A Cognitive Functional Therapy+ Pathway Versus an Interdisciplinary Pain Management Pathway for Patients With Severe Chronic Low Back Pain (CONFeTTI Trial): Protocol for a Pragmatic Randomized Controlled Trial.

OBJECTIVE: Chronic low back pain (cLBP) is the leading cause of disability. Interdisciplinary pain management is recommended for patients with severe/high-impact cLBP. Such programs are expensive, not easily accessible, and have limited effect; therefore, new cost-effective strategies are warranted. Cognitive functional therapy (CFT) has shown promising results but has not been compared with an interdisciplinary pain management approach. The primary aim of this randomized controlled trial is to investigate if a pathway starting with CFT including psychologist support (CFT+) with the option of additional usual care (if needed) is superior in improving disability and more cost-effective at 12 months compared with an interdisciplinary pain management pathway (usual care). METHODS: This pragmatic, 2-arm, parallel-group randomized controlled trial will randomly allocate patients (n = 176) aged 18 to 75 years referred to an interdisciplinary pain center due to severe cLBP to 1 of 2 groups (1:1 ratio). Participants randomized to CFT+ will participate in a 3-month functional rehabilitation pathway with the option of additional usual care (if needed), and participants randomized to the interdisciplinary pain management pathway will participate in an individualized program of longer duration designed to best suit the individual's situation, needs, and resources. The primary outcome is the proportion of participants with an 8-point improvement in the Oswestry Disability Index score at 12 months. Exploratory outcomes are change in Oswestry Disability Index scores over time and an economic analysis of quality-adjusted life years using the 3-level version of the EuroQol EQ-5D. IMPACT: The study evaluates the cost-effectiveness of CFT+ with the option of additional usual care (if needed) for individuals with severe cLBP. Findings can potentially improve future care pathways and reduce cost for the health care system.

Evaluation of training in guideline-oriented biopsychosocial management of low back pain in occupational health services: Protocol of a cluster randomized trial.

BACKGROUND: To prevent low back pain (LBP) from developing into a prolonged disabling condition, clinical guidelines advocate early stage assessment, risk-screening, and tailored interventions. Occupational health services recommend guideline-oriented biopsychosocial screening and individualized assessment and management. However, it is not known whether training a limited number of health care professionals improves the management process. The primary objective of this study is to investigate whether training in the biopsychosocial practice model is effective in reducing disability. Furthermore, we aim to evaluate health-economic impacts of the training intervention in comparison to usual medical care. METHODS: The occupational health service units will be allocated into a training or control arm in a two-arm cluster randomized controlled design. The training of occupational physiotherapists and physicians will include the assessment of pain-related psychosocial factors using the STarT Back Tool and the short version of the Örebro Musculoskeletal Pain Screening Questionnaire, the use of an evidence-based patient education booklet as part of the management of LBP, and tailored individualized management of LBP according to risk stratification. The control units will receive no training. The study population will include patients aged 18-65 with nonspecific LBP. The primary outcome is a patient-reported Oswestry Disability Index from baseline to 12 months. By estimating group differences over time, we aim to evaluate the effectiveness of the training intervention in comparison to usual medical care, and to undertake an economic evaluation using individual patients' health care records (participant-level data) and the participating units' registries (cluster-level data). In addition, through interviews and questionnaires, we will explore the health care professionals' conceptions of the adoption of, the barriers to, and the facilitators of the implementation of the practice model. DISCUSSION: The evaluation of training in the guideline-oriented biopsychosocial management of LBP in occupational health services is justified because LBP represents an enormous burden in terms of work disability.

Cognitive Functional Therapy for People with Nonspecific Persistent Low Back Pain in a Secondary Care Setting-A Propensity Matched, Case-Control Feasibility Study.

BACKGROUND: Effective, inexpensive, and low-risk interventions are needed for patients with nonspecific persistent low back pain (NS-PLBP) who are unresponsive to primary care interventions. Cognitive functional therapy (CFT) is a multidimensional behavioral self-management approach that has demonstrated promising results in primary care and has not been tested in secondary care. OBJECTIVE: To investigate the effect of CFT and compare it with usual care for patients with NS-PLBP. DESIGN: Case-control study. SETTING: A secondary care spine center. SUBJECTS: Thirty-nine patients received a CFT intervention and were matched using propensity scoring to 185 control patients receiving usual care. METHODS: The primary outcome was Roland Morris Disability Questionnaire (0-100 scale) score. Group-level differences at six- and 12-month follow-up were estimated using mixed-effects linear regression. RESULTS: At six-month follow-up, a statistically significant and clinically relevant difference in disability favored the CFT group (-20.7, 95% confidence interval [CI] = -27.2 to -14.2, P < 0.001). Significant differences also occurred for LBP and leg pain, fear, anxiety, and catastrophizing in favor of CFT. At 12-month follow-up, the difference in disability was smaller and no longer statistically significant (-8.1, 95% CI = -17.4 to 1.2, P = 0.086). Differences in leg pain intensity and fear remained significantly in favor of CFT. Treatment satisfaction was significantly higher in the CFT group at six- (93% vs 66%) and 12-month (84% vs 52%) follow-up. CONCLUSIONS: These findings support that CFT is beneficial for patients with NS-PLBP who are unresponsive to primary care interventions. Subsequent randomized controlled trials could incorporate booster sessions, which may result in larger effects at 12-month follow-up.

Does movement matter in people with back pain? Investigating 'atypical' lumbo-pelvic kinematics in people with and without back pain using wireless movement sensors.

BACKGROUND: Interventions for low back pain (LBP) commonly target 'dysfunctional' or atypical lumbo-pelvic kinematics in the belief that correcting aberrant movement improves patients' pain and activity outcomes. If atypical kinematic parameters and postures have a relationship to LBP, they could be expected to more prevalent in people with LBP compared to people without LBP (NoLBP). This exploratory study measured, defined and compared atypical kinematic parameters in people with and without LBP. METHODS: Wireless inertial motion and EMG sensors were used to measure lumbo-pelvic kinematics during standing trunk flexion (range of motion (ROM), timing, sequence coordination, and extensor muscle activation) and in sitting (relative sitting position, pelvic tilt range) in a sample of 126 of adults without LBP and 140 chronic LBP subjects. Atypical movement was defined using the 10th/90th centiles of the NoLBP group. Mean differences and prevalence rates for atypical movement were calculated. Dichotomised pain scores for 'high-pain-on-bending' and 'high-pain-on-sitting' were tested for their association with atypical kinematic variables. RESULTS: For standing flexion, significant mean differences, after adjusting for age and gender factors, were seen for the LBP group with (i) reduced ROM (trunk flexion (NoLBP 111o, LBP 93o, p < .0001), lumbar flexion (NoLBP 52o, LBP 46o, p < .0001), pelvic flexion (NoLBP 59o, LBP 48o, p < .0001), (ii) greater extensor muscle activation for the LBP group (NoLBP 0.012, LBP 0.25 p < .0001), (iii) a greater delay in pelvic motion at the onset of flexion (NoLBP - 0.21 s; LBP - 0.36 s, p = 0.023), (iv) and longer movement duration for the LBP group (NoLBP 2.28 s; LBP 3.18 s, p < .0001). Atypical movement was significantly more prevalent in the LBP group for small trunk (× 5.4), lumbar (× 3.0) and pelvic ROM (× 3.9), low FRR (× 4.9), delayed pelvic motion at 20o flexion (× 2.9), and longer movement duration (× 4.7). No differences between groups were seen for any sitting parameters. High pain intensity was significantly associated with small lumbar ROM and pelvic ROM. CONCLUSION: Significant movement differences during flexion were seen in people with LBP, with a higher prevalence of small ROM, slower movement, delayed pelvic movement and greater lumbar extensor muscle activation but without differences for any sitting parameter.

Endurance and fatigue characteristics of the neck flexor and extensor muscles during isometric tests in patients with postural neck pain.

Sustained postural loading of the cervical spine during work or recreational tasks may contribute to the development of neck pain. The aim of this study was to compare neck muscle endurance and fatigue characteristics during sub-maximal isometric endurance tests in patients with postural neck pain, with asymptomatic subjects. Thirteen female patients with postural neck pain and 12 asymptomatic female control subjects completed timed sub-maximal muscle endurance tests for the neck flexor and extensor muscles. Muscle fatigue, defined as the time-dependent decrease in median frequency electromyography (EMG), was examined using surface EMG analysis during the tests. The median extensor test holding time was lower but not significantly different in the neck pain group (165 s) that the control group (228 s) (p = 0.17). There was no difference between groups in the flexor test holding time (neck pain = 36 s, controls = 38 s) (p = 0.96). The neck pain group was characterised by greater variability in neck flexor (p = 0.03) and extensor (p = 0.006) muscle endurance. For both tests, the rate of decrease in median frequency EMG was highly variable within and between groups with no significant difference between groups for the flexor or extensor test (p = 0.05-0.82). Patients with postural neck pain did not have significant impairment of neck muscle endurance or accelerated fatigue compared to control subjects. However, the greater variability in these indices of muscle function may reflect patient-specific changes in muscle function associated with neck pain disorder.