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A patient's perceived sensitivity to medicines (PSM) might influence the reported side effects of a treatment. The experience of side effects can result in personal and structural costs (such as nonadherence). Research on nocebo mechanisms and the workings of side effect reporting has been disproportionally smaller compared to the emerging evidence of the individual and clinical impact of the matter. In this study, we explored and re-examined the association between PSM and reported side effects within a specific population (chronic low back pain patients receiving acupuncture treatment), including possible mediating variables (i.e., gender, medical and nonmedical care utilization, optimism, pessimism, anxiety, depression and treatment expectation). We conducted a secondary analysis of a randomized controlled trial that examined the influence of treatment outcome expectations in chronic low back pain (CLBP) patients. All measures in the analysis were self-assessments. We explored the association between PSM, reported side effects and personal characteristics using correlational and regression analyses. Our sample consisted of 152 CLBP patients (65.8% female), the mean age was 39.5 years (SD = 12.5). We found positive correlations between PSM and reported side effects (r = 0.24; p < 0.01) and between PSM and anxiety (r = 0.21; p < 0.05). However, the subsequent regression analyses did not confirm a mediating or moderating effect of anxiety between PSM and reported side effects. We confirmed and extended earlier research on PSM. Our study involved a specific pain population receiving a nonpharmacological intervention. Our results highlight the importance of targeting PSM and anxiety within a treatment to take measures to mitigate the prevalence of side effects.

IntroductionDiscogenic low back pain is a common form of chronic low back pain. In traditional Chinese medicine, combinations of acupuncture and herbal medicine are frequently used to manage this condition. However, evidence for the efficacy of a combined approach remains scarce. To address this gap, we designed a multicentre, randomised controlled trial to compare the effects of the combined use of acupuncture and Chinese herbal medicine, and their separate applications along with non-steroidal anti-inflammatory drugs, in treating discogenic low back pain.Methods and analysisThis is a multicentre, prospective, randomised, four-arm, parallel-controlled trial involving patients with discogenic low back pain. Patients will be randomly divided into four groups (acupuncture combined with herbal medicine, acupuncture, herbal medicine and positive drug control) at a 1:1:1:1 ratio. All patients will undergo a 4-week treatment regimen consisting of acupuncture (active or sham acupuncture) and oral medication (herbal medicine or placebo granules and celecoxib or placebo capsules), as well as a 3-month follow-up assessment. The primary outcome measure will be pain intensity, measured using the Visual Analogue Scale after a 4-week treatment period. Secondary outcome measures will include the lumbar pressure pain threshold, pain-related disability measured using the Oswestry Disability Index, Hospital Anxiety and Depression Scale, Pittsburgh Sleep Quality Index, 36-Item Short-Form Health Survey and incidence of adverse events. Assuming an SD of 1.8, minimal clinically important difference of 1.5 and a 10% dropout rate, at least 97 participants per group are needed, totalling 388 participants.Ethics and disseminationThe study was approved by the Ethics Committee of Dongzhimen Hospital Affiliated with Beijing University of Chinese Medicine (approval number: 2024DZMEC-083-03) and the other seven participating subcentres. All participants will provide written informed consent. This trial will be conducted in accordance with the principles outlined in the Declaration of Helsinki and its amendments. This work will be disseminated through the publication of peer-reviewed manuscripts.Trial registration numberChiCTR2400082428.

Objective: To assess the effectiveness of pilates method on patients with chronic non-specific low back pain (LBP). Method: A randomized controlled trial was carried out in sixty patients with a diagnosis of chronic non-specific LBP. Patients were randomly assigned to one of two groups: Experimental Group (EG) that maintained medication treatment with use of NSAID and underwent treatment with the pilates method and Control Group (CG) that continue medication treatment with use of NSAID and did not undergo any other intervention. A blinded assessor performed all evaluations at baseline (T0), after 45, 90, and 180 days (T45, T90 and T180) for: pain (VAS), function (Roland Morris questionnaire), quality of life (SF-36), satisfaction with treatment (Likert scale), flexibility (sit and reach test) and NSAID intake. Results: The groups were homogeneous at baseline. Statistical differences favoring the EG were found with regard to pain (P < 0.001), function (P < 0.001) and the quality of life domains of functional capacity (P < 0.046), pain (P < 0.010) and vitality (P < 0.029). Statistical differences were also found between groups regarding the use of pain medication at T45, T90 and T180 (P < 0.010), with the EG taking fewer NSAIDs than the CG. Conclusions: The pilates method can be used by patients with LBP to improve pain, function and aspects related to quality of life (functional capacity, pain and vitality). Moreover, this method has no harmful effects on such patients.

Chronic low back pain (cLBP) is the most prevalent chronic pain condition. There are no treatments that haven been found to directly assuage evoked cLBP. To this extent, mindfulness-meditation is a promising pain therapy. Yet, it is unclear if meditation can be utilized to directly attenuate evoked chronic pain through endogenous opioids. A double-blind, randomized, and placebo-controlled clinical trial with a drug crossover design examined if mindfulness-meditation, as compared to sham mindfulness-meditation, attenuated straight leg-raise test evoked chronic pain during intravenous (0.15 mg/kg bolus + 0.15 mg/kg/hour maintenance) naloxone (opioid antagonist) and placebo-saline infusion. Fifty-nine individuals with cLBP (mean age = 46 years; 30 females) completed all study procedures. After the pre-intervention pain testing session, patients were randomized to a four-session (20-min/session) mindfulness (n = 30) or sham mindfulness-meditation (n = 29) intervention. After the interventions, mindfulness and sham mindfulness-meditation were associated with significant reductions in back pain during saline and naloxone infusion when compared to rest (non-meditation) in response to the cLBP-evoking straight leg-raise test. These results indicate that meditation directly reduces evoked chronic pain through non-opioidergic processes. Importantly, after the interventions, the mindfulness group reported significantly lower straight leg-raise induced pain than the sham mindfulness-meditation group during rest (non-meditation) and meditation. Mindfulness and sham mindfulness-meditation training was also associated with significantly lower Brief Pain Inventory severity and interference scores. The pain-relieving effects of mindfulness meditation were more pronounced than a robust sham-mindfulness meditation intervention, suggesting that non-reactive appraisal processes may be uniquely associated with improvements in chronic low-back pain.Trial Registration: ClinicalTrials.gov identifier: NCT04034004.

IntroductionPeople experiencing low back pain (LBP) could potentially benefit from multimedia educational resources that integrate self-management strategies and improve awareness of the benefits of staying active and about medications that offer limited benefits, such as paracetamol. Primary care waiting rooms are potential spaces for presenting health promotion resources to improve health literacy through the dissemination of easily accessible health information. This feasibility study aims to explore the feasibility of conducting a large-scale trial to investigate the benefits of multimedia educational resources delivered at outpatient physiotherapy waiting rooms of public hospitals to support patients to participate in physical activity and reduce paracetamol intake for LBP.Methods and analysisA hybrid type III feasibility study will be conducted at a public hospital in Sydney, Australia, from March to September 2024. The multimedia strategy development (pre-implementation) involves collaborative planning among healthcare professionals, policymakers and community stakeholders in physiotherapy practice. Phase II (implementation) will evaluate the acceptability and implementation processes of delivering the multimedia educational resources in the physiotherapy waiting room following the RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) framework. Findings from the quantitative data will be reported descriptively, and categorical data by counts and percentages. Qualitative (open-ended questions) will be integrated with the feasibility trial outcomes to inform the design of a full-scale randomised controlled trial.Ethics and disseminationThis study has ethical approval from the Sydney Local Health District Human Research Ethics Committee (2023/ETH02683). The findings will be disseminated via peer-reviewed publications, articles in relevant newsletters and presentations at national and international conferences. Social media platforms including X will also be used to generate awareness.

We aimed to investigate whether the addition of non-steroidal anti-inflammatory drugs or spinal manipulative therapy, or both, would result in faster recovery for patients with acute low back pain receiving recommended first-line care. 240 patients with acute low back pain who had seen their general practitioner and had been given advice and paracetamol were randomly allocated to one of four groups in our community-based study: diclofenac 50 mg twice daily and placebo manipulative therapy (n=60); spinal manipulative therapy and placebo drug (n=60); diclofenac 50 mg twice daily and spinal manipulative therapy (n=60); or double placebo (n=60). The primary outcome was days to recovery from pain assessed by survival curves (log-rank test) in an intention-to-treat analysis. This trial was registered with the Australian Clinical Trials Registry, ACTRN012605000036617. Neither diclofenac nor spinal manipulative therapy appreciably reduced the number of days until recovery compared with placebo drug or placebo manipulative therapy (diclofenac hazard ratio 1·09, 95% CI 0·84–1·42, p=0·516; spinal manipulative therapy hazard ratio 1·01, 95% CI 0·77–1·31, p=0·955). 237 patients (99%) either recovered or were censored 12 weeks after randomisation. 22 patients had possible adverse reactions including gastrointestinal disturbances, dizziness, and heart palpitations. Half of these patients were in the active diclofenac group, the other half were taking placebo. One patient taking active diclofenac had a suspected hypersensitivity reaction and ceased treatment. Patients with acute low back pain receiving recommended first-line care do not recover more quickly with the addition of diclofenac or spinal manipulative therapy.

Background Low back pain is a highly prevalent and disabling condition worldwide. Clinical guidelines for the management of patients with acute low back pain recommend first-line treatment consisting of advice, reassurance and simple analgesics. Exercise is also commonly prescribed to these patients. The primary aim of this study was to evaluate the short-term effect of adding the McKenzie method to the first-line care of patients with acute low back pain. Methods A multi-centre randomized controlled trial with a 3-month follow-up was conducted between September 2005 and June 2008. Patients seeking care for acute non-specific low back pain from primary care medical practices were screened. Eligible participants were assigned to receive a treatment programme based on the McKenzie method and first-line care (advice, reassurance and time-contingent acetaminophen) or first-line care alone, for 3 weeks. Primary outcome measures included pain (0-10 Numeric Rating Scale) over the first seven days, pain at 1 week, pain at 3 weeks and global perceived effect (-5 to 5 scale) at 3 weeks. Treatment effects were estimated using linear mixed models. Results One hundred and forty-eight participants were randomized into study groups, of whom 138 (93%) completed the last follow-up. The addition of the McKenzie method to first-line care produced statistically significant but small reductions in pain when compared to first-line care alone: mean of -0.4 points (95% confidence interval, -0.8 to -0.1) at 1 week, -0.7 points (95% confidence interval, -1.2 to -0.1) at 3 weeks, and -0.3 points (95% confidence interval, -0.5 to -0.0) over the first 7 days. Patients receiving the McKenzie method did not show additional effects on global perceived effect, disability, function or on the risk of persistent symptoms. These patients sought less additional health care than those receiving only first-line care ( P = 0.002). Conclusions When added to the currently recommended first-line care of acute low back pain, a treatment programme based on the McKenzie method does not produce appreciable additional short-term improvements in pain, disability, function or global perceived effect. However, the McKenzie method seems to reduce health utilization although it does not reduce patient's risk of developing persistent symptoms. Trial Registration Australian New Zealand Clinical Trials Registry: ACTRN12605000032651

Background Non-specific low back pain is a common and costly global issue. Many people with low back pain live for years with ongoing symptom recurrence and disability, making it crucial to find effective prevention strategies. Motivational interviewing (MI) is an evidence-based patient-centred counselling style that helps motivate individuals to change their behaviours. In combination, MI and cognitive-behavioural therapy (MI-CBT) has the potential to yield long term improvements in pain and disability and reduce incidence of recurrence. Method This is a two-arm superiority randomised controlled trial comparing MI-CBT and Education ( n  = 83) with Education only ( n  = 83). Participants that have recovered from a recent episode of non-specific low back pain (7th consecutive day with pain ≤ 2 on a 0–10 numeric pain rating scale) will be eligible for inclusion into the study. Both groups will receive five 30-min sessions over a 10-week period as well as the Navigating Pain booklet, homework book and a standardised exercise programme. In the intervention group, MI-CBT techniques will be used to provide individualised support, identify beliefs, and increase engagement with the resources provided. Outcomes measures include pain (current and in the last 7 days) as rated on the numeric pain rating scale. This will be used to determine recurrence (number of participants who report back pain ≥ 3 out of 10 on the numeric pain rating scale). Furthermore, self-reported (1) pain intensity; (2) pain catastrophizing; (3) fear-avoidance beliefs; (4) pain self-efficacy; (5) depression and anxiety; (6) disability will be measured. All outcomes will be measured at baseline, and again at 3-, 6-, and 12-months post allocation. Discussion The effective delivery of self-management strategies to prevent recurrence of low back pain is an important aspect that requires urgent attention. This study will provide new information on the effectiveness of using an MI-CBT approach to facilitate self-management through education and exercise to improve low back pain outcomes. Evidence emerging from this trial has the potential to inform clinical practice and healthcare management of non-specific low back pain. Trial registration Prospectively registered with Australian New Zealand Clinical Trials Registry: ACTRN12623000746639 (10/07/2023).

BackgroundOne-size-fits-all interventions reduce chronic low back pain (CLBP) a small amount. An individualised intervention called cognitive functional therapy (CFT) was superior for CLBP compared with manual therapy and exercise in one randomised controlled trial (RCT). However, systematic reviews show group interventions are as effective as one-to-one interventions for musculoskeletal pain. This RCT investigated whether a physiotherapist-delivered individualised intervention (CFT) was more effective than physiotherapist-delivered group-based exercise and education for individuals with CLBP.Methods206 adults with CLBP were randomised to either CFT (n=106) or group-based exercise and education (n=100). The length of the CFT intervention varied according to the clinical progression of participants (mean=5 treatments). The group intervention consisted of up to 6 classes (mean=4 classes) over 6–8 weeks. Primary outcomes were disability and pain intensity in the past week at 6 months and 12months postrandomisation. Analysis was by intention-to-treat using linear mixed models.ResultsCFT reduced disability more than the group intervention at 6 months (mean difference, 8.65; 95% CI 3.66 to 13.64; p=0.001), and at 12 months (mean difference, 7.02; 95% CI 2.24 to 11.80; p=0.004). There were no between-group differences observed in pain intensity at 6 months (mean difference, 0.76; 95% CI -0.02 to 1.54; p=0.056) or 12 months (mean difference, 0.65; 95% CI -0.20 to 1.50; p=0.134).ConclusionCFT reduced disability, but not pain, at 6 and 12 months compared with the group-based exercise and education intervention. Future research should examine whether the greater reduction in disability achieved by CFT renders worthwhile differences for health systems and patients.Trial registration number ClinicalTrials.gov registry (NCT02145728).

Objective: To compare spinal manipulation, back school and individual physiotherapy in the treatment of chronic low back pain. Design: Randomized trial, 12-month follow-up. Setting: Outpatient rehabilitation department. Participants: 210 patients with chronic, non-specific low back pain, 140/210 women, age 59 ± 14 years. Interventions: Back school and individual physiotherapy scheduled 15 1-hour-sessions for 3 weeks. Back school included: group exercise, education/ ergonomics; individual physiotherapy: exercise, passive mobilization and soft-tissue treatment. Spinal manipulation, given according to Manual Medicine, scheduled 4 to 6 20’-sessions once-a-week. Outcome: Roland Morris Disability Questionnaire (scoring 0-24) and Pain Rating Scale (scoring 0-6) were assessed at baseline, discharge 3, 6, and 12 months. Results: 205 patients completed the study. At discharge, disability score decreased by 3.7 ± 4.1 for back school, 4.4 ± 3.7 for individual physiotherapy, 6.7 ± 3.9 for manipulation; pain score reduction was 0.9 ± 1.1, 1.1 ± 1.0, 1.0 ± 1.1, respectively. At 12 months, disability score reduction was 4.2 ± 4.8 for back school, 4.0 ± 5.1 for individual physiotherapy, 5.9 ± 4.6 for manipulation; pain score reduction was 0.7 ± 1.2, 0.4 ± 1.3, and 1.5 ± 1.1, respectively. Spinal manipulation was associated with higher functional improvement and long-term pain relief than back school or individual physiotherapy, but received more further treatment at follow-ups (P<0.001); pain recurrences and drug intake were also reduced compared to back school (P <0.05) or individual physiotherapy (P <0.001). Conclusions: Spinal manipulation provided better short and long-term functional improvement, and more pain relief in the follow-up than either back school or individual physiotherapy.