Prospective Study to Evaluate the Validity and Predictive Ability of Physical Exam Signs for Cervical Radiculopathy to Predict Epidural Steroid Injection (ESI) Treatment Outcomes

Neck pain is one of the five most common pain conditions and leading causes of disability worldwide. According to one systematic review, the estimated mean point, annual, and lifetime prevalence rates were 7.6%, 37.2% and 48.5%, respectively. In the only study examining the breakdown of neck pain according to mechanism, approximately 50% of people with chronic neck pain had neuropathic (i.e. radicular) pain. 

Among individuals with neuropathic neck pain, epidural steroid injections (ESI) are arguably the most effective non-surgical treatment, though questions remain regarding long-term benefit. Over the past 20 years, utilization of ESI in general and cervical ESI in particular almost tripled, leading to increased scrutiny on ESI and an Food & Drug Administration (FDA) panel discussion in November 2014. Cervical ESI may be associated with significant complications including paralysis, stroke and death, which led to calls to refine patient selection.

The use of non-organic signs to predict treatment outcomes has recently experienced a resurgence in interest. In 1980, the British orthopedic surgeon Gordon Waddell published a landmark article detailing eight non-organic clinical signs in five categories that they recommended be used as part of routine surgical screening. They found that people with multiple (> three out of five) non-organic signs (a.k.a. Waddell signs) were more likely to experience negative surgical outcomes for low back pain and to be identified as “problem patients.” Whereas subsequent studies have yielded mixed results for the ability of non-organic signs to predict low back pain treatment outcomes, these studies have generally been of poor quality, and until recently did not evaluate non-surgical interventional treatment outcomes (e.g. ESI). However, last year our group performed the first prospective study showing that non-organic signs were strongly correlated to low back pain (LBP) interventional treatment failure, including for lumbar ESI.

The main objectives of this study are to determine whether physical exam signs, including non-organic signs, predict cervical ESI outcomes; to validate the non-organic signs being published by determining their association with factors that may be associated with non-organic illness including psychopathology, secondary gain, and co-existing pain conditions; and to determine the prevalence of the various physical exam signs, including the non-organic signs, in patients with cervical radiculopathy.