Trial Outcomes & Findings for Bilateral Transforaminal Epidural Steroid Injections for Degenerative Lumbar Spinal Stenosis (NCT NCT01995461)

Results Overview

change from baseline (pre-1st injection) pain score, based on a numeric pain scale of 0-10(most severe pain), at 6 months post-1st injection

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

baseline (pre-1st injection) to 6 months post-1st injection

Results posted on

2015-11-24

Participant Flow

Participant milestones

Participant milestones
Measure	BTESI a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI) bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection.
Overall Study STARTED	26
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	BTESI a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI) bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection.
Overall Study Death	1
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Bilateral Transforaminal Epidural Steroid Injections for Degenerative Lumbar Spinal Stenosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BTESI n=26 Participants a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI) bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection.
Age, Continuous	74.7 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline (pre-1st injection) to 6 months post-1st injection

change from baseline (pre-1st injection) pain score, based on a numeric pain scale of 0-10(most severe pain), at 6 months post-1st injection

Outcome measures

Outcome measures
Measure	BTESI n=21 Participants a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI) bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection.
Change From Baseline Pain Score at 6 Months	-1.6 points Interval -2.9 to -0.2

SECONDARY outcome

Timeframe: baseline (pre-1st injection) to 6 months post-1st injection

The Swiss spinal stenosis score is a questionnaire composed of 18 multiple choice questions designed to give information as to how the patient's back and leg pain is affecting their ability to manage everyday life. The Swiss spinal stenosis (SSS) questionnaire consists of 12 baseline questions asked of all participants prior to injection and an additional 6 questions asked at each time point post-treatment. The initial 12 questions assess reliability and condition at baseline while the 6 post-treatment questions assess treatment satisfaction. All questions ask the patient to assess symptoms over the previous month with a total maximum score for the initial 12 questions of 53 and a total maximum score of 24 for the 6 additional questions. The final total score is expressed as a percentage of the maximum possible score. Total score increases with worsening disability.

Outcome measures

Outcome measures
Measure	BTESI n=21 Participants a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI) bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection.
Change From Baseline Swiss Spinal Stenosis Score at 6 Months	-8.3 points Interval -14.9 to -1.76

SECONDARY outcome

Timeframe: baseline (pre-1st injection) to 6 months post-1st injection

The 2 questions from this Index pertaining to Standing and Walking are being utilized to assess changes in duration of standing and walking in these patients. The two sections of the Oswestry Disability Index (ODI) used in the present study were those related to walking and standing (sections 4 and 6). For each section, the total possible score is 5 and overall ODI score was expressed as a percentage of the maximum possible score (10). Total score increases with worsening disability.

Outcome measures

Outcome measures
Measure	BTESI n=21 Participants a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI) bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection.
Change From Baseline Oswestry Disability Index at 6 Months	-7.1 points Interval -14.7 to -1.1

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline (pre-1st injection) to 6 months post-1st injection

Outcome measures

Outcome data not reported

Adverse Events

BTESI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Rachel Stankowski

Marshfield Clinic Research Foundation

Phone: 715-389-3442

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place