Clinical trial NCT04320836: Non-organic Signs to Predict Outcomes for Neck Pain
Official title: Prospective Study to Determine Evaluate the Validity and Predictive Ability of Physical Exam Signs for Cervical Radiculopathy to Predict Epidural Steroid Injection (ESI) Treatment Outcomes.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Radiculopathy
Cervical Radicular Pain
Keywords: Cervicalgia
Neck pain
Cervical radiculopathy
Cervical radicular pain
Epidural steroid injection
Non-organic sign
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Washington DC VA Medical Center
name: Seoul National University
First posted: 2020-03-25
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with clinical and MRI evidence of cervical radicular pain who are scheduled to undergo cervical epidural steroid injection

Brief summary: Neck pain is the 4th leading cause of disability in the world, with approximately 50% being neuropathic in nature. Epidural steroid injections (ESI) are one of the most commonly used treatments for cervical radiculopathy. Physical exam signs, including non-organic signs, have been shown to predict outcomes for low back pain treatments, but have yet to be adequately studied for neck pain.

In this prospective, observational study, 72 patients with cervical radiculopathy undergoing an initial ESI for this pain episode will undergo a comprehensive history and physical examination that includes the presence of Spurling test, midline and paraspinal tenderness, 9 non-organic tests in 5 categories, and 3 questionnaires to assess depression, anxiety, sleep, and somatization. The investigators will also evaluate patients' MRI results to determine patients' precise pathology. Patients will then receive interlaminar cervical ESI. The primary outcome measure will be the difference in the proportion of people with a positive categorical outcome, defined as a \>/= 2-point decrease in arm pain 4 weeks post-procedure coupled with a score \>/= 5 on a 7-point patient global impression of change (PGIC) scale 4 weeks post-treatment, indicating subjective improvement.

The main objectives of this study are to:

1. Determine the ability of physical exam, including non-organic signs, to predict ESI outcomes in individuals with cervical radicular pain.
2. Determine the prevalence of different non-organic signs, and the association with other factors that may be associated with non-organic illness such as psychopathology and multiple unrelated pain conditions.

Detailed description: Seventy-two patients with cervical radiculopathy undergoing an initial ESI for this pain episode will undergo a comprehensive history and physical examination that includes the presence of Spurling test, midline and paraspinal tenderness, 9 non-organic tests in 5 categories, and 3 questionnaires to assess depression, anxiety, sleep, and somatization.

Non-organic signs that the investigators will evaluate are:

1. Tenderness

   1. Superficial
   2. Non-anatomical (e.g. cervical radicular pain causing tenderness in the arm or mid-back)
2. Sham stimulation

   1. Downward pressure on head elicits neck pain
   2. With hands clasped behind neck, passive rotation of shoulders elicits neck pain
3. Distraction

   a. Inability to rotate head \> 45 degrees during overt range-of-motion testing, but significantly greater range of motion when patient is lying prone and asked to turn head to respond to physician request (e.g. sign paper, count fingers, answer question).
4. Regional disturbances

   1. Sensory disturbances that deviate from normal neuroanatomy or pathology (e.g. single herniated disc causing pain throughout entire arm or radiating into lower back)
   2. Motor disturbances that deviate from normal neuroanatomy or pathology (e.g. dramatic non-neurological weakness, give-away weakness)
5. Overreaction

   1. Verbal (e.g. crying, screaming)
   2. Non-verbal (e.g. exaggerated grimacing, clutching affected area, abnormally slow or rigid movements)

The investigators will evaluate MRI results to determine the precise pathology. Patients will then receive interlaminar cervical ESI. In accordance with standard practice, a Tuohy needle will be directed towards the side of the radicular pain, with correct needle position in the epidural space being confirmed with real-time contrast injection. Once the physician is satisfied with the spread, a 3 mL solution consisting of depo-methylprednisolone 40 mg + 2 mL normal saline will be injected. At Seoul National University, due to Korean healthcare regulations, the mixture will be a 3 mL solution containing 10 mg of dexamethasone and 2 mL saline. The primary outcome measure will be the difference in the proportion of people with a positive categorical outcome, defined as a \>/= 2-point decrease in average arm pain 4 weeks post-procedure coupled with a score \>/= 5 on a 7-point patient global impression of change (PGIC) scale 4 weeks post-treatment, indicating subjective improvement. Secondary outcome measures will include mean reductions in average and worst 0-10 numerical rating scale (NRS) arm pain scores over the past 7 days, mean reduction in average and worst neck pain scores, neck disability index (NDI) score, medication usage, patient global impression of change (PGIC), Hospital Anxiety and Depression Scale (HADS), Athens Insomnia Scale (AIS), Somatic Symptom Scale-8 (SSS-8), and side effects. Individuals who experience a positive categorical outcome at 4 weeks will continue to be evaluated at 12 weeks, while those with a negative outcome will exit the study.

Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Cervical radicular pain based on history and physical exam (e.g. pain radiating into one or both extremities, sensory loss, muscle weakness, Spurling's test etc.)
* Pain duration \> 6 weeks
* Average NRS arm pain score \> 4
* MRI evidence of disc pathology consistent with symptoms

Exclusion Criteria:

* Untreated coagulopathy
* Previous spine surgery
* No MRI study
* Epidural steroid injection within past 3 years
* Radiculopathy resulting from tumor or herpes zoster
* Signs or symptoms or myelopathy or spinal cord compression
* Allergic reactions to contrast allergy including macrocyclic gadolinium or depo-methylprednisolone
* Referrals from surgery for diagnostic injections for surgical evaluation
* Serious medical (e.g. congestive heart failure) condition that might preclude optimal outcome
* Pregnancy

Primary outcomes:
measure: Categorical response
timeFrame: 4 weeks
Secondary outcomes:
measure: Average arm pain
timeFrame: 4 weeks
measure: Worst arm pain
timeFrame: 4 weeks
measure: Average neck pain
timeFrame: 4 weeks
measure: Worst neck pain
timeFrame: 4 weeks
measure: Neck disability index (NDI) score
timeFrame: 4 weeks
measure: Somatic Symptom Scale (SS-8) score
timeFrame: 4 weeks
measure: Athens Insomnia Scale (AIS) score
timeFrame: 4 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 4 weeks
measure: Patient Global Impression of Change (PGIC) scale
timeFrame: 4 weeks
measure: Patient Global Impression of Change (PGIC) scale
timeFrame: 12 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 12 weeks
measure: Athens Insomnia Scale (AIS) score
timeFrame: 12 weeks
measure: Somatic Symptom Scale (SS-8) score
timeFrame: 12 weeks
measure: Average arm pain
timeFrame: 12 weeks
measure: Worst arm pain
timeFrame: 12 weeks
measure: Average neck pain
timeFrame: 12 weeks
measure: Worst neck pain
timeFrame: 12 weeks
measure: Neck disability index (NDI) score
timeFrame: 12 weeks
measure: Categorical response
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: DC VA Medical Center
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Seoul
country: Korea, Republic of
facility: Seoul National University
Study officials:
affiliation: Johns Hopkins University
name: Steven P Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fishbain DA, Cole B, Cutler RB, Lewis J, Rosomoff HL, Rosomoff RS. A structured evidence-based review on the meaning of nonorganic physical signs: Waddell signs. Pain Med. 2003 Jun;4(2):141-81. doi: 10.1046/j.1526-4637.2003.03015.x.
citation: Waddell G, McCulloch JA, Kummel E, Venner RM. Nonorganic physical signs in low-back pain. Spine (Phila Pa 1976). 1980 Mar-Apr;5(2):117-25. doi: 10.1097/00007632-198003000-00005.
citation: Jorritsma W, Dijkstra PU, De Vries GE, Geertzen JH, Reneman MF. Physical dysfunction and nonorganic signs in patients with chronic neck pain: exploratory study into interobserver reliability and construct validity. J Orthop Sports Phys Ther. 2014 May;44(5):366-76. doi: 10.2519/jospt.2014.4715. Epub 2014 Apr 14.