Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05880511 |
| Other study ID # |
16310 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2024 |
| Est. completion date |
December 1, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
McMaster University |
| Contact |
Aimee Nelson, PhD |
| Phone |
9055259140 |
| Email |
nelsonaj[@]mcmaster.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this research is to investigate whether 2-4 weeks of augmented reality
sensorimotor training induces positive changes so as to effect pain relief in patients with
chronic neck pain. In addition, this study aims to determine if repetitive transcranial
magnetic stimulation (rTMS) delivered prior to augmented reality sensorimotor training
enhances the benefits from the sensorimotor training. This study will also use a battery of
questionnaires, functional assessments and electroencephalography markers to identify changes
following the sensorimotor training that may be associated with benefits in pain symptoms.
Before we embark on a larger study, we plan to investigate the feasibility of our study
procedures in a feasibility study involving 40 patients.
Description:
Chronic neck pain (CNP) is cervical pain that arises in the absence of a traumatic injury or
other known pathological abnormality (Borghouts et al., 1998; Cerezo-Téllez et al., 2016).
CNP is associated with deficits in motor control (Jull & Falla, 2016), increased
fatiguability (Falla et al., 2003), and hyperalgesia, such as increased pain sensitivity to
pressure and heat (Castaldo et al., 2019; Piña-Pozo et al., 2019). Patients with CNP also
experience myofascial pain syndrome (Cerezo-Téllez et al., 2016; Fernández-de-las-Peñas et
al., 2007). Myofascial pain syndrome is referred pain from myofascial trigger points that can
cause autonomic, sensory, and motor effects in areas distant from the trigger point
(Cerezo-Téllez et al., 2016). CNP is a debilitating condition that leads to decreased quality
of life and affects approximately 22% of Canadians (Côté et al., 1998). Previous work has
cited that the incidence of CNP increases with age (Andersson et al., 1993; Brattberg et al.,
1989; McLean et al., 2010). Individuals aged 45-55 are twice as likely to develop CNP
compared to younger individuals (Korhonen et al., 2003). Age is also associated with poorer
pain outcomes at 3 and 12 months following the arise of symptoms (Bot et al., 2005). Despite
this, no gold standard treatment for older individuals with CNP currently exists.
Recently, virtual reality has been used to treat pain and motor symptoms of CNP.
Specifically, this approach works by promoting goal directed movements of the neck towards
targets presented within a virtual environment. Neck training using virtual reality (VR) has
been shown to be as effective as manual exercise for improving pain and mobility in
individuals with chronic neck pain (Tejera et al., 2020; Grassini 2022). In addition, VR may
be more engaging compared to traditional exercise and shows an additional improvement in
proprioception, pain, and decreased functional limitations (Cetin et al., 2022) beyond
traditional exercise (Nusser et al., 2021). These environments also distract participants
with CNP from pain during movements aiming to positively influence kinesiophobia
(Luque-Suarez et al., 2019). Additionally, these effects have been suggested to occur as a
result of increased eye-head coordination required to successfully navigate and interact with
object within the VR environment (Revel et al., 1994: Humphreys & Irgens 2002) which promotes
neural connectivity between the vestibular system, neck, and eyes (Sarig et al., 2015). These
environments can also be adaptable to participant performance and require complex and dynamic
movements to complete certain tasks. These movements may improve an individual's perception
of cervical position and fine motor control which has been shown to lead to a reduction in
neck pain symptoms (Jull et al., 2007; Röijezon et al., 2008). We have developed a novel
augmented reality (AR) sensorimotor training task that promotes targeted goal directed
actions with the head and neck. AR is defined as technology that overlays digital object or
information into the real world (Berryman 2012). AR provides a unique opportunity for
participants to engage in training that may benefit sensorimotor control of neck movements.
Specifically, it allows for users to interact with virtual object overlaid on their actual
environment.
The beneficial effects of AR training may indeed be enhanced using repetitive transcranial
magnetic stimulation (rTMS) prior to AR training. Specifically, rTMS delivered to the primary
motor cortex may create an environment within the sensory motor cortex that promotes
neuroplasticity. This is accomplished through high frequency rTMS which increase cortical
excitability (León et al., 2018). This in turn promotes intraneuronal connectivity and
reorganization achieved through sensorimotor integration provided by the AR sensorimotor
training task. Additionally, rTMS facilities neuroplasticity and the retraining of cortical
circuits. This can be used to restore cortical activity that is altered in patients with CNP
(León et al., 2018).
Changes to the primary motor cortex (M1) have been implicated in the pain network
underpinning CNP. These include changes in the cortical territory (Elgueta-Cancino et al.,
2019) and activation patterns of the area representing the affected muscles during painful
and non-painful head movements (Beinert et al., 2017). Additionally, increased resting state
functional connectivity between M1 and superior parietal cortex has been associated with
greater local hyperalgesia (Coppieters et al., 2021). Taken together, these results suggest
altered sensorimotor processing during motor control of the neck leads to pain. This is
supported by findings in subclinical neck pain that have demonstrated deficits in
neuromuscular control of the neck (Zabihhosseinian et al., 2015), sensorimotor processing
(Baarbé et al., 2016), sensorimotor integration, and greater inhibition of the motor cortex
(Baarbé et al., 2018) in patients with subclinical neck pain compared to healthy controls. As
a result, changes in sensorimotor control between the cortex and affected muscles may
accompany changes in pain symptoms following a sensorimotor training intervention.
Sensorimotor control in CNP may be reflected in corticomuscular coherence (CMC). CMC is
derived from the correlation between electroencephalography recorded over the primary motor
cortex and electromyography recorded from an active muscle. CMC is suggested to reflect the
flow of information from the motor cortex to the muscle, as well as feedback from the muscle
back to the somatosensory cortex (Gross et al., 2000; Lim et al., 2014; McClelland et al.,
2012; Riddle & Baker, 2005; Salenius et al., 1997; Witham et al., 2011). In healthy
participants, von Carlowitz-Ghori et al. (von Carlowitz-Ghori et al., 2015) demonstrated that
CMC can be volitionally modified. During a steady state hold with the thumb, participants
improved their CMC value through different strategies such as mental imagery and attention
(von Carlowitz-Ghori et al., 2015). Taken together, these results suggest that CMC can
reflect deficits in cortical control of movement and may be used as a marker of improved
sensorimotor control between the brain and active muscle following a training task
implemented using AR.
The objective of our study is to investigate the use of rTMS paired with a novel AR
sensorimotor training task in CNP patients, to induce positive neuroplastic changes so as to
effect temporary and long-term pain relief. In addition, this study aims to determine if AR
leads to improvements in sensorimotor control of the neck measured through CMC. AR
sensorimotor training may induce cortical reorganization and improve motor function leading
to analgesic effects in patients with CNP. In addition, this is the first study in CNP to use
CMC to assess deficits observed in the voluntary sensorimotor control of muscles of the neck.
Effective long-term pain relief for older patients with CNP is currently an unmet medical
need. As such, this work aims to implement an innovative technique to provide meaningful and
long-lasting pain relief. This intervention aims to break the cycle of pain and improve
activities of daily living and quality of life in CNP. This is the first study to the best of
our knowledge combing rTMS with AR to treat patient with CNP.
