Naturopathic Care for Chronic Low Back Pain: A Randomized Trial

OBJECTIVE: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: Naturopathic care provided significantly greater improvement than physiotherapy advice for patients with chronic low back pain. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN41920953

Brief psychosocial education, not core stabilization, reduced incidence of low back pain: results from the Prevention of Low Back Pain in the Military (POLM) cluster randomized trial

<p>Abstract</p> <p>Background</p> <p>Effective strategies for the primary prevention of low back pain (LBP) remain elusive with few large-scale clinical trials investigating exercise and education approaches. The purpose of this trial was to determine whether core stabilization alone or in combination with psychosocial education prevented incidence of low back pain in comparison to traditional lumbar exercise.</p> <p>Methods</p> <p>The Prevention of Low Back Pain in the Military study was a cluster randomized clinical study with four intervention arms and a two-year follow-up. Participants were recruited from a military training setting from 2007 to 2008. Soldiers in 20 consecutive companies were considered for eligibility (n = 7,616). Of those, 1,741 were ineligible and 1,550 were eligible but refused participation. For the 4,325 Soldiers enrolled with no previous history of LBP average age was 22.0 years (SD = 4.2) and there were 3,082 males (71.3%). Companies were randomly assigned to receive traditional lumbar exercise, traditional lumbar exercise with psychosocial education, core stabilization exercise, or core stabilization with psychosocial education, The psychosocial education session occurred during one session and the exercise programs were done daily for 5 minutes over 12 weeks. The primary outcome for this trial was incidence of low back pain resulting in the seeking of health care.</p> <p>Results</p> <p>There were no adverse events reported. Evaluable patient analysis (4,147/4,325 provided data) indicated no differences in low back incidence resulting in the seeking of health care between those receiving the traditional exercise and core stabilization exercise programs. However, brief psychosocial education prevented low back pain episodes regardless of the assigned exercise approach, resulting in a 3.3% (95% CI: 1.1 to 5.5%) decrease over two years (numbers needed to treat (NNT) = 30.3, 95% CI = 18.2 to 90.9).</p> <p>Conclusions</p> <p>Core stabilization has been advocated as preventative, but offered no such benefit when compared to traditional lumbar exercise in this trial. Instead, a brief psychosocial education program that reduced fear and threat of low back pain decreased incidence of low back pain resulting in the seeking of health care. Since this trial was conducted in a military setting, future studies are necessary to determine if these findings can be translated into civilian populations.</p> <p>Trial Registration</p> <p><a href="http://www.clinicaltrials.gov/ct2/show/NCT00373009">NCT00373009</a> at ClinicalTrials.gov - <url>http://clinicaltrials.gov/</url></p

Motor control or graded activity exercises for chronic low back pain? A randomised controlled trial

Background: Chronic low back pain remains a major health problem in Australia and around the world. Unfortunately the majority of treatments for this condition produce small effects because not all patients respond to each treatment. It appears that only 25-50% of patients respond to exercise. The two most popular types of exercise for low back pain are graded activity and motor control exercises. At present however, there are no guidelines to help clinicians select the best treatment for a patient. As a result, time and money are wasted on treatments which ultimately fail to help the patient

A systematic review on the effectiveness of complementary and alternative medicine for chronic non-specific low-back pain

The purpose of this systematic review was to assess the effects of spinal manipulative therapy (SMT), acupuncture and herbal medicine for chronic non-specific LBP. A comprehensive search was conducted by an experienced librarian from the Cochrane Back Review Group (CBRG) in multiple databases up to December 22, 2008. Randomised controlled trials (RCTs) of adults with chronic non-specific LBP, which evaluated at least one clinically relevant, patient-centred outcome measure were included. Two authors working independently from one another assessed the risk of bias using the criteria recommended by the CBRG and extracted the data. The data were pooled when clinically homogeneous and statistically possible or were otherwise qualitatively described. GRADE was used to determine the quality of the evidence. In total, 35 RCTs (8 SMT, 20 acupuncture, 7 herbal medicine), which examined 8,298 patients, fulfilled the inclusion criteria. Approximately half of these (2 SMT, 8 acupuncture, 7 herbal medicine) were thought to have a low risk of bias. In general, the pooled effects for the studied interventions demonstrated short-term relief or improvement only. The lack of studies with a low-risk of bias, especially in regard to SMT precludes any strong conclusions; however, the principal findings, which are based upon low- to very-low-quality evidence, suggest that SMT does not provide a more clinically beneficial effect compared with sham, passive modalities or any other intervention for treatment of chronic low-back pain. There is evidence, however, that acupuncture provides a short-term clinically relevant effect when compared with a waiting list control or when acupuncture is added to another intervention. Although there are some good results for individual herbal medicines in short-term individual trials, the lack of homogeneity across studies did not allow for a pooled estimate of the effect. In general, these results are in agreement with other recent systematic reviews on SMT, but in contrast with others. These results are also in agreement with recent reviews on acupuncture and herbal medicine. Randomized trials with a low risk of bias and adequate sample sizes are direly needed

The clinical course of low back pain: a meta-analysis comparing outcomes in randomised clinical trials (RCTs) and observational studies.

BACKGROUND: Evidence suggests that the course of low back pain (LBP) symptoms in randomised clinical trials (RCTs) follows a pattern of large improvement regardless of the type of treatment. A similar pattern was independently observed in observational studies. However, there is an assumption that the clinical course of symptoms is particularly influenced in RCTs by mere participation in the trials. To test this assumption, the aim of our study was to compare the course of LBP in RCTs and observational studies. METHODS: Source of studies CENTRAL database for RCTs and MEDLINE, CINAHL, EMBASE and hand search of systematic reviews for cohort studies. Studies include individuals aged 18 or over, and concern non-specific LBP. Trials had to concern primary care treatments. Data were extracted on pain intensity. Meta-regression analysis was used to compare the pooled within-group change in pain in RCTs with that in cohort studies calculated as the standardised mean change (SMC). RESULTS: 70 RCTs and 19 cohort studies were included, out of 1134 and 653 identified respectively. LBP symptoms followed a similar course in RCTs and cohort studies: a rapid improvement in the first 6 weeks followed by a smaller further improvement until 52 weeks. There was no statistically significant difference in pooled SMC between RCTs and cohort studies at any time point:- 6 weeks: RCTs: SMC 1.0 (95% CI 0.9 to 1.0) and cohorts 1.2 (0.7to 1.7); 13 weeks: RCTs 1.2 (1.1 to 1.3) and cohorts 1.0 (0.8 to 1.3); 27 weeks: RCTs 1.1 (1.0 to 1.2) and cohorts 1.2 (0.8 to 1.7); 52 weeks: RCTs 0.9 (0.8 to 1.0) and cohorts 1.1 (0.8 to 1.6). CONCLUSIONS: The clinical course of LBP symptoms followed a pattern that was similar in RCTs and cohort observational studies. In addition to a shared 'natural history', enrolment of LBP patients in clinical studies is likely to provoke responses that reflect the nonspecific effects of seeking and receiving care, independent of the study design

A systematic review on the effectiveness of physical and rehabilitation interventions for chronic non-specific low back pain

Low back pain (LBP) is a common and disabling disorder in western society. The management of LBP comprises a range of different intervention strategies including surgery, drug therapy, and non-medical interventions. The objective of the present study is to determine the effectiveness of physical and rehabilitation interventions (i.e. exercise therapy, back school, transcutaneous electrical nerve stimulation (TENS), low level laser therapy, education, massage, behavioural treatment, traction, multidisciplinary treatment, lumbar supports, and heat/cold therapy) for chronic LBP. The primary search was conducted in MEDLINE, EMBASE, CINAHL, CENTRAL, and PEDro up to 22 December 2008. Existing Cochrane reviews for the individual interventions were screened for studies fulfilling the inclusion criteria. The search strategy outlined by the Cochrane Back Review Groups (CBRG) was followed. The following were included for selection criteria: (1) randomized controlled trials, (2) adult (≥18 years) population with chronic (≥12 weeks) non-specific LBP, and (3) evaluation of at least one of the main clinically relevant outcome measures (pain, functional status, perceived recovery, or return to work). Two reviewers independently selected studies and extracted data on study characteristics, risk of bias, and outcomes at short, intermediate, and long-term follow-up. The GRADE approach was used to determine the quality of evidence. In total 83 randomized controlled trials met the inclusion criteria: exercise therapy (n = 37), back school (n = 5), TENS (n = 6), low level laser therapy (n = 3), behavioural treatment (n = 21), patient education (n = 1), traction (n = 1), and multidisciplinary treatment (n = 6). Compared to usual care, exercise therapy improved post-treatment pain intensity and disability, and long-term function. Behavioural treatment was found to be effective in reducing pain intensity at short-term follow-up compared to no treatment/waiting list controls. Finally, multidisciplinary treatment was found to reduce pain intensity and disability at short-term follow-up compared to no treatment/waiting list controls. Overall, the level of evidence was low. Evidence from randomized controlled trials demonstrates that there is low quality evidence for the effectiveness of exercise therapy compared to usual care, there is low evidence for the effectiveness of behavioural therapy compared to no treatment and there is moderate evidence for the effectiveness of a multidisciplinary treatment compared to no treatment and other active treatments at reducing pain at short-term in the treatment of chronic low back pain. Based on the heterogeneity of the populations, interventions, and comparison groups, we conclude that there are insufficient data to draw firm conclusion on the clinical effect of back schools, low-level laser therapy, patient education, massage, traction, superficial heat/cold, and lumbar supports for chronic LBP

A community-based primary prevention programme for type 2 diabetes mellitus integrating identification and lifestyle intervention for prevention: a cluster randomised controlled trial

Background: Prevention of type 2 diabetes mellitus (T2DM) is a global priority; however, there is a lack of evidence investigating how to effectively translate prevention research into a primary care setting.Objectives: (1) To develop and validate a risk score to identify individuals at high risk of T2DM in the UK; and (2) to establish whether or not a structured education programme targeting lifestyle and behaviour change was clinically effective and cost-effective at preventing progression to T2DM in people with prediabetes mellitus (PDM), identified through a risk score screening programme in primary care.Design: A targeted screening study followed by a cluster randomised controlled trial (RCT), with randomisation at practice level. Participants were followed up for 3 years.Setting: A total of 44 general practices across Leicestershire, UK. The intervention took place in the community.Participants: A total of 17,972 individuals from 44 practices identified through the risk score as being at high risk of T2DM were invited for screening; of these, 3449 (19.2%) individuals attended. All received an oral glucose tolerance test. PDM was detected in 880 (25.5%) of those screened. Those with PDM were included in the trial; of these, 36% were female, the average age was 64 years and 16% were from an ethnic minority group.Intervention: Practices were randomised to receive either standard care or the intervention. The intervention consisted of a 6-hour group structured education programme, with an annual refresher and regular telephone contact.Main outcome measures: The primary outcome was progression to T2DM. The main secondary outcomes were changes in glycated haemoglobin concentrations, blood glucose levels, cardiovascular risk, the presence of metabolic syndrome, step count and the cost-effectiveness of the intervention.Results: A total of 22.6% of the intervention group did not attend the education and 29.1% attended all sessions. A total of 131 participants developed T2DM (standard care, n = 67; intervention, n = 64). There was a 26% reduced risk of T2DM in the intervention arm compared with standard care, but this did not reach statistical significance (hazard ratio 0.74, 95% confidence interval 0.48 to 1.14; p = 0.18). There were statistically significant improvements in glycated haemoglobin concentrations, low-density lipoprotein cholesterol levels, psychosocial well-being, sedentary time and step count in the intervention group. The intervention was found to result in a net gain of 0.046 quality-adjusted life-years over 3 years at a cost of £168 per patient, with an incremental cost-effectiveness ratio of £3643 and a probability of 0.86 of being cost-effective at a willingness-to-pay threshold of £20,000.Conclusions: We developed and validated a risk score for detecting those at high risk of undiagnosed PDM/T2DM. We screened &gt; 3400 people using a two-stage screening programme. The RCT showed that a relatively low-resource pragmatic programme may lead to a reduction in T2DM and improved biomedical and psychosocial outcomes, and is cost-effective.Limitations: Only 19% of those invited to screening attended, which may limit generalisability. The variation in cluster size in the RCT may have limited the power of the study.Future work: Future work should focus on increasing attendance to both screening and prevention programmes and offering the programme in different modalities, such as web-based modalities. A longer-term follow-up of the RCT participants would be valuable.</br

A community-based primary prevention programme for type 2 diabetes mellitus integrating identification and lifestyle intervention for prevention: a cluster randomised controlled trial

Background: Prevention of type 2 diabetes mellitus (T2DM) is a global priority; however, there is a lack of evidence investigating how to effectively translate prevention research into a primary care setting.Objectives: (1) To develop and validate a risk score to identify individuals at high risk of T2DM in the UK; and (2) to establish whether or not a structured education programme targeting lifestyle and behaviour change was clinically effective and cost-effective at preventing progression to T2DM in people with prediabetes mellitus (PDM), identified through a risk score screening programme in primary care.Design: A targeted screening study followed by a cluster randomised controlled trial (RCT), with randomisation at practice level. Participants were followed up for 3 years.Setting: A total of 44 general practices across Leicestershire, UK. The intervention took place in the community.Participants: A total of 17,972 individuals from 44 practices identified through the risk score as being at high risk of T2DM were invited for screening; of these, 3449 (19.2%) individuals attended. All received an oral glucose tolerance test. PDM was detected in 880 (25.5%) of those screened. Those with PDM were included in the trial; of these, 36% were female, the average age was 64 years and 16% were from an ethnic minority group.Intervention: Practices were randomised to receive either standard care or the intervention. The intervention consisted of a 6-hour group structured education programme, with an annual refresher and regular telephone contact.Main outcome measures: The primary outcome was progression to T2DM. The main secondary outcomes were changes in glycated haemoglobin concentrations, blood glucose levels, cardiovascular risk, the presence of metabolic syndrome, step count and the cost-effectiveness of the intervention.Results: A total of 22.6% of the intervention group did not attend the education and 29.1% attended all sessions. A total of 131 participants developed T2DM (standard care, n = 67; intervention, n = 64). There was a 26% reduced risk of T2DM in the intervention arm compared with standard care, but this did not reach statistical significance (hazard ratio 0.74, 95% confidence interval 0.48 to 1.14; p = 0.18). There were statistically significant improvements in glycated haemoglobin concentrations, low-density lipoprotein cholesterol levels, psychosocial well-being, sedentary time and step count in the intervention group. The intervention was found to result in a net gain of 0.046 quality-adjusted life-years over 3 years at a cost of £168 per patient, with an incremental cost-effectiveness ratio of £3643 and a probability of 0.86 of being cost-effective at a willingness-to-pay threshold of £20,000.Conclusions: We developed and validated a risk score for detecting those at high risk of undiagnosed PDM/T2DM. We screened &gt; 3400 people using a two-stage screening programme. The RCT showed that a relatively low-resource pragmatic programme may lead to a reduction in T2DM and improved biomedical and psychosocial outcomes, and is cost-effective.Limitations: Only 19% of those invited to screening attended, which may limit generalisability. The variation in cluster size in the RCT may have limited the power of the study.Future work: Future work should focus on increasing attendance to both screening and prevention programmes and offering the programme in different modalities, such as web-based modalities. A longer-term follow-up of the RCT participants would be valuable