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Do Cervical Interlaminar Epidural Steroid Injections With Low-dose Lidocaine Cause Transient Objective Upper Extremity Weakness? A Prospective Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT03127137
Recruitment Status : Recruiting
First Posted : April 25, 2017
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
David Walega, Northwestern University

Tracking Information
First Submitted Date  ICMJE April 20, 2017
First Posted Date  ICMJE April 25, 2017
Last Update Posted Date June 4, 2019
Actual Study Start Date  ICMJE August 1, 2018
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2017)
Change in strength for each individual in each treatment group before and 30 minutes after CESI [ Time Frame: Baseline and 30 minutes after the CESI procedure ]
Change in strength for each individual in each treatment group before and 30 minutes after CESI using hand held Dynamometer
Original Primary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
Change in strength for each individual in each treatment group before and 30 minutes after CESI [ Time Frame: 30 minutes after the CESI procedure ]
Change in strength for each individual in each treatment group before and 30 minutes after CESI using hand held Dynamometer
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2017)
  • Change in mean arterial pressure [ Time Frame: Baselind and 30 minutes after CESI procedure ]
    Change in mean arterial pressure prior to and 30 minutes after CESI, via automated blood pressure cuff measure.
  • Change in heart rate [ Time Frame: Baseline and 30 minutes after CESI ]
    Change in heart rate prior to and 30 minutes after CESI
  • Pain Scores [ Time Frame: Baseline and 30 minutes after CESI ]
    Change in average pain score before and after CESI
  • UEFI score change [ Time Frame: Baseline and 30 minutes after CESI ]
    Change is UEFI (Upper Extremity Functional Index) scores before and after CESI
  • Complication rate [ Time Frame: Baseline and 24 hours after CESI procedure ]
    Procedure complications or adverse reactions to medications used
Original Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
  • Change in mean arterial pressure [ Time Frame: 30 minutes after CESI procedure ]
    Change in mean arterial pressure prior to and 30 minutes after CESI, via automated blood pressure cuff measure.
  • Change in heart rate [ Time Frame: 30 minutes after CESI ]
    Change in heart rate prior to and 30 minutes after CESI
  • Pain Scores [ Time Frame: 30 minutes after CESI ]
    Change in average pain score before and after CESI
  • UEFI score change [ Time Frame: 30 minutes after CESI ]
    Change is UEFI (Upper Extremity Functional Index) scores before and after CESI
  • Complication rate [ Time Frame: 24 hours after CESI procedure ]
    Procedure complications or adverse reactions to medications used
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Do Cervical Interlaminar Epidural Steroid Injections With Low-dose Lidocaine Cause Transient Objective Upper Extremity Weakness? A Prospective Randomized Controlled Trial
Official Title  ICMJE Do Cervical Interlaminar Epidural Steroid Injections With Low-dose Lidocaine Cause Transient Objective Upper Extremity Weakness? A Prospective Randomized Controlled Trial
Brief Summary

Cervical radicular pain is relatively common, often treated with epidural steroid injection (ESI), when conservative treatments like oral analgesics, physical therapy and activity modification have failed. There are no universal clinical practice guidelines for the use of diluents when CESI are performed.

Interlaminar CESI may be performed with or without the use of local anesthetics, due to training bias or theoretical concerns of weakness. CESI without the benefit of local anesthetic as a steroid diluent increases the latency of pain relief and may decrease diagnostic information immediately after a CESI with regard to pain generators responsible for symptoms, and may potentially decrease patient satisfaction.

By evaluating the effects of local anesthetic as a diluent during interlaminar cervical ESI, we will enhance the safety of this treatment with regard to expectations of objective motor weakness as well as post procedure pain control and patient satisfaction in the recovery phase after the injection procedure.

Research Question:

Does lidocaine versus saline as a steroid diluent effect objective upper extremity strength following cervical epidural steroid injection in patients being treated for cervical radiculitis?

Null Hypothesis:

Cervical epidural steroid injections that include local anesthetic as a diluent have no effect on objective upper extremity strength following the injection.

We hypothesized that cervical epidural lidocaine will cause an objective decrease in strength in functional movements of the upper extremity.

Detailed Description

Control Group: Prospective observational cohort study of UE strength in pain clinic patients undergoing trigger point injections and occipital nerve injections to serve as controls to measure variability of strength testing before and 30 min after such an intervention.

Experimental Groups: Prospective, randomized, controlled, double blinded trial in patients undergoing CESI for symptoms of cervical radiculitis.

Group #1: Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL 1% lidocaine (total volume 4 cc).

Group #2: Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL preservative saline (total volume 4 cc).

Adults who are eligible to have a CESI with triamcinolone for treatment of cervical radiculitis at the Northwestern Anesthesiology Pain Medicine Center will be approached by authorized research personnel prior to a patient's CESI is performed and will obtain informed consent from patients who agree to participate.

In every subject (Control Cohort, Group 1 and Group 2) a pre-procedure NRS pain score, and presence of subjective or objective symptoms of UE weakness will be recorded. Bilateral handgrip, wrist extension, elbow flexion, and elbow extension strength (myotomes C5-T1) will be measured by a trained research assistant prior to the injection procedure using a handheld JAMAR® PLUS+ digital dynamometer (Sammons Preston, Bollingbrook, IL) for hand grip strength and a push/pull handheld hydraulic dynamometer (Balego and Associates Inc., St. Paul, MN) for arm strength assessment. Three baseline strength measurements will be recorded for each strength test. Measurements will be taken prior to and 30 minutes following the injection procedure. Patients in Group #1 and Group #2 will also be queried with the Upper Extremity Functional Index (UEFI) before the injection procedure and again 1 day after the procedure (administered via telephone).

For Group 1 and Group 2, patients will be randomized to treatment group based on a random computer-generated schedule. Participants will be blinded to the group to which they are randomized. All standard procedures for CESIs will be followed as is standard practice including time out, skin prep, hemodynamic monitoring, image guidance etc.

Per randomization, triamcinolone acetonide 80 mg (Kenalog) (E. R. Squibb & Sons Limited, Uxbridge UK) will be combined with 2mL Lidocaine 1% or 2 mL preservative free saline and will be injected during the CESI procedure. In all cases, the total injectate volume will be 4 mL in all cases. All injections will be image guided with fluoroscopy, as is the current standard practice. Fluoroscopy time will be recorded.

The participant will be discharged from the clinic with written discharge instructions (current standard practice).

Participants will be telephoned by clinic personnel 1 day after the CESI to assess for subjective weakness in the hands or arms as well as any other adverse reactions. As above, the Upper Extremity Functional Index will be administered at this time.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Prospective Randomized Controlled Trial using control arm plus 2 arm experimental (placebo and active drug)
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
Participant will be blinded to group assignment. Outcome assessor will also be blinded to the randomization.
Primary Purpose: Treatment
Condition  ICMJE
  • Cervical Radiculitis
  • Pain
Intervention  ICMJE
  • Other: Control cohort group
    Control cohort group will receive medications not predetermined by the set protocol.
  • Drug: Experimental Group 1 triamcinolone and lidocaine
    Experimental Group 1 will receive Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL 1% lidocaine (total volume 4 cc)
    Other Name: Experimental Group 1
  • Drug: Experimental Group 2 triamcinolone and saline
    Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL preservative saline (total volume 4 cc)
    Other Name: Experimental Group 2
Study Arms  ICMJE
  • Control cohort Group
    Control cohort group will receive medications not predetermined by the set protocol.
    Intervention: Other: Control cohort group
  • Active Comparator: Experimental Group 1
    Experimental Group 1 will receive Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL 1% lidocaine (total volume 4 cc)
    Intervention: Drug: Experimental Group 1 triamcinolone and lidocaine
  • Placebo Comparator: Experimental Group 2
    Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL preservative saline (total volume 4 cc)
    Intervention: Drug: Experimental Group 2 triamcinolone and saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 5, 2018)
140
Original Estimated Enrollment  ICMJE
 (submitted: April 24, 2017)
145
Estimated Study Completion Date  ICMJE January 15, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients ages 18 years or older who will undergo CESI for treatment of cervical radiculitis

Exclusion Criteria:

  • Patient refusal
  • Lack of consent
  • Any contraindication to CESI
  • Inability to communicate with staff or to participate in follow up
  • Inability to perform handgrip or arm strength testing
  • Cervical spinal cord lesions
  • Cerebrovascular, demyelinating or other neuromuscular muscular disease
  • Patient request for or requirement of conscious sedation for the injection procedure
  • Pregnancy
  • Breast feeding
  • Sensitivity to amides
  • History of allergy to local anesthetics
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David Walega, M.D. 312-695-4052 d-walega@northwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03127137
Other Study ID Numbers  ICMJE STU00204980
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party David Walega, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Walega, M.D. Northwestern University
PRS Account Northwestern University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP