Effect of manual versus mechanically assisted manipulations of the thoracic spine in neck pain patients: study protocol of a randomized controlled trial
BACKGROUND
Neck pain is a common musculoskeletal condition with a point prevalence of around 15% in males and 23% in females that often presents in physiotherapy practice. Physical therapy and/or manipulation therapy is generally the first management option for patients with mechanical neck pain. Physical therapists treat mechanical neck pain with a number of interventions including joint mobilization and/or manipulation, therapeutic exercises or education. However, manipulation of the cervical spine carries some risks. Treating the thoracic spine for neck pain is an alternative approach. Emerging evidence suggests that it may be effective for treating neck pain without the risks associated with cervical spine manipulation. A new electromechanical device has recently been developed and tested for delivering multiple high velocity, low amplitude thrust manipulations to the spine. This device incorporates both auditory and visual systems that provide real time feedback on the applied treatment. The objective of this study is to compare the short- and long-term effects of manual versus mechanically assisted manipulations of the thoracic spine for neck pain patients.


METHODS/DESIGN
A 6-month, randomized controlled trial consisting of 54 patients with acute or chronic neck pain patients will be conducted. Patients with no signs of major pathology and with little or no interference with daily activities will be recruited. Three treatment sessions with 4-day intervals will be carried out. The patients will be randomly assigned to receive either manually performed manipulations or electromechanical manipulations at the thoracic spine. The primary outcome is pain intensity as measured by the Visual Analogue Pain Rating Scale. The secondary outcome measures are neck physical disability using the Neck Disability Index, quality of life measured by the European Quality of Life 5 Dimensions 5 Levels and patients' improvement using the Patient's Global Impression of Change Scale.


DISCUSSION
It is expected that both interventions will improve neck pain. This would be a significant finding, as thoracic spine manipulation for neck pain does not carry the same risk of injury as cervical spine manipulation. In addition, the results may provide useful information about therapeutic options for health care providers and patients for the problem of neck pain.


TRIAL REGISTRATION
Current Controlled Trials ISRCTN88585962, registered January 2013.