Spinal rehabilitative exercise or manual treatment for the prevention of tension-type headache in adults.

This is the protocol for a review and there is no abstract. The objectives are as follows: To assess the short- and long-term effects of manual treatment and spinal rehabilitative exercise for the prevention of tension-type headache in adults.

Spinal rehabilitative exercise or manual treatment for the prevention of cervicogenic headache in adults.

This is the protocol for a review and there is no abstract. The objectives are as follows: To quantify and compare the short- and long-term effects of manual treatment and spinal rehabilitative exercise for cervicogenic headache, classified according to the International Headache Society's (IHS) diagnostic criteria, with an active or placebo/sham comparison or wait-list control.

Spinal manipulation and home exercise with advice for subacute and chronic back-related leg pain: a trial with adaptive allocation.

BACKGROUND: Back-related leg pain (BRLP) is often disabling and costly, and there is a paucity of research to guide its management. OBJECTIVE: To determine whether spinal manipulative therapy (SMT) plus home exercise and advice (HEA) compared with HEA alone reduces leg pain in the short and long term in adults with BRLP. DESIGN: Controlled pragmatic trial with allocation by minimization conducted from 2007 to 2011. (ClinicalTrials.gov: NCT00494065). SETTING: 2 research centers (Minnesota and Iowa). PATIENTS: Persons aged 21 years or older with BRLP for least 4 weeks. INTERVENTION: 12 weeks of SMT plus HEA or HEA alone. MEASUREMENTS: The primary outcome was patient-rated BRLP at 12 and 52 weeks. Secondary outcomes were self-reported low back pain, disability, global improvement, satisfaction, medication use, and general health status at 12 and 52 weeks. Blinded objective tests were done at 12 weeks. RESULTS: Of the 192 enrolled patients, 191 (99%) provided follow-up data at 12 weeks and 179 (93%) at 52 weeks. For leg pain, SMT plus HEA had a clinically important advantage over HEA (difference, 10 percentage points [95% CI, 2 to 19]; P=0.008) at 12 weeks but not at 52 weeks (difference, 7 percentage points [CI, -2 to 15]; P=0.146). Nearly all secondary outcomes improved more with SMT plus HEA at 12 weeks, but only global improvement, satisfaction, and medication use had sustained improvements at 52 weeks. No serious treatment-related adverse events or deaths occurred. LIMITATION: Patients and providers could not be blinded. CONCLUSION: For patients with BRLP, SMT plus HEA was more effective than HEA alone after 12 weeks, but the benefit was sustained only for some secondary outcomes at 52 weeks. PRIMARY FUNDING SOURCE: U.S. Department of Health and Human Services.

Chiropractic and exercise for seniors with low back pain or neck pain: the design of two randomized clinical trials.

BACKGROUND: Low back pain (LBP) and neck pain (NP) are common conditions in old age, leading to impaired functional ability and decreased independence. Manual and exercise therapies are common and effective therapies for the general LBP and NP populations. However, these treatments have not been adequately researched in older LBP and NP sufferers. The primary aim of these studies is to assess the relative clinical effectiveness of 1) manual treatment plus home exercise, 2) supervised rehabilitative exercise plus home exercise, and 3) home exercise alone, in terms of patient-rated pain, for senior LBP and NP patients. Secondary aims are to compare the three treatment approaches in regards to patient-rated disability, general health status, satisfaction, improvement and medication use, as well as objective outcomes of spinal motion, trunk strength and endurance, and functional ability. Cost-effectiveness and cost-utility will also be assessed. Finally, using qualitative methods, older LBP and NP patient's perceptions of treatment will be explored and described. METHODS/DESIGN: This paper describes the design of two multi-methods clinical studies focusing on elderly patients with non-acute LBP and NP. Each study includes a randomized clinical trial (RCT), a cost-effectiveness study alongside the RCT, and a qualitative study. Four hundred and eighty participants (240 per study), ages 65 and older, will be recruited and randomized to one of three, 12-week treatment programs. Patient-rated outcome measures are collected via self-report questionnaires at baseline and at 4, 12, 26, and 52 weeks post-randomization. Objective outcomes are assessed by examiners masked to treatment assignment at baseline and 12 weeks. Health care cost data is collected through standardized clinician forms, monthly phone interviews, and self-report questionnaires throughout the study. Qualitative interviews using a semi-structured format are conducted at the end of the 12 week treatment period. DISCUSSION: To our knowledge, these are the first randomized clinical trials to comprehensively address clinical effectiveness, cost-effectiveness, and patients' perceptions of commonly used treatments for elderly LBP and NP sufferers.

Racial/Ethnic Differences in the Use of Complementary and Alternative Medicine in US Adults With Moderate Mental Distress.

OBJECTIVES: To examine the prevalence of complementary and alternative medicine (CAM) use by race/ethnicity and to identify sociodemographic and health-related factors associated with CAM use among US adults with moderate mental distress (MMD). METHODS: We analyzed data from the 2012 National Health Interview Survey (NHIS). We used data for 6016 noninstitutionalized US adults with MMD (3492 non-Hispanic whites, 953 non-Hispanic blacks, 1078 Hispanics, 268 Asians, and 225 others consisted of American Indian, Alaska Native, and those reporting multiple races). The 2012 NHIS asks about 36 types of CAM use in the past 12 months. We constructed (1) overall, any CAM use; (2) 5 major types of CAM use; and (3) individual types of CAM use indicators. Using a cross-sectional design with complex survey techniques, we estimated race/ethnicity-specific CAM prevalence, and odds of past year CAM use by race/ethnicity, sociodemographic, and health-related factors. RESULTS: Nearly 40% of adults with MMD used CAM in the past year compared with 32% of those without MMD ( P < .001). In adults with MMD, past year CAM use differed by race/ethnicity, ranging from 24.3% (blacks) to 44.7% (Asians) and 46.8% (others) ( P < .001). Being younger, female, living in the west, higher education, being employed, more than 4 ambulatory care visits, and functional limitations were associated with higher odds of CAM use ( P < .01). CONCLUSIONS: Adults with MMD use CAM more frequently than those without MMD. In addition, CAM use was significantly differed by race/ethnicity in adults with MMD. This underscores the need for good patient-provider communication and suggests opportunity for dialogue about integration between conventional providers and CAM practitioners to facilitate optimal mental health care.

Chiropractic clinical research: progress and recommendations.

OBJECTIVE: The purpose of this white paper is to help inform the chiropractic clinical research agenda with a focus on the United States. METHODS AND DISCUSSION: The recommendations and action items from 2 previous articles published in 1997 are discussed within the context of 3 broad topics: research culture, research infrastructure, and clinical research studies. Progress made toward the action items in these areas is summarized. A summary of findings is presented of the most influential clinical research studies during the past decade performed by or with major contributions by chiropractic investigators. In light of the current evidence and previous recommendations, new clinical research recommendations are proposed. CONCLUSIONS: Based on the assessment of the scientific literature and research currently underway, it is evident that members of the chiropractic research community have made important progress in becoming active players in the clinical research arena. During the past decade, the work of chiropractic researchers has contributed substantially to the amount and quality of the evidence for or against spinal manipulation in the management of low back pain, neck pain, headache, and other conditions.

Complementary and Alternative Medicine Use in the US Adult Low Back Pain Population.

BACKGROUND: Many people suffering from low back pain (LBP) have found conventional medical treatments to be ineffective for managing their LBP and are increasingly turning to complementary and alternative medicine (CAM) to find pain relief. A comprehensive picture of CAM use in the LBP population, including all of the most commonly used modalities, is needed. STUDY OBJECTIVE: To examine prevalence and perceived benefit of CAM use within the US LBP population by limiting vs nonlimiting LBP and to evaluate the odds of past year CAM use within the LBP population. METHODS: Data are from the 2012 National Health Interview Survey, Alternative Health Supplement. We examined a nationally representative sample of US adults with LBP (N=9665 unweighted). Multiple logistic regression was used to estimate the odds of past year CAM use. RESULTS: In all, 41.2% of the LBP population used CAM in the past year, with higher use reported among those with limiting LBP. The most popular therapies used in the LBP population included herbal supplements, chiropractic manipulation, and massage. The majority of the LBP population used CAM specifically to treat back pain, and 58.1% of those who used CAM for their back pain perceived a great deal of benefit. CONCLUSION: The results are indicative of CAM becoming an increasingly important component of care for people with LBP. Additional understanding of patterns of CAM use among the LBP population will help health professionals make more informed care decisions and guide investigators in development of future back pain-related CAM research.

Complementary and integrative healthcare for patients with mechanical low back pain in a U.S. hospital setting.

OBJECTIVES: Complementary and integrative healthcare (CIH) is commonly used to treat low back pain (LBP). While the use of CIH within hospitals is increasing, little is known regarding the delivery of these services within inpatient settings. We examine the patterns of CIH services among inpatients with mechanical LBP in a hospital setting. METHODS: This is a retrospective, practice-based study conducted at Abbot Northwestern hospital in Minnesota. Using electronic health record data from July 2009 to December 2012, 8095 inpatients with mechanical LBP were identified using ICD-9 codes. We classified patients by reason for hospitalization. We examined demographic and clinical characteristics by receipt of CIH services. Then, we estimated the prevalence of types of CIH delivered and clinical foci for CIH visits among inpatients with mechanical LBP. RESULTS: Most inpatients with mechanical LBP (>90%) were hospitalized for surgical procedures. Overall, 14.2% received inpatient CIH services. All demographic and clinical characteristics differed by receipt of CIH (P<0.001), except race/ethnicity. CIH recipients were in poorer health than those who did not. Most commonly delivered CIH services were massage (62.1%), relaxation techniques (42.0%) and acupuncture (25.7%). Pain (45.1%), relaxation (17.5%), and comfort (8.2%) were the top three reasons for CIH visits. CONCLUSION: There are important differences between CIH recipients and non-CIH recipients among patients with mechanical LBP within a hospital setting. The reasons documented for CIH visits included addressing physical, emotional and/or mental conditions of patients. Future studies are needed to determine the effectiveness of CIH services health and wellbeing outcomes in this population.

Distraction manipulation of the lumbar spine: a review of the literature.

OBJECTIVE: The purpose of this study is to review the literature concerning distraction manipulation of the lumbar spine, particularly regarding physiological effects, clinical efficacy, and safety. DATA SOURCES: A search of the English language literature was conducted using the MEDLINE, Embase, CINAHL, Chiropractic Research Archives Collection, and Manual, Alternative, and Natural Therapies Information System databases. A secondary hand search of bibliographies was completed to identify older or nonindexed literature. DATA SELECTION AND EXTRACTION: Articles were identified, which described the characteristics of distraction manipulation beyond a simple description or the results of treatment with distraction manipulation. Data were extracted on the basis of relevance to the stated objective. DATA SYNTHESIS AND RESULTS: Thirty articles were identified. Three were uncontrolled or pilot studies, 3 were basic science studies, and 6 were case series. Most were case reports. Lumbar distraction manipulation is a nonthrust mechanically assisted manual medicine technique with characteristics of manipulation, mobilization, and traction. It is used for a variety of lumbar conditions and chronic pelvic pain. The primary rationale for its use is on the basis of the biomechanical effects of axial spinal distraction. Little data are available describing the in vivo effect of distraction when used in combination with flexion or other motions. CONCLUSIONS: Despite widespread use, the efficacy of distraction manipulation is not well established. Further research is needed to establish the efficacy and safety of distraction manipulation and to explore biomechanical, neurological, and biochemical events that may be altered by this treatment.

Efficacy of spinal manipulation and mobilization for low back pain and neck pain: a systematic review and best evidence synthesis.

BACKGROUND CONTEXT: Despite the many published randomized clinical trials (RCTs), a substantial number of reviews and several national clinical guidelines, much controversy still remains regarding the evidence for or against efficacy of spinal manipulation for low back pain and neck pain. PURPOSE: To reassess the efficacy of spinal manipulative therapy (SMT) and mobilization (MOB) for the management of low back pain (LBP) and neck pain (NP), with special attention to applying more stringent criteria for study admissibility into evidence and for isolating the effect of SMT and/or MOB. STUDY DESIGN: RCTs including 10 or more subjects per group receiving SMT or MOB and using patient-oriented primary outcome measures (eg, patient-rated pain, disability, global improvement and recovery time). METHODS: Articles in English, Danish, Swedish, Norwegian and Dutch reporting on randomized trials were identified by a comprehensive search of computerized and bibliographic literature databases up to the end of 2002. Two reviewers independently abstracted data and assessed study quality according to eight explicit criteria. A best evidence synthesis incorporating explicit, detailed information about outcome measures and interventions was used to evaluate treatment efficacy. The strength of evidence was assessed by a classification system that incorporated study validity and statistical significance of study results. Sixty-nine RCTs met the study selection criteria and were reviewed and assigned validity scores varying from 6 to 81 on a scale of 0 to 100. Forty-three RCTs met the admissibility criteria for evidence. RESULTS: Acute LBP: There is moderate evidence that SMT provides more short-term pain relief than MOB and detuned diathermy, and limited evidence of faster recovery than a commonly used physical therapy treatment strategy. Chronic LBP: There is moderate evidence that SMT has an effect similar to an efficacious prescription nonsteroidal anti-inflammatory drug, SMT/MOB is effective in the short term when compared with placebo and general practitioner care, and in the long term compared to physical therapy. There is limited to moderate evidence that SMT is better than physical therapy and home back exercise in both the short and long term. There is limited evidence that SMT is superior to sham SMT in the short term and superior to chemonucleolysis for disc herniation in the short term. However, there is also limited evidence that MOB is inferior to back exercise after disc herniation surgery. Mix of acute and chronic LBP: SMT/MOB provides either similar or better pain outcomes in the short and long term when compared with placebo and with other treatments, such as McKenzie therapy, medical care, management by physical therapists, soft tissue treatment and back school. Acute NP: There are few studies, and the evidence is currently inconclusive. Chronic NP: There is moderate evidence that SMT/MOB is superior to general practitioner management for short-term pain reduction but that SMT offers at most similar pain relief to high-technology rehabilitative exercise in the short and long term. Mix of acute and chronic NP: The overall evidence is not clear. There is moderate evidence that MOB is superior to physical therapy and family physician care, and similar to SMT in both the short and long term. There is limited evidence that SMT, in both the short and long term, is inferior to physical therapy. CONCLUSIONS: Our data synthesis suggests that recommendations can be made with some confidence regarding the use of SMT and/or MOB as a viable option for the treatment of both low back pain and NP. There have been few high-quality trials distinguishing between acute and chronic patients, and most are limited to shorter-term follow-up. Future trials should examine well-defined subgroups of patients, further address the value of SMT and MOB for acute patients, establish optimal number of treatment visits and consider the cost-effectiveness of care.

Spinal manipulation, epidural injections, and self-care for sciatica: a pilot study for a randomized clinical trial.

OBJECTIVE: To assess the feasibility of recruiting sciatica patients and to evaluate their compliance in preparation for a full-scale randomized clinical trial. We also aimed to determine the responsiveness of key outcome measures. METHODS: Thirty-two subjects were randomly assigned to spinal manipulation (n=11), epidural steroid injections (n=11), or self-care education (n=10). No between-group comparisons were planned because of the small sample size. RESULTS: At week 12 (the end of the treatment phase), the outcome measures indicating the most improvement/change were the Oswestry disability score (mean, 22.9; SD, 19.9; effect size [ES], 1.8), leg pain severity (mean, 2.9; SD, 1.7; ES, 1.7), and if the symptoms were bothersome (mean, 25.2; SD, 16.0; ES, 1.6). Twenty-four patients were either "very satisfied" or "completely satisfied," and 22 of 32 patients reported 75% or 100% improvement. After 52 weeks, the outcome measure showing the most improvement/change was leg pain severity (mean, 2.3; SD, 2.6; ES, 1.35), followed by the Oswestry disability score (mean, 15.6; SD, 20; ES, 1.2) and if symptoms were bothersome (mean, 18.1; SD, 22.6; ES, 1.1). Eighteen patients were either "very satisfied" or "completely satisfied," and 15 of 32 patients reported 75% or 100% improvement. CONCLUSIONS: The results of this pilot study suggest that it is feasible to recruit subacute and chronic sciatica patients and to obtain their compliance for a full-scale randomized clinical.

Faculty development initiatives to advance research literacy and evidence-based practice at CAM academic institutions.

OBJECTIVES: To present the varied approaches of 9 complementary and alternative medicine (CAM) institutions (all grantees of the National Center for Complementary and Alternative Medicine) used to develop faculty expertise in research literacy and evidence-based practice (EBP) in order to integrate these concepts into CAM curricula. DESIGN: A survey to elicit information on the faculty development initiatives was administered via e-mail to the 9 program directors. All 9 completed the survey, and 8 grantees provided narrative summaries of faculty training outcomes. RESULTS: The grantees found the following strategies for implementing their programs most useful: assess needs, develop and adopt research literacy and EBP competencies, target early adopters and change leaders, employ best practices in teaching and education, provide meaningful incentives, capitalize on resources provided by grant partners, provide external training opportunities, and garner support from institutional leadership. Instructional approaches varied considerably across grantees. The most common were workshops, online resources, in-person short courses, and in-depth seminar series developed by the grantees. Many also sent faculty to intensive multiday extramural training programs. Program evaluation included measuring participation rates and satisfaction and the integration of research literacy and EBP learning objectives throughout the academic curricula. Most grantees measured longitudinal changes in beliefs, attitudes, opinions, and competencies with repeated faculty surveys. CONCLUSIONS: A common need across all 9 CAM grantee institutions was foundational training for faculty in research literacy and EBP. Therefore, each grantee institution developed and implemented a faculty development program. In developing the framework for their programs, grantees used strategies that were viewed critical for success, including making them multifaceted and unique to their specific institutional needs. These strategies, in conjunction with the grantees' instructional approaches, can be of practical use in other CAM and non-CAM academic environments considering the introduction of research literacy and EBP competencies into their curricula.

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.

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.

Individualized chiropractic and integrative care for low back pain: the design of a randomized clinical trial using a mixed-methods approach.

BACKGROUND: Low back pain (LBP) is a prevalent and costly condition in the United States. Evidence suggests there is no one treatment which is best for all patients, but instead several viable treatment options. Additionally, multidisciplinary management of LBP may be more effective than monodisciplinary care. An integrative model that includes both complementary and alternative medicine (CAM) and conventional therapies, while also incorporating patient choice, has yet to be tested for chronic LBP.The primary aim of this study is to determine the relative clinical effectiveness of 1) monodisciplinary chiropractic care and 2) multidisciplinary integrative care in 200 adults with non-acute LBP, in both the short-term (after 12 weeks) and long-term (after 52 weeks). The primary outcome measure is patient-rated back pain. Secondary aims compare the treatment approaches in terms of frequency of symptoms, low back disability, fear avoidance, self-efficacy, general health status, improvement, satisfaction, work loss, medication use, lumbar dynamic motion, and torso muscle endurance. Patients' and providers' perceptions of treatment will be described using qualitative methods, and cost-effectiveness and cost utility will be assessed. METHODS AND DESIGN: This paper describes the design of a randomized clinical trial (RCT), with cost-effectiveness and qualitative studies conducted alongside the RCT. Two hundred participants ages 18 and older are being recruited and randomized to one of two 12-week treatment interventions. Patient-rated outcome measures are collected via self-report questionnaires at baseline, and at 4, 12, 26, and 52 weeks post-randomization. Objective outcome measures are assessed at baseline and 12 weeks by examiners blinded to treatment assignment. Health care cost data is collected by self-report questionnaires and treatment records during the intervention phase and by monthly phone interviews thereafter. Qualitative interviews, using a semi-structured format, are conducted with patients at the end of the 12-week treatment period and also with providers at the end of the trial. DISCUSSION: This mixed-methods randomized clinical trial assesses clinical effectiveness, cost-effectiveness, and patients' and providers' perceptions of care, in treating non-acute LBP through evidence-based individualized care delivered by monodisciplinary or multidisciplinary care teams. TRIAL REGISTRATION: ClinicalTrials.gov NCT00567333.

What do patients think? Results of a mixed methods pilot study assessing sciatica patients' interpretations of satisfaction and improvement.

BACKGROUND: Little is known about the issues low back pain patients take into account when deciding their satisfaction with care, the importance placed on such satisfaction, or the factors they consider when assessing their overall improvement. OBJECTIVE: The purpose of this study was to explore these issues and to assess the feasibility of implementing qualitative research methods within a clinical trial. METHODS: Study participants were volunteers taking part in a randomized clinical pilot study comparing nonsurgical treatments for sciatica. Face-to-face interviews were conducted, transcribed, and analyzed using content analysis. RESULTS: All 31 individuals who participated in the pilot study were interviewed. When asked which issues they considered when deciding their satisfaction with care, the most frequently identified themes were change in pain, personnel, and the treatment experience. When assessing their overall improvement, all participants considered whether their pain had changed. In response to the question asking participants which outcomes they considered to be most important, severity of pain and quality of life were most commonly cited. CONCLUSION: This study demonstrated that a "mixed methods" approach using qualitative research methods within a clinical trial is not only feasible but can provide interesting and useful information for trial interpretation and future study design. By providing insight to the multidimensional nature of patients' beliefs and perceptions, this technique may not only shape but also redefine the focus of patient-oriented research and health care for low back pain conditions.