Michael Yelland

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.

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 (

The role of paracetamol in chronic pain: An evidence-based approach

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

Prolotherapy injections for chronic low back pain - A systematic review

Chronic pain is a significant public health burden. Several international guidelines and influential reviews recommend the use of paracetamol (acetaminophen) as the first-line analgesic of choice for the management of chronic pain. These recommendations are based largely on the balance of evidence, which favorably demonstrates the efficacy, safety, and low cost of paracetamol relative to other analgesics. A decade ago, March et al suggested that because of the dangers associated with conventional nonsteroidal antiinflammatory (NSAID) use, particularly in the elderly, they should ideally not be used without an individual n-of-1 trial to show that they are more effective than paracetamol. Today, the results of our investigations into the individualization of pain management options continue to support this suggestion. Based on the data available to date, it still seems prudent to use NSAIDs only in those patients in whom there is good evidence of improved efficacy over paracetamol. In patients with chronic pain, paracetamol can play an important role as an NSAID sparer, with resultant benefits in terms of reduced adverse effects and cost savings.

N-of-1 randomized trials to assess the efficacy of gabapentin for chronic neuropathic pain

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.

Can long-term impairment in general practitioner whiplash patients be predicted using screening and patient-reported outcomes?

OBJECTIVE The objective of this study was to compare the efficacy of gabapentin with placebo for neuropathic pain at the individual and population levels. DESIGN This study used an n-of-1 trial methodology with three double-blind, randomized, crossover comparisons of gabapentin with placebo. SETTING This study was carried out at specialist outpatient clinics at two Australian hospitals. Patients. The patients are adults with chronic neuropathic pain. INTERVENTIONS Following a dose-finding period, participants underwent three comparisons of 2-week periods on gabapentin (600-1,800 mg per day) and placebo. The dose-finding period was commenced by 112 patients, of whom 39 had no response so they did not enroll, leaving 73 trial participants. Of these, 48 completed and 7 partially completed their trials, and 18 withdrew. OUTCOME MEASURES The five outcome measures were the visual analog scale (0-10) of pain, sleep interference and functional limitation; frequency of adverse events and medication preference. The aggregate response was determined by weighting the response to each measure equally. RESULTS Of the 55 participants who completed at least one cycle, the aggregate response to gabapentin was better than placebo in 16 (29%), of whom 15 continued gabapentin posttrial. No difference was shown in 38 (69%), and 1 (2%) showed a better response to placebo. Fifteen of these 39 continued gabapentin posttrial. Meta-analysis of the mean scores showed lower mean (standard deviation) scores for gabapentin by 0.8 (0.2) for pain, 0.6 (0.2) for sleep interference, and 0.6 (0.2) for functional limitation. CONCLUSIONS The response rate and mean reduction in symptoms with gabapentin were small. Gabapentin prescribing posttrial was significantly influenced by the trial results.

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

The objective of this prospective pilot study was to investigate the predictors of outcome at 6 months for whiplash-associated disorder in a general practitioner primary care population. Psychosocial screening questionnaires, patient-reported outcomes of cervical functional impairment, demographic and accident-specific data have been indicated as predictive of future recovery status and treatment requirements. Participants (n=30, age=37±14 years, 77% females) from eight general practitioners were initially screened with a modified Orebro Musculoskeletal Pain Questionnaire, and had recovery status monitored and classified for 6 months using both patient-reported outcomes, quantitatively (Neck Disability Index) and qualitatively (patient status self-classification). Analysis at two separate cutoff levels showed 30% of participants nonrecovered and 17% with moderate/severe impairment. Nonrecovery status and increased treatment was predicted by a 109-point screening score cutoff while moderate/severe impairment was predicted by including the presence of cervical rotation at impact. Initial cervical functional impairment status measured with the Neck Disability Index was sensitive but not specific for prediction. A larger population study investigating these protocols is warranted.

Iatrogenic pneumothorax: safety concerns when using acupuncture or dry needling in the thoracic region

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/cm2) 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/cm2) for the treatment of chronic non-specific LBP resulted in clinical improvement unrelated to laser stimulation. Trial Registration http://www.anzctr.org.au ACTRN12610000043033.

An Algorithm for the Diagnosis and Management of Chest Pain in Primary Care

Abstract Background: Pneumothorax is a very rare but serious complication associated with acupuncture and dry needling around the thoracic region. Physiotherapists and other health practitioners should be aware of the risks associated with needling in this region and should take care to minimize the possibility of an iatrogenic pneumothorax. Findings: An awareness of the signs and symptoms of a pneumothorax is necessary for practitioners using acupuncture and dry needling in the thoracic region. Understanding the normal anatomy and its variants can minimize risk associated with needling practices in this region. Various technique modifications are suggested so that the pleura or lungs are avoided while using acupuncture or dry needling in the thoracic region. Discussion/Conclusion: Acupuncture and dry needling in this region administered by well-trained physiotherapists and other health practitioners is very safe; however, to maximize safety therapists should consider the relevant anatomy and not practise using advanced acupuncture and dry needling techniques without adequate competency-based training.

Are N-of-1 Trials an Economically Viable Option to Improve Access to Selected High Cost Medications? The Australian Experience

This article focuses on the key clinical and investigatory features that help differentiate the multiple causes of chest pain in adults in assessment of patients with undifferentiated chest pain in primary care using history, physical examination, and basic initial investigations. The initial treatment of many of the causes is discussed. Some treatments not only relieve symptoms but also provide further diagnostic information based on the response to treatment. Guidance for referral for specialist assessment and further investigations is provided, but the diagnostic usefulness of these measures is not discussed.