A single blind randomised placebo-controlled
Contents
Page
Abstract 2
Acknowledgement 4
List of Contents 5
List of Appendices 9
List of Figures 10
List of Tables 11
Section 1- Introduction 13
Section 2- Literature Review 21
2.1. Mechanisms of action of soft tissue mobilisation 22
2.2. The thoracolumbar fascia and low back pain 29
2.3. Evidence for Neurophysiological effects of soft tissue mobilisation 33
2.4 Justification for study 39
Section 3 – Research Questions and Hypothesis 40
3.1. Research Question 41
3.2. Hypothesis 41
3.3. Null Hypothesis 41
3.4. Objectives of study 42
Section 4 – Methodology 43
4.1. Research Design 44
4.2. Ethics 44
4.3. Pilot Study 44
4.4. Participants 45
4.4.1. Statistical power analysis 45
4.4.2. Criteria for Participant Selection 46
4.4.3. Randomisation of participants 47
4.5. Data Collection 47
4.5.1. The Environment 47
4.5.2. Equipment and Outcome Measurement 47
4.5.3. Standardisation for Palpation of Spine 49
4.5.4. Standardisation of positioning of participants 50
4.5.5. Standardisation of electrodes 51
4.5.6. Standardisation of blinding of researcher 51
4.5.7. Standardisation of position of researcher 52
4.6. Data Analysis 55
4.6.1. Homogeneity of the independent groups 55
4.6.2. Skin Conductance Differences 55
4.6.3. Post Intervention Questionnaire 56
Section 5 – Results 57
5.1. Homogeneity of the independent groups 58
5.2. Skin Conductance Differences 60
5.2.1. Skin conductance changes from baseline to final rest period 60
5.2.2. Skin conductance changes from baseline to treatment 64
5.2.3. Skin conductance changes from treatment to final rest period 67
5.3. Analysis based on Tukey Test 71
5.4. One Way ANOVA Analysis 72
Section 6 – Discussion 73
6.1. Research questions and Hypotheses 74
6.1. Limitations of study 80
6.2. Recommendations 82
Section 7 – Conclusion 84
Section 8 –References 87
Section 9 – List of Appendices 103
- INTRODUCTION A single blind randomised placebo-controlled
Low back pain (LBP) is a common musculoskeletal disorder that has been described as a myth in the medical world (Hollenbeck et al, 1992) due to the complexity of formulating accurate diagnosis (Gullian et al, 2001) and diagnostic uncertainties, (De Vet et al, 2002). It affects most people at least once in their life time with a lifetime prevalence of 84%; 23% will end up developing chronic low back pain and 11-13% of the population become disabled by low back pain, while about 9% will seek for physiotherapy intervention (Maniadakis and Grey, 200; NICE 2009, Health and Safety Executive, 2005).
Non specific low back pain (NSLBP) has been defined as “tension, soreness or stiffness” in the lower back, which is difficult to identify the specific cause or pathology of the nociceptive pain (Foster and Wright, 2006; Tulder et al, 2006). It is one of the major reasons for sick- leave/absenteeism at work in the United Kingdom, estimated at 12.5 % of total work absenteeism due to ill-health (Frank 1993). About 4.5 million of work days were estimated to be lost in 2004/2005 due to low back pain disorders (Health and Safety Executive, 2005). The impact of LBP on the individual, society, family and economy in the developed world is very substantial and costly Waddell (1996; Pransky et al (2011); costing about £10 billion in economic loss in 1998 (Maniadakis and Gray, 2000).
Recommendations (A single blind randomised placebo-controlled) by the Clinical Standards Advisory Group of 1994 on clinical guidelines in the management of NSLBP has resulted in further publications and guidelines in the early management of persistent NSLBP (NICE 2009, CSP 2006, CSAG, 1994). Recent guidelines in the management of NSLBP and a number of researches and systemic reviews, Slater et al (2012) & Bronfort et al, (2004) have recommended the use of physiotherapy in the management of non specific low back pain.
These guidelines/ recommendations have also supported the use of manual therapies in the management of NSLBP. Researchers have also recommended the need to investigate the effective treatment modalities for LBP, which is beneficial to the health care management of the patient and healthcare policy makers (Dagenais et al 2010 Brontfort et al, 2008).
Manual therapy is usually divided into “soft tissue” manual therapy and “joint based” manual therapy. The term, spinal manual therapy, is sometimes used to designate manual therapies including soft tissue mobilisation techniques, spinal mobilisation (or low intensity, high amplitude manipulation) technique, manipulative thrust (or high velocity low amplitude manipulative technique) and mobilisation with movement, designed by Mulligan (Maigne et al 2003).
It is commonly known that the spinal structures, which include the facet joints, vertebrae, intervertebral discs, spinal ligaments and the vertebrae, are common causes of NSLBP, the involvement of the muscles, fasciae and other soft tissues as causes of back pain has been undermined (Stecco et al, 2011). Soft tissue mobilisation as a manual therapy, involves all forms of mobilisation of the tissue like, myofascial release techniques (MFR), structural integration (Rolfing), trigger point release, , muscle energy releases, (MET), connective tissue release (CTM), instrument assisted myofascial release (Graston technique), strain-“counterstrain” technique and massage (Simmonds et al, 2012).
Despite A single blind randomised placebo-controlled, patient reported benefits of manual therapy, including soft tissue mobilisation in healthcare management of low back pain, there has been little researches done on the neurophysiological effects of STM, though does not negate the physiotherapeutic/ clinical effects of STM but results in limited acceptance of the use of this technique in the management of LBP within the scientific and healthcare communities (Sparkes 2005; Konstantinous et al, 2007).
There is also the debate about the significance and mechanism of the treatment effects of STM in the management of low back pain (Potter et al, 2005). However, the patient reported outcomes of STM in the management of low back pain are subjective, and there is the need to substantiate scientifically and to collect data on the neurophysiological effects, (using the BioPac System to collect data on skin conductance) in asymptomatic population. The analysis of this data and results will help in clinical application in a larger and symptomatic population.
There is increasing evidence of the involvement of muscles and fasciae in the development of back pain (Malanga et al, 2010; Schleip et al, 2005 & Willard et al, 2012). Researchers have reported that the lumbar dorsal horn receives nociceptive input from the nociceptive free nerve endings of the thoracolumbar fascia, hence the involvement of the thoracolumbar fascia in low back pain cannot be overlooked (Tesarz, et al, 2011, Corey, et al, 2011).
GiGiovanna et al, (2004) reported that trauma to the soft tissues results in irritation and pain in these soft tissues with resultant tension built-up in the muscles, and an eventual vicious cycle occurs with tissue ischaemia and tissue waste product built-up, which also act as a noxious stimulus, further irritation, pain and tissue inflammation and that MFR is able to relax these tensed muscles, increase blood circulation to the ischaemic tissues, stimulate the stretch reflex in hypotonic muscles and also increase venous and lymphatic drainage to these tissues, reducing local swelling or edema.
Physiotherapists use soft tissue mobilisation is used in the treatment of low back pain, and it has been established that pain is linked to the somatic and well as the autonomic changes in the body (Lewit, 2010). Autonomic activation such as changes in the heart rate (vagal tone), blood pressure and skin conductance have been observed in the use of manual therapies, such as myofascial release (Holey 2000). However, there has not been any clinical trial to demonstrate the effect of soft tissue mobilisation on the sympathetic nervous system.
This study investigates if using the myofascial release technique using sacral traction applied over the thoracolumbar fascia has any effect on the sympathetic…
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