BACKGROUND:No consistent relationship exists between pre-treatment expectations and therapeutic benefit from various complementary and alternative medicine (CAM) therapies in clinical trials. However, many different expectancy measures have been used in those studies, with no validated questionnaires clearly focused on CAM and pain. We undertook cognitive interviews as part of a process to develop and validate such a questionnaire.METHODS:We reviewed questions about expectations of benefits of acupuncture, chiropractic, massage, or yoga for pain. Components of the questions - verbs, nouns, response options, terms and phrases describing back pain - were identified. Using seven different cognitive interview scripts, we conducted 39 interviews to evaluate how individuals with chronic low back pain understood these individual components in the context of expectancy questions for a therapy they had not yet received. Chosen items were those with the greatest agreement and least confusion among participants, and were closest to the meanings intended by the investigators.RESULTS:The questionnaire drafted for psychometric evaluation had 18 items covering various domains of expectancy. "Back pain" was the most consistently interpreted descriptor for this condition. The most understandable response options were 0-10 scales, a structure used throughout the questionnaire, with 0 always indicating no change, and 10 anchored with an absolute descriptor such as "complete relief". The use of words to describe midpoints was found to be confusing. The word "expect" held different and shifting meanings for participants. Thus paired items comparing "hope" and "realistically expect" were chosen to evaluate 5 different aspects of treatment expectations (back pain / back dysfunction and global effects / impact of back pain on specific areas of life / sleep, mood, and energy / coping). "Impact of back pain" on various areas of life was found to be a consistently meaningful concept, and more global than "interference".CONCLUSIONS:Cognitive interviews identified wordings with considerable agreement among both participants and investigators. Some items widely used in clinical studies had different meanings to participants than investigators, or were confusing to participants. The final 18-item questionnaire is undergoing psychometric evaluation with goals of streamlining as well as identifying best items for use when questionnaire length is constrained.

This thesis comprises three phases with a combined aim which was to investigate the effect of position on the lumbar intervertebral disc (IVD). The effect of position on the lumbar IVD in asymptomatic subjects and subjects with discogenic low back pain (DLBP) was explored using positional Magnetic Resonance Imaging (pMRI). Convenience samples of 11 asymptomatic and 34 DLBP subjects were recruited to have sagittal and axial pMRI scans performed in sitting (Neutral, Flexed and Extended), standing and lying (Supine and Prone extension) positions. The sagittal plane migration of the nucleus pulposus (NP) of each lumbar IVD in each position was measured from the sagittal and axial pMRI scans. Within and between group inferential analysis was performed using nonparametric tests. Both the asymptomatic and DLBP subjects’ demonstrated that position had statistically significant effects on the sagittal plane NP migration. Both groups demonstrated significantly greater posterior sagittal plane NP migration in Neutral and Flexed sitting positions compared to the other positions. However, between group comparisons identified that the asymptomatic subjects also demonstrated significantly greater posterior sagittal plane NP migration than the DLBP subjects. This pattern was more common in the upper lumbar IVDs (L1/2 and L2/3) between positions and less common in the lower IVDs (L4/5 and L5/S1) between positions. New knowledge regarding the behaviour of the lumbar IVD emerged from this research. The differences detected between the asymptomatic and DLBP subjects suggest that some current theories regarding DLBP may be incorrect. The results also support imaging of DLBP subjects in sitting positions as opposed to current supine positions. Although the limitations of the study reduce generalisation of the results, the implications for clinical practice, imaging and suggestions for further research from this work are important to improve understanding and conservative management of DLBP.

Low Back Pain (LBP) is a condition that most people experience at least once in their lifetime and for which many will seek physiotherapeutic intervention. Recently published and internationally recognised clinical guidelines for the management of LBP recommend the use of spinal manual and manipulative therapy techniques alongside exercise, advice, education and pharmaceutical therapies, particularly in the early stages. Other areas of development in the last decade include classification systems, clinical prediction rules (CPR’s), patient-reported outcome measures (PROMS’s) and minimum clinically important difference (MCID) thresholds. Additionally, sympathetic nervous system (SNS) measures of treatment responses are now recognised as providing quantifiable indicators of peripheral, spinal and central effects of manual therapy interventions although research in the lumbar spine is very limited with none providing data on a patient population. The aims of the study were; to determine the reliability and stability of the Biopac System in recording skin conductance (SC) activity levels and calculate the smallest real difference (SRD) statistic; to generate data on the magnitude of SC response to two commonly utilised treatments for LBP; and to observe the changes in a clinical population receiving guideline-endorsed physiotherapy treatment for the management of acute and sub-acute LBP. Furthermore, clinical data analysis sought to identify correlations of SC measures to PROM’s and evaluate the feasibility of using SC responses as a predictive tool for therapeutic outcome. The ability of the Biopac System to reliably record SNS activity was established by using SC measurements with 12 participants on two occasions, one-week apart. Data was recorded within a natural, non-laboratory setting. Results established that SC measurements could be reliably recorded between data sessions with a measurement variability of; ICC=0.99 (p<0.005) with an SRD value of 0.315 μmho’s (4.633%). In conclusion, any SC change above the SRD could be regarded as an SNS change that is independent of any measurement error or variability thus representing a real change ascribable to the intervention under investigation. The pre-clinical investigation compared the magnitude of SC response (SCR) of two, independently administered, specific MT techniques, applied, after randomisation, to the Lumbar 4/5 segment of 50 asymptomatic healthy volunteers. Treatments included; a rotatory lumbar manipulation technique or a repeated McKenzie extension in lying exercise. Findings revealed that both techniques produced statistically significant changes in SNS activity in the lower limbs (> SRD) with manipulative technique SCR’s (76%) that were twice the size of the McKenzie repeated extension in lying exercise (EIL) technique (35.7%)( p=0.0005). Only the manipulation technique had a lasting effect that was carried into the final rest period (p=0.012) but the SNS response was not a side-specific phenomenon (p= 0.76). The final clinical study recruited 60 acute and sub-acute LBP patients (symptoms of up to 12 weeks duration) who received guideline-recommended physiotherapy treatment within a hospital-based musculoskeletal out-patient physiotherapy department. SCRs were recorded throughout all treatment episodes with standardised, validated PROM’s used for comparison of status at inception, mid-point and at discharge. Functional impairment was determined using the Oswestry Disability Index (ODI) and the Roland Morris Disability Questionnaire (RMDQ) with pain intensity evaluated with the Narrative Pain Rating Score (NPRS). A preliminary comparison, between the asymptomatic population and a random selection from the patient population, revealed that patients had treatment SCR’s that were significantly greater (three-fold) than those of the asymptomatic groups (manipulation, p=0.003; EIL exercises p=0.001). Analysis of the patient data indicated that pre-treatment/baseline SC activity levels in the inception data capture point were lower than at discharge (18 µMho’s; p<0.0005) but, conversely, that treatment SC levels were initially high, but diminished in magnitude by discharge (230 to 172 µMho’s; p<0.0005) representing a SCR reduction of 125%. Correlational analyses of change scores of maximum SCR’s to PROM’s, from inception to discharge suggested weak positive correlations of SCR treatment responses to functional disability score improvements (rho 0.278) and pain intensity reductions (rho=0.229) that were significant for function (p=0.033) but not significant for pain (p=0.080). The final analyses indicated that there were trends in the magnitude of response to specific elements of treatment with manipulation having the largest SCR (266%). Further evaluative analysis of SC readings as a predictor, at inception, of functional outcome, at discharge indicated that a critical/cut-off value of 195% may indicate those patients least and most likely to respond positively to MT treatment. Preliminary logistic regression analysis indicated that the 195% SCR value was excellent at identifying poor responders but less successful at identifying good responders, functionally, to treatment. Nonetheless, SCR was a better predictor of outcome than duration of symptoms and patient age. Characteristically, patients achieving the 195% value were most likely to have higher functional disability and pain intensity scores at inception but by discharge had required fewer treatments, had greater overall functional improvement and lower pain intensities than those not achieving this threshold. In conclusion, SC activity levels and SCR’s may be a reliable, stable, alternative and objective measure of LBP patients’ SNS status and changes that occur as a result of symptom abatement throughout a course of physiotherapy treatment. SC readings may (indirectly) reflect the state of dorsal horn (DH) sensitisation and of the central nervous system (CNS) processing system and its facilitatory capacity to activate the descending pain inhibitory system (DPIS). Further research, in patient populations (including chronic LBP patients), is recommended to verify these findings and validate the 195% SCR cut-off point. Definitive RCT’s are indicated to further the understanding of guideline-endorsed physiotherapy treatment (a complex intervention –MRC, 2000) and to determine whether the SNS activity measurements can be used to help classify, predict, and ultimately, direct the care of patients with LBP.

Disability due to low back pain is common. While evidence exist that exercise is effective in reducing pain and disability, it is still largely undetermined which kind of exercises that are most effective. The overall aim of this thesis was to evaluate and compare the effects of a high-load lifting exercise and individualized low-load motor control exercises for patients with nociceptive mechanical low back pain. A secondary aim was to evaluate which patients benefit from training with a high-load lifting exercise. All four papers in this thesis were based on a randomized controlled trial including 70 participants with nociceptive mechanical low back pain as their dominating pain pattern. Participants were randomized into training with either a high-load lifting exercise (HLL), the deadlift, (n=35) or individualized low-load motor control exercises (LMC) (n=35). Both interventions included aspects of pain education. All participants were offered twelve sessions during an eight week period. The effects of the interventions were evaluated directly after and twelve months after the end of the intervention period. Outcome measures were pain intensity, activity, disability, physical performance, lumbo-pelvic alignment and lumbar multifidus muscle thickness. There was a significant between-group effect in favour of the LMC intervention regarding improvements in activity, movement control tests and some tests of trunk muscle endurance. For pain intensity there were no significant differences between groups. A majority of participants in both intervention groups showed clinically meaningful improvements from baseline to two and twelve month follow-up regarding pain intensity and activity. There were no significant differences between HLL and LMC regarding the effect on lumbo-pelvic alignment or lumbar multifidus thickness. The participants who benefit the most from the HLL intervention were those with a low pain intensity and high performance in the Biering-Sørensen test at baseline. The results of this thesis showed that the HLL intervention was not more effective than the LMC intervention. The LMC was in fact more effective in improving activity, performance in movement control tests and some tests of trunk muscle endurance, compared to the HLL intervention. The results imply that the deadlift, when combined with education, could be considered as an exercise to produce clinically relevant improvements on pain intensity in patients who prefer a high-load exercise. However, before considering deadlift training, the results suggest that pain intensity and performance in the Biering-Sørensen test should be evaluated.

Thesis (MScPhysio (Physiotherapy))--Stellenbosch University, 2008. / The prevalence of low back pain (LBP) in United Arab Emirates (UAE) is estimated to be about 57% in males and 64% in females. Low back pain is commonly treated by primary care physicians and physiotherapists in the UAE. are increasingly used for clinical assessment, to demonstrate and reflect on the effectiveness of an intervention. Oswestry Disability Index (ODI) is Self-reported outcome measure that widely used and recommended for LBP. ODI Arabic version was developed and validated in women population. To date no UAE Arabic version of the ODI exists which has been cross-culturally adapted, validated and published in the peer-reviewed literature. . Objective The objectives are, to cross-culturally adapt the Arabic version of the ODI developed in Tunisia to devise a pre-final ODI-UAE Arabic version; to pre-test the pre-final ODI-UAE Arabic version in a target group of patients to devise the final ODI-UAE Arabic version; and to determine the reliability and construct validity of the final ODI-UAE Arabic version. Study design Culture adaptation, reliability and validity testing. Methodology The cross culture adaptation of the ODI Arabic version developed in Tunisia was performed in accordance with the published guidelines. For reliability 108 clients of UAE nationals with LBP were consecutively selected and completed the final ODI-UAE Arabic version, at baseline and 48 hours, and test–retest reliability and internal consistency were calculated. For validity 108 completed the final ODI-UAE Arabic version, VAS, and the Squat test at baseline and 4 weeks follow up; construct validity, items frequency response, response to change and floor and ceiling were evaluated. Results The ODI-UAE (9 questions) had high level of test–retest with ICC of 0.99; the mean at baseline and 48 hours was (0.68); Cronbach's alpha was 0.99. Strong positive correlation with VAS r =>0.70 (p = <0.01), and moderate inverse correlation between ODI and Squat r =>0.65 (p = <0.01).The results of the maximum frequency response were less than 80% for the entire 9 question. The effect size and the SRM of ODI-UAE, VAS and Squat test at baseline and 4 weeks were identical comparable the effect size, were 1.66, 1.85, and 1.59 respectively. ODI-UAE demonstrated absence of floor and ceiling effect; less than 15% of the respondents achieved the lowest or highest possible score respectively (0 -11.5) or (87-100%). Conclusion The ODI-UAE Arabic version is an easy to understand, reliable and valid condition-specific outcome measure for the measurement of the limitation of functional ability cause by LBP in the United Arab Emirates national population.

Thesis (MScPhysio (Interdisciplinary Health Sciences. Physiotherapy))--University of Stellenobosch, 2010. / Background: Low back pain (LBP) has a high prevalence worldwide. LBP is significantly associated with a range of poor socio-demographic circumstances which should be addressed in preventive programs. Despite this there is a dearth of information about the prevalence and associated factors among low-income communities in South Africa. It is speculated that the burden of LBP may be most significant in these underprivileged communities. Objective: The objective of this study was to assess the prevalence of LBP among the lowincome communities in the Cape Town Metropole and to establish associated factors in order to make recommendations for management. Study design: A cross-sectional study was conducted among the visitors of eight community health centres (CHCs) in the Cape Town Metropole. Methodology: A new measurement tool was developed based on existing validated outcome measures and initial testing of the psychometric properties of the questionnaire was conducted. The questionnaire was administered to 489 eligible subjects. Descriptive analysis was used to describe the sample and logistic regression analytical techniques were applied to determine associated factors. Main findings: Lifetime prevalence for LBP was 76.49% (n=358). About 37% (n=133) suffered from chronic LBP. LBP was significantly associated with belonging to the black ethnic group, any co-morbidity, poor perceived general health, and any type of pain medication. Lifting weights > 20 kg and kneeling and squatting were physical factors significantly associated with LBP. Severe psychological distress was significantly associated with acute and chronic LBP. Having a better or same perceived general health compared to a year ago, was protective for LBP. Conclusion: LBP has a high prevalence among the low income communities, visiting the CHCs, in the Cape Town Metropole. Multiple factors were associated with LBP, which imply that a tailormade multidisciplinary program addressing lifestyle issues, self management strategies, medication use, chronic diseases and psychosocial factors may be required for this population to combat LBP.

This thesis describes the development of artificial disc technology for the replacement of intervertebral discs in the human lumbar spine. The clinical problem is back pain. There may be a relationship between certain forms of back pain and disc degeneration. The mechanical properties of human intervertebral discs are examined in detail. The genetic basis of disc degeneration is presented. The hypothesis is that such degeneration leads to a loss of normal stiffness in the segments affected leading to abnormal mechanical behaviour which in turn leads to pain. The evidence for this is presented. The development of surgical solutions to relieve back pain, from fusion through first generation mechanical artificial discs to elastomeric designs, is traced. The author‘s personal contributions to this area of knowledge are set out. The appreciation of the requirement for a restoration of physiological stiffness is argued throughout, showing where fusion and first generation discs have not met the clinical aim of pain relief, because they have not restored physiological stiffness. The path to an elastomeric, viscoelastic, polyhydrocarbon, rubber solution in the form of the “Freedom“ disc has filled 17 years of the author‘s academic pursuits. It will be shown that this technology may represent a possible solution to the clinical problem. Failure is part of all new advancement and this too is presented, to show how that has influenced thinking, producing original ideas to overcome these failures. Providing lessons are learned from these failures then our patients in the future will benefit.

This paper describes and tests a largely ignored but important preliminary step for comparative effectiveness research: retrospective evidence syntheses to first establish a knowledge base of condition-based medical conditions. By aggregating and organizing what is already known about a treatment or system, gaps in knowledge can be identified and future research designed to meet those gaps.An information synthesis process may also discover that few knowledge gaps in the knowledge base yet exist, the gaps are negligible, and / or treatment effectiveness and study quality is stable across many years, but is simply not clinically important. A consistent finding of low effectiveness is evidence against more research, including exclusion of a treatment from future comparative effectiveness studies. Though proponents of weak treatments or systems may choose to proceed with further research, use of public funds or resources that eventually increase costs to the public are unwarranted.By first establishing a treatment or system knowledge base, at least three comparative effectiveness research decisions are conceivable: (1) treatment or system should be included in future comparative effectiveness trials to establish relative effectiveness for a given condition, (2) has promise but requires more research in a prospective CER trial, or (3) the treatment is less effective than others for a given condition, making future research unnecessary. Thus, a "retroactive comparative effectiveness research method," rCER, is proposed here to identify which treatments are worth including in future prospective trials and which are known to have small to modest effect sizes and are not worth the time and expense of a closer look.The rCER method herein showed that for non-surgical low back pain any treatments did not improve greatly upon the normal and natural pain trajectory for acute low back pain. Therefore, any advantage in pain reduction by any treatment of acute low back pain over back pain's normal course of resolution without care, is quite small, and as such, the incremental cost for the marginal improvement over no treatment becomes quite large. While the quality of non-surgical low back pain studies over the past 34 years has steadily increased, the effect size has not, leading to the conclusion that future research on non-surgical low back pain treatment is unwarranted.

Aims: The aim of this study was to investigate Core Stability Exercise (CSE) induced changes in trunk sagittal acceleration as a measure of performance in participants following an acute onset of non-specific low back pain (LBP). Methodology: A Lumbar Motion Monitor (LMM) was used to measure trunk sagittal acceleration. The LMM was demonstrated to be reliable [Intra-Class Correlation (ICC) for average sagittal acceleration (0.96, 95% CI 0.90-0.98) and peak sagittal acceleration (0.89, 95% CI 0.75-0.96) with a 95% limit of agreement for the repeated measure of between -100.64 and +59.84 Deg/s2 ]. Pain was measured using the Visual Analogue Scale (VAS) and disability was measured with the Roland Morris Disability Questionnaire (RMDQ). Results: Differences in mean trunk sagittal acceleration between control and experimental groups at time points were assessed using a regression analysis (ratio of geometric means [95%CI]) and demonstrated to be not statistically significant (3 weeks (20%) 1.2 [0.9 to 1.6], p=0.2; 6 weeks (10%) 1.1 [0.8 to 1.5], p=0.7; 3 months (20%) 1.2 [0.8 to 1.9], p=0.9). Similarly, differences in mean pain score (3 weeks (30%) 1.3 [0.8-2.2], p= 0.3); 6 weeks (20%) 1.2 [0.7-2.0], p=0.6; 3 months (0%) 1.0 [0.5-1.9], p=1.0) and difference in mean disability score (6 weeks (0%) 1.0 [0.7-1.5], p= 1.0, 3 months (30%) 1.3 [0.8-1.9], p= 0.3) between groups were also not statistically significant. Conclusions: This work does not infer that CSE are definitively effective in reducing pain, improving subjective disability and improving trunk performance after an onset acute of non-specific LBP. However, there is a suggestion of clinical importance and a possible mechanism by which they may work. Further investigation into this mechanism may provide future effective management strategies for intervention of acute non-specific low back pain with optimistic cost implications for healthcare delivery in general and Physiotherapy in particular.

Back pain is a massive global public health problem with multiple contributing factors including obesity. Obesity is thought to be linked to back pain through mechanical factors. However, obesity also causes a systemic low-grade inflammatory milieu. This would suggest a possible biochemical link between obesity, intervertebral disc degeneration, and back pain. Furthermore, the relationship between obesity and the clinical presentation of spine patients is unclear. This thesis aims to examine the effect of and relationship between obesity, the intervertebral discs, and back pain from biochemical, clinical, and epidemiological perspectives. In this thesis, an in vitro study assessed the effect of leptin, a fat-specific cytokine, upon the intervertebral disc. The bovine intervertebral disc was used as a model in a cell culture system. An ex vivo study examined leptin and pro-inflammatory cytokines produced by paraspinal adipose tissue taken during routine surgical procedures from spinal patients. Plasma taken from patients presenting with low back pain was analysed by mass spectrometry and multiplex immunoassay to identify possible protein biomarkers. At an epidemiological level, statistical modelling of the Genodisc patient population was conducted. This was a pan-European study of 2636 patients presenting to tertiary spinal units. Analyses were performed to examine relationships between obesity, quantified by body mass index (BMI), and pain, clinical diagnosis, and spinal degeneration identified on magnetic resonance imaging (MRI). Leptin was shown to increase the production of and expression of degradative and pain-generating molecules by disc cells. A pro-inflammatory environment, especially IL-6, potentiated this response. Leptin and pro-inflammatory cytokines produced by paraspinal fat were unrelated to clinical symptoms. However, levels of the pro-inflammatory cytokines, TNF-&alpha; and IL-6, were raised in the plasma of patients with greater pain or those with spinal stenosis. Furthermore, clusterin and complement were identified, by mass spectrometry, as potential biomarkers for spine patients. Epidemiological analyses revealed that obesity was associated with greater back pain, although the magnitude of this association was small. Similarly, obesity was associated with a diagnosis of spinal stenosis. Finally, increased BMI was found to be an independent predictor of disc degeneration, spinal stenosis, and disc herniation on MRI. In summary, this thesis has furthered the clinical understanding of lumbar spine pathology and back pain. It will provide clinicians with a better framework to assess spine patients. These results show that obesity is associated with lumbar spine degeneration and pain. Leptin could be a factor mediating this relationship. Further studies should concentrate on clarifying the mechanism of action of leptin upon the intervertebral disc and assessing the longitudinal effect of obesity upon the lumbar spine. In this thesis, an in vitro study assessed the effect of leptin, a fat-specific cytokine, upon the intervertebral disc. The bovine intervertebral disc was used as a model in a cell culture system. An ex vivo study examined leptin and pro-inflammatory cytokines produced by paraspinal adipose tissue taken during routine surgical procedures from spinal patients. Plasma taken from patients presenting with low back pain was analysed by mass spectrometry and multiplex immunoassay to identify possible protein biomarkers. At an epidemiological level, statistical modelling of the Genodisc patient population was conducted. This was a pan-European study of 2636 patients presenting to tertiary spinal units. Analyses were performed to examine relationships between obesity, quantified by body mass index (BMI), and pain, clinical diagnosis, and spinal degeneration identified on magnetic resonance imaging (MRI). Leptin was shown to increase the production of and expression of degradative and pain-generating molecules by disc cells. A pro-inflammatory environment, especially IL-6, potentiated this response. Leptin and pro-inflammatory cytokines produced by paraspinal fat were unrelated to clinical symptoms. However, levels of the pro-inflammatory cytokines, TNF-α and IL-6, were raised in the plasma of patients with greater pain or those with spinal stenosis. Furthermore, clusterin and complement were identified, by mass spectrometry, as potential biomarkers for spine patients. Epidemiological analyses revealed that obesity was associated with greater back pain, although the magnitude of this association was small. Similarly, obesity was associated with a diagnosis of spinal stenosis. Finally, increased BMI was found to be an independent predictor of disc degeneration, spinal stenosis, and disc herniation on MRI. In summary, this thesis has furthered the clinical understanding of lumbar spine pathology and back pain. It will provide clinicians with a better framework to assess spine patients. These results show that obesity is associated with lumbar spine degeneration and pain. Leptin could be a factor mediating this relationship. Further studies should concentrate on clarifying the mechanism of action of leptin upon the intervertebral disc and assessing the longitudinal effect of obesity upon the lumbar spine.