Neck Pain Clinical Trial
Official title:
Addition of 3D Posture Corrective Orthosis To A Multimodal Program In The Treatment Of Nonspecific Neck Pain. A Randomized Pilot Trial.
Nonspecific neck pain (NSNP) is one of the most common musculoskeletal problems treated by orthopaedic physicians and physiotherapists . NSNP has an annual incidence rate of 38 to 73% and a lifetime prevalence of approximately 48%, leading to both economic and social problems.
Posture has emerged as a major risk factor associated with NSNP, but most previous studies
have ignored correct posturing as an effective treatment. The few studies that used posture
corrective strategies were based on a dated concept that did not incorporate the 3D nature of
posture into the treatment strategy . Therefore, one of the major challenges faced by
clinicians is how to incorporate 3D posture findings into the treatment plan.
Harrison and colleagues reported that posture problems occurred in the head, ribs and pelvis
in three dimensions in the form of translations and rotational displacements. Therefore, we
should consider three-dimensional postural assessment and correction during the treatment of
NSNP to obtain long-lasting effects and prevent the recurrence of neck pain.
Several tools are available for objective postural measurements in clinical use, including
simple plumb line measure, photographic techniques , moiré topography and various
computer-assisted methods, such as electro goniometers. These methods are used in clinical
assessments, but they have limitations, including the inability to measure neck posture as
rotations and translations in six degrees of freedom, as mentioned by Harrison and
colleagues.
The current study will use a 3D analysis system called the Global Postural System (GPS) ,
which is a novel device that investigates all postural variables at once and provides the
managing physiotherapist with radiation-free and accurate measurements . This device also
provides further information about foot pressure analysis and other 3D features that allow
bracing designs to be tailored for each patient .
Numerous studies have shown that mirror images in motion exercises, which are prescribed
specifically to help normalize the patient's neuromuscular dysfunction and postural
deformation via reflecting the patient's posture across different planes, are more beneficial
than a less personalized programme.
With these considerations in mind and to integrate the findings of 3D postural assessment
into the treatment programme, we designed an adjustable cervico thoracic posture corrective
orthotic (CTPCO) to be worn by the patient for a short time. The device has the ability to
reflect all transitional displacements and rotational movements of the head. Ambulatory
exercises will be performed using a treadmill while the CTPCO holds the patient's reverse
posture.
We designed a randomized two-arm pilot trial to investigate the hypothesis that the addition
of a 3D adjustable CTPCO to a multimodal programme will produce short- and long-term
improvement effects on NSNP management outcomes (i.e., neck pain, neck disability and 3D
posture parameters of the head).
The primary aim of this study is to evaluate the feasibility of conducting a larger
randomized trial that considers recruitment, compliance to study protocols and adverse
events. The secondary aim is to investigate the effect size of the addition of ambulatory
mirror image functional re-training via the wearing of a 3D adjustable CTPCO compared to
control group interventions for neck pain, disability and 3D posture parameters.
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