Trial Outcomes & Findings for Epidural Lavage Study for Lumbar Stenosis (NCT NCT03511053)

NCT ID: NCT03511053

Last Updated: 2021-05-27

Results Overview

Number rating of back/leg pain from 0 to 10, 0 being no pain/discomfort, 10 being extreme pain/discomfort

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: Change between baseline, 1 month and 2 months post injection
• Results posted on: 2021-05-27

Participant Flow

Participants with Lumbar Spinal Stenosis were recruited from the spine clinic at the Veterans Affairs Medical Center, and were included in the study if they met the study criteria.

Participant milestones

Measure	All Participants Epidural Lavage followed by Lumbar Epidural Steroid Injection Epidural Steroid Injection with Lavage: All participants will receive a saline lavage prior to the epidural steroid injection.
Overall Study STARTED	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	All Participants Epidural Lavage followed by Lumbar Epidural Steroid Injection Epidural Steroid Injection with Lavage: All participants will receive a saline lavage prior to the epidural steroid injection.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Epidural Lavage Study for Lumbar Stenosis

Baseline characteristics by cohort

Measure	All Participants n=11 Participants Epidural Lavage followed by Lumbar Epidural Steroid Injection Epidural Steroid Injection with Lavage: All participants will receive a saline lavage prior to the epidural steroid injection.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=93 Participants
Age, Categorical >=65 years	7 Participants n=93 Participants
Age, Continuous	64 years STANDARD_DEVIATION 11 • n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	11 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants
Race (NIH/OMB) White	6 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants
Region of Enrollment United States	11 participants n=93 Participants
Pain Disability Questionnaire	77.5 units on a scale n=93 Participants
VAS-Questionnaires	64.1 units on a scale n=93 Participants

PRIMARY outcome

Timeframe: Change between baseline, 1 month and 2 months post injection

Number rating of back/leg pain from 0 to 10, 0 being no pain/discomfort, 10 being extreme pain/discomfort

Outcome measures

Measure	All Participants n=11 Participants Epidural Lavage followed by Lumbar Epidural Steroid Injection Epidural Steroid Injection with Lavage: All participants will receive a saline lavage prior to the epidural steroid injection.
Visual Analogue Scale Average at baseline	6.2 score on a scale Interval 5.7 to 7.0
Visual Analogue Scale Average at 1 month	5.0 score on a scale Interval 3.5 to 6.5
Visual Analogue Scale Average at 2 months	5.0 score on a scale Interval 3.5 to 6.5
Visual Analogue Scale Average 1 month change	0.8 score on a scale Interval -0.8 to 2.4
Visual Analogue Scale Average 2 month change	1 score on a scale Interval -0.7 to 2.7

PRIMARY outcome

Timeframe: Change between baseline, 1 month and 2 months post injection

Measures how pain due to spinal stenosis is effected the patient based on quality of life/pain questions and satisfaction questions for months 1 and 2 (no scales are used) SSSQ scores are reported in percentages 0-100%, higher scores indicate worse outcomes.

Outcome measures

Measure	All Participants n=11 Participants Epidural Lavage followed by Lumbar Epidural Steroid Injection Epidural Steroid Injection with Lavage: All participants will receive a saline lavage prior to the epidural steroid injection.
Swiss Spinal Stenosis Questionnaire Average at baseline	64.1 Percentage Interval 58.7 to 69.5
Swiss Spinal Stenosis Questionnaire Average at 1 month	53.2 Percentage Interval 41.7 to 64.7
Swiss Spinal Stenosis Questionnaire Average at 2 months	53.5 Percentage Interval 43.6 to 63.4
Swiss Spinal Stenosis Questionnaire Average at 1 month change	11.7 Percentage Interval -4.2 to 27.6
Swiss Spinal Stenosis Questionnaire Average at 2 month change	10.3 Percentage Interval -1.5 to 22.1

PRIMARY outcome

Timeframe: Change between baseline, 1 month and 2 months post injection

Measures how pain is affecting the patients lifestyle on a scale from 0 to 10 as defined by each question. The questionnaire contains 15 questions that each range on a scale form 0 to 10. The total score of the questionnaire ranges from 0 to 150. Lower values represent a better outcome.

Outcome measures

Measure	All Participants n=11 Participants Epidural Lavage followed by Lumbar Epidural Steroid Injection Epidural Steroid Injection with Lavage: All participants will receive a saline lavage prior to the epidural steroid injection.
Pain Disability Questionnaire Average at baseline	77.5 score on a scale Interval 64.6 to 90.4
Pain Disability Questionnaire Average at 1 month	53.3 score on a scale Interval 28.6 to 78.0
Pain Disability Questionnaire Average at 2 months	64.3 score on a scale Interval 34.5 to 94.1
Pain Disability Questionnaire Average at 1 month change	27.3 score on a scale Interval 7.6 to 47.0
Pain Disability Questionnaire Average at 2 month change	16.2 score on a scale Interval -10.2 to 42.6

Adverse Events

All Participants

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. Thiru M. Annaswamy, Staff Physician, PM&R Service

Dallas VA Medical Center

Phone: 2148570273

Email: thiru.annaswamy@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place