Persistent Non-specific Low Back Pain Research Articles

Care trajectories for musculoskeletal disorders following a new episode of low back pain

Abstract This study explored diverse care trajectories (CTs) for low back pain (LBP) and other musculoskeletal disorders (MSDs), over a 5-year period following a first episode of LBP. Based on Quebec's administrative health data from 2007 to 2011, this longitudinal cohort study involved 12,608 adults seeking health care for LBP. Using a new multidimensional state sequence analysis, we identified 6 distinct types of CTs. The most prevalent types 1, 2, and 3 (comprising 79.2%, 18.0%, and 21.7% of the cohort, respectively) exhibit rapid recovery and similar patterns of healthcare use over 5 years but differing in initial diagnoses: nonspecific LBP in type 1, trauma-related LBP in type 2 (mostly younger men and highest initial emergency consultation), and specific LBP in type 3. Types 4 to 6, representing smaller groups, show high healthcare utilization with comparable mixed LBP diagnoses at entry but distinctive subsequent care use patterns. Patients in types 4 and 6 (mainly older age groups and women) sought care for other MSDs from general practitioners or specialists, while middle-aged patients in type 5 experienced persistent nonspecific LBP with frequent general practitioner consultations over 5 years. The CTs typology revealed several key areas for improvement in nonpharmacological interventions, including the need to address possible inappropriate medical imaging and invasive interventions for older women with MSDs and the lack of ambulatory care access for younger patients with trauma-related LBP. Finally, results clearly highlighted poor access to rehabilitation physicians and rehabilitation services for all patients suffering from LBP and MSDs.

Effects of Pain Neuroscience Education and Physiotherapy on Chronic Low Back Pain, Fear of Movement and Functional Status: A Randomised Pilot Study.

Background: Chronic non-specific low back pain is a non-harmous condition often found in the general population. It is one of the most significant disabilities and needs different treatment modalities. This study investigates the effects of pain neuroscience education and physiotherapy on pain intensity, fear of movement and functional status in a Lithuanian cohort with non-specific low back pain. Methods: The study was performed at the primary health care unit in Kaunas, Lithuania. The key inclusion criterion was persistent non-specific low back pain longer than three months and which affects daily life functions. Thirty participants (mean 33.47, SD 4.38 years age, 70% women) were randomised into two training groups with and without pain neuroscience education (for a total of 60 min of teaching). Physiotherapy was performed twice per week during 45 min/session for a period of 10 weeks with exercises which strengthen, stabilize, and stretch the spinal cord muscles. Outcomes included pain intensity, kinesiophobia and disability and these were measured by self-scored questionnaires (numeric rating scale, Tampa scale for kinesiophobia-11, Oswestry disability index and the Roland-Morris questionnaire, respectively). Results: The results indicate that both groups improved in the measured outcomes, with the only difference between them being a better improvement in kinesiophobia in the group receiving physiotherapy and pain neuroscience education. Conclusions: The results of this study confirm that a relatively short intervention of pain neuroscience education enhances the effects of physiotherapy and should be implemented in clinical practice.

Assessment of Spinal and Pelvic Kinematics Using Inertial Measurement Units in Clinical Subgroups of Persistent Non-Specific Low Back Pain.

Inertial measurement units (IMUs) offer a portable and quantitative solution for clinical movement analysis. However, their application in non-specific low back pain (NSLBP) remains underexplored. This study compared the spine and pelvis kinematics obtained from IMUs between individuals with and without NSLBP and across clinical subgroups of NSLBP. A total of 81 participants with NSLBP with flexion (FP; n = 38) and extension (EP; n = 43) motor control impairment and 26 controls (No-NSLBP) completed 10 repetitions of spine movements (flexion, extension, lateral flexion). IMUs were placed on the sacrum, fourth and second lumbar vertebrae, and seventh cervical vertebra to measure inclination at the pelvis, lower (LLx) and upper (ULx) lumbar spine, and lower cervical spine (LCx), respectively. At each location, the range of movement (ROM) was quantified as the range of IMU orientation in the primary plane of movement. The ROM was compared between NSLBP and No-NSLBP using unpaired t-tests and across FP-NSLBP, EP-NSLBP, and No-NSLBP subgroups using one-way ANOVA. Individuals with NSLBP exhibited a smaller ROM at the ULx (p = 0.005), LLx (p = 0.003) and LCx (p = 0.01) during forward flexion, smaller ROM at the LLx during extension (p = 0.03), and a smaller ROM at the pelvis during lateral flexion (p = 0.003). Those in the EP-NSLBP group had smaller ROM than those in the No-NSLBP group at LLx during forward flexion (Bonferroni-corrected p = 0.005), extension (p = 0.013), and lateral flexion (p = 0.038), and a smaller ROM at the pelvis during lateral flexion (p = 0.005). Those in the FP-NSLBP subgroup had smaller ROM than those in the No-NSLBP group at the ULx during forward flexion (p = 0.024). IMUs detected variations in kinematics at the trunk, lumbar spine, and pelvis among individuals with and without NSLBP and across clinical NSLBP subgroups during flexion, extension, and lateral flexion. These findings consistently point to reduced ROM in NSLBP. The identified subgroup differences highlight the potential of IMU for assessing spinal and pelvic kinematics in these clinically verified subgroups of NSLBP.

Understanding how therapeutic exercise prescription changes outcomes important to patients with persistent non-specific low back pain: a realist review protocol

IntroductionPersistent low back pain (LBP) is the leading cause of disability worldwide, and therapeutic exercise is recommended as a first-line treatment in international guidelines. The effects of exercise on clinical outcomes of pain and physical function are small to moderate, despite broader impacts on cardiovascular systems, biological health, mood, and emotional well-being. Therapeutic exercise prescription is defined as exercise that is prescribed by a clinician for a health-related treatment. It is unknown how therapeutic exercise prescription creates effects on outcomes of importance. Realist reviews explore how underlying mechanisms (M) may be active in the context (C) of certain situations, settings, or populations to create an intended or unintended outcome (O). Our objective is to explore and understand the mechanisms by which therapeutic exercise prescription changes outcomes for people with persistent LBP.MethodsWe will develop initial programme theories based on preliminary data from a previous systematic review and consensus workshop. These theories will be modified with input from a steering group (experts), a stakeholder group (people with lived experience of exercise for persistent LBP and clinicians), and a scoping search of the published literature. An information specialist will design and undertake an iterative search strategy. These will be used to create CMO configurations, which will be refined and tested using the literature. The realist review will be reported following RAMESES guidance.DiscussionRealist reviews are uncommon in LBP research to date, yet those offer an opportunity to contrast with traditional methods of randomised controlled trials and systematic reviews and provide additional information regarding the contexts and mechanisms that may trigger certain outcomes. This can aid our understanding of the contextual features that may influence exercise prescription, such as for whom they are most effective, in what setting, how they are implemented and why. This realist synthesis will enhance our understanding of therapeutic exercise prescription to improve adherence and engagement and ultimately will provide clinically relevant recommendations regarding exercise prescription for those with persistent LBP.Systematic review registrationThe review has been registered with PROSPERO (CRD42017072023).

The clinical course of acute, subacute and persistent low back pain: a systematic review and meta-analysis.

Understanding the clinical course of low back pain is essential to informing treatment recommendations and patient stratification. Our aim was to update our previous systematic review and meta-analysis to gain a better understanding of the clinical course of acute, subacute and persistent low back pain. To update our 2012 systematic review and meta-analysis, we searched the Embase, MEDLINE and CINAHL databases from 2011 until January 2023, using our previous search strategy. We included prospective inception cohort studies if they reported on participants with acute (< 6 wk), subacute (6 to less than 12 wk) or persistent (12 to less than 52 wk) nonspecific low back pain at study entry. Primary outcome measures included pain and disability (0-100 scale). We assessed risk of bias of included studies using a modified tool and assessed the level of confidence in pooled estimates using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) tool. We used a mixed model design to calculate pooled estimates (mean, 95% confidence interval [CI]) of pain and disability at 0, 6, 12, 26 and 52 weeks. We treated time in 2 ways: time since study entry (inception time uncorrected) and time since pain onset (inception time corrected). We transformed the latter by adding the mean inception time to the time of study entry. We included 95 studies, with 60 separate cohorts in the systematic review (n = 17 974) and 47 cohorts (n = 9224) in the meta-analysis. Risk of bias of included studies was variable, with poor study attrition and follow-up, and most studies did not select participants as consecutive cases. For the acute pain cohort, the estimated mean pain score with inception time uncorrected was 56 (95% CI 49-62) at baseline, 26 (95% CI 21-31) at 6 weeks, 22 (95% CI 18-26) at 26 weeks and 21 (95% CI 17-25) at 52 weeks (moderate-certainty evidence). For the subacute pain cohort, the mean pain score was 63 (95% CI 55-71) at baseline, 29 (95% CI 22-37) at 6 weeks, 29 (95% CI 22-36) at 26 weeks and 31 (95% 23-39) at 52 weeks (moderate-certainty evidence). For the persistent pain cohort, the mean pain score was 56 (95% CI 37-74) at baseline, 48 (95% CI 32-64) at 6 weeks, 43 (95% CI 29-57) at 26 weeks and 40 (95% CI 27-54) at 52 weeks (very low-certainty evidence). The clinical course of disability was slightly more favourable than the clinical course of pain. Participants with acute and subacute low back pain had substantial improvements in levels of pain and disability within the first 6 weeks ( moderate-certainty evidence); however, participants with persistent low back pain had high levels of pain and disability with minimal improvements over time (very low-certainty evidence). Identifying and escalating care in individuals with subacute low back pain who are recovering slowly could be a focus of intervention to reduce the likelihood of transition into persistent low back pain. PROSPERO - CRD42020207442.

Similar improvements in patient-reported outcomes for non-specific low back pain patients with and without lumbar spinal stenosis symptoms following a structured education and exercise therapy program

BackgroundPeople with nonspecific low back pain (NSLBP) can also experience overlapping symptoms of lumbar spinal stenosis (LSS), but the impact on treatment outcomes is unknown. This study investigated differences in treatment outcomes for disability, back pain intensity, and leg pain intensity following an education and exercise therapy program for NSLBP patients with and without comorbid LSS symptoms.MethodsThis was a longitudinal analysis of 655 Danish participants in the GLA:D® Back program; an education and exercise therapy program for people with persistent NSLBP. Participants were classified as having comorbid LSS symptoms based on self-report. Linear mixed models were used to assess differences in change in disability (Oswestry Disability Index [0-100]) and back and leg pain intensity (Numeric Rating Scale [0–10]) at 3-, 6-, and 12-months between those with and without LSS symptoms.Results28% of participants reported LSS symptoms. No certain differences in change in disability or back pain intensity improvement were observed at any time-point between those with and without LSS symptoms. Participants with LSS symptoms had slightly greater improvement in leg pain intensity at 6- (-0.7, 95% CI -1.2 to -0.2) and 12-months (-0.6, 95% CI -1.2 to -0.1).ConclusionCompared to those without LSS symptoms, patients with persistent NSLBP and LSS symptoms can expect similar improvements in disability and back pain intensity, and slightly greater improvements in leg pain intensity with treatment. Therefore, education and exercise therapy programs designed for NSLBP are likely helpful for those also experiencing LSS symptoms.

Lumbopelvic stabilization versus Pilates exercises on spatiotemporal gait parameters in chronic nonspecific low back pain

Aim of the work: The purpose of the current study is to trace and investigate how lumbopelvic stabilization and Pilates exercises affect the spatiotemporal aspects of gait in persistent nonspecific low back pain cases (NS-CLBP). Methods: Patients with NS-CLBP (N=90) were randomly assigned to one of three groups: group A (stabilization + traditional therapy), group B (Pilates plus traditional therapy), and group C (conventional therapy) in a single-blinded randomized clinical trial with 12 treatments over six weeks. A Walkway pressure measurement system was used to determine both spatial and temporal parameters. The Visual Analog Scale, Modified Oswestry Disability Questionnaire, Biering–Sorensen test, and trunk flexion endurance test were adopted successfully to assess pain, function, and isometric endurance of trunk extensor and flexor. Results: According to a cross-group analysis, a statistically significant effect was found when p = 0.001 and f-value = 3.12. Also, a statistically clear interaction was figured out between treatment and time when p = 0.0001 and f-value = 3.44. Following therapy, the Pilates group showed a decrease in temporal parameters, pain, and functional impairment, as well as an increase in cadence and velocity (p 0.05).

Effect of Dry Cupping Therapy on Pain and Functional Disability in Persistent Non-Specific Low Back Pain: A Randomized Controlled Clinical Trial.

Cupping therapy is used to treat musculoskeletal conditions, including low back pain. The study assessed the effects of dry cupping on pain and functional disability from persistent nonspecific low back pain. This was a randomized controlled trial, where participants were allocated to a cupping therapy (n = 19) or sham (n = 18) group, for five 10-minute sessions of cupping therapy, twice a week, to stimulate the acupoints related to low back pain (GV4, BL23, BL24, BL25, and BL30, BL40 and BL58) and emotional aspects (HT3 and ST36). All participants were assessed at baseline, post-treatment and follow up (a finalization period of four weeks) using a visual analogue scale (VAS) and the Oswestry Disability Index (ODI). Groups were compared using the analysis of covariance (ANCOVA) and the effect size was calculated using Cohen̓s d. The cupping therapy group presented a lower mean VAS when compared to the sham, at post-treatment (mean difference: -2.36; standard error [SE]: 0.58; p < 0.001; "large" effect size: -0.94) and follow up (mean difference: -1.71; SE: 0.81; p < 0.042; 'large' effect size: -0.83). The cupping therapy group presented a lower mean ODI when compared to the sham post-treatment (mean difference: -4.68; SE: 1.85; p: 0.017; 'large' effect size: -0.87), although in follow-up, there was no difference between the groups (mean difference: 4.16; SE: 2.97; p: 0.17; "medium" effect size: -0.70). Dry cupping was more effective in improving pain and functional disability in people with persistent nonspecific low back pain when compared to the sham.

Specifying the treatment targets of exercise interventions: Do we?

Purpose: Exercise is the most widely recommended intervention for persistent non-specific low back pain (NSLBP). Despite efforts to improve the reporting of exercise interventions, the treatment targets of exercise interventions remain poorly described. The aim of this study was to assess whether trial authors identified treatment target(s) for the exercise intervention included in their randomised controlled trial (RCT) in an ongoing update of a Cochrane review of exercise interventions for persistent NSLBP.

A cross-sectional analysis of persistent low back pain, using correlations between lumbar stiffness, pressure pain threshold, and heat pain threshold

IntroductionLittle is known about the underlying biomechanical cause of low back pain (LBP). Recently, technological advances have made it possible to quantify biomechanical and neurophysiological measurements, potentially relevant factors in understanding LBP etiology. However, few studies have explored the relation between these factors. This study aims to quantify the correlation between biomechanical and neurophysiological outcomes in non-specific LBP and examine whether these correlations differ when considered regionally vs. segmentally.MethodsThis is a secondary cross-sectional analysis of 132 participants with persistent non-specific LBP. Biomechanical data included spinal stiffness (global stiffness) measured by a rolling indenter. Neurophysiological data included pain sensitivity (pressure pain threshold and heat pain threshold) measured by a pressure algometer and a thermode. Correlations were tested using Pearson’s product-moment correlation or Spearman’s rank correlation as appropriate. The association between these outcomes and the segmental level was tested using ANOVA with post-hoc Tukey corrected comparisons.ResultsA moderate positive correlation was found between spinal stiffness and pressure pain threshold, i.e., high degrees of stiffness were associated with high pressure pain thresholds. The correlation between spinal stiffness and heat pain threshold was poor and not statistically significant. Aside from a statistically significant minor association between the lower and the upper lumbar segments and stiffness, no other segmental relation was shown.ConclusionsThe moderate correlation between spinal stiffness and mechanical pain sensitivity was the opposite of expected, meaning higher degrees of stiffness was associated with higher pressure pain thresholds. No clinically relevant segmental association existed.

A service evaluation specifying the active components of a functional restorative programme to promote management of persistent non-specific low back pain

BackgroundFunctional Restorative Programmes (FRP) for persistent non-specific lower back pain have been shown to be effective, but they often lack sufficient detailed reporting of the intervention components to allow for accurate replication. ObjectivesThis study used the Behaviour Change Technique Taxonomy (v1) (BCTi) [1] to identify the main components of one such programme and interviewed patients to identify the most effective programme components and areas for improvement. DesignA mixed methods design was used. MethodsIntervention data were coded using the BCT Taxonomy (v1) to identify the BCTs utilised. Following this, semi-structured interviews with nine patients evaluated the BCTs included using thematic analysis and identified possible techniques for inclusion in future developments of the programme. ResultsForty-one different BCTs were identified in the coding phase with frequency of occurrence in the programme ranging from forty-nine to one. Four main themes emerged from the interviews: Social Support, Shaping Knowledge, Repetition and Substitution and Changes in Mindset. ConclusionThe results of this study identify the key ingredients in a programme for persistent, non-specific lower back pain, which facilitates the replication of this intervention and identified areas patients appreciated most as well as areas for improvement.

Treatment targets of exercise for persistent non-specific low back pain: a consensus study

ObjectivesDespite several hundred previous randomised controlled trials (RCTs), the key treatment targets of exercise for persistent non-specific low back pain (NSLBP) remain unclear. This study aimed to generate consensus about the key treatment targets of exercise interventions for patients with NSLBP. DesignConsensus was generated using modified nominal group technique in two, sequential, workshops. The results of a previous systematic review informed the first, national, workshop idea generation and the results of this workshop informed the second, international, workshop. The authors generated a starting list of 30 treatment targets from the systematic review. A pre-specified consensus threshold of 75% was used in the voting stage. ParticipantsWorkshop participants included people with experience of using exercise to manage their persistent NSLBP, clinicians who prescribe exercise for persistent NSLBP, and researchers who design and evaluate exercise interventions in RCTs. All participants generated, voted and ranked the treatment targets in each workshop using an online platform. ResultsA total of 39 participants contributed to the consensus (15 in the national workshop and 24 in the international workshop), comprising two people with NSLBP, six clinicians and 31 researchers/clinicians. A total of 40 exercise treatment targets were generated, and 25 were retained after voting and ranking. The prioritised targets of exercise for persistent NSLBP were: improving function, improving quality of life, reducing pain, meeting patient-specific goals and reducing fear of movement. ConclusionsFuture RCTs of exercise should specify the targets of their exercise intervention and consider assessing these treatment targets as well as including mediation analyses.

Description of content, structure and theoretical model of a group-based pain management programme in the treatment of patients with persistent non-specific low back pain and psychological risk factors in a secondary sector setting

Objective: To present the theoretical foundation and methodological considerations for a group-based pain management programme for patients with persistent non-specific low back pain and psychosocial risk factors. Method: The Template for Intervention Description and Replication (TIDieR) checklist was used as a framework for describing the content, structure and context of the program. The theoretical rationale underlying the pain management programme was described using the first three steps of the Intervention Mapping framework. The Fear-avoidance model and the Self-efficacy Theory were identified as the two main theories. These were used to establish specific factors addressed by the pain management programme as well as expected outcomes. Intervention description: A multidisciplinary, group-based programme using a cognitive-behavioural approach was developed. The programme consisting of six sessions of two hours duration, took place at a spine clinic at a regional hospital in Denmark. Psychoeducation and cognitive restructuring were specific strategies hypothesised to induce changes in outcome measures. The outcomes expected to change as a result of the intervention were disability, quality of life, sick leave and physical activity. A pilot study was performed, subsequent adjustments made and the final content and educational materials completed by January 2017. Conclusion: The theoretical foundation and underlying evidence for the hypothesised change mechanisms in the use of a cognitive-behavioural approach was presented. A theoretically sound and practically feasible intervention has been developed and its effectiveness is being determined in a randomised controlled trial, including 130 low back pain patients, which is currently underway.

Self-reports vs. physical measures of spinal stiffness.

BackgroundObjectively measured reduction in lumbar posterior-to-anterior (PA) stiffness is associated with pain relief in some, but not all persons with low back pain. Unfortunately, these measurements can be time consuming to perform. In comparison, the Lumbar Spine Instability Questionnaire (LSIQ) is intended to measure spinal instability and the Lumbar Spine Disability Index (LSDI) is created for self-reporting functional disability due to increased spinal stiffness. Given the above, the aim of this study is to compare measures of the LSIQ and LSDI with objective measures of lumbar PA stiffness as measured by a mechanical device, Vertetrack (VT), in patients with persistent non-specific low back pain (nsLBP).MethodsTwenty-nine patients with nsLBP completed the LSIQ and LSDI at baseline and after two weeks. On these same occasions, PA spinal stiffness was measured using the VT. Between measurements, patients received four sessions of spinal manipulation. The resulting data was analyzed to determine the correlation between the self-report and objective measures of stiffness at both time points. Further, the patients were categorized into responders and non-responders based on pre-established cut points depending on values from the VT and compared those to self-report measures in order to determine whether the LSIQ and the LSDI were sensitive to change.ResultsTwenty-nine participants completed the study. Measures from the LSIQ and LSDI correlated poorly with objectively measured lumbar PA stiffness at baseline and also with the change scores. The change in objectively measured lumbar PA stiffness following spinal manipulation did not differ between those who improved, and those who did not improve according to the pre-specified cut-points. Finally, a reduction in lumbar PA stiffness following intervention was not associated with improvement in LSIQ and LSDI outcomes.ConclusionsThe current data indicate that the LSIQ and LSDI questionnaires do not correlate with measures obtained objectively by VT. Our results suggest that these objective and self- reported measures represent different domains and as such, cannot stand in place of one another.

Specifying the treatment targets of exercise interventions: do we?

Persistent non-specific low back pain (NSLBP) is the leading cause of disability worldwide.1 Although exercise is the most recommended intervention for NSLBP,2 the effects are small to moderate.3 Researchers who...

Periodized resistance training for persistent non-specific low back pain: a mixed methods feasibility study

BackgroundWe investigated the feasibility of a 16-week supervised heavy resistance training program with weekly undulating periodization for individuals with persistent non-specific low-back pain (LBP).MethodsTwenty-five adults with persistent non-specific LBP participated in this mixed methods feasibility study. Participants trained a whole-body program consisting of squat, bench press, deadlift and pendlay row two times per week for 16 weeks. We assessed pain intensity, pain-related disability, pain self-efficacy and one-repetition maximum strength at baseline, 8 weeks and 16 weeks. Three focus group interviews were conducted at the end of the program. Linear mixed models were used to assess changes in outcomes, and the qualitative data was assessed using systematic text condensation.ResultsWe observed clinically meaningful reductions in pain intensity after 8 and 16 weeks of training. The mean difference on the numeric pain rating scale (0–10) in the last 2 weeks from baseline to 8 weeks was 2.6 (95% CI: 1.8–3.6) and from baseline to 16 weeks 3.4 (95% CI: 2.5–4.4). In addition, there were improvements in pain-related disability (3.9, 95% CI: 2.3–5.5), pain self-efficacy (7.7, 95% CI: 5.4–10.1) and muscle strength. In the focus group interviews, participants talked about challenges regarding technique, the importance of supervision and the advantages of periodizing the training. Perceived benefits were improved pain, daily functioning, energy level and sleep, and changes in views on physical activity.ConclusionPeriodized resistance training with weekly undulating periodization is a feasible training method for this group of individuals with persistent non-specific LBP. A randomized clinical trial should assess the efficacy of such an intervention.Trial registrationclinicaltrials.gov/ Identifier – NCT04284982, Registered on February 24th 2020.

Achieving consensus on the treatment targets of exercise in persistent non-specific low back pain: a modified nominal group workshop process

Background and Aim of Study Despite several hundred RCTs of exercise for persistent non-specific low back pain (NSLBP), the treatment targets of exercise are unclear. In a systematic review we obse...

Periodized Resistance Training for Persistent Non-specific Low Back Pain

Periodized Resistance Training for Persistent Non-specific Low Back Pain

Wet-Cupping Is Effective on Persistent Nonspecific Low Back Pain: A Randomized Clinical Trial.

To compare the possible effects of wet-cupping therapy with conventional therapy on persistent nonspecific low back pain (PNSLBP). In this randomized clinical trial, 180 participants with the mean age of 45±10 years old, who had been suffering from PNSLBP were randomly assigned to wet-cupping and conventional groups. The wet-cupping group was treated with two separate sessions (4 weeks in total) on the inter-scapular and sacrum area. In the conventional group, patients were conservatively treated using rest (6 weeks) and oral medications (3 weeks). The primary and the secondary outcome were the quantity of disability using Oswestry Disability Index (ODI), and pain intensity using Visual Analogue Scale (VAS), respectively. There was no significant difference in demographic characteristics (age, gender, and body mass index) between the two groups (P>0.05). Therapeutic effect of wet-cupping therapy was comparable to conventional treatment in the 1st month follow-up visits (P<0.05). The functional outcomes of wet-cupping at the 3rd and 6th month visits were significantly increased compared to the conventional group. Final ODI scores in the wet-cupping and conventional groups were 16.7 ± 5.7 and 22.3 ± 4.5, respectively (P<0.01). Wet-cupping may be a proper method to decrease PNSLBP without any conventional treatment. The therapeutic effects of wet-cupping can be longer lasting than conventional therapy. (Registration No. IRCT2013021672741)).

Facet joint injections for people with persistent non-specific low back pain (Facet Injection Study): a feasibility study for a randomised controlled trial.

The National Institute for Health and Care Excellence (NICE) 2009 guidelines for persistent low back pain (LBP) do not recommend the injection of therapeutic substances into the back as a treatment for LBP because of the absence of evidence for their effectiveness. This feasibility study aimed to provide a stable platform that could be used to evaluate a randomised controlled trial (RCT) on the clinical effectiveness and cost-effectiveness of intra-articular facet joint injections (FJIs) when added to normal care. To explore the feasibility of running a RCT to test the hypothesis that, for people with suspected facet joint back pain, adding the option of intra-articular FJIs (local anaesthetic and corticosteroids) to best usual non-invasive care is clinically effective and cost-effective. The trial was a mixed design. The RCT pilot protocol development involved literature reviews and a consensus conference followed by a randomised pilot study with an embedded mixed-methods process evaluation. Five NHS acute trusts in England. Participants were patients aged ≥ 18 years with moderately troublesome LBP present (> 6 months), who had failed previous conservative treatment and who had suspected facet joint pain. The study aimed to recruit 150 participants (approximately 30 per site). Participants were randomised sequentially by a remote service to FJIs combined with 'best usual care' (BUC) or BUC alone. All participants were to receive six sessions of a bespoke BUC rehabilitation package. Those randomised into the intervention arm were, in addition, given FJIs with local anaesthetic and steroids (at up to six injection sites). Randomisation occurred at the end of the first BUC session. Process and clinical outcomes. Clinical outcomes included a measurement of level of pain on a scale from 0 to 10, which was collected daily and then weekly via text messaging (or through a written diary). Questionnaire follow-up was at 3 months. Fifty-two stakeholders attended the consensus meeting. Agreement informed several statistical questions and three design considerations: diagnosis, the process of FJI and the BUC package and informing the design for the randomised pilot study. Recruitment started on 26 June 2015 and was terminated by the funder (as a result of poor recruitment) on 11 December 2015. In total, 26 participants were randomised. Process data illuminate some of the reasons for recruitment problems but also show that trial processes after enrolment ran smoothly. No between-group analysis was carried out. All pain-related outcomes show the expected improvement between baseline and follow-up. The mean total cost of the overall treatment package (injection £419.22 and BUC £264.00) was estimated at £683.22 per participant. This is similar to a NHS tariff cost for a course of FJIs of £686.84. Poor recruitment was a limiting factor. This feasibility study achieved consensus on the main challenges in a trial of FJIs for people with persistent non-specific low back pain. Further work is needed to test recruitment from alternative clinical situations. EudraCT 2014-000682-50 and Current Controlled Trials ISRCTN93184143. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 30. See the NIHR Journals Library website for further project information.