A single blind randomised placebo-controlled

 

ContentsA single blind randomised placebo-controlled

                                                                                                                                                 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 7Conclusion                                                                                                             84

Section 8References                                                                                                              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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