Effectiveness of Cervical Transforaminal Epidural Steroid Injection

NCT04544683 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB 116040
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Study Purpose: This study is intended to monitor outcomes for 1 year following cervical TFESI. Based on current clinic volume and enrollment rates into a current study of cervical epidural injections that is nearing completion, we conservatively estimate a study enrollment period of 18 months and a total period of 2.5 years from enrollment to final follow-up data collection. If the study were to theoretically start enrolling in July 2019, we would anticipate completion by February 2022. Objectives:

1. 1.Determine the proportion of patients with an 80% or greater improvement in arm and neck numerical rating scale pain (NRS) score following an initial cervical transforaminal steroid injection (TFESI) at 4 weeks post-injection and the duration of response up to 12 months.
2. 2.Determine the proportion of patients with a 50%-79% improvement in arm and neck NRS score following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months.
3. 3.Determine the proportion of patients with less than 50% improvement in arm and neck NRS score following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months.
4. 4.Determine the proportion of patients with an initial injection plus up to 3 additional injections that maintain 80% or greater, as well as 50-79%, improvement in arm and neck NRS score for up to 12 months.
5. 5.Determine the proportion of patients with a clinically significant change in function defined by a minimally clinically significant change (MCIC) (≥10 point improvement ) or 30% improvement in Neck Disability Index (NDI) score following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months.
6. 6.Determine the proportion of patients with clinically significant improvement in the Medication Quantification Scale (MQS III) score (≥6.8 point change , equivalent to 10 oral morphine equivalents ) following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months.

Conditions

Cervical Radiculopathy; Cervical Spondylosis; Disk, Herniated

Keywords

Transforaminal Epidural Injection

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Reporting ≥50% Reduction in Index Numeric Rating Scale (NRS) Arm Pain Score

  Percentage of participants reporting 50% or greater improvement in index arm pain following an initial cervical transforaminal injection of steroid (CTFESI) at 1, 3, 6, and 12 months post-injection. Patient-reported arm pain intensity scores were captured at baseline and the designated follow-up time points using an 11-point Numeric Rating Scale ranging from 0 to 10, with 0 representing "no pain at all" and 10 representing "the worst pain imaginable".

  1 month, 3 months, 6 months, 12 months

Secondary Outcomes (7)

• Percentage of Participants Reporting ≥50% Reduction in Index Numeric Rating Scale (NRS) Neck Pain Score

  1 month, 3 months, 6 months, 12 months

• The Number of Participants With a ≥30% Improvement in Neck Disability Index (NDI-5)

  1 month, 3 months, 6 months, 12 months

• The Number of Participants With a ≥0.03 Point Increase in EuroQol Health-Related Quality of Life (EQ-5D) Score

  1 month, 3 months, 6 months, 12 months

• The Number of Participants With a ≥6.8 Point Change in Medication Quantification Scale (MQS-III) Score

  1 month, 3 months, 6 months, 12 months

• The Number of Participants With a ≥30% Change in Chronic Pain Sleep Inventory (CPSI) Score

  1 month, 3 months, 6 months, 12 months

Study Arms (1)

Cervical Pain for 6 months or less and scheduled for TFESI

OTHER

Participants who meet inclusion and exclusion criteria will be enrolled into the study after consenting to and before receiving a first cervical TFESI. The baseline examination and all baseline questionnaires will be completed within 2 weeks before the first cervical TFESI. Participants will be given a daily pain diary chart to record NRS and percentage improvement during the 1st month post-injection. Participants will be contacted in the 1st week post-injection with a standardized questionnaire about their symptoms and a reminder about the 4 week (+/- 1 week) post-injection follow up. Routine scheduled follow-up by clinic visit or telephone call will occur at 4 weeks (+/- 1 week), 8 weeks (+/- 2 weeks), 3 months (+/- 2 weeks), 6 months (+/- 1 month), and 12 months (+/- 1 month), at which times all follow-up measures will be obtained.

Drug: Cervical Transforaminal Epidural Injection with dexamethasone sodium phosphate

Interventions

Cervical Transforaminal Epidural Injection with dexamethasone sodium phosphate DRUG

Transforaminal epidural steroid injection: Injection of 1 to 2 mL of 1% lidocaine to the skin and subcutaneous tissues, a 25-gauge spinal needle will be placed at the level and side of radicular pathology, based on clinical correlation of symptoms/signs and magnetic resonance imaging findings. Advancement to the appropriate target position in the neuroforamen will be performed under fluoroscopic guidance. Satisfactory target position achieved and confirmed in both anterior-posterior and oblique views, 0.5 to 1 mL of contrast will be injected under live fluoroscopic observation with or without digital subtraction angiography depending on suggestion of vascular uptake. Upon confirmation of a satisfactory epidural contrast pattern without vascular uptake, the injectate will be delivered: dexamethasone sodium phosphate 1mL (10mg/mL) and 0.5 ml of 1% preservative-free lidocaine (total volume 1.5 mL).

Cervical Pain for 6 months or less and scheduled for TFESI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 18-80 capable of understanding and providing consent in English and capable of complying with the outcome instruments used.
• Arm pain or shoulder girdle pain/periscapular pain with or without neck pain with duration less than or equal to 6 months.
• day average numeric pain rating score (NRS) for arm pain or shoulder girdle/periscapular pain of at least 4/10 at baseline evaluation, with neck pain score not exceeding arm and/or shoulder girdle/periscapular pain score.
• MRI (or CT if MRI not available) shows either a one level cervical disc herniation, disc osteophyte complex or degenerative foraminal stenosis, corresponding in side and location with predominately unilateral radicular pain, with or without neurological deficits. MRI may show degenerative changes at other levels.
• Patient consents to treatment with epidural injection in a shared decision-making process with the treating physician.
• Pain duration of at least 6 weeks or more.

You may not qualify if:

• Those receiving remuneration for their pain treatment (e.g., disability, worker's compensation).
• Those involved in active litigation relevant to their pain.
• The patient is incarcerated.
• Neck pain is greater than arm pain or shoulder girdle/periscapular pain.
• Bilateral radicular signs/symptoms (\< 90% laterality of pain intensity, or bilateral neurological signs).
• BMI\>35.
• Prior epidural steroid injections for treatment of current episode.
• Those unable to read English and complete the assessment instruments.
• Spondylolisthesis at the involved or adjacent segments.
• Systemic inflammatory arthritis (e.g., rheumatoid, lupus).
• Addictive behavior, severe clinical depression, or psychotic features.
• Possible pregnancy or other reason that precludes the use of fluoroscopy.
• Treatment of infection with antibiotics within the past 7 days.
• Progressive motor deficit and/or clinical signs of myelopathy.
• History of prior cervical spine surgery.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Radiculopathy; Spondylosis; Intervertebral Disc Displacement

Interventions

dexamethasone 21-phosphate

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Aaron Conger, MD
• Organization: University of Utah Orthopaedic Center/ Physical Medicine & Rehabilitation

u6007025@umail.utah.edu

801-587-1493

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Zachary McCormick, MD FAAPMR, Associate Professor, Director of Clinical Spine Research, Director of Interventional Spine and Musculoskeletal Medicine Fellowship

Model Details: Through a research questionnaire, pre-procedure and post procedure NRS pain score for both neck and arm we will obtain data regarding cervical epidural steroid injections via a transforaminal approach for research purposes only. Also current pain medications of patient throughout treatment will be obtained for research purposes.

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 10, 2020
• Study Start: October 23, 2018
• Primary Completion: October 31, 2022
• Study Completion: December 7, 2023
• Last Updated: April 10, 2024
• Results First Posted: April 10, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)