Cost-effectiveness analysis of acupuncture compared with usual care for acute non-specific low back pain: secondary analysis of a randomised controlled trial.

OBJECTIVE: To assess the cost-effectiveness of a single treatment session of acupuncture, when applied in addition to usual care for acute low back pain (ALBP). METHODS: Secondary analysis of a multicentre randomised controlled trial in Norwegian general practice. In total, 171 participants with ALBP ⩽14 days were randomised to a control group (CG) receiving usual care or to an acupuncture group (AG) receiving one additional session of Western medical acupuncture alongside usual care. Primary outcome measures for this cost-effectiveness analysis were quality-adjusted life years (QALYs), health care costs and societal costs at days 28 and 365, the incremental cost-effectiveness ratio (ICER) and net monetary benefit (NMB). The NMB was calculated on the basis of the Norwegian cost-effectiveness threshold of NOK 275,000 (USD 35,628) per QALY gained. Missing data were replaced by multiple chained imputation. RESULTS: Eighty-six participants in the CG and 81 in the AG were included in the analysis. We found no QALY gain at day 28. At day 365, the incremental QALY of 0.035 was statistically significant. The differences in health care costs and societal costs were not statistically significant. Three out of four calculations led to negative ICERs (cost saving) and positive NMBs. For the health care perspective at day 365, the ICER was USD -568 per QALY and the NMB was USD 1265, with 95.9% probability of acupuncture being cost-effective. CONCLUSION: To our knowledge, this is the first cost-effectiveness analysis of acupuncture for ALBP. The findings indicate that acupuncture may be cost-effective from a 1-year perspective, but more studies are needed. TRIAL REGISTRATION NUMBER: NCT01439412 (ClinicalTrials.gov).

Characteristics of older adults with back pain associated with choice of first primary care provider: a cross-sectional analysis from the BACE-N cohort study.

OBJECTIVES: To describe characteristics of older adults with back pain in primary care, and to assess associations between patient characteristics and type of first primary care provider (general practitioner (GP), physiotherapist (PT) or chiropractor). DESIGN: Cross-sectional analysis from the Back Complaints in the Elders-Norway cohort study. SETTING: Norwegian GP, PT and chiropractic primary care centres. PARTICIPANTS: Patients aged ≥55 years seeking Norwegian primary care with a new episode of back pain were invited to participate. Between April 2015 and February 2020, we included 452 patients: 127 first visited a GP, 130 first visited a PT and 195 first visited a chiropractor. PRIMARY AND SECONDARY OUTCOME MEASURES: For the first objective, the outcome measure was descriptive statistics of patient characteristics, covering the following domains: sociodemographic, general health, current and previous back pain, psychological and clinical factors. For the second objective, first primary care provider was the outcome measure. Associations between patient characteristics and visiting a GP or PT compared with a chiropractor were assessed with multiple multinomial regression analyses. RESULTS: Median (IQR) age was 66 (59-72) years. Levels of back-related disability was moderate to severe, with a median (IQR) Roland-Morris Disability Questionnaire (range 0-24) score of 9 (5-13). Recurring episodes were common, 301 (67%) patients had monthly or yearly recurrences. Patients with worse back-related disability, longer duration of symptoms, lower expectations for full recovery and worse physical performance measured with the Back Performance Scale had higher odds of visiting a GP or PT compared with a chiropractor (p<0.05). CONCLUSION: Older back pain patients in primary care had moderate to severe levels of back-related disability, and most had recurring episodes. Our results suggest that older adult's choice of first primary care provider was associated with important patient characteristics, which highlights the need for caution with generalisations of study results across primary care populations. TRIAL REGISTRATION NUMBER: NCT04261309.

Cross-Cultural Adaptation and Validation of the Nepali Version of the Pelvic Girdle Questionnaire.

OBJECTIVE: The purpose of this study was to translate, cross-culturally adapt, and assess the reliability and validity of the Pelvic Girdle Questionnaire (PGQ) in pregnant Nepalese women. METHODS: The cross-cultural adaptation process was conducted according to the Guillemin guidelines. Reliability and validity were assessed using cross-sectional design. The participants responded to questionnaires of sociodemographics, the Nepali version of the PGQ, the Oswestry Disability Index, the Patient-Specific Functional Scale, the 5-item version of the Edinburgh Depression Scale, and the Numerical Pain Rating Scale. The internal consistency was assessed with Cronbach's alpha. The test-retest reliability was calculated using the intraclass correlation coefficient and smallest detectable change. Construct validity was assessed by testing 9 a priori hypotheses that examine correlations between the PGQ activity and symptom subscales, and also among the PGQ subscales and Oswestry Disability Index, Numerical Pain Rating Scale, Patient-Specific Functional Scale, and 5-item version of the Edinburgh Depression Scale. Spearman and Pearson's correlation were used to assess the correlations. RESULTS: A sample of 111 pregnant women were included in the study. The Cronbach's alpha for the Nepali version of the total PGQ was good (α = 0.83), and the test-retest reliability was acceptable (ICC2.1, 0.72) with a measurement error of SDC95% 18.6 points. Seven of the 9 hypotheses found support, which confirms acceptable construct validity of the Nepali PGQ. CONCLUSION: The Nepali version of the PGQ is a reliable and valid tool for assessing pelvic girdle pain in pregnant Nepalese women.

Acupuncture for acute non-specific low back pain: a randomised, controlled, multicentre intervention study in general practice-the Acuback study.

OBJECTIVES: The aim of this study was to evaluate whether a single treatment session of acupuncture, when applied in addition to standard treatment for acute low back pain (ALBP), reduces the time to recovery compared with standard treatment alone. DESIGN: A multicentre, randomised, controlled trial. SETTING: Conducted at 11 Norwegian general practitioners' (GPs') offices. PARTICIPANTS: 171 adults aged 20-55 years seeking their GP for ALBP (≤14 days) between March 2014 and March 2017. Patients with secondary back pain and previous sick leave and acupuncture treatment was excluded. INTERVENTIONS: The participants were randomised to either the control group (CG) or the acupuncture group (AG) by online software. The CG received standard treatment according to the Norwegian guidelines, while the AG received one session of Western medical acupuncture treatment in addition to standard treatment. The statistician was blinded to group status. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was median days to recovery. Secondary outcomes were pain intensity, global improvement, back-specific functional status, sick leave, medication and adverse effects. RESULTS: 185 participants were randomised, 95 in the CG and 90 in the AG. 14 participants did not receive the allocated intervention and 4 were excluded from the analysis. Thus, 167 participants were included in the analysis, 86 in the CG and 81 in the AG. The groups were similar according to baseline characteristics. The median time to recovery was 14 days for the CG and 9 days for the AG, HR 1.37 (95% CI 0.95 to 1.96), (p=0.089). No serious adverse effects were reported. CONCLUSIONS: We did not find any statistically significant reduction in time-to-recovery after a single session of acupuncture for ALBP compared with standard care. TRIAL REGISTRATION NUMBER: NCT01439412.

Antibiotic treatment In patients with chronic low back pain and Modic changes (the AIM study): study protocol for a randomised controlled trial.

BACKGROUND: A previous randomised controlled trial (RCT) of patients with chronic low back pain (LBP) and vertebral bone marrow (Modic) changes (MCs) on magnetic resonance imaging (MRI), reported that a 3-month, high-dose course of antibiotics had a better effect than placebo at 12 months' follow-up. The present study examines the effects of antibiotic treatment in chronic LBP patients with MCs at the level of a lumbar disc herniation, similar to the previous study. It also aims to assess the cost-effectiveness of the treatment, refine the MRI assessment of MCs, and further evaluate the impact of the treatment and the pathogenesis of MCs by studying genetic variability and the gene and protein expression of inflammatory biomarkers. METHODS/DESIGN: A double-blinded RCT is conducted at six hospitals in Norway, comparing orally administered amoxicillin 750 mg, or placebo three times a day, over a period of 100 days in patients with chronic LBP and type I or II MCs at the level of a MRI-confirmed lumbar disc herniation within the preceding 2 years. The inclusion will be stopped when at least 80 patients are included in each of the two MC type groups. In each MC type group, the study is designed to detect (ß = 0.1, α = 0.05) a mean difference of 4 (standard deviation 5) in the Roland Morris Disability Questionnaire score between the two treatment groups (amoxicillin or placebo) at 1-year follow-up. The study includes cost-effectiveness measures. Blood samples are assessed for security measures and for possible inflammatory mediators and biomarkers at different time points. MCs are evaluated on MRI at baseline and after 12 months. A blinded intention-to-treat analysis of treatment effects will be performed in the total sample and in each MC type group. DISCUSSION: To ensure the appropriate use of antibiotic treatment, its effect in chronic LBP patients with MCs should be re-assessed. This study will investigate the effects and cost-effectiveness of amoxicillin in patients with chronic LBP and MCs at the level of a disc herniation. The study may also help to refine imaging and characterise the biomarkers of MCs. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02323412 . Registered on 21 November 2014.

Effectiveness of an Integrated Multidisciplinary Osteoarthritis Outpatient Program versus Outpatient Clinic as Usual: A Randomized Controlled Trial.

OBJECTIVE: Osteoarthritis (OA) is one of the leading causes of pain and disability. Given the constraint in the provision of care, there is a need to develop and assess effectiveness of new treatment models. The objective was to compare satisfaction with and effectiveness of a new integrated multidisciplinary outpatient program with usual care in an outpatient clinic for patients with OA. METHODS: Patients with clinical OA referred to a rheumatology outpatient clinic were randomized to a 3.5-h multidisciplinary group-based educational program followed by individual consultations, or to usual care. The primary outcome was satisfaction with the health service evaluated on a numerical rating scale (0 = extremely unsatisfied, 10 = extremely satisfied) after 4 months. Secondary outcomes included health-related quality of life measures. RESULTS: Of 391 patients, 86.4% (n = 338) were women, and mean age was 61.2 (SD 8.0) years. At 4 months, patients who received integrated multidisciplinary care were significantly more satisfied with the health service compared with controls, with a mean difference of -1.05 (95% CI -1.68 to -0.43, p < 0.001). Among secondary outcomes, only self-efficacy with other symptoms scale (10-100) improved significantly in the multidisciplinary group compared with controls at 4 months (3.59, 95% CI 0.69-6.5, p = 0.02). At 12 months, the Australian/Canadian Hand Osteoarthritis Index pain (0-10) and fatigue scores (0-10) were slightly worse in the multidisciplinary group with differences of 0.38 (95% CI 0.06-0.71, p = 0.02) and 0.55 (95% CI 0.02-1.07, p = 0.04), respectively. CONCLUSION: Patients receiving an integrated multidisciplinary care model were more satisfied with healthcare than those receiving usual care, whereas there were no clinically relevant improvements in health outcomes.

Acupuncture for acute non-specific low back pain: a protocol for a randomised, controlled multicentre intervention study in general practice--the Acuback Study.

INTRODUCTION: Some general practitioners (GPs) treat acute low back pain (LBP) with acupuncture, despite lacking evidence of its effectiveness for this condition. The aim of this study was to evaluate whether a single treatment session with acupuncture can reduce time to recovery when applied in addition to standard LBP treatment according to the Norwegian national guidelines. Analyses of prognostic factors for recovery and cost-effectiveness will also be carried out. METHODS AND ANALYSIS: In this randomised, controlled multicentre study in general practice in Southern Norway, 270 patients will be allocated into one of two treatment groups, using a web-based application based on block randomisation. Outcome assessor will be blinded for group allocation of the patients. The control group will receive standard treatment, while the intervention group will receive standard treatment plus acupuncture treatment. There will be different GPs treating the two groups, and both groups will just have one consultation. Adults who consult their GP because of acute LBP will be included. Patients with nerve root affection, 'red flags', pregnancy, previous sick leave more than 14 days and disability pension will be excluded. The primary outcome of the study is the median time to recovery (in days). The secondary outcomes are rated global improvement, back-specific functional status, sick leave, medication, GP visits and side effects. A pilot study will be conducted. ETHICS AND DISSEMINATION: Participation is based on informed written consent. The authors will apply for an ethical approval from the Regional Committee for Medical and Health Research Ethics when the study protocol is published. Results from this study, positive or negative, will be disseminated in scientific medical journals. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT01439412.

Traditional Chinese acupuncture was not superior to sham acupuncture for knee osteoarthritis but delivering treatment with high expectations of improvement was superior to delivering treatment with neutral expectations.

QUESTION: What are the comparative effects of Traditional Chinese Acupuncture (TCA) and sham acupuncture for patients with knee osteoarthritis (OA) when controlling for the effect of the acupuncturists' communication styles. DESIGN: A nested 2-stage randomised clinical trial, where patients were randomised to 1 of 3 style groups, waiting list, high expectations, or neutral expectations, and nested within style, TCA, or sham acupuncture. SETTING: A hospital general internal medicine department in Texas, USA. PARTICIPANTS: Men and women over 49 years with knee OA according to the American College of Rheumatology criteria. Additional inclusion criteria were pain in the knee in the preceding 2 weeks, > 3/10 on a visual analogue scale, no prior treatment with acupuncture, stable treatment with nonsteroidal anti-inflammatory drugs, analgesics, or glucosamine. Exclusion criterion was intraarticular injections in the knee in the previous 2 months. Randomisation of 560 participants allocated 238 to the high expectations group, 242 to the neutral expectations group, and 80 to the waiting list group. INTERVENTIONS: Six acupuncturists licensed in traditional Chinese medicine carried out the intervention. For the communication style intervention, providers conveyed high expectations of improvement, by using positive utterances such as 'I think this will work for you', while neutral expectations were conveyed with uncertainty utterances such as 'It may or may not work for you'. For the acupuncture intervention the procedure and specific points were standardised by a panel consisting of the acupuncturists in each of the 2 arms: TCA points on the basis of clinical practice, and sham points outside the relevant meridians. OUTCOME MEASURES: The primary outcomes were Joint-Specific Multidimensional Assessment of Pain (J-MAP), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, and Satisfaction with Knee Procedure (SKIP) measured at 4 weeks, 6 weeks (end of treatment), and 3 months. RESULTS: 527 (94%) participants completed the study. There were no significant differences between the TCA and sham groups in any of the outcome measures. Patients in the high expectations communication style group had statistically significant improvements in pain (J-MAP) and satisfaction (SKIP) compared with the neutral group. Mean differences (95% CI) at 3 months follow up were 0.4 (0.1 to 0.7) for J-MAP (1 to 7 scale), and 0.2 (0.03 to 0.3) for SKIP (1 to 5 scale). CONCLUSION: In patients with knee OA, needling of meridian points was not more effective than the use of sham points, whereas acupuncturists' communication styles had a small but statistically significant effect on pain reduction and satisfaction.

What's in team rehabilitation care after arthroplasty for osteoarthritis? Results from a multicenter, longitudinal study assessing structure, process, and outcome.

BACKGROUND: Clinical course and outcome connected to rehabilitation after hip or knee arthroplasty have been studied extensively, but few studies have assessed the content of team rehabilitation care for these patients. OBJECTIVE: The purpose of this study was to provide a thorough description of the structure, process, and outcome of team rehabilitation care for patients with hip or knee arthroplasty for osteoarthritis. DESIGN: This was a multicenter, longitudinal observational study. METHODS: Patients (N=183) from 6 rehabilitation centers in Norway who were undergoing inpatient rehabilitation following hip or knee arthroplasty were included in the study. Structure and process components were recorded by participants and health care professionals in a patient diary. Participants also completed questionnaires regarding their experiences during their rehabilitation stay and recorded data for outcome measures at admission, at discharge, and 6 months after discharge. The main outcome measures were pain intensity and physical function, as assessed with the physical function scale of the Medical OUTCOMES: Study 36-Item Short-Form Health Survey (SF-36). RESULTS: Data were complete for 172 participants (94%) at discharge and for 148 patients (81%) at the 6-month follow-up. Health care professionals, physical therapists, nurses, and physicians were most often involved in team care. Occupational therapists, social workers, and psychologists were seldom part of the rehabilitation team. Exercises provided by physical therapists were the most common treatment modality. Patient education, massage, and manual therapy also frequently were provided. The participants were very satisfied with their care and its organization, information, and communication and with the availability of health care professionals. They were moderately satisfied with the social environment of the rehabilitation setting. The participants had large improvements in the outcome measures during the rehabilitation stay and at the 6-month follow-up. LIMITATIONS: For typical physical therapy modalities such as exercises, electrotherapy, and acupuncture, there are limited descriptions and assessments of treatment doses. CONCLUSIONS: Current team rehabilitation care involves a traditional team with physical therapists, nurses, and physicians. Several types of treatment modalities are used, with greatest emphasis on physical training. This detailed description of current team rehabilitation practice might help clinicians and researchers in planning clinical trials within a rehabilitation setting, as well as in improving rehabilitation practice.