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

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ClinicalTrials.gov Identifier: NCT02226159
Recruitment Status : Active, not recruiting
First Posted : August 27, 2014
Results First Posted : October 20, 2020
Last Update Posted : October 20, 2020
Sponsor:
Collaborator:
Charlotte Surgery Center an affiate of SCA
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pain, Radiating Drug: Lidocaine Drug: Lidocaine with Dexamethasone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Surgery Prevention by Transforaminal Injection of Epidural Steroids for Cervical Radicular Pain (SPIES): a Randomized, Controlled Trial
Actual Study Start Date : August 2014
Actual Primary Completion Date : May 2019
Estimated Study Completion Date : December 2020


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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

  3. 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. 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).

  5. 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. 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).

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02226159


Locations
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United States, North Carolina
OrthoCarolina
Charlotte, North Carolina, United States, 28207
Sponsors and Collaborators
OrthoCarolina Research Institute, Inc.
Charlotte Surgery Center an affiate of SCA
Investigators
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Principal Investigator: Sam Bhagia, MD OrthoCarolina Research Institute, Inc.
  Study Documents (Full-Text)

Documents provided by OrthoCarolina Research Institute, Inc.:
Publications:

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Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT02226159    
Other Study ID Numbers: 9086-14019
First Posted: August 27, 2014    Key Record Dates
Results First Posted: October 20, 2020
Last Update Posted: October 20, 2020
Last Verified: September 2020
Keywords provided by OrthoCarolina Research Institute, Inc.:
cervical
radicular pain
transforaminal epidural steroid injections
Additional relevant MeSH terms:
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Pain
Neurologic Manifestations
Dexamethasone
Dexamethasone acetate
Lidocaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators