Randomised controlled trial to compare surgical stabilisation of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilisation trial

Objectives To assess the clinical effectiveness of surgical stabilisation (spinal fusion) compared with intensive rehabilitation for patients with chronic low back pain.Design Multicentre randomised controlled trial.Setting 15 secondary care orthopaedic and rehabilitation centres across the United Kingdom.Participants 349 participants aged 18-55 with chronic low back pain of at least one year''s duration who were considered candidates for spinal fusion.Intervention Lumbar spine fusion or an intensive rehabilitation programme based on principles of cognitive behaviour therapy.Main outcome measure The primary outcomes were the Oswestry disability index and the shuttle walking test measured at baseline and two years after randomisation. The SF-36 instrument was used as a secondary outcome measure.Results 176 participants were assigned to surgery and 173 to rehabilitation. 284 (81%) provided follow-up data at 24 months. The mean Oswestry disability index changed favourably from 46.5 (SD 14.6) to 34.0 (SD 21.1) in the surgery group and from 44.8 (SD14.8) to 36.1 (SD 20.6) in the rehabilitation group. The estimated mean difference between the groups was –4.1 (95% confidence interval –8.1 to –0.1, P = 0.045) in favour of surgery. No significant differences between the treatment groups were observed in the shuttle walking test or any of the other outcome measures.Conclusions Both groups reported reductions in disability during two years of follow-up, possibly unrelated to the interventions. The statistical difference between treatment groups in one of the two primary outcome measures was marginal and only just reached the predefined minimal clinical difference, and the potential risk and additional cost of surgery also need to be considered. No clear evidence emerged that primary spinal fusion surgery was any more beneficial than intensive rehabilitation.     

Supervised exercise with or without laser-guided feedback for people with non-specific chronic low back pain. A randomized controlled clinical trial

BackgroundAmong the most effective therapeutic interventions in non-specific chronic low back pain (NSCLBP), clinical practice guidelines highlight exercise therapy and patient education; However, regarding the combined intervention of exercise and Pain Neuroscience Education (PNE), there is no consensus on the most effective form of exercise.ObjetiveTo find out what changes occurred after the application of two exercise modalities [Supervised Exercise (SE) and Laser-Guided Exercise (LGE)] and PNE on pain, pain pressure thresholds, disability, catastrophizing, kinesiophobia and lumbar proprioception in subjects with NSCLBP.MethodsSingle-blind randomized clinical controlled trial. 60 subjects with NSCLBP. Both groups performed a a total of 16 therapeutic exercise sessions and 8 Pain Neuroscience Education sessions. With the Laser-Guided Exercise Therapy group performing laser-guided exercises.ResultsA significant decrease was observed for pain intensity for both groups between baseline and post-intervention and the 3 month follow-up (p < 0.001). There was a significant between-group difference between baseline and post-intervention scores in terms of pain intensity and kinesiophobia in favour of the LGE group.ConclusionSupervised exercise with or without laser feedback, when combined with PNE, reduces pain intensity, disability, pain catastrophizing, kinesiophobia and improves proprioception and PPTs in patients with NSCLBP. At a 3-month follow-up, the combination of LGE plus PNE is most effective for reducing pain intensity.     

Randomised controlled trial of graded exercise in patients with the chronic fatigue syndrome.

OBJECTIVE: To test the efficacy of a graded aerobic exercise programme in the chronic fatigue syndrome. DESIGN: Randomised controlled trial with control treatment crossover after the first follow up examination. SETTING: Chronic fatigue clinic in a general hospital department of psychiatry. SUBJECTS: 66 patients with the chronic fatigue syndrome who had neither a psychiatric disorder nor appreciable sleep disturbance. INTERVENTIONS: Random allocation to 12 weeks of either graded aerobic exercise or flexibility exercises and relaxation therapy. Patients who completed the flexibility programme were invited to cross over to the exercise programme afterwards. MAIN OUTCOME MEASURE: The self rated clinical global impression change score, "very much better" or "much better" being considered as clinically important. RESULTS: Four patients receiving exercise and three receiving flexibility treatment dropped out before completion. 15 of 29 patients rated themselves as better after completing exercise treatment compared with eight of 30 patients who completed flexibility treatment. Analysis by intention to treat gave similar results (17/33 v 9/33 patients better). Fatigue, functional capacity, and fitness were significantly better after exercise than after flexibility treatment. 12 of 22 patients who crossed over to exercise after flexibility treatment rated themselves as better after completing exercise treatment 32 of 47 patients rated themselves as better three months after completing supervised exercise treatment 35 of 47 patients rated themselves as better one year after completing supervised exercise treatment. CONCLUSION: These findings support the use of appropriately prescribed graded aerobic exercise in the management of patients with the chronic fatigue syndrome.     

Surgical stabilisation of the spine compared with a programme of intensive rehabilitation for the management of patients with chronic low back pain: cost utility analysis based on a randomised controlled trial

Objective To determine whether, from a health provider and patient perspective, surgical stabilisation of the spine is cost effective when compared with an intensive programme of rehabilitation in patients with chronic low back pain.Design Economic evaluation alongside a pragmatic randomised controlled trial.Setting Secondary care.Participants 349 patients randomised to surgery (n = 176) or to an intensive rehabilitation programme (n = 173) from 15 centres across the United Kingdom between June 1996 and February 2002.Main outcome measures Costs related to back pain and incurred by the NHS and patients up to 24 months after randomisation. Return to paid employment and total hours worked. Patient utility as estimated by using the EuroQol EQ-5D questionnaire at several time points and used to calculate quality adjusted life years (QALYs). Cost effectiveness was expressed as an incremental cost per QALY.Results At two years, 38 patients randomised to rehabilitation had received rehabilitation and surgery whereas just seven surgery patients had received both treatments. The mean total cost per patient was estimated to be £7830 (SD £5202) in the surgery group and £4526 (SD £4155) in the intensive rehabilitation arm, a significant difference of £3304 (95% confidence interval £2317 to £4291). Mean QALYs over the trial period were 1.004 (SD 0.405) in the surgery group and 0.936 (SD 0.431) in the intensive rehabilitation group, giving a non-significant difference of 0.068 (–0.020 to 0.156). The incremental cost effectiveness ratio was estimated to be £48 588 per QALY gained (–£279 883 to £372 406).Conclusion Two year follow-up data show that surgical stabilisation of the spine may not be a cost effective use of scarce healthcare resources. However, sensitivity analyses show that this could change—for example, if the proportion of rehabilitation patients requiring subsequent surgery continues to increase.     

Controlled trial of mobilisation and manipulation for low back pain: hospital patients.

Ninety-four patients with non-specific lumbar pain referred to hospital rheumatology and orthopaedic clinics participated in a double-blind controlled trial comparing mobilisation and manipulation with placebo physiotherapy. Results were assessed immediately after the tratment course, two months later, and at one year. Many patients showed improvement, but in contrast to a study on general-practitioner patients with nonspecific back pain no definite advantage could be associated with mobilisation and manipulation. The benefits of mobilisation and manipulation for low back pain are probably restricted to hastening recovery in patients likely rapidly to improve spontaneously. Hence patients whose severity and duration of symptoms warrant specialist referral are less likely to benefit from the technique.     

Effectiveness of focused structural massage and relaxation massage for chronic low back pain: protocol for a randomized controlled trial

Background

Hypertension affects 29% of the adult U.S. population and is a leading cause of heart disease, stroke, and kidney failure. Despite numerous effective treatments, only 53% of people with hypertension are at goal blood pressure. The chronic care model suggests that blood pressure control can be achieved by improving how patients and physicians address patient self-care.

Methods and design

This paper describes the protocol of a nested 2 × 2 randomized controlled trial to test the separate and combined effects on systolic blood pressure of a behavioral intervention for patients and a quality improvement-type intervention for physicians. Primary care practices were randomly assigned to the physician intervention or to the physician control condition. Physician randomization occurred at the clinic level. The physician intervention included training and performance monitoring. The training comprised 2 internet-based modules detailing both the JNC-7 hypertension guidelines and lifestyle modifications for hypertension. Performance data were collected for 18 months, and feedback was provided to physicians every 3 months. Patient participants in both intervention and control clinics were individually randomized to the patient intervention or to usual care. The patient intervention consisted of a 6-month behavioral intervention conducted by trained interventionists in 20 group sessions, followed by 12 monthly phone contacts by community health advisors. Follow-up measurements were performed at 6 and 18 months. The primary outcome was the mean change in systolic blood pressure at 6 months. Secondary outcomes were diastolic blood pressure and the proportion of patients with adequate blood pressure control at 6 and 18 months.

Discussion

Overall, 8 practices (4 per treatment group), 32 physicians (4 per practice; 16 per treatment group), and 574 patients (289 control and 285 intervention) were enrolled. Baseline characteristics of patients and providers and the challenges faced during study implementation are presented. The HIP interventions may improve blood pressure control and lower cardiovascular disease risk in a primary care practice setting by addressing key components of the chronic care model. The study design allows an assessment of the effectiveness and cost of physician and patient interventions separately, so that health care organizations can make informed decisions about implementation of 1 or both interventions in the context of local resources.

Trial registration

ClinicalTrials.gov identifier NCT00201136     

Randomised controlled trial and economic evaluation of a chest pain observation unit compared with routine care

Objectives To measure the effectiveness and cost effectiveness of providing care in a chest pain observation unit compared with routine care for patients with acute, undifferentiated chest pain.Design Cluster randomised controlled trial, with 442 days randomised to the chest pain observation unit or routine care, and cost effectiveness analysis from a health service costing perspective.Setting The emergency department at the Northern General Hospital, Sheffield, United Kingdom.Participants 972 patients with acute, undifferentiated chest pain (479 attending on days when care was delivered in the chest pain observation unit, 493 on days of routine care) followed up until six months after initial attendance.Main outcome measures The proportion of participants admitted to hospital, the proportion with acute coronary syndrome sent home inappropriately, major adverse cardiac events over six months, health utility, hospital reattendance and readmission, and costs per patient to the health service.Results Use of a chest pain observation unit reduced the proportion of patients admitted from 54% to 37% (difference 17%, odds ratio 0.50, 95% confidence interval 0.39 to 0.65, P < 0.001) and the proportion discharged with acute coronary syndrome from 14% to 6% (8%, -7% to 23%, P = 0.264). Rates of cardiac event were unchanged. Care in the chest pain observation unit was associated with improved health utility during follow up (0.0137 quality adjusted life years gained, 95% confidence interval 0.0030 to 0.0254, P = 0.022) and a saving of £78 per patient (-£56 to £210, P = 0.252).Conclusions Care in a chest pain observation unit can improve outcomes and may reduce costs to the health service. It seems to be more effective and more cost effective than routine care.     

Randomised controlled trial to evaluate early discharge scheme for patients with stroke.

OBJECTIVE: To assess the clinical effectiveness of an early discharge policy for patients with stroke by using a community based rehabilitation team. DESIGN: Randomised controlled trial to compare conventional care with an early discharge policy. SETTING: Two teaching hospitals in inner London. SUBJECTS: 331 medically stable patients with stroke (mean age 71) who lived alone and were able to transfer independently or who lived with a resident carer and were able to transfer with help. INTERVENTIONS: 167 patients received specialist community rehabilitation for up to 3 months after randomisation. 164 patients continued with conventional hospital and community care. MAIN OUTCOME MEASURES: Barthel score at 12 months. Secondary outcomes measured impairment with motoricity index, minimental state examination, and Frenchay aphasia screening test; disability with the Rivermead activity of daily living scales, hospital anxiety and depression scale, and 5 m walk; handicap with the Nottingham health profile; carer stress with caregiver strain index and patient and carer satisfaction. The main process measure was length of stay after randomisation. RESULTS: One year after randomisation no significant differences in clinical outcomes were found apart from increased satisfaction with hospital care in the community therapy group. Length of stay after randomisation in the community therapy group was significantly reduced (12 v 18 days; P < 0.0001). Patients with impairments were more likely to receive treatment in the community therapy group. CONCLUSIONS: Early discharge with specialist community rehabilitation after stroke is feasible, as clinically effective as conventional care, and acceptable to patients. Considerable reductions in use of hospital beds are achievable.     

Exercise intervention for unilateral amputees with low back pain: study protocol for a randomised,controlled trial

Background

Atraumatic lower limb amputation is a life-changing event for approximately 185,000 persons in the United States each year. A unilateral amputation is associated with rapid changes to the musculoskeletal system including leg and back muscle atrophy, strength loss, gait asymmetries, differential mechanical joint loading and leg length discrepancies. Even with high-quality medical care and prostheses, amputees still develop secondary musculoskeletal conditions such as chronic low back pain (LBP). Resistance training interventions that focus on core stabilization, lumbar strength and dynamic stability during loading have strong potential to reduce LBP and address amputation-related changes to the musculoskeletal system. Home-based resistance exercise programs may be attractive to patients to minimize travel and financial burdens.

Methods/design

This study will be a single-assessor-blinded, pre-post-test randomised controlled trial involving 40 men and women aged 18–60 years with traumatic, unilateral transtibial amputation. Participants will be randomised to a home-based, resistance exercise group (HBRX) or a wait-list control group (CON). The HBRX will consist of 12 weeks of elastic resistance band and bodyweight training to improve core and lumbopelvic strength. Participants will be monitored via Skype or Facetime on a weekly basis. The primary outcome will be pain severity (11-point Numerical Pain Rating Scale; NRS_pain). Secondary outcomes will include pain impact on quality of life (Medical Outcomes Short Form 36, Oswestry Disability Index and Roland Morris Disability Questionnaire), kinematics and kinetics of walking gait on an instrumented treadmill, muscle morphology (muscle thickness of multifidus, transversus abdominis, internal oblique), maximal muscle strength of key lumbar and core muscles, and daily step count.

Discussion

The study findings will determine whether a HBRX program can decrease pain severity and positively impact several physiological and mechanical factors that contribute to back pain in unilateral transtibial amputees with chronic LBP. We will determine the relative contribution of the exercise-induced changes in these factors on pain responsiveness in this population.

Trial registration

ClinicalTrials.gov, ID: NCT03300375. Registered on 2 October 2017.

     

Supplementation with alkaline minerals reduces symptoms in patients with chronic low back pain

The cause of low back pain is heterogeneous, it has been hypothesised that a latent chronic acidosis might contribute to these symptoms. It was tested whether a supplementation with alkaline minerals would influence symptoms in patients with low back pain symptoms. In an open prospective study 82 patients with chronic low back pain received daily 30 g of a lactose based alkaline multimineral supplement (Basica) over a period of 4 weeks in addition to their usual medication. Pain symptoms were quantified with the "Arhus low back pain rating scale" (ARS). Mean ARS dropped highly significant by 49% from 41 to 21 points after 4 weeks supplemention. In 76 out of 82 patients a reduction in ARS was achieved by the supplementation. Total blood buffering capacity was significantly increased from 77.69 +/- 6.79 to 80.16 +/- 5.24 mmol/L (mean +/- SEM, n = 82, p < 0.001) and also blood pH rose from 7.456 +/- 0.007 to 7.470 +/- 0.007 (mean +/- SEM, n = 75, p < 0.05). Only intracellular magnesium increased by 11% while other intracellular minerals were not significantly changed in sublingual tissue as measured with the EXA-test. Plasma concentrations of potassium, calcium, iron, copper, and zinc were within the normal range and not significantly influenced by the supplementation. Plasma magnesium was slightly reduced after the supplemenation (-3%, p < 0.05). The results show that a disturbed acid-base balance may contribute to the symptoms of low back pain. The simple and safe addition of an alkaline multimineral preparate was able to reduce the pain symptoms in these patients with chronic low back pain.     

Effect of experimental low back pain on neuromuscular control of the trunk in healthy volunteers and patients with chronic low back pain

Studies of electromyographic (EMG) activity and lumbopelvic rhythm have led to a better understanding of neuromuscular alterations in chronic low back pain (cLBP) patients. Whether these changes reflect adaptations to chronic pain or are induced by acute pain is still unclear. This work aimed to assess the effects of experimental LBP on lumbar erector spinae (LES) EMG activity and lumbopelvic kinematics during a trunk flexion–extension task in healthy volunteers and LBP patients. The contribution of disability to these effects was also examined. Twelve healthy participants and 14 cLBP patients performed flexion–extension tasks in three conditions; control, innocuous heat and noxious heat, applied on the skin over L5 or T7. The results indicated that noxious heat at L5 evoked specific increases in LES activity during static full trunk flexion and extension, irrespective of participants’ group. Kinematic data suggested that LBP patients adopted a different movement strategy than controls when noxious heat was applied at the L5 level. Besides, high disability was associated with less kinematic changes when approaching and leaving full flexion. These results indicate that experimental pain can induce neuromechanical alterations in cLBP patients and healthy volunteers, and that higher disability in patients is associated with decreased movement pattern changes.     

Effectiveness and economic evaluation of a nurse delivered home exercise programme to prevent falls. 1: Randomised controlled trial

ObjectivesTo assess the effectiveness of a trained district nurse individually prescribing a home based exercise programme to reduce falls and injuries in elderly people and to estimate the cost effectiveness of the programme.DesignRandomised controlled trial with one year''s follow up.SettingCommunity health service at a New Zealand hospital.Participants240 women and men aged 75 years and older.Intervention121 participants received the exercise programme (exercise group) and 119 received usual care (control group); 90% (211 of 233) completed the trial.ResultsFalls were reduced by 46% (incidence rate ratio 0.54, 95% confidence interval 0.32 to 0.90). Five hospital admissions were due to injuries caused by falls in the control group and none in the exercise group. The programme cost $NZ1803 (£523) (at 1998 prices) per fall prevented for delivering the programme and $NZ155 per fall prevented when hospital costs averted were considered.ConclusionA home exercise programme, previously shown to be successful when delivered by a physiotherapist, was also effective in reducing falls when delivered by a trained nurse from within a home health service. Serious injuries and hospital admissions due to falls were also reduced. The programme was cost effective in participants aged 80 years and older compared with younger participants.

What is already known on this topic

Falls are the costliest type of injury among elderly people, and the healthcare costs increase with frequency of falls and severity of injuriesAn exercise programme delivered by a physiotherapist was successful in reducing falls and moderate injuries in elderly people

What this study adds

An exercise programme to prevent falls in elderly people worked well when delivered by a district nurse from a home health service in the suburbs of a large cityResearchers, public health administrators, and health practitioners can work together to benefit elderly people in the community     

Randomised controlled trial of antibiotics in patients with cough and purulent sputum.

Two hundred and twelve adults with cough and purulent sputum of up to one week''s duration were allocated randomly to treatment with doxycycline or placebo capsules for up to 10 days. Cough, purulent sputum, feeling "off colour," and time off work lasted as long in treatment and control groups, but running nose persisted for a shorter time in the doxycycline group. The number of new episodes of lower respiratory tract infections, vaginal infections, gastrointestinal upsets, and otitis media over the next six months were the same in both groups, but fewer new upper respiratory infections were experienced by the doxycycline-treated patients. There is no consensus among doctors about using antibiotics in patients with cough and purulent sputum, and these results indicate that otherwise healthy people with these symptoms will usually get better without antibiotic treatment.     

The impact of wool in the patients with chronic non-specific low back pain

The aim was to assess the effect of wool underwear use in patients with chronic non specific low back pain. The study employed two-group, experimental design. A total of 48 patients with chronic non specific low back pain were selected for the study. They were distributed into two groups: a control group and a treatment group. The 24 patients in each group were randomly selected and the compositions of the two groups. The patients in the treatment group wore woolen underwear during the experimental period of 2 month. All patients were assessed at the beginning the trial (pre-test) and the end of 8th (post-test) week. Data were collected using the visual analogue pain scale, Oswestry Disability Index and Schober test measurements. Patients in the treatment group reported significant improvements in their conditions including a reduction in pain levels and Oswestry Disability Index, and Schober test measurements increased (p<0.001). Patients with chronic non-specific low back pain who wore wool underwear experienced significant improvements in pain intensity, disability, and lower back flexibility.     

Randomised controlled trial of nicotine chewing-gum.

The effectiveness of 2 mg nicotine chewing-gum as an aid to stopping smoking was compared with a placebo containing 1 mg nicotine, but unbuffered, in a double-blind randomised trial. Of 58 subjects given the active gum, 27 (47%) were not smoking at one-year follow-up compared with 12 (21%) of the 58 subjects treated with placebo (p less than 0.025). By the most stringent criterion of outcome, 18 (31%) subjects in the active treatment group and eight (14%) in the placebo group had not smoked at all from the start of treatment to follow-up at one year (p less than 0.05). Subjects receiving the active gum experienced less severe withdrawal symptoms and rated their gum as more helpful than did the placebo group. Minor side effects were common but only gastric symptoms were more frequent with the active gum. Subjects receiving active gum used it for longer than those receiving placebo but most stopped using it within six months and only four (7%) developed longer-term dependence. The number of gums used daily correlated significantly with pretreatment blood nicotine concentrations in the active treatment group and with pretreatment cigarette consumption in the placebo group. A lower pretreatment blood nicotine value was the best predictor of success at one year (p less than 0.001) but there was no significant relation to cigarette consumption, sex, and social class. The results clearly confirm the usefulness of nicotine chewing-gum as an aid to stopping smoking and imply a definite role for nicotine in cigarette dependence and withdrawal. Successful use of the gum requires careful attention to subjects'' expectations and clear instructions on how to use it.     

Plasma N-glycome composition associates with chronic low back pain

Background

Low back pain (LBP) is the symptom of a group of syndromes with heterogeneous underlying mechanisms and molecular pathologies, making treatment selection and patient prognosis very challenging. Moreover, symptoms and prognosis of LBP are influenced by age, gender, occupation, habits, and psychological factors. LBP may be characterized by an underlying inflammatory process. Previous studies indicated a connection between inflammatory response and total plasma N-glycosylation. We wanted to identify potential changes in total plasma N-glycosylation pattern connected with chronic low back pain (CLBP), which could give an insight into the pathogenic mechanisms of the disease.