Prolotherapy injections and physiotherapy used singly and in combination for lateral epicondylalgia: a single-blinded randomised clinical trial.

BACKGROUND: Lateral epicondylalgia (tennis elbow) is a common, debilitating and often treatment-resistant condition. Two treatments thought to address the pathology of lateral epicondylalgia are hypertonic glucose plus lignocaine injections (prolotherapy) and a physiotherapist guided manual therapy/exercise program (physiotherapy). This trial aimed to compare the short- and long-term clinical effectiveness, cost effectiveness, and safety of prolotherapy used singly and in combination with physiotherapy. METHODS: Using a single-blinded randomised clinical trial design, 120 participants with lateral epicondylalgia of at least 6 weeks' duration were randomly assigned to prolotherapy (4 sessions, monthly intervals), physiotherapy (weekly for 4 sessions) or combined (prolotherapy+physiotherapy). The Patient-Rated Tennis Elbow Evaluation (PRTEE) and participant global impression of change scores were assessed by blinded evaluators at baseline, 6, 12, 26 and 52 weeks. Success rate was defined as the percentage of participants indicating elbow condition was either 'much improved' or 'completely recovered.' Analysis was by intention-to-treat. RESULTS: Eighty-eight percent completed the 12-month assessment. At 52 weeks, there were substantial, significant improvements compared with baseline status for all outcomes and groups, but no significant differences between groups. The physiotherapy group exhibited greater reductions in PRTEE at 12 weeks than the prolotherapy group (p = 0.014). CONCLUSION: There were no significant differences amongst the Physiotherapy, Prolotherapy and Combined groups in PRTEE and global impression of change measures over the course of the 12-month trial. TRIAL REGISTRATION: ACTRN12612000993897 .

Low-level laser therapy for chronic non-specific low back pain: a meta-analysis of randomised controlled trials.

OBJECTIVE: The efficacy of low-level laser treatment (LLLT) for chronic back pain remains controversial due to insufficient trial data. We aimed to conduct an updated review to determine if LLLT (including laser acupuncture) has specific benefits in chronic non-specific low back pain (CNLBP). METHODS: Electronic databases were searched for randomised trials using sham controls and blinded assessment examining the intervention of LLLT in adults with CNLBP. Primary outcomes were pain and global assessment of improvement with up to short-term follow-up. Secondary outcomes were disability, range of back movement, and adverse effects. A random effects meta-analysis was conducted. Subgroup analyses were based on laser dose, duration of baseline pain, and whether or not laser therapy used an acupuncture approach. RESULTS: 15 studies were selected involving 1039 participants. At immediate and short-term follow-up there was significant pain reduction of up to WMD (weighted mean difference) -1.40 cm (95% CI -1.91 to -0.88 cm) in favour of laser treatment, occurring in trials using at least 3 Joules (J) per point, with baseline pain <30 months and in non-acupuncture LLLT trials. Global assessment showed a risk ratio of 2.16 (95% CI 1.61 to 2.90) in favour of laser treatment in the same groups only at immediate follow-up. CONCLUSIONS: We demonstrated moderate quality of evidence (GRADE) to support a clinically important benefit in LLLT for CNLBP in the short term, which was only seen following higher laser dose interventions and in participants with a shorter duration of back pain. Rigorously blinded trials using appropriate laser dosage would provide greater certainty around this conclusion.

Psychological interventions for symptomatic management of non-specific chest pain in patients with normal coronary anatomy.

BACKGROUND: Recurrent chest pain in the absence of coronary artery disease is a common problem which sometimes leads to excess use of medical care. Although many studies have examined the causes of pain in these patients, few clinical trials have evaluated treatment. This is an update of a Cochrane review originally published in 2005 and last updated in 2010. The studies reviewed in this paper provide an insight into the effectiveness of psychological interventions for this group of patients. OBJECTIVES: To assess the effects of psychological interventions for chest pain, quality of life and psychological parameters in people with non-specific chest pain. SEARCH METHODS: We searched the Cochrane Library (CENTRAL, Issue 4 of 12, 2014 and DARE Issue 2 of 4, 2014), MEDLINE (OVID, 1966 to April week 4 2014), EMBASE (OVID, 1980 to week 18 2014), CINAHL (EBSCO, 1982 to April 2014), PsycINFO (OVID, 1887 to April week 5 2014) and BIOSIS Previews (Web of Knowledge, 1969 to 2 May 2014). We also searched citation lists and contacted study authors. SELECTION CRITERIA: Randomised controlled trials (RCTs) with standardised outcome methodology that tested any form of psychotherapy for chest pain with normal anatomy. Diagnoses included non-specific chest pain (NSCP), atypical chest pain, syndrome X or chest pain with normal coronary anatomy (as either inpatients or outpatients). DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies for inclusion, extracted data and assessed quality of studies. We contacted trial authors for further information about the included RCTs. MAIN RESULTS: We included two new papers, one of which was an update of a previously included study. Therefore, a total of 17 RCTs with 1006 randomised participants met the inclusion criteria, with the one new study contributing an additional 113 participants. There was a significant reduction in reports of chest pain in the first three months following the intervention: random-effects relative risk = 0.70 (95% CI 0.53 to 0.92). This was maintained from three to nine months afterwards: relative risk 0.59 (95% CI 0.45 to 0.76). There was also a significant increase in the number of chest pain-free days up to three months following the intervention: mean difference (MD) 3.00 (95% CI 0.23 to 5.77). This was associated with reduced chest pain frequency (random-effects MD -2.26, 95% CI -4.41 to -0.12) but there was no evidence of effect of treatment on chest pain frequency from three to twelve months (random-effects MD -0.81, 95% CI -2.35 to 0.74). There was no effect on severity (random-effects MD -4.64 (95% CI -12.18 to 2.89) up to three months after the intervention. Due to the nature of the main interventions of interest, it was impossible to blind the therapists as to whether the participant was in the intervention or control arm. In addition, in three studies the blinding of participants was expressly forbidden by the local ethics committee because of issues in obtaining fully informed consent . For this reason, all studies had a high risk of performance bias. In addition, three studies were thought to have a high risk of outcome bias. In general, there was a low risk of bias in the other domains. However, there was high heterogeneity and caution is required in interpreting these results. The wide variability in secondary outcome measures made it difficult to integrate findings from studies. AUTHORS' CONCLUSIONS: This Cochrane review suggests a modest to moderate benefit for psychological interventions, particularly those using a cognitive-behavioural framework, which was largely restricted to the first three months after the intervention. Hypnotherapy is also a possible alternative. However, these conclusions are limited by high heterogeneity in many of the results and low numbers of participants in individual studies. The evidence for other brief interventions was less clear. Further RCTs of psychological interventions for NSCP with follow-up periods of at least 12 months are needed.

Direct observation of the nutrition care practices of Australian general practitioners.

INTRODUCTION: Nutrition care refers to nutrition-related advice or counselling provided by health professionals in an attempt to improve the nutrition behaviour of patients. AIM: The aim of this study was to describe the practices of a sample of Australian general practitioners (GPs) when providing nutrition care to adult patients. METHODS: Eighteen GPs (13 male, 5 female) were observed by fourth-year medical students during their general practice rotation. Each GP was observed for five consultations that included nutrition care, totalling 90 observed consultations. In each consultation, students completed a 31-item nutrition care checklist of nutrition care practices that could feasibly occur in a standard consultation. Each practice was marked with either a 'yes' (completed), 'no' (did not complete) or 'completed by practice nurse prior to or after the consultation'. RESULTS: Twenty-eight nutrition care practices were observed at least once. The most frequently observed practices were measuring and discussing blood pressure (76.7%; n=69), followed by general questions about current diet (74.4%; n=67). Approximately half of the consultations included a statement of a nutrition-related problem (52.2%; n=47), and the provision of nutrition advice that focused on a nutrient (45.6%; n=41) or food group (52.2%; n=47). Consultations with male GPs, as well as GPs with more than 25 years of experience, were associated with an increased number of nutrition care practices per consultation. DISCUSSION: The GPs performed nutrition care practices in varying frequencies. Further research is required to identify the most effective GP nutrition care practices to improve the nutrition behaviour of patients.

Low-dose laser acupuncture for non-specific chronic low back pain: a double-blind randomised controlled trial.

OBJECTIVE: To determine if infrared laser acupuncture (LA) may have a specific effect in reducing pain and disability in treatment of chronic low back pain (LBP). METHODS: This was a double-blind sham laser controlled trial performed in general practices in Perth, Western Australia. The participants were 144 adults with chronic non-specific LBP. They were randomised to receive eight once-weekly treatments. Laser machines (20 mW, 840 nm diode, power density 0.1 W/cm(2)) stimulated points in three treatment groups: sham (0 joules/point), low dose (0.2 J/point) and high dose (0.8 joules/point). Participants were followed-up at 1 and 6 weeks, and 6 and 12 months post treatment. Primary outcomes were pain (Numerical Pain Rating Scale (NPRS)) and disability (Oswestry Disability Inventory (ODI)) at 6 weeks post treatment. Secondary outcomes included numerical rating scale for limitation of activity, global assessment of improvement, analgesic usage and adverse effects after treatment. RESULTS: The analysis showed no difference between sham and the laser groups at 6 weeks for pain or disability. There was a significant reduction in mean pain and disability in all groups at 6 weeks (p<0.005); NPRS: sham (-1.5 (95% CI -2.1 to -0.8)), low dose (-1.3 (-2.0 to -0.8)), high dose (-1.1 (-1.7 to -0.5)). ODI: sham (-4.0 (-7.1 to -1.0)), low dose (-4.1, (-6.7 to -1.5)), high dose (-2.6 (-5.7 to 0.5)). All secondary outcomes also showed clinical improvement over time but with no differences between groups. CONCLUSIONS: LA using energy density range (0-4 J/cm(2)) for the treatment of chronic non-specific LBP resulted in clinical improvement unrelated to laser stimulation. TRIAL REGISTRATION: http://www.anzctr.org.au ACTRN12610000043033.

Psychological interventions for symptomatic management of non-specific chest pain in patients with normal coronary anatomy.

BACKGROUND: Recurrent chest pain in the absence of coronary artery disease is a common problem that sometimes leads to excess use of medical care. Although many studies examine the causes of pain in these patients, few clinical trials have evaluated treatment. The studies reviewed in this paper provide an insight into the effectiveness of psychological interventions for this group of patients. OBJECTIVES: To update the previously published systematic review. SEARCH METHODS: We searched the Cochrane LIbrary (CENTRAL and DARE) (Issue 3 of 4 2011), MEDLINE (1966 to August Week 5, 2011), CINAHL (1982 to Sept 2011) EMBASE (1980 to Week 35 2011), PsycINFO (1887 to Sept Week 1, 2011), and Biological Abstracts (January 1980 to Sept 2011). We also searched citation lists and approached authors. SELECTION CRITERIA: Randomised controlled trials (RCTs) with standardised outcome methodology that tested any form of psychotherapy for chest pain with normal anatomy. Diagnoses included non-specific chest pain (NSCP), atypical chest pain, syndrome X, or chest pain with normal coronary anatomy (as either inpatients or outpatients). DATA COLLECTION AND ANALYSIS: Two authors independently selected studies for inclusion, extracted data and assessed quality of studies. The authors contacted trial authors for further information about the RCTs included. MAIN RESULTS: Six new RCTs were located and added to the existing trials, therefore, a total of 15 RCTs (803 participants) were included. There was a significant reduction in reports of chest pain in the first three months following the intervention; fixed-effect relative risk = 0.68 (95% CI 0.57 to 0.81). This was maintained from three to nine months afterwards; relative risk = 0.59 (95% CI 0.45 to 0.76). There was also a significant increase in the number of chest pain free days up to three months following the intervention; mean difference = 2.81 (95% CI 1.28 to 4.34). This was associated with reduced chest pain frequency (random-effects mean difference = -2.26 95% CI -4.41 to -0.12) but there was no evidence of effect of treatment on chest pain frequency from three to twelve months (random-effects mean difference -0.81 95% CI -2.35, 0.74). There was no effect on severity (random-effects mean difference = -4.64 (95% CI -12.18 to 2.89) up to three months after the intervention. Overall there was generally a low risk of bias, however, there was high heterogeneity and caution is required in interpreting these results. Wide variability in outcome measures made integration of studies for secondary outcome measures difficult to report on. AUTHORS' CONCLUSIONS: This review suggests a modest to moderate benefit for psychological interventions, particularly those using a cognitive-behavioural framework, which was largely restricted to the first three months after the intervention. Hypnotherapy is also a possible alternative. The evidence for brief interventions was less clear. Further RCTs of psychological interventions for NSCP with follow-up periods of at least 12 months are needed.

Prolotherapy injections and eccentric loading exercises for painful Achilles tendinosis: a randomised trial.

OBJECTIVE: To compare the effectiveness and cost-effectiveness of eccentric loading exercises (ELE) with prolotherapy injections used singly and in combination for painful Achilles tendinosis. DESIGN: A single-blinded randomised clinical trial. The primary outcome measure was the VISA-A questionnaire with a minimum clinically important change (MCIC) of 20 points. SETTING: Five Australian primary care centres. PARTICIPANTS: 43 patients with painful mid-portion Achilles tendinosis commenced and 40 completed treatment protocols. INTERVENTIONS: Participants were randomised to a 12-week program of ELE (n=15), or prolotherapy injections of hypertonic glucose with lignocaine alongside the affected tendon (n=14) or combined treatment (n=14). MAIN OUTCOME MEASUREMENTS: VISA-A, pain, stiffness and limitation of activity scores; treatment costs. RESULTS: At 12 months, proportions achieving the MCIC for VISA-A were 73% for ELE, 79% for prolotherapy and 86% for combined treatment. Mean (95% CI) increases in VISA-A scores at 12 months were 23.7 (15.6 to 31.9) for ELE, 27.5 (12.8 to 42.2) for prolotherapy and 41.1 (29.3 to 52.9) for combined treatment. At 6 weeks and 12 months, these increases were significantly less for ELE than for combined treatment. Compared with ELE, reductions in stiffness and limitation of activity occurred earlier with prolotherapy and reductions in pain, stiffness and limitation of activity occurred earlier with combined treatment. Combined treatment had the lowest incremental cost per additional responder ($A1539) compared with ELE. CONCLUSIONS: For Achilles tendinosis, prolotherapy and particularly ELE combined with prolotherapy give more rapid improvements in symptoms than ELE alone but long-term VISA-A scores are similar. TRIAL REGISTRATION NUMBER: ACTRN: 12606000179538.

Psychological interventions for symptomatic management of non-specific chest pain in patients with normal coronary anatomy.

BACKGROUND: Recurrent chest pain in the absence of coronary artery disease is a common problem that sometimes leads to excess use of medical care. Although many studies examine the causes of pain in these patients, few clinical trials have evaluated treatment. The studies reviewed in this paper provide an insight into the effectiveness of psychological interventions for this group of patients. OBJECTIVES: To investigate psychological treatments for non-specific chest pain (NSCP) with normal coronary anatomy. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2008, Issue 4), MEDLINE (1966 to December 2008), CINAHL (1982 to December 2008) EMBASE (1980 to December 2008), PsycINFO (1887 to December 2008), the Database of Abstracts of Reviews of Effectiveness (DARE) and Biological Abstracts (January 1980 to December 2008). We also searched citation lists and approached authors. SELECTION CRITERIA: Randomised controlled trials (RCTs) with standardised outcome methodology that tested any form of psychotherapy for chest pain with normal anatomy. Diagnoses included non-specific chest pain, atypical chest pain, syndrome X, or chest pain with normal coronary anatomy (as either inpatients or outpatients). DATA COLLECTION AND ANALYSIS: Two authors independently selected studies for inclusion, extracted data and assessed quality of studies. The authors contacted trial authors for further information about the RCTs included. MAIN RESULTS: Ten RCTs (484 participants) were included. There was a significant reduction in reports of chest pain in the first three months following the intervention; fixed effects relative risk = 0.68 (95% CI 0.57 to 0.81). This was maintained from 3 to 9 months afterwards; relative risk = 0.59 (95% CI 0.45 to 0.76). There was also a significant increase in the number of chest pain free days up to three months following the intervention; mean difference = 2.81 (95% CI 1.28 to 4.34). This was associated with reduced chest pain frequency (mean difference = -1.73 (95% CI -2.21 to -1.26)) and severity (mean difference = -6.86 (95% CI -10.74 to -2.97)). However, there was high heterogeneity and caution is required in interpreting these results. Wide variability in outcome measures made integration of studies for secondary outcome measures difficult to report on. AUTHORS' CONCLUSIONS: This review suggests a modest to moderate benefit for psychological interventions, particularly those using a cognitive-behavioural framework, which was largely restricted to the first three months after the intervention. Hypnotherapy is also a possible alternative. The evidence for brief interventions was less clear. Further RCTs of psychological interventions for NSCP with follow-up periods of at least 12 months are needed.

Defining worthwhile and desired responses to treatment of chronic low back pain.

OBJECTIVE: To describe patients' perceptions of minimum worthwhile and desired reductions in pain and disability upon commencing treatment for chronic low back pain. DESIGN AND SETTING: Descriptive study nested within a community-based randomized controlled trial on prolotherapy injections and exercises. PATIENTS: A total of 110 participants with chronic low back pain. Interventions. Prior to treatment, participants were asked what minimum percentage reductions in pain and disability would make treatment worthwhile and what percentage reductions in pain and disability they desired with treatment. OUTCOME MEASURES: Minimum worthwhile reductions and desired reductions in pain and disability. RESULTS: Median (inter-quartile range) minimum worthwhile reductions were 25% (20%, 50%) for pain and 35% (20%, 50%) for disability. This compared with desired reductions of 80% (60%, 100%) for pain and 80% (50%, 100%) for disability. The internal consistency between pain and disability responses was high (Spearman's coefficient of association of 0.81 and 0.87, respectively). A significant association existed between minimum worthwhile reductions and desired reductions, but no association was found between these two factors and patient age, gender, pain severity or duration, disability, anxiety, depression, response to treatment, or treatment satisfaction. CONCLUSIONS: Inquiring directly about patients' expectations of reductions in pain and in disability is important in establishing realistic treatment goals and setting benchmarks for success. There is a wide disparity between the reductions that they regard as minimum worthwhile and reductions that they hope to achieve. However, there is a high internal consistency between reductions in pain and disability that they expect.

Do individualized medication effectiveness tests (n-of-1 trials) change clinical decisions about which drugs to use for osteoarthritis and chronic pain?

To assess the impact of individualized medication effectiveness tests (IMETs, or n-of-1 trials), on patients' short-term decision making about medications for chronic pain. Survey evaluation of patients undergoing a double-blind, crossover comparison of drug versus placebo, drug versus drug, or drug versus drug combination using paracetamol and ibuprofen in 3 pairs of treatment periods, randomized within pairs. General practice patients (supplemented by a few from 2 tertiary pain clinics) with either chronic pain (> or =3 months), or osteoarthritis (with pain for > or =1 month) severe enough to warrant consideration of long-term nonsteroidal antiinflammatory drug (NSAID) use but for whom there was doubt about the efficacy of NSAID or alternative. Pain and stiffness in sites nominated by the patient, global pain, use of escape analgesia, and side effects. Of 116 IMETs started, 71 were completed. Drug management changed for 46 of 71 (65%). The most common change was to add paracetamol or to substitute the NSAID or COX-2 inhibitor with paracetamol (25 of 71 patients and 54% of changes). Of the 37 who were using NSAIDs or COX-2 inhibitors before the IMET, 12 (32%) ceased these afterward. Paracetamol was as effective or more effective than ibuprofen in 37 (68%) of the 54 IMETs directly comparing these drugs. IMETs provide useful information for clinical decisions. Paracetamol continues to be useful for patients with chronic pain whose optimal drug choice is in doubt. Our results provide a new (individual) perspective on the well-known recommendation for paracetamol as first-line treatment for chronic pain and demonstrate that it is feasible to provide IMETs nationally by mail and telephone.

Prolotherapy injections for chronic low back pain: a systematic review.

STUDY DESIGN: A systematic review of randomized and quasi-randomized controlled trials. OBJECTIVES: To determine the efficacy of prolotherapy injections in adults with chronic low back pain. SUMMARY OF BACKGROUND DATA: Prolotherapy is an injection-based treatment for chronic low back pain. Proponents of prolotherapy suggest that some back pain stems from weakened or damaged ligaments. Repeatedly injecting them with irritant solutions is thought to strengthen the ligaments and reduce pain and disability. Prolotherapy protocols usually include co-interventions to enhance the effectiveness of the injections. METHODS: The authors searched MEDLINE, EMBASE, CINAHL, and Science Citation Index up to January 2004, and the Cochrane Controlled Trials Register 2004, issue 1, and consulted content experts. Both randomized and quasi-randomized controlled trials comparing prolotherapy injections to control injections, either alone or in combination with other treatments, were included. Studies had to include measures of pain and disability before and after the intervention. Two reviewers independently selected the trials and assessed them for methodologic quality. Treatment and control group protocols varied from study to study, making meta-analysis impossible. RESULTS: Four studies, all of high quality and with a total of 344 participants, were included. All trials measured pain and disability levels at 6 months, three measured the proportion of participants reporting a greater than 50% reduction in pain or disability scores from baseline to 6 months. Two studies showed significant differences between the treatment and control groups for those reporting more than 50% reduction in pain or disability. Their results could not be pooled. In one, co-interventions confounded interpretation of results; in the other, there was no significant difference in mean pain and disability scores between the groups. In the third study, there was little or no difference between groups in the number of individuals who reported more than 50% improvement in pain and disability. The fourth study reporting only mean pain and disability scores showed no differences between groups. CONCLUSIONS: There is conflicting evidence regarding the efficacy of prolotherapy injections in reducing pain and disability in patients with chronic low back pain. Conclusions are confounded by clinical heterogeneity among studies and by the presence of co-interventions. There was no evidence that prolotherapy injections alone were more effective than control injections alone. However, in the presence of co-interventions, prolotherapy injections were more effective than control injections, more so when both injections and co-interventions were controlled concurrently.

Prolotherapy injections, saline injections, and exercises for chronic low-back pain: a randomized trial.

OBJECTIVES: To assess the efficacy of a prolotherapy injection and exercise protocol in the treatment of chronic nonspecific low back pain. DESIGN: Randomized controlled trial with two-by-two factorial design, triple-blinded for injection status, and single-blinded for exercise status. SETTING: General practice. PARTICIPANTS: One hundred ten participants with nonspecific low-back pain of average 14 years duration were randomized to have repeated prolotherapy (20% glucose/0.2% lignocaine) or normal saline injections into tender lumbo-pelvic ligaments and randomized to perform either flexion/extension exercises or normal activity over 6 months. MAIN OUTCOME MEASURES: Pain intensity (VAS) and disability scores (Roland-Morris) at 2.5, 4, 6, 12, and 24 months. RESULTS: Follow-up was achieved in 96% at 12 months and 80% at 2 years. Ligament injections, with exercises and with normal activity, resulted in significant and sustained reductions in pain and disability throughout the trial, but no attributable effect was found for prolotherapy injections over saline injections or for exercises over normal activity. At 12 months, the proportions achieving more than 50% reduction in pain from baseline by injection group were glucose-lignocaine: 0.46 versus saline: 0.36. By activity group these proportions were exercise: 0.41 versus normal activity: 0.39. Corresponding proportions for >50% reduction in disability were glucose-lignocaine: 0.42 versus saline 0.36 and exercise: 0.36 versus normal activity: 0.38. There were no between group differences in any of the above measures. CONCLUSIONS: In chronic nonspecific low-back pain, significant and sustained reductions in pain and disability occur with ligament injections, irrespective of the solution injected or the concurrent use of exercises.