Kym

Kymbo's part of Proposal: It is anticipated that participants for the study will be drawn from the osteopathic student population at Victoria University. Participants will be recruited via posters placed around the teaching clinics, at both the City Flinders Campus and Footscray Park Campus. Participants will be invited to contact the principle researcher to indicate their willingness to participate in the study.
 * __Method: __**
 * __Participants: __**

 30 healthy volunteers will be needed to obtain a power value of ….. **__ Nick to compleyte power value and effect size __**  **__Exclusion criteria:__** Participants will be excluded from this study if they have a history of, or are currently suffering from lower back pain for longer than six months. All participants will be given a consent form to fill out and sign. They will also be neurologically screened by one clinician before initiating the experiments to exclude subjects with radiculopathy or peripheral neuropathy. Any participants who would be contraindicative to HVLA will also be excluded.

**__Experimental design: __**  Cross-over design???, ( __**Nick to complete type of study design)**__ where participants will be in both the control and experimental group which will allow us to definitively compare the two groups. The control and experimental procedures will be tested one week apart. The control measure will be assessed first, as it has been shown that HVLa can have lasting affects over a period of 6months. By testing the control first, we hope to eliminate any effect that previous HVLA manipulation could have on our study. 

Subjects were positioned supine in the treatment table. At the beginning of the experimental session, the TMS impulse intensity was set to 60% of maximum output. Stimulus intensity was increased in 10% increments on successive trials until stimulus intensity reached 100% of stimulus output. At 100% of stimulus output, the TMS coil was repositioned by hand until an MEP was recordered with a maximal amplitude and a minimal latency. Motor threshold is defined as the lowest stimulus intensity required to produce a MEP of at least 50μV amplitude in at least 5 of 10 consecutive trials. (ref) if a MEP cannot be produced at 50μV of 100% stimulator, then these patients will be excluded from the study. (GARY TO CHECK): During the procedure to determine the optimal stimulation site, a cap with co-ordinates placed on it will be used. This can then be used as a reference point during the study. ?????????  After determining the optimal stimulation site, 10 MEP’s will be recorded as baseline values. Immediately after the spinal manipulation or control side posture was performed, MEP’s were measured at 20-second intervals within the first 120seconds to determine the acute time course of post manipulation effects on central motor pathways. Ten MEP’s were also recorded at 5 and 10minute after manipulation (GARY TO CHECK): MEP’s were recorded by using an analog-to-digital converter (12-bit resolution) interfaced to a computer. The sampling rate was 5 kHz per channel. MEP amplitudes were measured online and stored in a data output file for statistical analyses. Labview software was used for data acquisition and data analysis The operator assisted the participant into a side posture; however no lower limb flexion or truncal torque was applied. In an effort to eliminate the effects of the manual application of force and velocity to the zygapophyseal joints, no manual contact was made with the spine. The participant was then returned to the supine testing position immediately after this side-posture, control procedure. After collection of the 10 baseline MEP’s a right sided L5-S1 side-posture HVLA manipulation will be administered. The patient is placed in a side-lying position, with hips in approximately 20degrees of flexion. The lower left leg is left straight, with the upper right leg slightly flexed. The upper body is rotated to the right until the level of L5-S1. The clinician then manually contacts the tissues overlying the zygapophyseal joint, reinforcing both the lower and upper body rotation. Ensuring that the participant is relaxed and once tissue tension was maximised, a HVLA force is applied. The thrust is applied in the direction of the apophysial joint plane, commonly in a direction of a line along the long axis of the patient’s right femur. After the L5-S1 HVLA has been applied, the participant is immediately returned to the supine testing position to record the MEP’s. (GARY NEEDED)
 * __Procedure: __**
 * Experimental Protocol **
 * Control group: **
 * HVLA **
 * Statistical Analysis: **

Alan's article regarding TMS use written last year has a method that we might be able to borrow portions from.. particularly the description of the TMS setup.. http://hvlaandtms.wikispaces.com/file/view/Pearce+2009+Corticomotor+excitability+during+precision+tasks.pdf

2) Ethics 3) Effects of lumbosacral manipulation (overview of the research showing effects – no need to be too detailed: ROM, pain, sympathetic responses, etc



hey th ese are the articles im reading atm:
 * Lx manip and postural pertubation- i thikn its a dishman article
 * Mechanical vs manual manipulation= __done! see below__

also just found an ebook on the librarys website TMS in clinical psychiatry so that had a chapter on safety stuff which i have copied and will read through and see what is relevant. There is also a book on TMS at footscray that i am getting sent over

**__SUMMARY FROM EBOOK:__** TMS is generally regarded as safe and without lasting side effect //s //. There have been no significant cognitive (Little et al. 2000; Triggs et al. 1999), neurological (Nahas et al. 2000), or cardiovascular sequelae reported as a result of repetitive TMS (rTMS). Single-pulse TMS has been in use for nearly 15 years. It is generally regarded <span style="-moz-background-inline-policy: -moz-initial; background: yellow; font-family: Times New Roman; font-size: 10pt; line-height: 115%;">as safe and virtually without lasting side effects
 * Safety:**

<span style="-moz-background-inline-policy: -moz-initial; background: yellow; font-family: Calibri; font-size: 10pt;">With extensive experience and encouraging results in human safety studies (Bridgers 1991; Bridgers and Delaney 1989), a general consensus has arisen that single-pulse TMS can <span style="-moz-background-inline-policy: -moz-initial; background: yellow; font-family: AGaramond-Regular; font-size: 10pt;">be performed safely in most individuals. Precautionary measures for single-pulse TMS studies vary widely. Generally, <span style="-moz-background-inline-policy: -moz-initial; background: yellow; font-family: Calibri; font-size: 10pt;">all that is required from the point of view of safety is to obtain a brief screening history to rule out the presence of metal in the head or eyes, implanted electronic <span style="-moz-background-inline-policy: -moz-initial; background: yellow; font-family: AGaramond-Regular; font-size: 10pt;">devices, and intracardiac lines. Guidelines for using single-pulse TMS are given in  <span style="-moz-background-inline-policy: -moz-initial; background: yellow; font-family: Calibri; font-size: 10pt;">a publication of the International Federation of Clinical Neurophysiology (Rossini <span style="-moz-background-inline-policy: -moz-initial; background: yellow; font-family: AGaramond-Regular; font-size: 10pt;">et al. 1994). <span style="-moz-background-inline-policy: -moz-initial; background: yellow; font-family: Calibri; font-size: 10pt;">To our knowledge, seizures have not occurred in healthy individuals undergoing single-pulse TMS, and reported adverse effects other than seizures have been limited to local discomfort and headache.
 * Single-pulse vs repeated**
 * Adverse reactions:**

hearing loss- <span style="-moz-background-inline-policy: -moz-initial; background: yellow; font-family: Calibri; font-size: 10pt;">A study of single-pulse TMS in humans <span style="-moz-background-inline-policy: -moz-initial; background: yellow; font-family: AGaramond-Regular; font-size: 10pt; line-height: 115%;">did not find any hearing loss (Pascual-Leone et al. 1992). headaches- At the Medical University of South Carolina, we studied 60 healthy young men in a sleep deprivation study (parietal cortex, 110% of MT [motor threshold], frequency range+1–20 Hz) (Anderson et al. 2006). They received large doses of TMS or sham TMS on three different days within a week. Of the 153 active TMS treatments delivered in the study, 19% were associated with reports of headache. Of the 29 sham treatments delivered, 17% were associated with headache. These differences were not significant. Rates of the occurrence and severity of headaches for this study are summarized in Tables 1–4 and 1–5, respectively. <span style="-moz-background-inline-policy: -moz-initial; background: yellow; font-family: Calibri; font-size: 10pt;">In this study of healthy young men, active TMS was not associated with a significant increase in reported headaches compared to sham TMS. It should be noted, however, that sham TMS is not completely inert. Of course, only active TMS actually results in cortical stimulation; however, both active and sham TMS produce loud (~80 dB) clicks (i.e., pressure waves), and both active and sham TMS procedures require subjects to sit still with their chins in a mechanical head holder. Although subjects wear ear protection and efforts are made to ensure they are reasonably comfortable in the TMS chair, the effects of the noise and prolonged immobility may result in increased muscle tension, fatigue, and headache in some subjects, even if no cortical stimulation is occurring. There is very little long-term (more than several weeks following treatment) <span style="-moz-background-inline-policy: -moz-initial; background: yellow; font-family: Times New Roman; font-size: 10pt; line-height: 115%;">safety data on subjects who have undergone TMS studies <span style="-moz-background-inline-policy: -moz-initial; background: yellow; font-family: Calibri; font-size: 10pt;">Like MR scanning, TMS may cause paramagnetic objects to move. Therefore, essentially the same precautions should be taken with TMS subjects regarding the <span style="-moz-background-inline-policy: -moz-initial; background: yellow; font-family: AGaramond-Regular; font-size: 10pt;">presence of paramagnetic metal objects in the head or eye. <span style="-moz-background-inline-policy: -moz-initial; background: yellow; font-family: Calibri; font-size: 10pt;">Conductive objects, including electrodes, implanted in or on the brain pose another potential problem for single-pulse TMS as well because of their theoretical ability to provide a lowresistance pathway for induced current and locally high-charge densities that could cause tissue damage. However, single-pulse TMS has been carried out in patients with subdural and thalamic electrodes. <span style="font-family: 'Times New Roman','serif'; font-size: 8pt;">© George, Mark S.; Belmaker, Robert H., Dec 05, 2006, Transcranial Magnetic Stimulation in Clinical Psychiatry <span style="font-family: 'Times New Roman','serif'; font-size: 8pt; line-height: 115%;">American Psychiatric Publishing, Inc., Arlington, ISBN: 9781585626373 Pages 20-30
 * Effects of TMS on paramagnetic or conductive objects in or on the head-**
 * Exposure during pregnancy-** <span style="-moz-background-inline-policy: -moz-initial; background: yellow; font-family: Calibri; font-size: 10pt;">The potential effects of TMS on a gestating fetus when the stimulation is administered to the mother’s head are not known. Therefore, pregnant women should not be exposed to TMS or other sources of powerful electromagnetic fields except <span style="-moz-background-inline-policy: -moz-initial; background: yellow; font-family: Times New Roman; font-size: 10pt; line-height: 115%;">when it is judged that the potential clinical benefit outweighs the risk

= this article wasnt really as good as i thought it could be and there wasnt much to take out of it at all but these are the points i found:
 * __ SUMMARY OF MECHANICAL VS MANUAL __**
 * spinal manip is an established and effective treatment of acute LBP
 * exclusion criteria (thought this would be similar to us, pretty much just containdictations)
 * red flags of serious pathology, inc history of cancer, pregnancy, previous lumbar surgery, stenosis, instability or other serious pathology
 * absolute contraindictations to manip- severe osteoporosis, prolonged use of steroids
 * positive nerve root tension signs
 * sensory or motor deficit in the lower extremities
 * the aim of the study was to explore the question of whether there is a difference in clinical outcome using activator and manual thrust manipulation for treatment of LBP. Results showed that there was a larger reduction in pain scores in the manual manipulation cohort