Effectiveness of a web-based, individually tailored decision aid for depression or acute low back pain: a randomized controlled trial

Objective

To evaluate the effectiveness of a web-based, individually tailored decision aid (Patient Dialogue) on depression or acute low back pain for insurees of a German sickness fund.

Methods

Patient Dialogue (PD) was compared to the non-tailored Static Patient Information (SPI) in an online randomized controlled trial (RCT). The primary outcome was decisional conflict; secondary outcomes included knowledge, preparation for decision-making, preference for participation, involvement in decision-making, decision regret, and adherence.

Results

Out of 2480 randomized participants, 657 (26.5%) provided analyzable data immediately after using the system. Three months later, data from 131 (5.3%) participants could be included in the analysis. The PD group reported a significantly lower overall decisional conflict than the SPI group (38.7 vs. 45.1; p = 0.028 via multiple imputation estimator). The largest standardized effect (Cohen's d 0.56) resulted from the preparation for decision-making (PD 59.4 vs. SPI 46.8; p < 0.001).

Conclusion

PD may be an effective tool to reduce decisional conflict and prepare participants for treatment decision-making. However, the large dropout rate needs to be taken into account.

Practice implications

This study shows how a health insurance fund can support shared decision-making and how a decision aid can be evaluated in a RCT under routine care conditions.     

Implementation of RCGP guidelines for acute low back pain: a cluster randomised controlled trial.

BACKGROUND: The Royal College of General Practitioners (RCGP) has produced guidelines for the management of acute low back pain in primary care. AIM: To investigate the impact on patient management of an educational strategy to promote these guidelines among general practitioners (GPs). DESIGN OF STUDY: Group randomised controlled trial, using the health centre as the unit of randomisation. SETTING: Primary care teams in north-west England. METHOD: Twenty-four health centres were randomly allocated to an intervention or control arm. Practices in the intervention arm were offered outreach visits to promote national guidelines on acute low back pain, as well as access to fast-track physiotherapy and to a triage service for patients with persistent symptoms. RESULTS: Twenty-four centres were randomised. Two thousand, one hundred and eighty-seven eligible patients presented with acute low back pain during the study period: 1049 in the intervention group and 1138 in the control group. There were no significant differences between study groups in the proportion of patients who were referred for X-ray, issued with a sickness certificate, prescribed opioids or muscle relaxants, or who were referred to secondary care, but significantly more patients in the intervention group were referred to physiotherapy or the back pain unit (difference in proportion = 12.2%, 95% confidence interval [CI] = 2.8% to 21.6%). CONCLUSION: The management of patients presenting with low back pain to primary care was mostly unchanged by an outreach educational strategy to promote greater adherence to RCGP guidelines among GPs. An increase in referral to physiotherapy or educational programmes followed the provision of a triage service.     

Radiography for low back pain: a randomised controlled trial and observational study in primary care.

BACKGROUND: Lumbar spine radiography has limited use in diagnosing the cause of acute low back pain. Consensus-based guidelines recommend that lumbar spine x-rays are not used routinely. However there have been no studies of the effect of referral for radiography at first presentation with low back pain in primary care. AIM: To compare short and long-term physical, social, and psychiatric outcomes for patients with low back pain who are referred or not referred for lumbar spine x-ray at first presentation in general practice. DESIGN OF STUDY: A randomised unblinded controlled trial with an observational arm to enable comparisons to be made with patients not recruited to the trial. SETTING: Ninety-four general practices in south London and the South Thames region. METHOD: Patients consulting their general practitioner (GP) with low back pain at first presentation were recruited to a randomised controlled trial (RCT) or to an observational group. Patients in the trial were randomly allocated to immediate referral for x-ray or to no referral. All patients were asked to complete questionnaires initially, and then at six weeks and one year after recruitment. RESULTS: Six hundred and fifty-nine patients were recruited over 26 months: 153 to the randomised trial and 506 to the observational arm. In the RCT referral for x-ray had no effect on physical functioning, pain or disability, but was associated with a small improvement in psychological wellbeing at six weeks and one year. These findings were supported by the observational study in which there were no differences between the groups in physical outcomes after adjusting for length of episode at presentation; however, those referred for x-ray had lower depression scores. CONCLUSIONS: Referral for lumbar spine radiography for first presentation of low back pain in primary care is not associated with improved physical functioning, pain or disability. The possibility of minor psychological improvement should be balanced against the high radiation dose involved.     

Effects of intracutaneous injections of sterile water in patients with acute low back pain: a randomized,controlled, clinical trial

Intracutaneous sterile water injection (ISWI) is used for relief of low back painduring labor, acute attacks of urolithiasis, chronic neck and shoulder pain followingwhiplash injuries, and chronic myofascial pain syndrome. We conducted a randomized,double-blinded, placebo-controlled trial to evaluate the effect of ISWI for relief ofacute low back pain (aLBP). A total of 68 patients (41 females and 27 males) between18 and 55 years old experiencing aLBP with moderate to severe pain (scores ≥5 on an11-point visual analogue scale [VAS]) were recruited and randomly assigned to receiveeither ISWIs (n=34) or intracutaneous isotonic saline injections (placebo treatment;n=34). The primary outcome was improvement in pain intensity using the VAS at 10, 45,and 90 min and 1 day after treatment. The secondary outcome was functionalimprovement, which was assessed using the Patient-Specific Functional Scale (PSFS) 1day after treatment. The mean VAS score was significantly lower in the ISWI groupthan in the control group at 10, 45, and 90 min, and 1 day after injection(P<0.05, t-test). The mean increment in PSFS score of the ISWIgroup was 2.9±2.2 1 day after treatment, while that in the control group was 0.9±2.2.Our study showed that ISWI was effective for relieving pain and improving function inaLBP patients at short-term follow-up. ISWI might be an alternative treatment foraLBP patients, especially in areas where medications are not available, as well as inspecific patients (e.g., those who are pregnant or have asthma), who are unable toreceive medications or other forms of analgesia because of side effects.     

Collaborative care for depression in UK primary care: a randomized controlled trial

BACKGROUND: Collaborative care is an effective intervention for depression which includes both organizational and patient-level intervention components. The effect in the UK is unknown, as is whether cluster- or patient-randomization would be the most appropriate design for a Phase III clinical trial. METHOD: We undertook a Phase II patient-level randomized controlled trial in primary care, nested within a cluster-randomized trial. Depressed participants were randomized to 'collaborative care' - case manager-coordinated medication support and brief psychological treatment, enhanced specialist and GP communication - or a usual care control. The primary outcome was symptoms of depression (PHQ-9). RESULTS: We recruited 114 participants, 41 to the intervention group, 38 to the patient randomized control group and 35 to the cluster-randomized control group. For the intervention compared to the cluster control the PHQ-9 effect size was 0.63 (95% CI 0.18-1.07). There was evidence of substantial contamination between intervention and patient-randomized control participants with less difference between the intervention group and patient-randomized control group (-2.99, 95% CI -7.56 to 1.58, p=0.186) than between the intervention and cluster-randomized control group (-4.64, 95% CI -7.93 to -1.35, p=0.008). The intra-class correlation coefficient for our primary outcome was 0.06 (95% CI 0.00-0.32). CONCLUSIONS: Collaborative care is a potentially powerful organizational intervention for improving depression treatment in UK primary care, the effect of which is probably partly mediated through the organizational aspects of the intervention. A large Phase III cluster-randomized trial is required to provide the most methodologically accurate test of these initial encouraging findings.     

A randomized, single blind placebo controlled clinical trial on the effect of continuous ultrasound on low back pain

Low back pain (LBP) is a very common problem in primary care and a major cause of disability. There is no evidence for the efficacy of therapeutic modalities such as ultrasound in LBP In a randomized, single blind placebo controlled clinical trial, we aimed to evaluate the effect of continuous ultrasound (US) in patients with non specific LBP Of the fifty eight patients recruited, 10 patients (8 women and 2 men) randomly allocated to ultrasound (n=5) or placebo controlled (n=5) groups. The patients were treated by either US or sham-US for ten sessions, three days per week, every other day. The outcome measures were Functional Rating Index (FRI), Hmax/Mmax ratio and range of motion (ROM), which were measured at baseline, after 5 treatment sessions and at the end of treatment. To analyze the data, The Mann Whitney U test and Wilcoxon Signed Rank test were used. After treatment, both US and placebo groups showed statistically significant decrease in FRI scores indicating improvement in functional ability (p = 0.042 and p = 0.043, respectively). The mean changes of FRI during the second five treatment sessions and after the end of treatment was significantly better in the US group than in the placebo group (p = 0.016 and p = 0.032, respectively). Before and after treatment, the mean H reflex latency and Hmax/Mmax ratio, right and left side were similar in the groups (p > 0.05), and no significant changes were observed in the treatment groups (p > 0.05). After treatment, the extension and lateral flexion range of motion significantly increased in the US group (p = 0.04), but the back movements in the placebo group did not show significant changes (p > 0.05). The present study supports the significant effect of US on LBP, and suggests that US may improve the functional ability of patients with non specific low back pain.     

The effect of intermittent diet and/or physical therapy in patients with chronic low back pain: A single-blinded randomized controlled trial

Background and purposeThis study aimed to investigate the effect of intermittent diet and/or physical therapy in patients with chronic low back pain.Materials and methodsSixty sedentary volunteers with chronic low back pain participated in the study. Body weight and body mass index (BMI) were measured. Pain severity was assessed using Visual Analogue Scale (VAS) and Leeds Assessment of Neuropathic Symptoms and Signs (LANSS), while assessment of disability was done using Barthel Index (BI).ResultsThe weight and BMI were reduced after treatment with diet only and diet plus physical therapy (p < 0.001). The pain severity was reduced in all the treated groups (p < 0.001), while BI was increased in the group treated with only physical therapy (p < 0.001).ConclusionThe present study indicated that intermittent diet and/or physical therapy are beneficial to patients with chronic low back pain in terms of pain sensation and daily activities.     

Efficacy and safety of acupuncture for the treatment of non-specific acute low back pain: a randomised controlled multicentre trial protocol [ISRCTN65814467]

Background  

Low back pain and its associated incapacitating effects constitute an important healthcare and socioeconomic problem, as well as being one of the main causes of disability among adults of working age. The prevalence of non-specific low back pain is very high among the general population, and 60–70% of adults are believed to have suffered this problem at some time. Nevertheless, few randomised clinical trials have been made of the efficacy and efficiency of acupuncture with respect to acute low back pain. The present study is intended to assess the efficacy of acupuncture for acute low back pain in terms of the improvement reported on the Roland Morris Questionnaire (RMQ) on low back pain incapacity, to estimate the specific and non-specific effects produced by the technique, and to carry out a cost-effectiveness analysis.     

TTM-based motivational counselling does not increase physical activity of low back pain patients in a primary care setting--A cluster-randomized controlled trial

OBJECTIVE: To investigate the effectiveness of a TTM-based motivational counselling approach by trained practice nurses to promote physical activity of low back pain patients in a German primary care setting. METHODS: Data were collected in a cluster-randomized controlled trial with three study arms via questionnaires and patient interviews at baseline and after 6 and 12 months. We analysed total physical activity and self-efficacy by using random effect models to allow for clustering. RESULTS: A total of 1378 low back pain patients, many with acute symptoms, were included in the study. Nearly 40% of all patients reported sufficient physical activity at baseline. While there were significant improvements in patients' physical activity behaviour in all study arms, there was no evidence for an intervention effect. CONCLUSION: The outcome may be explained by insufficient performance of the practice nurses, implementation barriers caused by the German health care system and the heterogenous sample. PRACTICE IMPLICATIONS: Given the objective to incorporate practice nurses into patient education, there is a need for a better basic training of the nurses and for a change towards an organizational structure that facilitates patient-nurse communication. Counselling for low back pain patients has to consider more specificated aims for different subgroups.     

A controlled trial of corticosteroid injections into facet joints for chronic low back pain.

BACKGROUND. Chronic low back pain is a common problem with many treatments, few of which have been rigorously evaluated. This randomized, placebo-controlled trial was designed to evaluate the efficacy of injections of corticosteroid into facet joints to treat chronic low back pain. METHODS. Patients with chronic low back pain who reported immediate relief of their pain after injections of local anesthetic into the facet joints between the fourth and fifth lumbar vertebrae and the fifth lumbar and first sacral vertebrae were randomly assigned to receive under fluoroscopic guidance injections of either methylprednisolone acetate (20 mg; n = 49) or isotonic saline (n = 48) in the same facet joints. Ninety-five patients were followed for six months and their condition assessed with scales of pain severity, back mobility, and limitation of function. RESULTS. After one month, none of the outcome measures evaluating pain, functional status, and back flexion differed clinically or statistically between the two study groups. Forty-two percent of the patients who received methylprednisolone and 33 percent of those who received placebo reported marked or very marked improvement (95 percent confidence interval for the difference, -11 to 28 percentage points; P = 0.53). The results were similar after three months. At the six-month evaluation, the patients treated with methylprednisolone reported more improvement, less pain on the visual-analogue scale, and less physical disability. The differences were reduced, however, when concurrent interventions were taken into account. Moreover, only 11 patients (22 percent) in the methylprednisolone group and 5 (10 percent) in the placebo group had sustained improvement from the first month to the sixth month (95 percent confidence interval for the difference, -2 to 26; P = 0.19). CONCLUSIONS. We conclude that injecting methylprednisolone acetate into the facet joints is of little value in the treatment of patients with chronic low back pain.     

Guided self-help for bulimia nervosa in primary care: a randomized controlled trial

BACKGROUND: To increase access to cognitive behavioural therapy for bulimia nervosa new delivery modes are being examined. Guided Self-Help (GSH) in primary care is potentially valuable in this respect. This research aimed to compare outcomes following GSH delivered by general practitioners (GPs) in the normal course of their practice to a delayed treatment control (DTC) condition, and to examine the maintenance of treatment gains at 3 and 6 months following completion of GSH. METHOD: Participants were 109 women with full syndrome or sub-threshold bulimia nervosa, randomly allocated to GSH ( n = 54) and DTC ( n = 55). The GSH group received direction and support from a GP over a 17-week period while working through the manual in Bulimia Nervosa and Binge-Eating: A Guide to Recovery by P. J. Cooper (1995). GSH and DTC groups were assessed pre-treatment and 1 week following the 17-week intervention or waiting interval. The GSH group was reassessed at 3- and 6-month follow-up. RESULTS: Intention-to-treat analyses at end of treatment revealed significant improvements in bulimic and psychological symptoms in GSH compared with DTC, reduction in mean frequency of binge-eating episodes by 60% in GSH and 6% in DTC, and remission from all binge-eating and compensatory behaviours in 28% of the GSH and 11% of the DTC sample. Treatment gains were maintained at 3- and 6-month follow-up. CONCLUSION: Outcomes in GSH compare favourably with those of specialist-delivered psychological treatments. These findings are considered in light of the nature of the therapy offered and the primary care context.     

Screening elderly people in primary care: a randomized controlled trial.

A randomized controlled trial was carried out to test the effectiveness of a screening programme carried out by nurses for elderly people aged 75 years and over in a general practice. A total of 151 people were randomly allocated to the test group and 145 to the control group. The test group received a home visit from a nurse at which an assessment lasting 45 minutes was made of: activities of daily living, social functioning, sensory functions, mental and emotional problems, current medical problems, blood pressure, urinalysis, haemoglobin level and compliance with medication. Both groups completed a selection of items from four health indices before and 20 months after the intervention. At follow up, the test group scored significantly better than the control group on a morale scale. However, this trial provided no evidence for better resolution of physical problems or finding activities of daily living easier in the test group compared with the control group. It is suggested that the main benefit of such a screening process is that the special attention and education provided improves adaptation to old age and awareness of the support systems available. The government has proposed an annual review of elderly people in their own home and this study suggests that the objectives of this scheme should be clarified.     

Reduction of chronic non-specific low back pain: A randomised controlled clinical trial on acupuncture and baclofen

Background  

Chronic non-specific low back pain (LBP) is a prevalent (80%) and multi-dimensional illness. This study aims to test whether acupuncture, baclofen, or combined treatment with acupuncture and baclofen alleviates symptoms of non-specific chronic LBP in men.     

The relationship between pain and depression in a trial using paroxetine in sufferers of chronic low back pain

Previous studies have shown a positive association between pain and depression, though evidence supporting a direct link between these two variables is less robust. Using a placebo-controlled trial, the authors examined the analgesic and antidepressant efficacy of paroxetine (20 mg) in chronic low back pain sufferers. The authors examined the associations among pain, depression, disability, and illness attitudes. Paroxetine showed no effects on pain or depression compared with placebo; however, subjects randomized to paroxetine were more likely to reduce concomitant analgesic medication. The cross-sectional association of depression and pain at baseline (r = 0.2, P = 0.02) was weaker than the association between depression and disability (r = 0.3, P = 0.004). Similarly, the association of change in depression scores with change in pain (r = 0.25, P = 0.016) was weaker than change between depression and disability (r = 0.49, P<0.0005). Whereas the relationship between pain and depression became nonsignificant when disability and illness attitudes were controlled, the relationship between depression and disability remained highly significant when pain and illness attitudes were controlled. These data are consistent with the association between pain and depression being wholly modulated by disability and illness attitudes, with no direct relationship between pain and depression.     

Educating patient educators: enhancing instructional effectiveness in physical therapy for low back pain patients

The objective of this research project was to study the effectiveness of a training program for the enhancement of patient education skills in physical therapy. In this paper the improvement of five of these skills is tested. These skills are aimed at a better monitoring of adherence problems during the treatment and at enhancing self-efficacy of the patient after treatment. In order to test the effectiveness of the program, complete treatments of 19 physiotherapists have been assessed before (1142 sessions, 130 patients) and after (775 sessions, 88 patients) the training program. Information on the instructions and solutions given to the patients was obtained with a registration form, completed after each session by the physiotherapist. The patient's perception of the effectiveness and feasibility of instructions was obtained from questionnaires, completed by the patient on three occasions. After the training only a minority of the trained skills appeared to be improved. All in all, the training program was not very effective. More effort is needed to develop training programs aimed at promoting patients' self-efficacy as well as measurement instruments to assess the effects of such programs.     

A controlled trial of transcutaneous electrical nerve stimulation (TENS) and exercise for chronic low back pain

A number of treatments are widely prescribed for chronic back pain, but few have been rigorously evaluated. We examined the effectiveness of transcutaneous electrical nerve stimulation (TENS), a program of stretching exercises, or a combination of both for low back pain. Patients with chronic low back pain (median duration, 4.1 years) were randomly assigned to receive daily treatment with TENS (n = 36), sham TENS (n = 36), TENS plus a program of exercises (n = 37), or sham TENS plus exercises (n = 36). After one month no clinically or statistically significant treatment effect of TENS was found on any of 11 indicators of outcome measuring pain, function, and back flexion; there was no interactive effect of TENS with exercise. Overall improvement in pain indicators was 47 percent with TENS and 42 percent with sham TENS (P not significant). The 95 percent confidence intervals for group differences excluded a major clinical benefit of TENS for most outcomes. By contrast, after one month patients in the exercise groups had significant improvement in self-rated pain scores, reduction in the frequency of pain, and greater levels of activity as compared with patients in the groups that did not exercise. The mean reported improvement in pain scores was 52 percent in the exercise groups and 37 percent in the nonexercise groups (P = 0.02). Two months after the active intervention, however, most patients had discontinued the exercises, and the initial improvements were gone. We conclude that for patients with chronic low back pain, treatment with TENS is no more effective than treatment with a placebo, and TENS adds no apparent benefit to that of exercise alone.     

Preliminary evidence of the short-term effectiveness of alternative treatments for low back pain.

In recent years, there has been increased popularity for use of alternative treatment modalities for low back pain with limited investigation into whether they are effective in returning the worker to normal functionality. The objective of this study was to investigate the short-term impact on the restoration of the functional ability of common treatment modalities including physical therapy, acupuncture, chiropractic treatment, and massage therapy. A within subjects design was used that compared a baseline assessment to three follow-up assessments: immediately following treatment, two days and seven days post treatment. Individuals suffering from low back pain were recruited from local clinics that specialize in one of the four treatment modalities. Twenty-four individuals who were suffering from low back pain and had started one of the treatment modalities were recruited into the study. Three-dimensional motions (ROM, velocity, and acceleration) during a standardized functional capacity protocol were measured prior to and during three follow-up periods. The results show the effectiveness of the treatments was dependent upon time and were predominantly in the non-sagittal motion planes (velocities and accelerations). Individual subjective pain levels also indicate all the treatment modalities were effective after the 1-week follow-up. Findings suggest those modalities primarily focused on the back musculature (acupuncture, massage, physical therapy) were more effective with respect to functional capacity restoration. The current results provide a quantitative evaluation, based upon trunk dynamics, of the effectiveness of these four treatment modalities.