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.

Investigating differences in trunk muscle activity in non-specific chronic low back pain subgroups and no-low back pain controls during functional tasks: a case-control study.

BACKGROUND: Trunk muscle dysfunction is often regarded as a key feature of non-specific chronic low back pain (NSCLBP) despite being poorly understood and variable with increases, decreases and no change in muscle activity reported. Differences in thoraco-lumbar kinematics have been observed in motor control impairment NSCLBP subgroups (Flexion Pattern, Active Extension Pattern) during static postures and dynamic activities. However, potential differences in muscle activity during functional tasks has not been established in these subgroups to date. METHODS: A case-control study design recruited 50 NSCLBP subjects (27 Flexion Pattern, 23 Active Extension Pattern) and 28 healthy individuals. Surface electromyography determined muscle activity during functional tasks: reaching upwards, step-down, step-up, lifting and replacing a box, stand-to-sit, sit-to-stand, bending to retrieve (and returning from retrieving) a pen from the floor. Normalised (% sub-maximal voluntary contraction) mean amplitude electromyography of bilateral musculature (transversus abdominis/internal oblique, external oblique, superficial lumbar multifidus and longissimus thoracis) was analysed using Kruskal-Wallis and post-hoc Mann-Whitney U tests. RESULTS: Transversus abdominis/internal oblique activity was significantly increased in the Flexion Pattern group compared to controls during stand-to-sit (p = 0.009) on the left side only. External oblique activity was significantly greater in the Active Extension Pattern group compared to controls during box lift (p = 0.016) on the right side only. Significantly greater activity was identified in the right Superficial lumbar multifidus during step up (p = 0.029), reach up (p = 0.013) and box replace (p = 0.007) in the Active Extension Pattern group compared to controls. However left-sided superficial lumbar multifidus activity was significantly greater in the Flexion Pattern group (compared to controls) only during stand-to-sit (p = 0.009). No significant differences were observed in longissimus thoracis activity bilaterally during any task. No significant differences between NSCLBP subgroups were observed. CONCLUSIONS: Muscle activity in these NSCLBP subgroups appears to be highly variable during functional tasks with no clear pattern of activity identified. The findings reflect inconsistencies and variability in trunk muscle activity previously observed in these NSCLBP subgroups. Further work evaluating ratios of muscle activity and changes in muscle activity throughout task duration is warranted.

Non-specific chronic low back pain: differences in spinal kinematics in subgroups during functional tasks.

PURPOSE: A multidimensional classification approach suggests that motor control impairment subgroups exist in non-specific chronic low back pain (NSCLBP). Differences in sitting lumbar posture have been identified between two such subgroups [flexion pattern (FP) and active extension pattern (AEP)] and healthy individuals; however, functional spinal movement has not been explored. This study will evaluate whether NSCLBP subgroups exhibit regional spinal kinematic differences, compared to healthy individuals, during functional tasks. METHODS: Observational, cross-sectional study design. Spinal kinematics of 50 NSCLBP subjects (27 FP, 23 AEP) and 28 healthy individuals were investigated using 3D motion analysis (Vicon™) during functional tasks [reaching upwards, step down, step up, lifting, and replacing a box, stand-to-sit, sit-to-stand, bending to retrieve (and returning from retrieving) a pen from the floor]. Mean sagittal angle for the total thoracic, total lumbar, upper thoracic, lower thoracic, upper lumbar, and lower lumbar regions between groups was compared. RESULTS: Significant differences were observed in lower thoracic and upper lumbar regions between NSCLBP subgroups during most tasks. Significant differences were observed between the FP and healthy group in the lower thoracic region during stand-to-sit-to-stand tasks and bending (and returning from) to retrieve a pen from the floor. All significant results demonstrated the FP group to operate in comparatively greater flexion. CONCLUSIONS: The thoraco-lumbar spine discriminated between FP and AEP, and FP and healthy groups during functional tasks. FP individuals demonstrated more kyphotic thoraco-lumbar postures, which may be pain provocative. No significant differences were observed between AEP and healthy groups, suggesting that alternative mechanisms may occur in AEP.

Inertial Measurement Units for Clinical Movement Analysis: Reliability and Concurrent Validity.

The aim of this study was to investigate the reliability and concurrent validity of a commercially available Xsens MVN BIOMECH inertial-sensor-based motion capture system during clinically relevant functional activities. A clinician with no prior experience of motion capture technologies and an experienced clinical movement scientist each assessed 26 healthy participants within each of two sessions using a camera-based motion capture system and the MVN BIOMECH system. Participants performed overground walking, squatting, and jumping. Sessions were separated by 4 ± 3 days. Reliability was evaluated using intraclass correlation coefficient and standard error of measurement, and validity was evaluated using the coefficient of multiple correlation and the linear fit method. Day-to-day reliability was generally fair-to-excellent in all three planes for hip, knee, and ankle joint angles in all three tasks. Within-day (between-rater) reliability was fair-to-excellent in all three planes during walking and squatting, and poor-to-high during jumping. Validity was excellent in the sagittal plane for hip, knee, and ankle joint angles in all three tasks and acceptable in frontal and transverse planes in squat and jump activity across joints. Our results suggest that the MVN BIOMECH system can be used by a clinician to quantify lower-limb joint angles in clinically relevant movements.

A novel clinical approach for assessing hop landing strategies: a 2D telescopic inverted pendulum (TIP) model.

PURPOSE: Single leg hop for distance is used to inform rehabilitation and return to sport following anterior cruciate ligament reconstruction. However, impairment of landing mechanics may persist after the recommended performance parameter (hop distance) has been met; therefore, alternative methods are required. This study follows the COSMIN guideline to investigate the measurement properties of data from a new instrument (2D TIP). This is a simple motion analysis instrument to assess landing strategy based on more complex biomechanical modelling. METHODS: Data collected in the clinical setting from 30 subjects with chronic ACL deficiency (mean 15.5, SD 4.3 months following injury) before and 6 months after ACL reconstruction and a healthy control group were analysed. Reliability and measurement error were calculated using two repeated measures from three independent raters. Construct validity was assessed by hypothesis testing, and known groups validity and responsiveness were defined by differences between groups. RESULTS: The data demonstrate excellent inter-rater (ICC = 0.81-1.00) and intra-rater (ICC = 0.85-1.00) reliability with low measurement error. Of the eight construct validity hypothesis, six were fully and two partially supported. Between-group differences were significant (P < 0.05) supporting the validity and responsiveness hypothesis. CONCLUSION: 2D TIP is a simple and inexpensive instrument for assessing landing strategy that has demonstrated appropriate reliability, validity and responsiveness in the ACL-injured population. The instrument will now be used to identify altered movement strategies and develop novel rehabilitation interventions that target strategy and performance. LEVEL OF EVIDENCE: Prospective diagnostic study, Level II.

Development of an aid to detect adults acetabular hip dysplasia (the ALPHA alert): A mixed methods study.

OBJECTIVES: To identify the signs and symptoms that people living with acetabular hip dysplasia (AHD) describe and to provide an aid for translating the findings into practice. METHODS: A three-phased mixed methods study. Phase 1 employed an open-question online survey that enabled people with AHD (aged ≥16 years) to describe features associated with their condition. Responses were thematically analysed. A Phase 2 survey used these themes to establish how common those features were. Phase 3 created a mnemonic that prompts clinicians to suspect AHD. RESULTS: Ninety-eight respondents completed Phase 1 and sixty-two completed Phase 2. From the responses, five themes were identified: Demographic and Diagnostic Profile; Characteristics of Posture and Gait; Pain; Childhood Hip and Family History; and Hip Joint Characteristics. Within these themes, 19 common signs and symptoms were reported, represented by the ALPHA mnemonic. ALPHA describes a young age at onset of problems (Age), a limp (Limp), progressing pain (Pain), a history of childhood and family hip anomalies (History) as well as hip joint hypermobility and instability (Articulation). CONCLUSION: The findings extend current understanding of AHD indicators. ALPHA alerts clinicians to suspect a diagnosis of AHD. ALPHA may facilitate timelier referral of patients for diagnostic X-Ray and appropriate treatment. Future studies should evaluate its clinical utility.

Relationships between trunk muscle activation and thoraco-lumbar kinematics in non-specific chronic low back pain subgroups during a forward bending task.

BACKGROUND: Trunk muscle activity and thoraco-lumbar kinematics can discriminate between non-specific chronic low back pain (NSCLBP) subgroups and healthy controls. However, research commonly focuses on lumbar kinematics, with limited understanding of relationships between kinematics and muscle activity across clinical subgroups. Similarly, the thoracic spine, whilst intuitively associated with NSCLBP, has received less attention and potential relationships between spinal regions and muscle activity requires exploration. RESEARCH QUESTION: Is there a relationship between trunk muscle activation and regional thoracic and lumbar kinematics in NSCLBP subgroups during a forward bending task? METHODS: Observational, case-control study. Fifty subgrouped NSCLBP motor control impairment participants (27 Flexion Pattern (FP-MCI), 23 Active Extension Pattern (AEP-MCI)) and 28 pain-free controls were evaluated using 3D motion analysis (Vicon™) and surface electromyography during a forward bending and return to upright task. Mean sagittal angles for the upper-thoracic (UTx), lower-thoracic (LTx), upper-lumbar (ULx) and lower-lumbar (LLx) regions were compared with normalised (% sub-maximal voluntary contraction) mean amplitude electromyography of bilateral transversus abdominis/internal oblique, external oblique, superficial lumbar multifidus and erector spinae (longissimus thoracis) muscles between groups. Pearson correlations were computed to assess relationships (significance p < 0.01). RESULTS: AEP-MCI individuals demonstrated statistically significant relationships between superficial lumbar multifidus and ULx and LLx kinematics (-.812 to.659). FP-MCI individuals exhibited statistically significant relationships between erector spinae and superficial lumbar multifidus and LLx and LTx kinematics (-.686 to.664) in both task phases, and between external oblique and LTx during forward bending) (-.459 to.572). Correlations were moderate to strong for all significant relationships (-.812 to .664). SIGNIFICANCE: Relationships between muscle activity and regional spinal kinematics varied between NSCLBP subgroups, suggesting that those with flexion- or extension-related LBP adopt different motor control strategies when performing a bending task. As effectively mechanical biomarkers, these findings may inform treatment by improving understanding of varied motor strategies in subgroups.

Understanding the Sociocultural Challenges and Opportunities for Affordable Wearables to Support Poststroke Upper-Limb Rehabilitation: Qualitative Study.

Background: People who survive a stroke in many cases require upper-limb rehabilitation (ULR), which plays a vital role in stroke recovery practices. However, rehabilitation services in the Global South are often not affordable or easily accessible. For example, in Bangladesh, the access to and use of rehabilitation services is limited and influenced by cultural factors and patients' everyday lives. In addition, while wearable devices have been used to enhance ULR exercises to support self-directed home-based rehabilitation, this has primarily been applied in developed regions and is not common in many Global South countries due to potential costs and limited access to technology. Objective: Our goal was to better understand physiotherapists', patients', and caregivers' experiences of rehabilitation in Bangladesh, existing rehabilitation practices, and how they differ from the rehabilitation approach in the United Kingdom. Understanding these differences and experiences would help to identify opportunities and requirements for developing affordable wearable devices that could support ULR in home settings. Methods: We conducted an exploratory study with 14 participants representing key stakeholder groups. We interviewed physiotherapists and patients in Bangladesh to understand their approaches, rehabilitation experiences and challenges, and technology use in this context. We also interviewed UK physiotherapists to explore the similarities and differences between the 2 countries and identify specific contextual and design requirements for low-cost wearables for ULR. Overall, we remotely interviewed 8 physiotherapists (4 in the United Kingdom, 4 in Bangladesh), 3 ULR patients in Bangladesh, and 3 caregivers in Bangladesh. Participants were recruited through formal communications and personal contacts. Each interview was conducted via videoconference, except for 2 interviews, and audio was recorded with consent. A total of 10 hours of discussions were transcribed. The results were analyzed using thematic analysis. Results: We identified several sociocultural factors that affect ULR and should be taken into account when developing technologies for the home: the important role of family, who may influence the treatment based on social and cultural perceptions; the impact of gender norms and their influence on attitudes toward rehabilitation and physiotherapists; and differences in approach to rehabilitation between the United Kingdom and Bangladesh, with Bangladeshi physiotherapists focusing on individual movements that are necessary to build strength in the affected parts and their British counterparts favoring a more holistic approach. We propose practical considerations and design recommendations for developing ULR devices for low-resource settings. Conclusions: Our work shows that while it is possible to build a low-cost wearable device, the difficulty lies in addressing sociotechnical challenges. When developing new health technologies, it is imperative to not only understand how well they could fit into patients', caregivers', and physiotherapists' everyday lives, but also how they may influence any potential tensions concerning culture, religion, and the characteristics of the local health care system.

A 3D motion analysis study comparing the effectiveness of cervical spine orthoses at restricting spinal motion through physiological ranges.

OBJECTIVE: To compare the effectiveness of the Aspen, Aspen Vista, Philadelphia, Miami-J and Miami-J Advanced collars at restricting cervical spine movement in the sagittal, coronal and axial planes. METHODS: Nineteen healthy volunteers (12 female, 7 male) were recruited to the study. Collars were fitted by an approved physiotherapist. Eight ProReflex (Qualisys, Sweden) infrared cameras were used to track the movement of retro-reflective marker clusters placed in predetermined positions on the head and trunk. 3D kinematic data were collected during forward flexion, extension, lateral bending and axial rotation from uncollared to collared subjects. The physiological range of motion in the three planes was analysed using the Qualisys Track Manager System. RESULTS: The Aspen and Philadelphia were significantly more effective at restricting flexion/extension than the Vista (p < 0.001), Miami-J (p < 0.001 and p < 0.01) and Miami-J Advanced (p < 0.01 and p < 0.05). The Aspen was significantly more effective at restricting rotation than the Vista (p < 0.001) and the Miami-J (p < 0.05). The Vista was significantly the least effective collar at restricting lateral bending (p < 0.001). CONCLUSION: Our motion analysis study found the Aspen collar to be superior to the other collars when measuring restriction of movement of the cervical spine in all planes, particularly the sagittal and transverse planes, while the Aspen Vista was the least effective collar.

Preliminary study: reliability of the spinal wheel. A novel device to measure spinal postures applied to sitting and standing.

Postural re-education is an integral part of physiotherapy management in patients with back pain. Although the link between posture and back pain is largely unknown, postural re-education is performed on the premise of optimizing spinal alignment to minimize stresses on the passive structures of the spine, to facilitate optimal muscular support and thus to prevent possible damage and further pain. A reliable and clinically meaningful measurement of spinal postures to monitor such interventions remains challenging. This study evaluated within-day (intra-tester, inter-tester) and between-day (test-retest) reliability of a novel spinal wheel device measuring thoracic and lumbar postures during sitting and standing. 17 healthy volunteers (age 39.5 +/- 5.4, BMI 25 +/- 9.2; 9 males) were measured three times, by three testers, on two separate occasions (1 week apart). The angular change between C7 and T12 and between T12 and S1 provided thoracic and lumbar curvatures, respectively. Intra-class correlation coefficient (ICC) with 95% confidence intervals and typical error were calculated. Excellent reliability was demonstrated with intra-tester ICCs between 0.947 and 0.980 and typical error between 1.7 degrees and 3.7 degrees and inter-tester ICCs between 0.949 and 0.986 and typical error between 2.0 degrees and 4.7 degrees. Test-retest reliability was high with ICCs 0.719-0.908 and typical error between 4.0 degrees and 7.4 degrees. In conclusion, the spinal wheel demonstrated excellent within-day and high between-day reliability. The device may be used in conjunction with 2D camcorder to provide clinically useful visual evaluation of postures for assessment, intervention monitoring, and feedback during postural re-education.

Identifying non-specific low back pain clinical subgroups from sitting and standing repositioning posture tasks using a novel Cardiff Dempster-Shafer Theory Classifier.

BACKGROUND: Low back pain (LBP) classification systems are used to deliver targeted treatments matched to an individual profile, however, distinguishing between different subsets of LBP remains a clinical challenge. METHODS: A novel application of the Cardiff Dempster-Shafer Theory Classifier was employed to identify clinical subgroups of LBP on the basis of repositioning accuracy for subjects performing a sitting and standing posture task. 87 LBP subjects, clinically subclassified into flexion (n = 50), passive extension (n = 14), and active extension (n = 23) motor control impairment subgroups and 31 subjects with no LBP were recruited. Thoracic, lumbar and pelvic repositioning errors were quantified. The Classifier then transformed the error variables from each subject into a set of three belief values: (i) consistent with no LBP, (ii) consistent with LBP, (iii) indicating either LBP or no LBP. FINDINGS: In discriminating LBP from no LBP the Classifier accuracy was 96.61%. From no-LBP, subsets of flexion LBP, active extension and passive extension achieved 93.83, 98.15% and 97.62% accuracy, respectively. Classification accuracies of 96.8%, 87.7% and 70.27% were found when discriminating flexion from passive extension, flexion from active extension and active from passive extension subsets, respectively. Sitting lumbar error magnitude best discriminated LBP from no LBP (92.4% accuracy) and the flexion subset from no-LBP (90.1% accuracy). Standing lumbar error best discriminated active and passive extension from no LBP (94.4% and 95.2% accuracy, respectively). INTERPRETATION: Using repositioning accuracy, the Cardiff Dempster-Shafer Theory Classifier distinguishes between subsets of LBP and could assist decision making for targeted exercise in LBP management.

Comparison of gait, functional activities, and patient-reported outcome measures in patients with knee osteoarthritis and healthy adults using 3D motion analysis and activity monitoring: an exploratory case-control analysis.

OBJECTIVE: To examine functional performance differences using kinematic and kinetic analysis between participants with and without knee osteoarthritis (OA) to determine which outcomes best characterize persons with and without knee OA. METHODS: Participants with unilateral moderate knee OA (Kellgren-Lawrence grades 2 or 3) and controls without knee pain were matched for age, gender, and body mass index. Primary outcomes included temporal parameters, joint rotations and moments, and ground reaction forces assessed via 3D motion capture during walking and ascending/descending stairs. Secondary outcomes included timed functional activities (sit to stand; tying shoelaces), 48 hrs lower limb activity monitoring, and patient-reported outcome measures (Knee Injury and Osteoarthritis Outcome Score, Western Ontario and McMaster Universities Osteoarthritis Index, European Quality of Life-5 Dimensions). RESULTS: Eight matched pairs were analyzed. Compared with controls, OA participants exhibited significant reductions in peak frontal hip and sagittal knee moments, and decreased peak anterior ground reaction force with the affected limb while walking. Ascending stairs, OA participants had slower speed, fewer strides per minute, longer cycle and stance times, and increased trunk range of motion (ROM) in assessments of both limbs; longer swing time and reduced ankle ROM in the affected limb; and increased knee frontal ROM in the unaffected limb. Descending stairs, OA participants had fewer strides per minute and decreased trunk transverse ROM in assessments of both limbs; increased knee frontal ROM in the affected limb; and longer strides, shorter stance and cycle times, increased trunk sagittal and decreased knee transverse ROMs in the unaffected limbs vs controls. Compared with controls, OA participants had slower walking cadence (120-130 vs 100-110 steps/min, respectively), took significantly longer on timed functional measures, and had significantly worse scores in patient-reported outcomes. CONCLUSION: Several objectives and patient-reported measures examined in this study could potentially be considered as outcomes in pharmacologic or physical therapy OA trials.

Can different seating aids influence a sitting posture in healthy individuals and does gender matter?

This study determined differences in spinal-pelvic kinematics sitting on (i) mat (ii) block and (iii) novel 10º forward inclined wedge (ButtaflyTM) in a same-subject repeated measures cross-over design in 60 healthy individuals (34 females). Repeated measures ANOVA revealed statistically significant differences between sitting conditions and lumbar and pelvic sagittal angles. Both, the inclined wedge and the block seating aids reduced overall flexion, but the inclined wedge had a greater influence in the lumbar region whilst the block induced the greatest change in the pelvis. This may be relevant for seating aid design personalised to posture type. Statistically significant gender differences were identified in all 3 seating conditions with males adopting more flexed lumbar spine and posteriorly tilted pelvis. Females flexed less in thoracic spine when sitting on an inclined wedge and a block. These statistically significant differences between males and females may provide first explorative direction for bespoke seating aids design.

Frontal plane movement of the pelvis and thorax during dynamic activities in individuals with and without anterior cruciate ligament injury.

BACKGROUND: For elite athletes with anterior cruciate ligament (ACL) reconstruction, reducing pelvis and trunk obliquities is a common goal of rehabilitation. It is not known if this is also a suitable goal for the general population. This study aimed to quantify pelvis and thorax obliquities during dynamic activities in individuals from the general population with and without history of ACL injury. METHODS: Retrospective analysis of cross-sectional data from 30 participants with ACL reconstruction, 28 participants with ACL deficiency (ACLD), and 32 controls who performed overground walking and jogging, single-leg squat, and single-leg hop for distance. Pelvis and thorax obliquities were quantified in each activity and compared across groups using one-way ANOVA. Coordination was quantified using cross covariance. RESULTS: In the stance phase of walking and jogging, pelvis and thorax obliquities were within ±10° of neutral and there was a negative correlation between the two segments at close to zero phase lag. In single-leg squat and hop, range of obliquities varied across individuals and there was no consistent pattern of coordination. Eight ACLD participants felt unable to perform the single-leg hop. In the remaining participants, range of pelvis (p = 0.04) and thorax (p = 0.02) obliquities was smaller in ACLD than controls. CONCLUSIONS: In challenging single-leg activities, minimal frontal plane motion was not the typical movement pattern observed in the general population. Coordination between the pelvis and thorax was inconsistent within and across individuals. Care should be taken when considering minimising pelvis and thorax obliquities in patients with ACL injury.

Lessons learnt from a discontinued randomised controlled trial: adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica (Subcutaneous Injection of Adalimumab Trial compared with Control: SCIATiC).

BACKGROUND: Adalimumab, a biological treatment targeting tumour necrosis factor α, might be useful in sciatica. This paper describes the challenges faced when developing a new treatment pathway for a randomised controlled trial of adalimumab for people with sciatica, as well as the reasons why the trial discussed was stopped early. METHODS: A pragmatic, parallel group, randomised controlled trial with blinded (masked) participants, clinicians, outcome assessment and statistical analysis was conducted in six UK sites. Participants were identified and recruited from general practices, musculoskeletal services and outpatient physiotherapy clinics. They were adults with persistent symptoms of sciatica of 1 to 6 months' duration with moderate to high level of disability. Eligibility was assessed by research physiotherapists according to clinical criteria, and participants were randomised to receive two doses of adalimumab (80 mg then 40 mg 2 weeks later) or saline placebo subcutaneous injections in the posterior lateral thigh. Both groups were referred for a course of physiotherapy. Outcomes were measured at baseline, 6-week, 6-month and 12-month follow-up. The main outcome measure was disability measured using the Oswestry Disability Index. The planned sample size was 332, with the first 50 in an internal pilot phase. RESULTS: The internal pilot phase was discontinued after 10 months from opening owing to low recruitment (two of the six sites active, eight participants recruited). There were several challenges: contractual delays; one site did not complete contract negotiations, and two sites signed contracts shortly before trial closure; site withdrawal owing to patient safety concerns; difficulties obtaining excess treatment costs; and in the two sites that did recruit, recruitment was slower than planned because of operational issues and low uptake by potential participants. CONCLUSIONS: Improved patient care requires robust clinical research within contexts in which treatments can realistically be provided. Step changes in treatment, such as the introduction of biologic treatments for severe sciatica, raise complex issues that can delay trial initiation and retard recruitment. Additional preparatory work might be required before testing novel treatments. A randomised controlled trial of tumour necrosis factor-α blockade is still needed to determine its cost-effectiveness in severe sciatica. TRIAL REGISTRATION: Current Controlled Trials, ISRCTN14569274 . Registered on 15 December 2014.

Subcutaneous Injection of Adalimumab Trial compared with Control (SCIATiC): a randomised controlled trial of adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica.

BACKGROUND: Biological treatments such as adalimumab (Humira®; AbbVie Ltd, Maidenhead, UK) are antibodies targeting tumour necrosis factor alpha, released from ruptured intervertebral discs, which might be useful in sciatica. Recent systematic reviews concluded that they might be effective, but that a definitive randomised controlled trial was needed. Usual care in the NHS typically includes a physiotherapy intervention. OBJECTIVES: To test whether or not injections of adalimumab plus physiotherapy are more clinically effective and cost-effective than injections of saline plus physiotherapy for patients with sciatica. DESIGN: Pragmatic, parallel-group, randomised controlled trial with blinded participants and clinicians, and an outcome assessment and statistical analysis with concurrent economic evaluation and internal pilot. SETTING: Participants were referred from primary care and musculoskeletal services to outpatient physiotherapy clinics. PARTICIPANTS: Adults with persistent symptoms of sciatica of 1-6 months' duration and with moderate to high levels of disability. Eligibility was assessed by research physiotherapists according to clinical criteria for diagnosing sciatica. INTERVENTIONS: After a second eligibility check, trial participants were randomised to receive two doses of adalimumab (80 mg and then 40 mg 2 weeks later) or saline injections. Both groups were referred for a course of physiotherapy. MAIN OUTCOME MEASURES: Outcomes were measured at the start, and after 6 weeks' and 6 months' follow-up. The main outcome measure was the Oswestry Disability Index (ODI). Other outcomes: leg pain version of the Roland-Morris Disability Questionnaire, Sciatica Bothersomeness Index, EuroQol-5 Dimensions, 5-level version, Hospital Anxiety and Depression Scale, resource use, risk of persistent disabling pain, pain trajectory based on a single question, Pain Self-Efficacy Questionnaire, Tampa Scale of Kinesiophobia and adverse effects. SAMPLE SIZE: To detect an effect size of 0.4 with 90% power, a 5% significance level for a two-tailed t-test and 80% retention rate, 332 participants would have needed to be recruited. ANALYSIS PLAN: The primary effectiveness analysis would have been linear mixed models for repeated measures to measure the effects of time and group allocation. An internal pilot study would have involved the first 50 participants recruited across all centres. The primary economic analysis would have been a cost-utility analysis. RESULTS: The internal pilot study was discontinued as a result of low recruitment after eight participants were recruited from two out of six sites. One site withdrew from the study before recruitment started, one site did not complete contract negotiations and two sites signed contracts shortly before trial closure. In the two sites that did recruit participants, recruitment was slow. This was partly because of operational issues, but also because of a low rate of uptake from potential participants. LIMITATIONS: Although large numbers of invitations were sent to potential participants, identified by retrospective searches of general practitioner (GP) records, there was a low rate of uptake. Two sites planned to recruit participants during GP consultations but opened too late to recruit any participants. CONCLUSION: The main failure was attributable to problems with contracts. Because of this we were not able to complete the internal pilot or to test all of the different methods for primary care recruitment we had planned. A trial of biological therapy in patients with sciatica still needs to be done, but would require a clearer contracting process, qualitative research to ensure that patients would be willing to participate, and simpler recruitment methods. TRIAL REGISTRATION: Current Controlled Trials ISRCTN14569274. FUNDING: 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. 60. See the NIHR Journals Library website for further project information.

Clinical challenges of classification based targeted therapies for non-specific low back pain: What do physiotherapy practitioners and managers think?

BACKGROUND: Classification of non-specific low back pain (NSLBP) was recommended to better target care and so maximise treatment potential. This study investigated physiotherapy practitioners' (PPs) and managers' (PMs) views, experiences and perceptions of barriers and enablers for using classification systems (CSs) to better target treatment for NSLBP in the NHS primary care setting. DESIGN: Qualitative focus group and interviews. METHODS: Data from semi-structured interviews of three PMs and a focus group with five PPs, considered local opinion leaders in physiotherapy, was thematically analysed. RESULTS: Five themes emerged (i) CS knowledge: PPs and PMs were aware of CSs and agreed with its usefulness. PPs were mostly aware of CSs informing specific treatments whilst PMs were aware of prognosis based CSs. (ii) Using CSs: PPs classify by experience and clinical reasoning skills, shifting between multiple CSs. PMs were confident that evidence-based practice takes place but believed CSs may not be always used. (iii) Advantages/disadvantages of CSs: Effective targeting of treatments to patients was perceived as advantageous; but the amount of training required was perceived as disadvantageous. (iv) Barriers: Patients' expectations, clinicians' perceptions, insufficiently complex CSs, lack of training resources. (v) Enablers: Development of sufficiently complex CSs, placed within the clinical reasoning process, mentoring, positive engagement with stakeholders and patients. CONCLUSIONS: PPs and PMs were aware of CSs and agreed with its usefulness. The current classification process was perceived to be largely influenced by individual practitioner knowledge and clinical reasoning skills rather than being based on one CS alone. Barriers and enablers were identified for future research.

Assessing participation in the ACL injured population: Selecting a patient reported outcome measure on the basis of measurement properties.

BACKGROUND/AIM: A return to pre injury activity participation remains a common but often elusive goal following ACL injury. Investigations to improve our understanding of participation restrictions are limited by inconsistent use of insufficiently investigated measurement tools. The aim of this study was to follow the consensus based standards for the selection of health measurement instruments (COSMIN) guideline to provide a comparative evaluation of four patient reported outcomes (PROMs) on the basis of measurement properties. This will inform recommendations for measuring participation of ACL injured subjects, particularly in the United Kingdom (UK) National Health Service (NHS). METHODS: Thirteen criteria were compiled from the COSMIN guideline. These included reliability, measurement error, content validity, construct validity, responsiveness and interpretability. Data from 51 subjects collected as part of a longitudinal observational study of recovery over the first year following ACLR was used in the analysis. RESULTS: Of the thirteen criteria, the required standard was met in 11 for Tegner, 11 for International Knee Documentation Committee (IKDC), 6 for Cincinnati Sports Activity Scale (CSAS) and 6 for Marx. The two weaknesses identified for the Tegner are more easily compensated for during interpretation than those in the IKDC; for this reason the Tegner is the recommended PROM. CONCLUSIONS: The Tegner activity rating scale performed consistently well in respect of all measurement properties in this sample, with clear benefits over the other PROMs. The measurement properties presented should be used to inform implementation and interpretation of this outcome measure in clinical practice and research. LEVEL OF EVIDENCE: Level II prospective study.

Derivation and identification of questions that act as predictors of abdominal pain of musculoskeletal origin.

OBJECTIVE: Although most causes of abdominal pain have a visceral origin, the musculoskeletal system must be considered when the cause is not obvious. This prospective study aimed to identify questions that would aid the diagnosis of patients with abdominal pain of musculoskeletal origin. DESIGN: Assessment of consecutive patients with abdominal pain recruited from gastroenterological outpatient clinics to develop diagnostic pointers to identify abdominal pain arising from musculoskeletal disorders. PARTICIPANTS: Subjects with benign abdominal pain, with or without a change in bowel habit, were recruited from gastroenterological clinics. Patients with inflammatory or neoplastic disease were excluded. SETTING: The study was conducted in the Physiotherapy Department, Addenbrooke's NHS Trust Hospital, Cambridge. MAIN OUTCOME MEASURES: A set of questions developed to indicate a musculoskeletal cause of a patient's abdominal symptoms. RESULTS The questions 'Does taking a deep breath aggravate your symptoms?' and 'Does twisting your back aggravate your symptoms?' had a significant positive indication of abdominal symptoms of musculoskeletal origin. The questions 'Has there been any change in bowel habit since onset of your symptoms?', 'Does eating foods aggravate your symptoms?' and 'Has there been any weight change since onset of symptoms?' had a significant negative indication for abdominal symptoms not of musculoskeletal origin. A combination of these questions gave 96% specificity and 67% sensitivity. CONCLUSION: These questions may help with the early identification of patients with abdominal pain of musculoskeletal origin and will be tested in further studies.

Altered biomechanical strategies and medio-lateral control of the knee represent incomplete recovery of individuals with injury during single leg hop.

Anterior cruciate ligament (ACL) injury can result in failure to return to pre-injury activity levels and future osteoarthritis predisposition. Single leg hop is used in late rehabilitation to evaluate recovery and inform treatment but biomechanical understanding of this activity is insufficient. This study investigated single leg hop for distance aiming to evaluate if ACL patients had recovered: (1) landing strategies and (2) medio-lateral knee control. We hypothesized that patients with reconstructive surgery (ACLR) would have more similar landing strategies and knee control to healthy controls than patients treated conservatively (ACLD). 16 ACLD and 23 ACLR subjects were compared to 20 healthy controls (CONT). Kinematic and ground reaction force data were collected while subjects hopped their maximum distance. The main output parameters were hop distance, peak knee flexor angles and extensor moments and Fluency (a measure introduced to represent medio-lateral knee control). Statistical differences between ACL and control groups were analyzed using a general linear model univariate analysis, with COM velocity prior to landing as covariate. Hop distance was the smallest for ACLD and largest for CONT (p<0.001; ACLD 57.1±14.1; ACLR 75.1±17.8; CONT 77.7±14.07% height). ACLR used a similar kinematic strategy to CONT, but had a reduced peak knee extensor moment (p<0.001; ACLD 0.32±0.14; ACLR 0.31±0.16; CONT 0.42±0.13 BW.height). Fluency was reduced in both ACLD and ACLR (p=0.006; ACLD 0.13±0.34; ACLR 0.14±0.34; CONT 0.17±0.41s). Clinical practice uses hopping distance to evaluate ACL patients' recovery. This study demonstrated that aspects such as movement strategies and knee control need to be evaluated.