Non-organic Signs to Predict Outcomes for Neck Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-15

Study Completion Date

2022-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effectiveness of Cervical Transforaminal Epidural Steroid Injection

NCT04544683

Cervical Radiculopathy Cervical Spondylosis Disk, Herniated

COMPLETED PHASE4

Correlation of Intravascular Injection Rate and Severity of Cervical Neural Foraminal Stenosis

NCT04071483

Analgesia, Epidural

UNKNOWN NA

Transforaminal Versus Lateralized Interlaminar Cervical Epidurals

NCT03389620

Cervicogenic Upper Extremity Radiculopathy

COMPLETED PHASE2

Dispersal Pattern for Spine Injections (Gadolinium Contrast)

NCT02217280

Cervical Radiculopathy

COMPLETED NA

Comparative Trial Via Tranforaminal Approach Versus Epidural Catheter Via Interlaminar Approach

NCT03382821

Cervical Radiculopathy

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Radiculopathy Cervical Radicular Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cervical epidural steroid injection

This group will receive an interlaminar cervical ESI at C6-7 or C7-T1 with 1 mL steroid (depo-methylprednisolone 40 mg at Johns Hopkins and the DC VA Hospital or dexamethasone 10 mg at Seoul National University) and 2 mL normal saline.

Cervical epidural steroid injection

Intervention Type PROCEDURE

Interlaminar cervical epidural steroid injection with steroid and normal saline at C6-7 and C7-T1 (standard of care).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cervical epidural steroid injection

Interlaminar cervical epidural steroid injection with steroid and normal saline at C6-7 and C7-T1 (standard of care).

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No