants, moderate quality). These findings are consistent for function at intermediate-term follow-up (one trial, 182 participants, moderate quality). For chronic CGH, multiple sessions of cervical manipulation (two trials, 125 participants, low quality) may be more effective than massage in improving pain and function at short/intermediate-term follow-up. Multiple sessions of cervical manipulation (one trial, 65 participants, very low quality) may be favoured over transcutaneous electrical nerve stimulation (TENS) for pain reduction at short-term follow-up. For acute neck pain, multiple sessions of cervical manipulation (one trial, 20 participants, very low quality) may be more effective than thoracic manipulation in improving pain and function at short/intermediate-term follow-up. Thoracic manipulation versus inactive control: Three trials (150 participants) using a single session were assessed at immediate-, short- and intermediate-term follow-up. At short-term follow-up, manipulation improved pain in participants with acute and subacute neck pain (five trials, 346 participants, moderate quality, pooled SMD -1.26, 95% confidence interval (CI) -1.86 to -0.66) and improved function (four trials, 258 participants, moderate quality, pooled SMD -1.40, 95% CI -2.24 to -0.55) in participants with acute and chronic neck pain. A funnel plot of these data suggests publication bias. These findings were consistent at intermediate follow-up for pain/function/quality of life (one trial, 111 participants, low quality). Thoracic manipulation versus another active treatment: No studies provided sufficient data for statistical analyses. A single session of thoracic manipulation (one trial, 100 participants, moderate quality) was comparable with thoracic mobilisation for pain relief at immediate-term follow-up for chronic neck pain. Mobilisation versus inactive control: Mobilisation as a stand-alone intervention (two trials, 57 participants, ranged from very low to low quality) may not reduce pain more than an inactive control. Mobilisation versus another active treatment: For acute and subacute neck pain, anterior-posterior mobilisation (one trial, 95 participants, very low quality) may favour pain reduction over rotatory or transverse mobilisations at immediate-term follow-up. For chronic CGH with temporomandibular joint (TMJ) dysfunction, multiple sessions of TMJ manual therapy (one trial, 38 participants, very low quality) may be more effective than cervical mobilisation in improving pain/function at immediate- and intermediate-term follow-up. For subacute and chronic neck pain, cervical mobilisation alone (four trials, 165 participants, ranged from low to very low quality) may not be different from ultrasound, TENS, acupuncture and massage in improving pain, function, QoL and participant satisfaction at immediate- and intermediate-term follow-up. Additionally, combining laser with manipulation may be superior to using manipulation or laser alone (one trial, 56 participants, very low quality). AUTHORS' CONCLUSIONS: Although support can be found for use of thoracic manipulation versus control for neck pain, function and QoL, results for cervical manipulation and mobilisation versus control are few and diverse. Publication bias cannot be ruled out. Research designed to protect against various biases is needed. Findings suggest that manipulation and mobilisation present similar results for every outcome at immediate/short/intermediate-term follow-up. Multiple cervical manipulation sessions may provide better pain relief and functional improvement than certain medications at immediate/intermediate/long-term follow-up. Since the risk of rare but serious adverse events for manipulation exists, further high-quality research focusing on mobilisation and comparing mobilisation or manipulation versus other treatment options is needed to guide clinicians in their optimal treatment choices.

Exercises for mechanical neck disorders.

BACKGROUND: Neck pain is common, disabling and costly. Exercise is one treatment approach. OBJECTIVES: To assess the effectiveness of exercises to improve pain, disability, function, patient satisfaction, quality of life and global perceived effect in adults with neck pain. SEARCH METHODS: We searched MEDLINE, MANTIS, ClinicalTrials.gov and three other computerized databases up to between January and May 2014 plus additional sources (reference checking, citation searching, contact with authors). SELECTION CRITERIA: We included randomized controlled trials (RCTs) comparing single therapeutic exercise with a control for adults suffering from neck pain with or without cervicogenic headache or radiculopathy. DATA COLLECTION AND ANALYSIS: Two review authors independently conducted trial selection, data extraction, 'Risk of bias' assessment and clinical relevance. The quality of the evidence was assessed using GRADE. Meta-analyses were performed for relative risk and standardized mean differences (SMD) with 95% confidence intervals (CIs) after judging clinical and statistical heterogeneity. MAIN RESULTS: Twenty-seven trials (2485 analyzed /3005 randomized participants) met our inclusion criteria.For acute neck pain only, no evidence was found.For chronic neck pain, moderate quality evidence supports 1) cervico-scapulothoracic and upper extremity strength training to improve pain of a moderate to large amount immediately post treatment [pooled SMD (SMDp) -0.71 (95% CI: -1.33 to -0.10)] and at short-term follow-up; 2) scapulothoracic and upper extremity endurance training for slight beneficial effect on pain at immediate post treatment and short-term follow-up; 3) combined cervical, shoulder and scapulothoracic strengthening and stretching exercises varied from a small to large magnitude of beneficial effect on pain at immediate post treatment [SMDp -0.33 (95% CI: -0.55 to -0.10)] and up to long-term follow-up and a medium magnitude of effect improving function at both immediate post treatment and at short-term follow-up [SMDp -0.45 (95%CI: -0.72 to -0.18)]; 4) cervico-scapulothoracic strengthening/stabilization exercises to improve pain and function at intermediate term [SMDp -14.90 (95% CI:-22.40 to -7.39)]; 5) Mindfulness exercises (Qigong) minimally improved function but not global perceived effect at short term. Low evidence suggests 1) breathing exercises; 2) general fitness training; 3) stretching alone; and 4) feedback exercises combined with pattern synchronization may not change pain or function at immediate post treatment to short-term follow-up. Very low evidence suggests neuromuscular eye-neck co-ordination/proprioceptive exercises may improve pain and function at short-term follow-up.For chronic cervicogenic headache, moderate quality evidence supports static-dynamic cervico-scapulothoracic strengthening/endurance exercises including pressure biofeedback immediate post treatment and probably improves pain, function and global perceived effect at long-term follow-up. Low grade evidence supports sustained natural apophyseal glides (SNAG) exercises.For acute radiculopathy, low quality evidence suggests a small benefit for pain reduction at immediate post treatment with cervical stretch/strengthening/stabilization exercises. AUTHORS' CONCLUSIONS: No high quality evidence was found, indicating that there is still uncertainty about the effectiveness of exercise for neck pain. Using specific strengthening exercises as a part of routine practice for chronic neck pain, cervicogenic headache and radiculopathy may be beneficial. Research showed the use of strengthening and endurance exercises for the cervico-scapulothoracic and shoulder may be beneficial in reducing pain and improving function. However, when only stretching exercises were used no beneficial effects may be expected. Future research should explore optimal dosage.

Regional lumbar motion and patient-rated outcomes: a secondary analysis of data from a randomized clinical trial.

OBJECTIVE: The purpose of this study was to examine the relationship in change scores between regional lumbar motion and patient-rated pain of the previous week and back-related function in chronic low back pain patients enrolled in a randomized clinical trial and treated with either exercise therapy or spinal manipulation using 6 different motion parameters. METHODS: Regional lumbar motions were sampled using a 6 degrees of freedom instrumented spatial linkage system in 199 participants at baseline and 12-week follow-up. The regional lumbar motion data were analyzed as a total cohort as well as relative to subgroup stratifications; back pain only vs back and leg pain, and treatment modality. For identifying clinically meaningful improvements in the measurements of back pain and back-related function, we used a 30% threshold. RESULTS: The relationship between change scores in patient-rated outcomes and objective measures of regional lumbar motion was found to be weak. In contrast, distribution of pain and treatment received affected associations between motion parameters and patient-rated outcomes. Thus, stronger correlation coefficients and significant differences between clinically relevant improved vs no clinical relevant change were found in some motion parameters in the subgroup with back pain only and the treatment group receiving spinal manipulation. CONCLUSION: Overall, changes in regional lumbar motion were poorly associated with patient-rated outcomes measured by back-related function and back pain intensity scores. However, associations between regional lumbar motion vs patient-rated pain and back-related function were different in relative subgroups (back pain only vs back and leg pain and treatment).

Exploring patient satisfaction: a secondary analysis of a randomized clinical trial of spinal manipulation, home exercise, and medication for acute and subacute neck pain.

OBJECTIVE: The purpose of this study was to assess satisfaction with specific aspects of care for acute neck pain and explore the relationship between satisfaction with care, neck pain, and global satisfaction. METHODS: This study was a secondary analysis of patient satisfaction from a randomized trial of spinal manipulation therapy (SMT) delivered by doctors of chiropractic, home exercise and advice (HEA) delivered by exercise therapists, and medication (MED) prescribed by a medical doctors for acute/subacute neck pain. Differences in satisfaction with specific aspects of care were analyzed using a linear mixed model. The relationship between specific aspects of care and (1) change in neck pain (primary outcome of the randomized trial) and (2) global satisfaction were assessed using Pearson's correlation and multiple linear regression. RESULTS: Individuals receiving SMT or HEA were more satisfied with the information and general care received than MED group participants. Spinal manipulation therapy and HEA groups reported similar satisfaction with information provided during treatment; however, the SMT group was more satisfied with general care. Satisfaction with general care (r = -0.75 to -0.77; R(2) = 0.55-0.56) had a stronger relationship with global satisfaction compared with satisfaction with information provided (r = -0.65 to 0.67; R(2) = 0.39-0.46). The relationship between satisfaction with care and neck pain was weak (r = 0.17-0.38; R(2) = 0.08-0.21). CONCLUSIONS: Individuals with acute/subacute neck pain were more satisfied with specific aspects of care received during spinal manipulation therapy or home exercise interventions compared to receiving medication. The relationship between neck pain and satisfaction with care was weak.

Reliability and measurement error of 3-dimensional regional lumbar motion measures: a systematic review.

OBJECTIVE: The purpose of this study was to systematically review the literature on reproducibility (reliability and/or measurement error) of 3-dimensional (3D) regional lumbar motion measurement systems. METHODS: Electronic searches were performed in PubMed, Cumulative Index of the Nursing and Allied Health Literature, Embase, and Mantis databases. To be included, original studies had to report on the reproducibility of a 3D computerized regional lumbar spinal motion analysis system in human subjects. A detailed checklist was developed based on guidelines for reporting reliability and agreement studies, the standards for reporting of diagnostic accuracy, and quality assessment of diagnostic accuracy studies and used for data extraction and quality assessment. The checklist consisted of descriptive items divided into 4 domains: study population, testing circumstances, equipment, and data analysis and presentation. The descriptive items were used as foundation for the quality assessment reflecting the reporting level of the included articles. RESULTS: A total of 15 articles were included in this study. We found incomplete reporting in 1 or more domains in all articles. A varying amount of measurement error was reported in 8 of the 15 articles. Because of incomplete reporting, these reliability and measurement error estimates are difficult to interpret. CONCLUSIONS: The current literature on the reliability and measurement error of measures created by regional 3D spinal instruments contains uncertainties especially in relevant clinical populations. There is uncertainty with respect to the degree that repeated measurements by 3D regional spinal motion instruments are reproducible. However, limited to the studies where reliability estimates were provided, most instruments used under standardized conditions may be considered reliable enough to be used for research purposes on the group level, but it is uncertain if they can be used on the individual patient level.

Exercises for mechanical neck disorders.

BACKGROUND: Neck disorders are common, disabling and costly. The effectiveness of exercise as a physiotherapy intervention remains unclear. OBJECTIVES: To improve pain, disability, function, patient satisfaction, quality of life and global perceived effect in adults with neck pain. SEARCH METHODS: Computerized searches were conducted up to February 2012. SELECTION CRITERIA: We included single therapeutic exercise randomized controlled trials for adults with neck pain with or without cervicogenic headache or radiculopathy. DATA COLLECTION AND ANALYSIS: Two review authors independently conducted selection, data extraction, 'Risk of bias' assessment, and clinical relevance. The quality of the body of evidence was assessed using GRADE. Relative risk and standardized mean differences (SMD) were calculated.  After judging clinical and statistical heterogeneity, we performed meta-analyses. MAIN RESULTS: Six of the 21 selected trials had low risk of bias. Moderate quality evidence shows that combined cervical, scapulothoracic stretching and strengthening are beneficial for pain relief post treatment (pooled SMD -0.35, 95% confidence interval (CI): -0.60, -0.10) and at intermediate follow-up (pooled SMD -0.31, 95% CI: -0.57, -0.06), and improved function short term and intermediate term (pooled SMD -0.45, 95% CI: -0.72, -0.18) for chronic neck pain. Moderate quality evidence demonstrates patients are very satisfied with their care when treated with therapeutic exercise. Low quality evidence shows exercise is of benefit for pain in the short term and for function up to long-term follow-up for chronic neck pain. Low to moderate quality evidence shows that chronic neck pain does not respond to upper extremity stretching and strengthening or a general exercise program.Low to moderate quality evidence supports self-mobilization, craniocervical endurance and low load cervical-scapular endurance exercises in reducing pain, improving function and global perceived effect in the long term for subacute/chronic cervicogenic headache. Low quality evidence supports neck strengthening exercise in acute cervical radiculopathy for pain relief in the short term. AUTHORS' CONCLUSIONS: Low to moderate quality evidence supports the use of specific cervical and scapular stretching and strengthening exercise for chronic neck pain immediately post treatment and intermediate term, and cervicogenic headaches in the long term. Low to moderate evidence suggests no benefit for some upper extremity stretching and strengthening exercises or a general exercise program.  Future trials should consider using an exercise classification system to establish similarity between protocols and adequate sample sizes. Factorial trials would help determine the active treatment agent within a treatment regimen where a standardized representation of dosage is essential. Standardized reporting of adverse events is needed for balancing the likelihood of treatment benefits over potential harms.

Spinal manipulation, medication, or home exercise with advice for acute and subacute neck pain: a randomized trial.

BACKGROUND: Mechanical neck pain is a common condition that affects an estimated 70% of persons at some point in their lives. Little research exists to guide the choice of therapy for acute and subacute neck pain. OBJECTIVE: To determine the relative efficacy of spinal manipulation therapy (SMT), medication, and home exercise with advice (HEA) for acute and subacute neck pain in both the short and long term. DESIGN: Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00029770) SETTING: 1 university research center and 1 pain management clinic in Minnesota. PARTICIPANTS: 272 persons aged 18 to 65 years who had nonspecific neck pain for 2 to 12 weeks. INTERVENTION: 12 weeks of SMT, medication, or HEA. MEASUREMENTS: The primary outcome was participant-rated pain, measured at 2, 4, 8, 12, 26, and 52 weeks after randomization. Secondary measures were self-reported disability, global improvement, medication use, satisfaction, general health status (Short Form-36 Health Survey physical and mental health scales), and adverse events. Blinded evaluation of neck motion was performed at 4 and 12 weeks. RESULTS: For pain, SMT had a statistically significant advantage over medication after 8, 12, 26, and 52 weeks (P ≤ 0.010), and HEA was superior to medication at 26 weeks (P = 0.02). No important differences in pain were found between SMT and HEA at any time point. Results for most of the secondary outcomes were similar to those of the primary outcome. LIMITATIONS: Participants and providers could not be blinded. No specific criteria for defining clinically important group differences were prespecified or available from the literature. CONCLUSION: For participants with acute and subacute neck pain, SMT was more effective than medication in both the short and long term. However, a few instructional sessions of HEA resulted in similar outcomes at most time points. PRIMARY FUNDING SOURCE: National Center for Complementary and Alternative Medicine, National Institutes of Health.

Development of disease-specific quality indicators for Danish chiropractic patients with low back pain.

OBJECTIVE: The purpose of this study is to develop disease-specific quality indicators for Danish chiropractic patients with low back pain (LBP) as an initial effort to include chiropractors in the Danish Health Care Quality Programme. METHODS: A cross-disciplinary Indicator Group consisting of researchers and clinicians prioritized 9 evidence-based quality indicators and quality performance standards in a systematic consensus process. A feasibility study involving 20 chiropractors in 8 chiropractic clinics and 206 LBP patients was undertaken. Afterward, an audit meeting was held where participating clinicians could voice their opinion and share experiences. After the test and audit, the Indicator Group reconvened and decided on the final set of indicators. RESULTS: The following quality indicators were chosen: case history, test for discogenic back pain, neurology, radiology, classification, exercise therapy, outcome assessment, and reevaluation. Only the outcome assessment indicators met the standards set by the Indicator Group. Based on the feedback supplied at the audit meeting and after evaluating the test results, the Indicator Group decided to reduce the standards but keep all indicators. CONCLUSIONS: This study showed that it is possible to describe quality indicators for the assessment and treatment of LBP patients, to identify the patient population, and to collect data. The participating clinics did not meet the original quality standards set by the Indicator Group. Reasons for this may include unrealistically high thresholds set by the Indicator Group and the somewhat complex or compound structure of some of the indicators. The Indicator Group and the test clinics recommend future nationwide implementation of the developed quality indicators.

Supervised exercise, spinal manipulation, and home exercise for chronic low back pain: a randomized clinical trial.

BACKGROUND CONTEXT: Several conservative therapies have been shown to be beneficial in the treatment of chronic low back pain (CLBP), including different forms of exercise and spinal manipulative therapy (SMT). The efficacy of less time-consuming and less costly self-care interventions, for example, home exercise, remains inconclusive in CLBP populations. PURPOSE: The purpose of this study was to assess the relative efficacy of supervised exercise, spinal manipulation, and home exercise for the treatment of CLBP. STUDY DESIGN/SETTING: An observer-blinded and mixed-method randomized clinical trial conducted in a university research clinic in Bloomington, MN, USA. PATIENT SAMPLE: Individuals, 18 to 65 years of age, who had a primary complaint of mechanical LBP of at least 6-week duration with or without radiating pain to the lower extremity were included in this trial. OUTCOME MEASURES: Patient-rated outcomes were pain, disability, general health status, medication use, global improvement, and satisfaction. Trunk muscle endurance and strength were assessed by blinded examiners, and qualitative interviews were performed at the end of the 12-week treatment phase. METHODS: This prospective randomized clinical trial examined the short- (12 weeks) and long-term (52 weeks) relative efficacy of high-dose, supervised low-tech trunk exercise, chiropractic SMT, and a short course of home exercise and self-care advice for the treatment of LBP of at least 6-week duration. The study was approved by local institutional review boards. RESULTS: A total of 301 individuals were included in this trial. For all three treatment groups, outcomes improved during the 12 weeks of treatment. Those who received supervised trunk exercise were most satisfied with care and experienced the greatest gains in trunk muscle endurance and strength, but they did not significantly differ from those receiving chiropractic spinal manipulation or home exercise in terms of pain and other patient-rated individual outcomes, in both the short- and long-term. CONCLUSIONS: For CLBP, supervised exercise was significantly better than chiropractic spinal manipulation and home exercise in terms of satisfaction with treatment and trunk muscle endurance and strength. Although the short- and long-term differences between groups in patient-rated pain, disability, improvement, general health status, and medication use consistently favored the supervised exercise group, the differences were relatively small and not statistically significant for these individual outcomes.

Chiropractic and self-care for back-related leg pain: design of a randomized clinical trial.

BACKGROUND: Back-related leg pain (BRLP) is a common variation of low back pain (LBP), with lifetime prevalence estimates as high as 40%. Often disabling, BRLP accounts for greater work loss, recurrences, and higher costs than uncomplicated LBP and more often leads to surgery with a lifetime incidence of 10% for those with severe BRLP, compared to 1-2% for those with LBP.In the US, half of those with back-related conditions seek CAM treatments, the most common of which is chiropractic care. While there is preliminary evidence suggesting chiropractic spinal manipulative therapy is beneficial for patients with BRLP, there is insufficient evidence currently available to assess the effectiveness of this care. METHODS/DESIGN: This study is a two-site, prospective, parallel group, observer-blinded randomized clinical trial (RCT). A total of 192 study patients will be recruited from the Twin Cities, MN (n = 122) and Quad Cities area in Iowa and Illinois (n = 70) to the research clinics at WHCCS and PCCR, respectively.It compares two interventions: chiropractic spinal manipulative therapy (SMT) plus home exercise program (HEP) to HEP alone (minimal intervention comparison) for patients with subacute or chronic back-related leg pain. DISCUSSION: Back-related leg pain (BRLP) is a costly and often disabling variation of the ubiquitous back pain conditions. As health care costs continue to climb, the search for effective treatments with few side-effects is critical. While SMT is the most commonly sought CAM treatment for LBP sufferers, there is only a small, albeit promising, body of research to support its use for patients with BRLP.This study seeks to fill a critical gap in the LBP literature by performing the first full scale RCT assessing chiropractic SMT for patients with sub-acute or chronic BRLP using important patient-oriented and objective biomechanical outcome measures. TRIAL REGISTRATION: ClinicalTrials.gov NCT00494065.

Integrative care for the management of low back pain: use of a clinical care pathway.

BACKGROUND: For the treatment of chronic back pain, it has been theorized that integrative care plans can lead to better outcomes than those achieved by monodisciplinary care alone, especially when using a collaborative, interdisciplinary, and non-hierarchical team approach. This paper describes the use of a care pathway designed to guide treatment by an integrative group of providers within a randomized controlled trial. METHODS: A clinical care pathway was used by a multidisciplinary group of providers, which included acupuncturists, chiropractors, cognitive behavioral therapists, exercise therapists, massage therapists and primary care physicians. Treatment recommendations were based on an evidence-informed practice model, and reached by group consensus. Research study participants were empowered to select one of the treatment recommendations proposed by the integrative group. Common principles and benchmarks were established to guide treatment management throughout the study. RESULTS: Thirteen providers representing 5 healthcare professions collaborated to provide integrative care to study participants. On average, 3 to 4 treatment plans, each consisting of 2 to 3 modalities, were recommended to study participants. Exercise, massage, and acupuncture were both most commonly recommended by the team and selected by study participants. Changes to care commonly incorporated cognitive behavioral therapy into treatment plans. CONCLUSION: This clinical care pathway was a useful tool for the consistent application of evidence-based care for low back pain in the context of an integrative setting. TRIAL REGISTRATION: ClinicalTrials.gov NCT00567333.

Manual therapy and exercise for neck pain: a systematic review.

Manual therapy is often used with exercise to treat neck pain. This cervical overview group systematic review update assesses if manual therapy, including manipulation or mobilisation, combined with exercise improves pain, function/disability, quality of life, global perceived effect, and patient satisfaction for adults with neck pain with or without cervicogenic headache or radiculopathy. Computerized searches were performed to July 2009. Two or more authors independently selected studies, abstracted data, and assessed methodological quality. Pooled relative risk (pRR) and standardized mean differences (pSMD) were calculated. Of 17 randomized controlled trials included, 29% had a low risk of bias. Low quality evidence suggests clinically important long-term improvements in pain (pSMD-0.87(95% CI: -1.69, -0.06)), function/disability, and global perceived effect when manual therapy and exercise are compared to no treatment. High quality evidence suggests greater short-term pain relief [pSMD-0.50(95% CI: -0.76, -0.24)] than exercise alone, but no long-term differences across multiple outcomes for (sub)acute/chronic neck pain with or without cervicogenic headache. Moderate quality evidence supports this treatment combination for pain reduction and improved quality of life over manual therapy alone for chronic neck pain; and suggests greater short-term pain reduction when compared to traditional care for acute whiplash. Evidence regarding radiculopathy was sparse. Specific research recommendations are made.

Manual therapy with or without physical medicine modalities for neck pain: a systematic review.

Manual therapy interventions are often used with or without physical medicine modalities to treat neck pain. This review assessed the effect of 1) manipulation and mobilisation, 2) manipulation, mobilisation and soft tissue work, and 3) manual therapy with physical medicine modalities on pain, function, patient satisfaction, quality of life (QoL), and global perceived effect (GPE) in adults with neck pain. A computerised search for randomised trials was performed up to July 2009. Two or more authors independently selected studies, abstracted data, and assessed methodological quality. Pooled relative risk (RR) and standardised mean differences (SMD) were calculated when possible. We included 19 trials, 37% of which had a low risk of bias. Moderate quality evidence (1 trial, 221 participants) suggested mobilisation, manipulation and soft tissue techniques decrease pain and improved satisfaction when compared to short wave diathermy, and that this treatment combination paired with advice and exercise produces greater improvements in GPE and satisfaction than advice and exercise alone for acute neck pain. Low quality evidence suggests a clinically important benefit favouring mobilisation and manipulation in pain relief [1 meta-analysis, 112 participants: SMD -0.34(95% CI: -0.71, 0.03), improved function and GPE (1 trial, 94 participants) for participants with chronic cervicogenic headache when compared to a control at intermediate and long term follow-up; but no difference when used with various physical medicine modalities.

Manipulation or mobilisation for neck pain: a Cochrane Review.

Manipulation and mobilisation are often used, either alone or combined with other treatment approaches, to treat neck pain. This review assesses if manipulation or mobilisation improves pain, function/disability, patient satisfaction, quality of life (QoL), and global perceived effect (GPE) in adults experiencing neck pain with or without cervicogenic headache or radicular findings. A computerised search was performed in July 2009. Randomised trials investigating manipulation or mobilisation for neck pain were included. Two or more authors independently selected studies, abstracted data, and assessed methodological quality. Pooled relative risk (pRR) and standardised mean differences (pSMD) were calculated. 33% of 27 trials had a low risk of bias. Moderate quality evidence showed cervical manipulation and mobilisation produced similar effects on pain, function and patient satisfaction at intermediate-term follow-up. Low quality evidence suggested cervical manipulation may provide greater short-term pain relief than a control (pSMD -0.90 (95%CI: -1.78 to -0.02)). Low quality evidence also supported thoracic manipulation for pain reduction (NNT 7; 46.6% treatment advantage) and increased function (NNT 5; 40.6% treatment advantage) in acute pain and immediate pain reduction in chronic neck pain (NNT 5; 29% treatment advantage). Optimal technique and dose need to be determined.