Clinical Research

72131
Proposal to Evaluate the Efficacy of the InterX 5000 in the Treatment of Chronic Neck and Shoulder Pain.

Triano, Jay

Electrical stimulation modalities of various types have been used as a therapeutic intervention for years in a wide variety of applications. Individuals with neck and shoulder pain represent a significant segment of the pain population seeking relief. However, there is a paucity of data from quality studies published in mainstream peer-reviewed journals supporting the effectiveness of this intervention [Hurley, McDonough, et al. 2004],[Godfrey, Morgan, et al. 1984],[Pope M.H., Phillips, et al. 1994],[Bronfort, Jacobesen, et al. 2004]. No well-designed prospective, randomized, controlled trials investigating the efficacy or effectiveness of this intervention in patients with chronic neck and shoulder pain have been reported.

72138
Acuball Clinical Trial.

Triano, Jay

Plantar fasciitis is a common musculoskeletal disorder which is characterized by the inflammation of the plantar fascia of the foot generally thought to be due to excessive traction (Stuber and Kristmanson, 2006). The pathologic changes of fasciitis are distinct and well defined with thickening of the fascia that may be associated with the accumulation of fluid and a bone spur from the calcaneous. Traditional treatment often is inadequate with continued pain associated on prolonged weight bearing. The Acuball Mini is a sphere approximately 2 inches in diameter with surface protrusions. The unique design is intended to provide an effective stretch and focal massage of the soft tissue that are reported anecdotally to reduce swelling and pain. The postulated effect is to improve the nutrient and blood flow to the affected area while removing any waste products and diminishing irritation (Cohen, 2005). The research aims to evaluate the Acuball Mini's ability to help in plantar fasciitis rehabilitation by self-application of spot pressure daily versus typical stretching procedures.

72150
Effectiveness of a lumbar support in maintaining the lumbar lordosis in sitting: A
radiographic comparison of initial and long-term effects on lumbar spine and pelvic posture during simulated prolonged driving.

De Carvalho ,Diana

According to the 2005 Statistics Canada General Social Survey, Canadians spend increasingly more time commuting to work; on average 63 minutes round trip. For professional drivers, such as truck drivers and police officers, driving time per day can be expected to be at least 7 hours. Sitting for prolonged periods of time in a vehicle has been identified as a cause of mechanical low back pain in the literature. In sitting, the pelvis rotates posteriorly and the lumbar lordosis flattens out. This places increased demand on back muscles and ligaments to hold the upper body erect and increases pressure in the discs of the spine. Maintaining the lumbar lordosis of the low back with a built in lumbar support has been suggested to relieve low back pain associated with prolonged sitting in a car seat. It is presently unknown whether this intervention actually causes a change at the level of the spine or merely compresses the soft tissue of the back. To date only one study has radiographically examined the changes in the lumbar spine in response to a lumbar support when sitting in a car seat; however, this study only included two participants one of which suffered from back pain. Radiographic analysis is deemed to be the most accurate representation of spine and pelvic mechanics as external measures of postures have been shown to be unreliable in the literature. Therefore, this study will explore the effectiveness of a lumbar support to cause a change in posture at the skeletal level at increments of horizontal excursion. Plain film x-rays taken concurrently with tri-axial accelerometers will be used to measure changes in lumbar spine and pelvic posture with and without a lumbar support.

72155
Validation of a novel sham cervical spinal manipulation procedure.
Vernon, Howard

A number of clinical trials of manual therapies for chronic neck pain have been published. The largest number of trials involves spinal manipulation as the primary therapy. No clinical trial of spinal manipulation for chronic neck pain, either of a single or multiple intervention sessions, has employed a sham control group. This calls the conclusions of these studies into question. The ability to employ placebo-type groups in future trials would greatly clarify the magnitude of the true therapeutic effect (“attributable” effect) of this form of treatment and help distinguish this effect from other non-specific effects.

We intend to validate a novel practical sham cervical spinal manipulation procedure by designing a placebo-controlled, repeated-measures design in eligible human subjects with chronic neck pain who will be randomized to receive either a “real” cervical or “sham” cervical manipulation procedure and determining if this design results in satisfactory blinding of participants (primary outcome #1). We intend to determine the immediate and short-term effects of these procedures on cervical paraspinal tenderness (primary outcome #2) as well as subjective pain ratings, cervical ranges of motion, cervical paraspinal EMG behaviour and postural control (secondary outcomes). We also intend to apply biomechanical analyses during these procedures to investigate the specificity of their effects, as measured by 1] the presence of joint cavitation, and, 2] the profile of forces imparted to the cervical spine.

This proposal has the potential to provide a novel, valid, practical sham procedure for use in clinical trials of cervical spinal manipulation as well as a novel, valid design for such future trials. This improvement in clinical trial methodology will assist our team (in future R01 proposals) as well as other researchers in determining the true benefit of this form of treatment to patients with neck pain.

Neck pain is very common. There is no sham control procedure for clinical trials of spinal manipulation for neck pain. Our study will validate such a procedure and help determine the effect of spinal manipulation on neck pain.

82002
Correlation of NDI scores with non-organic symptoms and fear-avoidance beliefs in neck pain patients.

Vernon, Howard

The concept of fear of movement or re-injury has gained considerable credence in rehabilitation theory in the recent past. It has been applied in the interpretation of patients' responses to their musculoskeletal pain complaints, particularly in interpreting what have come to be called "non-organic symptoms/signs" or "yellow flags". That is to say, such behaviors are increasingly understood as manifestations of pain-related fear or anxiety, which has been operationalized as fear-avoidance beliefs. Several measures of this phenomenon have been developed, including the Fear Avoidance Beliefs Questionnaire and the Tampa Scale for Kinesiophobia (TSK). These measures have not fully been applied in neck pain patients.

In this study, the correlation between levels of self-rated disability (scores on the Neck Disability Index (NDI)) will be correlated with scores of fear-avoidance beliefs (TSK scores) and non-organic symptoms (scores on the Pain Diagram) in patients with acute -chronic neck pain presenting at the CMCC Outpatient Clinic and at the North York Rehabilitation Clinic. It is predicted that high NDI scores will be positively correlated with high TSK and PD scores as well as with age and duration of complaint.

82003
Strength and flexibility of the psoas muscle and low back pain in athletes.

Forand, Dominique

Purpose: To determine the association between the strength and flexibility of the psoas and back pain in athletes. The null hypothesis is that increased strength and decreased flexibility will be associated with back pain.

Biography: The research on the function of the psoas muscle has brought forth conflicting evidence on the exact purpose of this muscle. Bogduk and McGill agree that the psoas acts as a hip flexor while causing shear and compression in the lumbar spine. Hockey is a sport that poses high demand on the psoas muscle, while flatwater kayaking poses low demand on the psoas muscle.

Methods: The hip flexor strength and flexibility of thirty hockey players and thirty flatwater kayakers between the ages of 16 and 20 will be measured. These athletes will also complete an Oswestry Back Disability Questionnaire. A T-Test will be used to determine the statistical significance between Oswestry scores for the hockey players and the kayakers. A T-Test will also be used to determine the statistical significance between hip flexor strength for the hockey players and the kayakers.

A regression analysis will be done to determine the relationship between hip flexor strength, hip flexibility, back pain and sport (hockey or kayaking).

82005
A Case of Trigeminal Neuralgia Presenting in a Rural Chiropractic Setting.

Rodine, Rob

A patient presents to a Chiropractic clinic with symptoms representative of Trigeminal Neuralgia (TN) and concomitant neck pain. The symptoms of TN started approximately 8 years earlier following surgery to remove a brain tumour. A short trial of therapy, including spinal manipulative therapy, resulted in improvement regarding symptoms and quality of life. TN will be explored through this case report, providing information on anatomy, neurology, clinical presentation, physical examination and diagnostic confirmation. The treatment choice of spinal manipulative therapy for concomitant neck pain will be explored, with specific anatomical relevance through the trigemino-cervical nucleus.

82006
A study of "simulated malingering" with neck isometric dynamometry.

Vernon, Howard

The phenomenon of insincere effort on muscular strength testing in the cervical spine, particularly in whiplash patients, has not been fully explored, despite its importance in the clinical setting. Target values of mean strength for each range, consistency of effort and presence of normal ratios of performance have not been established by which to evaluate isometric strength test performance in order to identify sincere vs insincere effort. In this study, normal subjects will feign malingering during isometric cervical muscle strength testing.
These tests will be compared to tests of their maximum tolerable efforts.

A convenience sample of student subjects with no neck pain and otherwise in good health will be employed. They will provide paired trials of isometric maximal tolerable effort (ME) in cervical flexion, extension, right and left bending against a stationary load cell. They will then be instructed to feign or simulate being a malingerer (SM) and then provide the same paired trials again.

Mean values for each range, average consistency, flexion/extension ratio and bilateral ratio will be derived in each mode. Inter-mode comparisons will be conducted with the appropriate parametric or non-parametric statistic.

82010
Validation of a novel group of cervical non-organic signs (C-NOS): neck pain patients.

Vernon, Howard

Cervical non-organic signs (C-NOS) are not as well-established as those for the lumbar spine. Sobel et al. [2000] have developed a set of such signs; however, the number of truly cervically-related signs (not symptoms) in this group is limited to one test. We propose that there should be additional tests in the C-NOS battery. We propose four new tests. We intend to determine if these tests qualify as NOS by performing them on normal, healthy students and on neck pain patients. Subjects will be asked to indicate if the tests provoke or aggravate neck pain (Yes/No) and if they appear to be relevant to the examination of the neck (Yes/No). Tests achieving a 95% rating on these two questions will be considered valid and potentially useful in future clinical studies.

82013
Hip Range of Motion and the influence on pitching performance.

Robb, Andrew

Overhand throwing involves a “motion-dependent interaction and sequencing” of the lower extremity to generate and transmit torque to the upper extremity to produce maximal ball thrown velocity (Putnam 1993) This model of interaction is known as the kinetic link or kinetic chain theory. The lower extremity, specifically the lead hip in pitching, is exposed to repetitive uniaxial loading, approximately 1.75 times body weight (Bach & Goldberg, 2006) concurrent rotational stressors with landing (MacWilliams et al, 1998; Mullaney et al, 2004). Ellenbecker et al (MacWilliams et al, 1998) described the hip rotational range of motion (rROM) profiles amongst professional baseball players exhibiting a greater proportion of with limitations in active external rotation (42%) than active internal rotation (17%). However, Vad et al (2003) noted internal rotational deficits of the lead hip (less than 7.6 degrees) and dominant throwing shoulder (less than 15.2 degrees) when compared to the uninvolved joints amongst tennis players. These range of motion deficits were only correlated with pain pathology in the absence of performance. This study proposes to correlate lead hip passive ROM (PROM) and pitched ball velocity in professional baseball pitchers by utilizing 3D motion analysis technology to capture and identify appropriate biomechanical data pitchers. 

This is a multi-institutional investigation involving the Canadian Memorial Chiropractic College (CMCC) and the American Sports Medicine Institute (ASMI) in Birmingham, Alabama. Dr. Andrew Robb (AR) will travel to Birmingham to collect data and recruit subjects July 1-13, 2008. A group of healthy male professional baseball pitchers (n=25) ages 18-40 years of age will be recruited from 2006-2008 baseball seasons. Currently, 20 subjects have been recruited and measured. AR will collect an additional 5 participants from the Birmingham Barons. Data collection will consist of history intake (medical, athletic, and physical examination), ball velocity measured using a radar gun, and kinematic data using inverse dyanmics. Biomechanical data collection is consistent with protocol previously described (Fleisig et al 1999; Dun et al, 2007; Miller & Nelson, 1973; Werner et al, 1993; Wood & Marshall, 1986; Barrentine et al, 1998). The primary research question is based on a correlation coefficient (r) model between passive hip ROM prior to pitching and ball velocity. For the p-value (p <0.05) anticipated, the strength of association will be set at r = 0.70 and a power of 0.80. (Winter, 1990). The sample size estimate is for 12 subjects, therefore there will be no problem of obtaining an appropriate sample size.

82016
An exploratory, uncontrolled, pilot study investigating the effects of subtalar joint manipulation on two outcome measures: weight bearing dorsiflexion range of motion and center of pressure excursion index.

Lee, Alex

Faulty biomechanical foot function, excessive pronation or supination, has been implicated in the generation of various lower extremity overuse injuries. Central to the creation of these complex movements is the function of the subtalar joint. The subtalar joint also plays a role in producing joint coupling movements that facilitate the development of gross functional foot movements, such as weight bearing dorsiflexion. It is postulated that subtalar joint manipulation may be able to correct aberrant subtalar joint motion and re-establish proper joint coupling during functional lower extremity maneuvers. Considering the subtalar joint pronates to contribute to the development of weight bearing lower limb dorsiflexion, the weight bearing dorsiflexion lunge test may be used to study the effects of subtalar joint manipulation. Plantar pressure parameters, specifically the center of pressure excursion index (CPEI), has been used previously to study various foot and ankle movements and pathologies. This measure has the potential to be used to study the effects of subtalar joint manipulation on dynamic foot function. No studies to date have investigated the effects of subtalar joint manipulation. Consequently, there exist no studies in the literature that can be used to obtain a sample size estimate. It is the purpose of this uncontrolled, exploratory pilot study to evaluate the utility of 2 outcome measures (weight bearing dorsilfexion range of motion and center of pressure excursion index) to study the effects of subtalar joint manipulation on foot function and to obtain data to determine a sample size estimate for a larger study investigating the effects of subtalar joint manipulation on foot function.