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1.  Surgery versus conservative care for neck pain: a systematic review 
European Spine Journal  2012;22(1):87-95.
General practitioners refer patients with continued neck pain that do not respond well to conservative care frequently to secondary care for further assessment. Are surgical interventions to the cervical spine effective when compared to conservative care for patients with neck pain?
Systematic review.
The search strategy outlined by the Cochrane Back Review Group (CBRG) was followed. The primary search was conducted in MEDLINE, EMBASE, CINAHL, CENTRAL, and PEDro up to June 2011. Randomised controlled trials (RCTs) and controlled clinical trials (CCTs) of adults with neck pain, which evaluated at least one clinically relevant primary outcome measure (e.g. pain, functional status, recovery), were included. In addition, treatments had to include surgery and conservative care. Two authors independently assessed risk of bias using the criteria recommended by the CBRG and extracted the data. The quality of the evidence was rated using the GRADE method.
Patients included had neck pain with or without radiculopathy or myelopathy. In total, three RCTs and six CCTs were identified comparing different surgical interventions with conservative care, of which one had a low risk of bias. Overall there is very low quality of evidence available on the effectiveness of surgery compared to conservative care in neck pain patients showing overall no differences.
Most studies on surgical techniques comparing these to conservative care showed a high risk of bias. The benefit of surgery over conservative care is not clearly demonstrated.
PMCID: PMC3540296  PMID: 23104514
Systematic review; Randomised controlled trials; Surgery; Conservative care
2.  Exploring integrative medicine for back and neck pain - a pragmatic randomised clinical pilot trial 
A model for integrative medicine (IM) adapted to Swedish primary care was previously developed. The aim of this study was to explore the feasibility of a pragmatic randomised clinical trial to investigate the effectiveness of the IM model versus conventional primary care in the management of patients with non-specific back/neck pain. Specific objectives included the exploration of recruitment and retention rates, patient and care characteristics, clinical differences and effect sizes between groups, selected outcome measures and power calculations to inform the basis of a full-scale trial.
Eighty patients with back/neck pain of at least two weeks duration were randomised to the two types of care. Outcome measures were standardised health related quality of life (the eight domains of SF-36) complemented by a set of exploratory "IM tailored" outcomes targeting self-rated disability, stress and well-being (0-10 scales); days in pain (0-14); and the use of analgesics and health care over the last two weeks (yes/no). Data on clinical management were derived from medical records. Outcome changes from baseline to follow-up after 16 weeks were used to explore the differences between the groups.
Seventy-five percent (80/107) of screened patients in general practice were eligible and feasible to enrol into the trial. Eighty-two percent (36/44) of the integrative and 75% (27/36) of the conventional care group completed follow-up after 16 weeks. Most patients had back/neck pain of at least three months duration. Conventional care typically comprised advice and prescription of analgesics, occasionally complemented with sick leave or a written referral to physiotherapy. IM care generally integrated seven treatment sessions from two different types of complementary therapies with conventional care over ten weeks. The study was underpowered to detect any statistically significant differences between the groups. One SF-36 domain showed a clinically relevant difference between groups that was also supported by a small distribution based effect size, i.e. vitality (-7.3 points, Cohen's d -0.34) which was in favour of IM. There was a clinical trend between groups showing that IM contributed to less use of prescription and non-prescription analgesics (-11.7 and - 9.7 percent units respectively) compared to conventional care. Exploring clinically relevant differences and the SF-36 as the basis for a main outcome measure showed that the sample sizes needed per arm to adequately power a full-scale trial depended on the target domain, i.e. ranging from 60 (vitality) to 339 (role emotion).
This pilot study investigated the implementation of IM in the primary care management of non-specific back and neck pain. Recruiting patients and implementing IM in routine clinical practice was feasible. The results warrant further exploration into different perspectives and relevant combinations of outcome measures including the use of health resources, drugs and cost-effectiveness to help understand the relevance of IM in primary care. Future research should prioritise larger scale studies considering variability, pain duration and small to moderate treatment effects.
Trial registration
Clinical trials NCT00565942
PMCID: PMC2749805  PMID: 19735542
3.  The Tampa Scale of Kinesiophobia and neck pain, disability and range of motion: a narrative review of the literature 
The Tampa Scale of Kinesiophobia (TSK) that was developed in 1990 is a 17 item scale originally developed to measure the fear of movement related to chronic lower back pain.
To review the literature regarding TSK and neck pain, perceived disability and range of motion of the cervical spine.
Medline, MANTIS, Index to Chiropractic Literature and CINAHL were searched.
A total of 16 related articles were found and divided into four categories: TSK and Neck Pain; TSK, Neck Pain and Disability; TSK, Neck Pain, Disability and Strength; and TSK, Neck Pain and Surface Electromyography.
The fear avoidance model can be applied to neck pain sufferers and there is value from a psychometric perspective in using the TSK to assess kinesiophobia. Future research should investigate if, and to what extent, other measureable factors commonly associated with neck pain, such as decreased range of motion, correlate with kinesiophobia.
PMCID: PMC3154068  PMID: 21886284
kinesiophobia; neck pain; cervical spine; kinésiophobie; douleur au cou; colonne cervicale
4.  Randomised controlled trial of a short course of traditional acupuncture compared with usual care for persistent non-specific low back pain 
BMJ : British Medical Journal  2006;333(7569):623.
Objective To determine whether a short course of traditional acupuncture improves longer term outcomes for patients with persistent non-specific low back pain in primary care.
Design Pragmatic, open, randomised controlled trial.
Setting Three private acupuncture clinics and 18 general practices in York, England.
Participants 241 adults aged 18-65 with non-specific low back pain of 4-52 weeks' duration.
Interventions 10 individualised acupuncture treatments from one of six qualified acupuncturists (160 patients) or usual care only (81 patients).
Main outcome measures The primary outcome was SF-36 bodily pain, measured at 12 and 24 months. Other outcomes included reported use of analgesics, scores on the Oswestry pain disability index, safety, and patient satisfaction.
Results 39 general practitioners referred 289 patients of whom 241 were randomised. At 12 months average SF-36 pain scores increased by 33.2 to 64.0 in the acupuncture group and by 27.9 to 58.3 in the control group. Adjusting for baseline score and for any clustering by acupuncturist, the estimated intervention effect was 5.6 points (95% confidence interval -0.2 to 11.4) at 12 months (n = 213) and 8.0 points (2.8 to 13.2) at 24 months (n = 182). The magnitude of the difference between the groups was about 10%-15% of the final pain score in the control group. Functional disability was not improved. No serious or life threatening events were reported.
Conclusions Weak evidence was found of an effect of acupuncture on persistent non-specific low back pain at 12 months, but stronger evidence of a small benefit at 24 months. Referral to a qualified traditional acupuncturist for a short course of treatment seems safe and acceptable to patients with low back pain.
Trial registration ISRCTN80764175.
PMCID: PMC1570824  PMID: 16980316
5.  Randomised controlled trial of exercise for low back pain: clinical outcomes, costs, and preferences 
BMJ : British Medical Journal  1999;319(7205):279-283.
To evaluate effectiveness of an exercise programme in a community setting for patients with low back pain to encourage a return to normal activities.
Randomised controlled trial of progressive exercise programme compared with usual primary care management. Patients’ preferences for type of management were elicited independently of randomisation.
187 patients aged 18-60 years with mechanical low back pain of 4 weeks to 6 months’ duration.
Exercise classes led by a physiotherapist that included strengthening exercises for all main muscle groups, stretching exercises, relaxation session, and brief education on back care. A cognitive-behavioural approach was used.
Main outcome measures
Assessments of debilitating effects of back pain before and after intervention and at 6 months and 1 year later. Measures included Roland disability questionnaire, Aberdeen back pain scale, pain diaries, and use of healthcare services.
At 6 weeks after randomisation, the intervention group improved marginally more than the control group on the disability questionnaire and reported less distressing pain. At 6 months and 1 year, the intervention group showed significantly greater improvement in the disability questionnaire score (mean difference in changes 1.35, 95% confidence interval 0.13 to 2.57). At 1 year, the intervention group also showed significantly greater improvement in the Aberdeen back pain scale (4.44, 1.01 to 7.87) and reported only 378 days off work compared with 607 in the control group. The intervention group used fewer healthcare resources. Outcome was not influenced by patients’ preferences.
The exercise class was more clinically effective than traditional general practitioner management, regardless of patient preference, and was cost effective.
Key messagesPatients with back pain need to return to normal activities as soon as possible but are often afraid that movement or activity may be harmfulAn exercise programme led by a physiotherapist in the community and based on cognitive-behavioural principles helped patients to cope better with their pain and function better even one year laterPatients’ preferences for type of management did not affect outcomePatients in the intervention group tended to use fewer healthcare resources and took fewer days off workThis type of exercise programme should be more widely available
PMCID: PMC28176  PMID: 10426734
6.  The association between neck pain, the Neck Disability Index and cervical ranges of motion: a narrative review 
The Neck Disability Index (NDI) and Cervical Ranges of Motion (CROM) are measurement tools that are used for neck pain patients.
To review the literature to determine how the NDI is associated with neck pain and CROM outcomes.
Computer based searches of 5 databases were performed and supplemented by internet and hand searching of article references and “related citations.”
The search yielded 23 studies that met the inclusion and exclusion criteria and these were summarized into four categories: NDI, NDI and other questionnaires, whiplash and NDI and cervical range of motion and NDI. The NDI was shown to be a well validated and reliable self-reported questionnaire, especially when compared to other questionnaires, in both neck pain and whiplash (WAD) patients. There are very few studies that discuss the NDI and cervical range of motion.
This review outlines the strength of the NDI as a self-reported neck disability questionnaire, but also demonstrates a need for further research to explore the association between the NDI, neck pain and cervical ranges of motion.
PMCID: PMC3154067  PMID: 21886283
neck pain; neck disability index; range of motion; whiplash; douleur au couleur; indice d’invalidité du cou; portée du mouvement cervical; coup de fouet cervical
7.  Randomised trial of a brief physiotherapy intervention compared with usual physiotherapy for neck pain patients: outcomes and patients' preference 
BMJ : British Medical Journal  2005;330(7482):75.
Objectives Firstly, to compare the effectiveness of a brief physiotherapy intervention with “usual” physiotherapy for patients with neck pain. Secondly, to evaluate the effect of patients' preferences on outcome.
Design Non-inferiority randomised controlled trial eliciting preferences independently of randomisation.
Setting Physiotherapy departments in a community setting in Yorkshire and north Lincolnshire.
Participants 268 patients (mean age 48 years) with subacute and chronic neck pain, who were referred by their general practitioner and randomly assigned to a brief physiotherapy intervention (one to three sessions) using cognitive behaviour principles to encourage self management and return to normal function or usual physiotherapy, at the discretion of the physiotherapist concerned.
Main outcome measures The Northwick Park neck pain questionnaire (NPQ), a specific measure of functional disability resulting from neck pain. Also, the short form 36 (SF-36) questionnaire, a generic, health related, quality of life measure; and the Tampa scale for kinesophobia, a measure of fear and avoidance of movement.
Results At 12 months, patients allocated to usual physiotherapy had a small but significant improvement in NPQ scores compared with patients in the brief intervention group (mean difference 1.99, 95% confidence interval 0.45 to 3.52; P = 0.01). Although the result shows a significant inferiority of the intervention, the confidence interval shows that the effect could be in the non-inferiority range for the brief intervention (below 1.2 points of NPQ score). Patients who preferred the brief intervention and received this treatment had similar outcomes to patients receiving usual physiotherapy.
Conclusions Usual physiotherapy may be only marginally better than a brief physiotherapy intervention for neck pain. Patients with a preference for the brief intervention may do at least as well with this approach. Additional training for the physiotherapists in cognitive behaviour techniques might improve this approach further.
PMCID: PMC543869  PMID: 15585539
8.  A retrospective study of the effectiveness of physical rehabilitation on low back pain patients in a multidisciplinary setting 
To evaluate the effectiveness of physical rehabilitation of low back pain patients in a multidisciplinary setting.
A retrospective study profiled and analysed objective data from patients seen through a rehabilitation program in a private multidisciplinary facility.
147 patients with low back pain were analysed.
The sample consisted mainly of patients with motor vehicle accident-related or work-related injuries to the lower back. They ranged from acute to chronic in nature.
Main outcome measures:
The primary measures were the Oswestry Pain Disability Index (ODI) and the Pain Visual Analogue Scale. Secondary measures included SLR, sit and reach test, grip strength, leg lift strength and ranges of motion.
The outcome measures used in the study showed statistical significance (p < 0.05). Positive clinical trends were shown in pain VAS, ODI, leg lift and sit and reach tests. Ninety percent of patients were cleared to return to work upon discharge from the program.
Further studies of active physical rehabilitation should employ a prospective randomized controlled trial design. The study should also follow up patients to confirm that they have continued to work following discharge from the program. As indicated by the statistical analysis provided by this study, a minimum sample size of 53 subjects per intervention group would be required.
PMCID: PMC2485360
multidisciplinary; rehabilitation; outcomes; low back pain
9.  Naturopathic Care for Chronic Low Back Pain: A Randomized Trial 
PLoS ONE  2007;2(9):e919.
Chronic low back pain represents a substantial cost to employers through benefits coverage and days missed due to incapacity. We sought to explore the effectiveness of Naturopathic care on chronic low back pain.
This study was a randomized clinical trial. We randomized 75 postal employees with low back pain of longer than six weeks duration to receive Naturopathic care (n = 39) or standardized physiotherapy (n = 36) over a period of 12 weeks. The study was conducted in clinics on-site in postal outlets. Participants in the Naturopathic care group received dietary counseling, deep breathing relaxation techniques and acupuncture. The control intervention received education and instruction on physiotherapy exercises using an approved education booklet. We measured low back pain using the Oswestry disability questionnaire as the primary outcome measure, and quality of life using the SF-36 in addition to low back range of motion, weight loss, and Body Mass Index as secondary outcomes.
Sixty-nine participants (92%) completed eight weeks or greater of the trial. Participants in the Naturopathic care group reported significantly lower back pain (−6.89, 95% CI. −9.23 to −3.54, p = <0.0001) as measured by the Oswestry questionnaire. Quality of life was also significantly improved in the group receiving Naturopathic care in all domains except for vitality. Differences for the aggregate physical component of the SF-36 was 8.47 (95% CI, 5.05 to 11.87, p = <0.0001) and for the aggregate mental component was 7.0 (95% CI, 2.25 to 11.75, p = 0.0045). All secondary outcomes were also significantly improved in the group receiving Naturopathic care: spinal flexion (p<0.0001), weight-loss (p = 0.0052) and Body Mass Index (−0.52, 95% CI, −0.96 to −0.08, p = 0.01).
Naturopathic care provided significantly greater improvement than physiotherapy advice for patients with chronic low back pain.
Trial Registration ISRCTN41920953
PMCID: PMC1976391  PMID: 17878954
10.  Effective management of low back pain: it’s time to accept the evidence 
Low back pain is a ubiquitous and economically costly problem. Unfortunately, the clinical management of low back pain is not yet well understood. Chiropractic management of back pain, long the black sheep of back care, has undergone a transition and is now a more respected and understood alternative to conservative medical care, itself under increased scrutiny due to unsatisfactory outcomes and unacceptable iatrogenic side effects. The substantial amount of clinical and related research on the effectiveness of manipulation for low back pain is summarized here from a larger study, divided into randomized control trials, case-control trials, meta-analyses and descriptive studies. The chiropractic management of low back pain is found to be a more effective way of dealing with this medical, social and economic problem. It is suggested that greater utilization of chiropractors be encouraged such that the “right people are doing the right things at the right time”.
PMCID: PMC2485083
chiropractic; manipulation; utilization; backache; clinical trials
11.  Two pragmatic trials of treatment for shoulder disorders in primary care: generalisability, course, and prognostic indicators 
Annals of the Rheumatic Diseases  2005;64(7):1056-1061.
Objective: To investigate predictors of long term prognosis in patients treated for shoulder pain in primary care.
Methods: Data were taken from two pragmatic randomised clinical trials investigating the effectiveness of conservative treatments for shoulder pain presenting to primary care. Shoulder pain severity, disability, and perceived recovery measured in the long term (UK, 18 months; Netherlands, 12 months) were considered as outcome measures. Prognostic indicators measured before randomisation were determined by linear regression (pain severity and disability) and logistic regression (perceived recovery).
Results: 316 adults with a new episode of shoulder pain were recruited (UK, n = 207; Netherlands, n = 109). In multivariate analysis, greater shoulder disability at follow up was associated with higher baseline disability score, concomitant neck pain, and a gradual onset and longer duration of shoulder symptoms. Pain scores at follow up were higher in women and in those with longer baseline duration of symptoms and higher baseline pain or disability scores. Being female, reporting gradual onset of symptoms, and a higher baseline disability score each independently reduced the likelihood of perceived recovery.
Conclusions: The results suggest that there is no long term difference in outcome between patients with shoulder pain treated with different clinical interventions in different clinical settings, or having different clinical diagnoses. Baseline clinical characteristics of this consulting population, rather than the randomised treatments which they received, were the most powerful predictors of outcome. Whether this highlights the need for earlier intervention or reflects different natural histories of shoulder pain is a topic for further research.
PMCID: PMC1755568  PMID: 15640264
12.  Should treatment of (sub)acute low back pain be aimed at psychosocial prognostic factors? Cluster randomised clinical trial in general practice 
BMJ : British Medical Journal  2005;331(7508):84.
Objective To compare the effects of a minimal intervention strategy aimed at assessment and modification of psychosocial prognostic factors and usual care for treatment of (sub)acute low back pain in general practice.
Design Cluster randomised clinical trial.
Setting 60 general practitioners in 41 general practices.
Participants 314 patients with non-specific low back pain of less than 12 weeks' duration, recruited by their general practitioner.
Interventions In the minimal intervention strategy group the general practitioner explored the presence of psychosocial prognostic factors, discussed these factors, set specific goals for reactivation, and provided an educational booklet. The consultation took about 20 minutes. Usual care was not standardised.
Main outcome measures Functional disability (Roland-Morris disability questionnaire), perceived recovery, and sick leave because of low back pain assessed at baseline and after 6, 13, 26, and 52 weeks.
Results The dropout rate was 8% in the minimal intervention strategy group and 9% in the usual care group. Multilevel analyses showed no significant differences between the groups on any outcome measure during 12 months of follow-up in the whole group or in relevant subgroups (patients with high scores on psychosocial measures at baseline or a history of frequent or prolonged low back pain).
Conclusion This study provides no evidence that (Dutch) general practitioners should adopt our new treatment strategy aimed at psychosocial prognostic factors in patients with (sub)acute low back pain. Further research should examine why our new strategy was not more effective than usual care.
PMCID: PMC558614  PMID: 15967762
13.  Effects of Ambulant Myofeedback Training and Ergonomic Counselling in Female Computer Workers with Work-Related Neck-Shoulder Complaints: A Randomized Controlled Trial 
Objective: To investigate the effects of ambulant myofeedback training including ergonomic counselling (Mfb) and ergonomic counselling alone (EC), on work-related neck-shoulder pain and disability. Methods: Seventy-nine female computer workers reporting neck-shoulder complaints were randomly assigned to Mfb or EC and received four weeks of intervention. Pain intensity in neck, shoulders, and upper back, and pain disability, were measured at baseline, immediately after intervention, and at three and six months follow-up. Results: Pain intensity and disability had significantly decreased immediately after four weeks Mfb or EC, and the effects remained at follow up. No differences were observed between the Mfb and EC group for outcome and subjects in both intervention groups showed comparable chances for improvement in pain intensity and disability. Conclusions: Pain intensity and disability significantly reduced after both interventions and this effect remained at follow-up. No differences were observed between the two intervention groups.
PMCID: PMC1915628  PMID: 17260162
Work-related neck-shoulder complaints; Myofeedback training; Neck-shoulder region
14.  An interdisciplinary clinical practice model for the management of low-back pain in primary care: the CLIP project 
Low-back pain is responsible for significant disability and costs in industrialized countries. Only a minority of subjects suffering from low-back pain will develop persistent disability. However, this minority is responsible for the majority of costs and has the poorest health outcomes. The objective of the Clinic on Low-back pain in Interdisciplinary Practice (CLIP) project was to develop a primary care interdisciplinary practice model for the clinical management of low-back pain and the prevention of persistent disability.
Using previously published guidelines, systematic reviews and meta-analyses, a clinical management model for low-back pain was developed by the project team. A structured process facilitating discussions on this model among researchers, stakeholders and clinicians was created. The model was revised following these exchanges, without deviating from the evidence.
A model consisting of nine elements on clinical management of low-back pain and prevention of persistent disability was developed. The model's two core elements for the prevention of persistent disability are the following: 1) the evaluation of the prognosis at the fourth week of disability, and of key modifiable barriers to return to usual activities if the prognosis is unfavourable; 2) the evaluation of the patient's perceived disability every four weeks, with the evaluation and management of barriers to return to usual activities if perceived disability has not sufficiently improved.
A primary care interdisciplinary model aimed at improving quality and continuity of care for patients with low-back pain was developed. The effectiveness, efficiency and applicability of the CLIP model in preventing persistent disability in patients suffering from low-back pain should be assessed.
PMCID: PMC2390556  PMID: 18426590
15.  Cost effectiveness of physiotherapy, manual therapy, and general practitioner care for neck pain: economic evaluation alongside a randomised controlled trial 
BMJ : British Medical Journal  2003;326(7395):911.
To evaluate the cost effectiveness of physiotherapy, manual therapy, and care by a general practitioner for patients with neck pain.
Economic evaluation alongside a randomised controlled trial.
Primary care.
183 patients with neck pain for at least two weeks recruited by 42 general practitioners and randomly allocated to manual therapy (n=60, spinal mobilisation), physiotherapy (n=59, mainly exercise), or general practitioner care (n=64, counselling, education, and drugs).
Main outcome measures
Clinical outcomes were perceived recovery, intensity of pain, functional disability, and quality of life. Direct and indirect costs were measured by means of cost diaries that were kept by patients for one year. Differences in mean costs between groups, cost effectiveness, and cost utility ratios were evaluated by applying non-parametric bootstrapping techniques.
The manual therapy group showed a faster improvement than the physiotherapy group and the general practitioner care group up to 26 weeks, but differences were negligible by follow up at 52 weeks. The total costs of manual therapy (€447; £273; $402) were around one third of the costs of physiotherapy (€1297) and general practitioner care (€1379). These differences were significant: P<0.01 for manual therapy versus physiotherapy and manual therapy versus general practitioner care and P=0.55 for general practitioner care versus physiotherapy. The cost effectiveness ratios and the cost utility ratios showed that manual therapy was less costly and more effective than physiotherapy or general practitioner care.
Manual therapy (spinal mobilisation) is more effective and less costly for treating neck pain than physiotherapy or care by a general practitioner.
What is already known on this topicThe cost of treating neck pain is considerableMany conservative interventions are available, such as prescription drugs, yet their cost effectiveness has not been evaluatedNo randomised trials of conservative treatment for neck pain have so far included an economic evaluationWhat this study addsManual therapy is more effective and less costly than physiotherapy or care by a general practitioner for treating neck painPatients undergoing manual therapy recovered more quickly than those undergoing the other interventions
PMCID: PMC153837  PMID: 12714472
16.  Symptomatic reactions, clinical outcomes and patient satisfaction associated with upper cervical chiropractic care: A prospective, multicenter, cohort study 
Observational studies have previously shown that adverse events following manipulation to the neck and/or back are relatively common, although these reactions tend to be mild in intensity and self-limiting. However, no prospective study has examined the incidence of adverse reactions following spinal adjustments using upper cervical techniques, and the impact of this care on clinical outcomes.
Consecutive new patients from the offices of 83 chiropractors were recruited for this practice-based study. Clinical outcome measures included 1) Neck pain disability index (100-point scale), 2) Oswestry back pain index (100-point scale), 3) 11-point numerical rating scale (NRS) for neck, headache, midback, and low back pain, 4) treatment satisfaction, and 5) Symptomatic Reactions (SR). Data were collected at baseline, and after approximately 2 weeks of care. A patient reaching sub-clinical status for pain and disability was defined as a follow-up score <3 NRS and <10%, respectively. A SR is defined as a new complaint not present at baseline or a worsening of the presenting complaint by >30% based on an 11-point numeric rating scale occurring <24 hours after any upper cervical procedure.
A total of 1,090 patients completed the study having 4,920 (4.5 per patient) office visits requiring 2,653 (2.4 per patient) upper cervical adjustments over 17 days. Three hundred thirty- eight (31.0%) patients had SRs meeting the accepted definition. Intense SR (NRS ≥8) occurred in 56 patients (5.1%). Outcome assessments were significantly improved for neck pain and disability, headache, mid-back pain, as well as lower back pain and disability (p <0.001) following care with a high level (mean = 9.1/10) of patient satisfaction. The 83 chiropractors administered >5 million career upper cervical adjustments without a reported incidence of serious adverse event.
Upper cervical chiropractic care may have a fairly common occurrence of mild intensity SRs short in duration (<24 hours), and rarely severe in intensity; however, outcome assessments were significantly improved with less than 3 weeks of care with a high level of patient satisfaction. Although our findings need to be confirmed in subsequent randomized studies for definitive risk-benefit assessment, the preliminary data shows that the benefits of upper cervical chiropractic care may outweigh the potential risks.
PMCID: PMC3204272  PMID: 21974915
Chiropractic; Adverse Effects; Symptomatic Reactions; Manipulation; Upper Cervical
17.  Chiropractic and exercise for seniors with low back pain or neck pain: the design of two randomized clinical trials 
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.
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.
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.
Trial Registration
NCT00269321 and NCT00269308
PMCID: PMC2048958  PMID: 17877825
18.  Acute Low Back Pain and Primary Care: How to Define Recovery and Chronification? 
Spine  2011;36(26):2316-2323.
Study Design
Prospective cohort study
to establish outcome measures for recovery and chronic pain for studies with patients that present with recent-onset acute low back pain in primary care
Summary of Background Data
Among back pain researchers, no consensus exists about outcome definitions or how to identify primary-care patients as not-recovered from an episode of low back pain. Cut points for outcome scales have mostly been arbitrarily chosen. Theoretical models for establishing minimal important change (MIC) values in studies of patients with low back pain have been proposed and need to be applied to real data.
In a sample of 521 patients which presented with acute low back pain (<4 weeks) in primary care clinics and were followed for 6 months, scores for pain and disability were compared with ratings on a global perceived effect scale. Using multiple potential “gold standards” as anchors (reference standards), the receiver operating characteristics method was used to determine optimal cut points for different ways of defining non-recovery from acute low back pain.
MIC values and upper limits for pain and disability scores as well as minimal important percent changes are presented for five different definitions of recovery. A previously suggested 30% change from baseline scores does not accurately discriminate between recovered and not recovered patients in patients presenting with acute low back pain in primary care.
Outcome definitions that combine ratings from perceived recovery scales with pain and disability measures provide the highest accuracy in discriminating recovered from non-recovered patients.
PMCID: PMC3100452  PMID: 21311400
Acute low back pain; primary care; outcome definitions; minimal important change; receiver operating characteristics
19.  Back, neck, and shoulder pain in Finnish adolescents: national cross sectional surveys 
BMJ : British Medical Journal  2002;325(7367):743.
To study changes in pain of the back and neck in adolescents between 1985 and 2001 and pain of the neck, shoulder, and lower back between 1991 and 2001.
Biennial nationwide postal surveys, 1985-2001, and annual classroom surveys, 1996-2001.
62 677 12, 14, 16, and 18 year olds and 127 217 14-16 year olds.
Main outcome measures
Pain in the back and neck, neck and shoulder, or lower back, at least weekly.
Prevalence of pain in the back and neck was greater in the 1990s than in the 1980s and increased steadily from 1993 to 1997. Pain of the neck and shoulder and pain of the lower back was much more common in 1999 than in 1991 and in 2001 than in 1999. Pain was more common among girls and older groups: pain of the neck and shoulder affected 24% of girls and 12% of boys in 14 year olds, 38% of girls and 16% of boys in 16 year olds, and 45% of girls and 19% of boys in 18 year olds; pain in the lower back affected 8% of girls and 7% of boys in 14 year olds, 14% of girls and 11% of boys in 16 year olds, and 17% of boys and 13% of girls in 18 year olds.
Pain in the neck, shoulder, and lower back is becoming more common in Finnish adolescents. This pain suggests a new disease burden of degenerative musculoskeletal disorders in future adults.
What is already known on this topicBack pain, particularly of the lower back, is common in children and adolescents, and the lifetime prevalence of back pain is in the range 30-51%Neck-shoulder pain has been little studied in children and adolescentsDegeneration of lower lumbar discs has been observed at the age of 15 and is a significant risk factor for chronic lower back pain in early adulthoodWhat this study addsIn two independent data sets—one for the lower back and another for neck-shoulder—the prevalence of pain increased in adolescents through the 1990s, particularly in the latter half of the decadeNeck-shoulder pain is common in 12-18 year olds
PMCID: PMC128374  PMID: 12364301
20.  Multidisciplinary rehabilitation for chronic low back pain: systematic review 
BMJ : British Medical Journal  2001;322(7301):1511-1516.
To assess the effect of multidisciplinary biopsychosocial rehabilitation on clinically relevant outcomes in patients with chronic low back pain.
Systematic literature review of randomised controlled trials.
A total of 1964 patients with disabling low back pain for more than three months.
Main outcome measures
Pain, function, employment, quality of life, and global assessments.
Ten trials reported on a total of 12 randomised comparisons of multidisciplinary treatment and a control condition. There was strong evidence that intensive multidisciplinary biopsychosocial rehabilitation with functional restoration improves function when compared with inpatient or outpatient non-multidisciplinary treatments. There was moderate evidence that intensive multidisciplinary biopsychosocial rehabilitation with functional restoration reduces pain when compared with outpatient non-multidisciplinary rehabilitation or usual care. There was contradictory evidence regarding vocational outcomes of intensive multidisciplinary biopsychosocial intervention. Some trials reported improvements in work readiness, but others showed no significant reduction in sickness leaves. Less intensive outpatient psychophysical treatments did not improve pain, function, or vocational outcomes when compared with non-multidisciplinary outpatient therapy or usual care. Few trials reported effects on quality of life or global assessments.
The reviewed trials provide evidence that intensive multidisciplinary biopsychosocial rehabilitation with functional restoration reduces pain and improves function in patients with chronic low back pain. Less intensive interventions did not show improvements in clinically relevant outcomes.
What is already known on this topicDisabling chronic pain is regarded as the result of interrelating physical, psychological, and social or occupational factors requiring multidisciplinary interventionTwo previous systematic reviews of multidisciplinary rehabilitation for chronic pain were open to bias and did not include any of the randomised controlled trials now availableWhat this study addsIntensive, daily biopsychosocial rehabilitation with a functional restoration approach improves pain and function in chronic low back painLess intensive interventions did not show improvements in clinically relevant outcomesIt is unclear whether the improvements are worth the cost of these intensive treatments
PMCID: PMC33389  PMID: 11420271
21.  Long-term trajectories of back pain: cohort study with 7-year follow-up 
BMJ Open  2013;3(12):e003838.
To describe long-term trajectories of back pain.
Monthly data collection for 6 months at 7-year follow-up of participants in a prospective cohort study.
Primary care practices in Staffordshire, UK.
228 people consulting their general practitioners with back pain, on whom information on 6-month back pain trajectories had been collected during 2001–2003, and who had valid consent and contact details in 2009–2010, were contacted. 155 participants (68% of those contacted) responded and provided sufficient data for primary analyses.
Outcome measures
Trajectories based on patients’ self-reports of back pain were identified using longitudinal latent class analysis. Trajectories were characterised using information on disability, psychological status and presence of other symptoms.
Four clusters with different back pain trajectories at follow-up were identified: (1) no or occasional pain, (2) persistent mild pain, (3) fluctuating pain and (4) persistent severe pain. Trajectory clusters differed significantly from each other in terms of disability, psychological status and other symptoms. Most participants remained in a similar trajectory as 7 years previously (weighted κ 0.54; 95% CI 0.42 to 0.65).
Most people with back pain appear to follow a particular pain trajectory over long time periods, and do not have frequently recurring or widely fluctuating patterns. The results are limited by lack of information about the time between data collection periods and by loss to follow-up. However, findings do raise questions about standard divisions into acute and chronic back pain. A new framework for understanding the course of back pain is proposed.
PMCID: PMC3863121  PMID: 24334157
Epidemiology; Primary Care; Rheumatology
22.  Does 48 hours' bed rest influence the outcome of acute low back pain? 
BACKGROUND. Bed rest is a traditional treatment for back pain, yet only in recent years has the therapeutic benefit of this been questioned. AIM. The aim of this pilot study was to ascertain whether or not 48 hours' bed rest had an effect on the outcome of acute low back pain. METHOD. The study was conducted as a randomized controlled trial to compare a prescription of 48 hours' strict bed rest with controls; the control subjects were encouraged to remain mobile and to have no daytime rest. Nine general practitioners from practices in the West Midlands recruited patients in the age range 16-60 years who presented with low back pain of less than seven days' duration, with or without pain radiation. The outcome measures assessed were: change in straight leg raise and lumbar flexion after seven days, Oswestry and Roland-Morris disability scores after seven days and 28 days, and time taken from work. RESULTS. Forty two patients were recruited: 20 were allocated to bed rest and 22 as controls. Compared with the bed rest group the control group had statistically better Roland-Morris scores at day seven (P < 0.05) but not at day 28. At day seven, there were no statistically significant differences between groups in straight leg raise or lumbar flexion measurements although the control group had a better mean lumbar flexion than the bed rest group. The improvement in disability scores at day seven compared with day one was similar for the two groups but more of the control group had fully recovered (defined as scores of one or zero on the Roland-Morris disability scale and five or less on the Oswestry disability scale) by day seven. Remaining mobile did not appear to cause any adverse effects. The number of days lost from work in both groups was equal. A large number of self-remedies and physical therapies were recorded by subjects from both groups. CONCLUSION. The results of this pilot study did not indicate whether bed rest or remaining mobile was superior for the treatment of acute low back pain; however, the study sample was small. Subjects in the control group possibly fared better as they appeared to have better lumbar flexion at day seven. It appears that 48 hours' bed rest cannot be recommended for the treatment of acute low back pain on the basis of this small study. Large-scale definitive trials are required to detect clinically significant differences.
PMCID: PMC1239372  PMID: 7546872
23.  Cost-effectiveness of an intensive group training protocol compared to physiotherapy guideline care for sub-acute and chronic low back pain: design of a randomised controlled trial with an economic evaluation. [ISRCTN45641649] 
Low back pain is a common disorder in western industrialised countries and the type of treatments for low back pain vary considerably.
In a randomised controlled trial the cost-effectiveness and cost-utility of an intensive group training protocol versus physiotherapy guideline care for sub-acute and chronic low back pain patients is evaluated. Patients with back pain for longer than 6 weeks who are referred to physiotherapy care by their general practitioner or medical specialist are included in the study. The intensive group training protocol combines exercise therapy with principles of behavioural therapy ("graded activity") and back school. This training protocol is compared to physiotherapy care according to the recently published Low Back Pain Guidelines of the Royal Dutch College for Physiotherapy. Primary outcome measures are general improvement, pain intensity, functional status, work absenteeism and quality of life. The direct and indirect costs will be assessed using cost diaries. Patients will complete questionnaires at baseline and 6, 13, 26 and 52 weeks after randomisation.
No trials are yet available that have evaluated the effect of an intensive group training protocol including behavioural principles and back school in a primary physiotherapy care setting and no data on cost-effectiveness and cost-utility are available.
PMCID: PMC535932  PMID: 15560843
24.  Ten-year survey reveals differences in GP management of neck and back pain 
European Spine Journal  2012;21(7):1283-1289.
Clinical guidelines provide similar recommendations for the management of new neck pain and low back pain (LBP) but it is unclear if general practitioner’s (GP) care is similar. While GP’s management of LBP is well documented, little is known about GP’s management of neck pain. We aimed to describe GP’s management of new neck pain and compare this to GP’s management of new LBP in Australia between April 2000 and March 2010.
All GP–patient encounters for a new (i.e. first visit to any medical practitioner) neck pain or LBP problem were compared in terms of treatment delivered, referral patterns and requests for laboratory and imaging investigations.
General practitioners in Australia have managed new neck pain and LBP problems at a rate of 3.1 and 5.8 per 1,000 GP–patient encounters, respectively. GP’s primarily utilised medications, in particular non-steroidal anti-inflammatory drugs, to manage new neck and LBP problems and referred approximately 25% of all patients for imaging. Patients with new neck pain are more frequently managed using physical treatments and were referred more often to allied health professionals and specialists. In comparison, patients with new LBP were managed more frequently with medication, advice, provision of a sickness certificate and ordering of pathology tests.
This is the first time GP management of a new episode of neck pain has been documented using a nationally representative sample and it is also the first time that the management of back and neck pain has been compared. Despite guidelines endorsing a similar approach for the management of new neck pain and LBP, in actual clinical practice Australian GPs manage these two conditions differently.
Electronic supplementary material
The online version of this article (doi:10.1007/s00586-011-2135-5) contains supplementary material, which is available to authorized users.
PMCID: PMC3389113  PMID: 22228573
Primary care; General practice; Low back pain; Neck pain
25.  Population based intervention to change back pain beliefs and disability: three part evaluation 
BMJ : British Medical Journal  2001;322(7301):1516-1520.
To evaluate the effectiveness of a population based, state-wide public health intervention designed to alter beliefs about back pain, influence medical management, and reduce disability and costs of compensation.
Quasi-experimental, non-randomised, non-equivalent, before and after telephone surveys of the general population and postal surveys of general practitioners with an adjacent state as control group and descriptive analysis of claims database.
Two states in Australia.
4730 members of general population before and two and two and a half years after campaign started, in a ratio of 2:1:1; 2556 general practitioners before and two years after campaign onset.
Main outcome measures
Back beliefs questionnaire, knowledge and attitude statements about back pain, incidence of workers' financial compensation claims for back problems, rate of days compensated, and medical payments for claims related to back pain and other claims.
In the intervention state beliefs about back pain became more positive between successive surveys (mean improvement in questionnaire score 1.9 (95% confidence interval 1.3 to 2.5), P<0.001 and 3.2 (2.6 to 3.9), P<0.001, between baseline and the second and third survey, respectively). Beliefs about back pain also improved among doctors. There was a clear decline in number of claims for back pain, rates of days compensated, and medical payments for claims for back pain over the duration of the campaign.
A population based strategy of provision of positive messages about back pain improves population and general practitioner beliefs about back pain and seems to influence medical management and reduce disability and workers' compensation costs related to back pain.
What is already known on this topicThe number of people with disability from back pain has risen rapidly in the past 50 yearsMost attempts to limit this disability include modification of occupational risk factors or dealing with the problem once it has developedPatients' attitudes and beliefs play an important part in the development of such chronic disabilityWhat this study addsA population based primary prevention intervention that provided explicit advice about back pain improved beliefs about back pain in the general population and knowledge and attitudes in general practitionersThe number of workers' compensation claims for back pain decreased and the rate of days compensated and medical payments for back claims were reduced
PMCID: PMC33390  PMID: 11420272

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