Surgery Prevention by Transforaminal Injection of Epidural Steroids for Cervical Radicular Pain (SPIES)

April 1, 2024 updated by: OrthoCarolina Research Institute, Inc.

Surgery Prevention by Transforaminal Injection of Epidural Steroids for Cervical Radicular Pain (SPIES): a Randomized, Controlled Trial

Cervical radicular pain is a common cause of disability and pain in the upper extremity and neck with an annual incidence of 83.2/100,000 (1). The initial treatment is conservative and includes relative rest, use of anti-inflammatory and analgesic medication, as well as physical therapy and home exercise. For patients who have persistent and significant symptoms, interventional pain management and surgical management are considered. Cervical epidural injections are the mainstay of the interventional, non-surgical modalities. They can be considered to provide short and long-term relief when disc herniation, foraminal stenosis or central canal stenosis pathology is identified. We are not aware of any published prospective, randomized, controlled, double-blinded studies demonstrating the efficacy of cervical transforaminal epidural steroid injections. However, the North American Spine Society (NASS) Review and Recommendation Statement states that based on the literature and expert opinion, a minimum of one or two cervical epidural steroid injections would be very appropriate in the treatment of a specific episode of cervical radicular pain.

The purpose of this study is to determine the effectiveness of cervical transforaminal epidural steroid injections in decreasing the need for an operation in patients with cervical radicular pain, otherwise considered to be operative candidates.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

Cervical radicular pain is a common cause of disability and pain in the upper extremity and neck with an annual incidence of 83.2/100,000 (1). The initial treatment is conservative and includes relative rest, use of anti-inflammatory and analgesic medication, as well as physical therapy and home exercise. For patients who have persistent and significant symptoms, interventional pain management and surgical management are considered. Cervical epidural injections are the mainstay of the interventional, non-surgical modalities. They can be considered to provide short and long-term relief when disc herniation, foraminal stenosis or central canal stenosis pathology is identified.

Cervical epidural injections can be performed by two different approaches, transforaminal and interlaminar. Transforaminal epidural injections allow delivery of medication to the ventral epidural space, while the interlaminar approach reaches the ventral epidural space in only 28% of injections (2-4). The results of cervical epidural injections remain controversial and their efficacy in decreasing the need for surgery in patients who would otherwise be operative candidates has not been thoroughly investigated. Studies have been limited by small sample sizes, lack of control groups, and lack of randomization. Kolstad et al reported that 23% (5/21) of patients waiting for cervical disc surgery cancelled surgery when assessed at four months after having a series of two cervical epidural injections (6). Lin et al reported that 63% (44/70) of patients who were deemed to be surgical candidates were able to avoid surgery with an average of 13-month follow up (7). Lee et al reported that over 80% of 98 patients evaluated with cervical radiculopathy were able to avoid surgery with a 2-year follow-up (8). Anderberg et al reported that there was no short-term difference in symptoms of cervical radiculopathy between patients who received transforaminal injections of steroid with local anesthetic versus saline with local anesthetic. However, this study did not evaluate whether the injections were successful in the patients avoiding surgery (11).

In terms of lumbar transforaminal epidural injections, Riew et al demonstrated that steroid injections obviated the need for surgery in patients with lumbar radiculopathy. Moreover, Reiw et al showed that steroid combined with local anesthetic was more effective than local anesthetic alone in a prospective, randomized, controlled, double-blinded study (9). Riew et al later studied the efficacy of cervical transforaminal epidural injections in the same fashion, but the findings were not statistically significant (p<0.35) and not published (10).

We are not aware of any published prospective, randomized, controlled, double-blinded studies demonstrating the efficacy of cervical transforaminal epidural steroid injections. However, the North American Spine Society (NASS) Review and Recommendation Statement states that based on the literature and expert opinion, a minimum of one or two cervical epidural steroid injections would be very appropriate in the treatment of a specific episode of cervical radicular pain. This literature also suggests that a maximum of four injections can be used within six months, assuming there was a positive response and improvement seen with the previous injections.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • OrthoCarolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects who have cervical radicular pain without significant neurologic deficit (neurologic deficit is defined as manual muscle testing less than 3/5), MRI/CT findings of neural compression (neural compression is defined as disc herniation or central or foraminal spinal stenosis),
  • Failed 6 weeks of conservative treatment (conservative treatment is defined as relative rest, home exercise, physical therapy, and use of anti-inflammatory and/or analgesic medications),
  • Deemed to be good operative candidates by spine surgeons (patients with MRI/CT findings of neural compression with concordant symptoms) and had agreed to possible operative intervention

Exclusion Criteria:

  • History of

    1. acute trauma,
    2. diabetes (type I or type II),
    3. active infection
  • Active progressive neurological deficit (neurologic is deficit defined as manual muscle testing less than 3/5),
  • Medical condition that may affect the cervical spine neurological exam and/or pain assessment (e.g. peripheral neuropathy),
  • Bilateral disease,
  • More than one cervical level requiring injection,
  • Bleeding disorders or other medical contraindications to the injection procedure,
  • Absence of substantial radicular pain (radicular pain is defined as arm pain greater than neck pain),
  • Involvement in workers' compensation claim, or any litigation related to neck injury.
  • Patients who are pregnant, or who plan to become pregnant in the next 12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lidocaine
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc normal saline
Drug: Lidocaine
Experimental: Lidocaine with Dexamethasone
Cervical transforaminal injection: 1.0 cc Lidocaine 1.0% with 1.0 cc of Dexamethasone (10 mg/cc)
Drug: Lidocaine with Dexamethasone
Other Names:
  • Lidocaine
  • Dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Avoidance of Neck Surgery
Time Frame: 12 months after the first injection
The primary outcome variable is the avoidance of surgery. Treatment success is defined as the avoidance of surgery, while treatment failure is defined as having surgery due to failure of the injection treatment to alleviate pain and improve function over the 12 months they are being followed for purposes of this study. Avoided neck surgery noted as 'Yes'; avoided neck surgery 'No' the patient had neck surgery.
12 months after the first injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability
Time Frame: 4 weeks
Neck Disability Index (NDI) - The NDI consists of 10 questions. Each of the 10 items is scored from 0 (minimum) - 5(maximum). The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score (i.e. a score of 50 indicates 100% disability). Scores are reported as the percentage (i.e. 100 is the max score for data presented).
4 weeks
Numeric Pain Scre
Time Frame: 4 weeks
Verbal Numeric Pain Scale (VNPS) -Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain
4 weeks
Patient Satisfaction
Time Frame: 4 weeks
Patient satisfaction with the treatment. Scale is an inverse of verbal numeric pain score. A 0 on VNPS equates to a 10 on patient satisfaction, 10 on VNPS equates to 0 on patient satisfaction
4 weeks
Disability
Time Frame: 12 weeks
Neck Disability Index- The NDI consists of 10 questions. Each of the 10 items is scored from 0 (minimum) - 5(maximum). The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score (i.e. a score of 50 indicates 100% disability). Scores are reported as the percentage (i.e. 100 is the max score for data presented).
12 weeks
Disability
Time Frame: 6 Months
Neck Disability Index- The NDI consists of 10 questions. Each of the 10 items is scored from 0 (minimum) - 5(maximum). The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score (i.e. a score of 50 indicates 100% disability). Scores are reported as the percentage (i.e. 100 is the max score for data presented).
6 Months
Disability
Time Frame: 12 Months
Neck Disability Index- The NDI consists of 10 questions. Each of the 10 items is scored from 0 (minimum) - 5(maximum). The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score (i.e. a score of 50 indicates 100% disability). Scores are reported as the percentage (i.e. 100 is the max score for data presented).
12 Months
Numeric Pain Score
Time Frame: 12 weeks
Verbal Numeric Pain Scale-Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain
12 weeks
Numeric Pain Score
Time Frame: 6 Months
Verbal Numeric Pain Scale-Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain
6 Months
Numeric Pain Score
Time Frame: 12 Months
Verbal Numeric Pain Scale-Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain
12 Months
Patient Satisfaction
Time Frame: 12 weeks
Patient satisfaction with the treatment. Scale is an inverse of verbal numeric pain score. A 0 on VNPS equates to a 10 on patient satisfaction, 10 on VNPS equates to 0 on patient satisfaction
12 weeks
Patient Satisfaction
Time Frame: 6 months
Patient satisfaction with the treatment. Scale is an inverse of verbal numeric pain score. A 0 on VNPS equates to a 10 on patient satisfaction, 10 on VNPS equates to 0 on patient satisfaction
6 months
Patient Satisfaction
Time Frame: 12 months
Patient satisfaction with the treatment. Scale is an inverse of verbal numeric pain score. A 0 on VNPS equates to a 10 on patient satisfaction, 10 on VNPS equates to 0 on patient satisfaction
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OrthoCarolina Research Institute, Inc.

Collaborators

Charlotte Surgery Center an affiate of SCA

Investigators

  • Principal Investigator: Sam Bhagia, MD, OrthoCarolina Research Institute, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

May 1, 2019

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

August 25, 2014

First Submitted That Met QC Criteria

August 25, 2014

First Posted (Estimated)

August 27, 2014

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9086-14019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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