Trial Outcomes & Findings for Threshold Response of Lumbar Selective Nerve Root Block in Predicting Good Outcome Following Lumbar Foraminotomy (NCT NCT03801356)

Last Updated: 2023-07-21

Results Overview

Aim: 0-2 point improvement The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' (0) and 'pain as bad as it could be' (10). The patient is asked to mark their pain level on the line between the two endpoints. The distance and change between '0' and the mark then defines the subject's pain. This will be measured at each subject visit.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

11 participants

Primary outcome timeframe

12-months

Results posted on

2023-07-21

Participant Flow

Participant milestones

Participant milestones
Measure	Selective Nerve Root Block Patient will receive a Selective Nerve Root Block injection at the target level prior to surgical intervention. Selective Nerve Root Block: Prior to single level foraminotomy for lumbar foraminal stenosis, patients will undergo SNRB of the suspected nerve root. Patients will undergo surgery despite the response to injection. Patients will complete an ambulation assessment immediately before and after the injection. Distance and time will be noted. Patients will be called within 48 hours of injection to determine response to injection, and recorded as Pre-and Post-injection VAS leg as well as duration of the response. Patients will be seen at 6 weeks, 3,6, and 12 months post-surgery and outcome measured by VAS-leg, ODI, PDQ and EQ-5D scores. Data will be used to determine the ideal improvement in leg pain and duration of improvement, predicting a statistical and meaningful improvement in leg pain following foramintomy.
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Threshold Response of Lumbar Selective Nerve Root Block in Predicting Good Outcome Following Lumbar Foraminotomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Selective Nerve Root Block n=11 Participants Patient will receive a Selective Nerve Root Block injection at the target level prior to surgical intervention. Selective Nerve Root Block: Prior to single level foraminotomy for lumbar foraminal stenosis, patients will undergo SNRB of the suspected nerve root. Patients will undergo surgery despite the response to injection. Patients will complete an ambulation assessment immediately before and after the injection. Distance and time will be noted. Patients will be called within 48 hours of injection to determine response to injection, and recorded as Pre-and Post-injection VAS leg as well as duration of the response. Patients will be seen at 6 weeks, 3,6, and 12 months post-surgery and outcome measured by VAS-leg, ODI, PDQ and EQ-5D scores. Data will be used to determine the ideal improvement in leg pain and duration of improvement, predicting a statistical and meaningful improvement in leg pain following foramintomy.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 12-months

Population: Paired T-Test was conducted to compare the change in VAS score from Baseline Visit to 12 Month Visit. Although 11 patients were consented and completed a Baseline Visit, only 7 patients had a 12 Month Visit. Analysis included the 7/11 patients that completed a 12 Month Visit that captured the VAS Leg Pain Score.

Outcome measures

Outcome measures
Measure	Selective Nerve Root Block n=7 Participants Patient will receive a Selective Nerve Root Block injection at the target level prior to surgical intervention. Selective Nerve Root Block: Prior to single level foraminotomy for lumbar foraminal stenosis, patients will undergo SNRB of the suspected nerve root. Patients will undergo surgery despite the response to injection. Patients will complete an ambulation assessment immediately before and after the injection. Distance and time will be noted. Patients will be called within 48 hours of injection to determine response to injection, and recorded as Pre-and Post-injection VAS leg as well as duration of the response. Patients will be seen at 6 weeks, 3,6, and 12 months post-surgery and outcome measured by VAS-leg, ODI, PDQ and EQ-5D scores. Data will be used to determine the ideal improvement in leg pain and duration of improvement, predicting a statistical and meaningful improvement in leg pain following foramintomy.
Visual Analog Scale (VAS) Leg Pain Score	1.14 score on a scale Standard Deviation 3.34

SECONDARY outcome

Timeframe: 12-Months

Population: Although 11 patients were consented and completed the Baseline Visit and 7/11 patients completed the VAS Leg Pain Score at 12 Month Visit, 0/11 patients completed an ODI Questionnaire at 12 Month Visit. Due to no patient completing the ODI at 12 Month Visit, no analysis was completed for this outcome measure.

Aim: 15-point improvement The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain. Structure / Content There are 10 questions. The questions are designed in a way that to realize how the back or leg pain is affecting the patient's ability to manage in everyday life. Scoring Method Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The score can be multiplied by 2 to produce a percentage. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5 Interpretation 1.0%-20%: Minimal disability. Usually no treatment is indicated. 2.20%-40% Moderate disability 3.40%-60%: Severe disability 4.60%-80%: Crippled 5.80%-100%: These patients are either bed-bound or exaggerating their symptoms.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12-Months

Population: Although 11 patients were consented and completed the Baseline Visit and 7/11 patients completed the VAS Leg Pain Score at 12 Month Visit, 0/11 patients completed an EQ-5D Questionnaire at 12 Month Visit. Due to no patient completing the EQ-5D at 12 Month Visit, no analysis was completed for this outcome measure.

Aim: Improvement in quality of life The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The questionnaire also records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labeled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12-months

Population: Although 11 patients were consented and completed the Baseline Visit and 7/11 patients completed the VAS Leg Pain Score at 12 Month Visit, 0/11 patients completed a PDQ Questionnaire at 12 Month Visit. Due to no patient completing the PDQ at 12 Month Visit, no analysis was completed for this outcome measure.

Aim: 26-point improvement The Pain Disability Questionnaire (PDQ) assesses perception of disability in relation to pain. PDQ scores: mild/moderate (0-70), severe (71-100), and extreme (101-150).

Outcome measures

Outcome data not reported

Adverse Events

Selective Nerve Root Block

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. Michael Steinmetz

Cleveland Clinic

Phone: 216-445-5754

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place