Trial Outcomes & Findings for Selecting Effective Combinations of Treatment for Low Back Pain (NCT NCT03520387)
NCT ID: NCT03520387
Last Updated: 2021-09-05
Results Overview
The RMDQ is a validated, commonly used, and widely accepted 'legacy' measure of back-related functional limitations (range 0 to 24, with higher scores representing greater functional limitations).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
3 months
Results posted on
2021-09-05
Participant Flow
Recruitment dates: 11/15/2018 to 03/17/2020 at the VA Puget Sound Health Care System
The post-enrollment, pre-randomization run-in period was designed to exclude subjects who no longer met study criteria by the day of randomization, and those who were unlikely to be able to complete the study processes such as the telephone assessments used for data collection and the use of technology (synchronizing activity trackers).
Participant milestones
| Measure |
Pre-Randomization Run-In Period
The pre-randomization run-in period was designed to exclude subjects who no longer met study criteria by the day of randomization, and those who were unlikely to be able to complete the study processes such as the telephone assessments used for data collection and the use of technology (synchronizing activity trackers). Of those who began the run-in period (n=16), 3 were withdrawn during the run-in period and prior to randomization, leaving 13 who were randomized.
|
Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT)
Participants received both:
1. Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.
and
2. Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress.
|
Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT)
Participants received both:
1. Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and 2) the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.
and
2. Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress.
|
Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE)
Participants received both:
1. Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.
and
2. Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook.
|
Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE)
Participants received both:
1. Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.
and
2. Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook.
|
|---|---|---|---|---|---|
|
Pre-Randomization
STARTED
|
16
|
0
|
0
|
0
|
0
|
|
Pre-Randomization
COMPLETED
|
13
|
0
|
0
|
0
|
0
|
|
Pre-Randomization
NOT COMPLETED
|
3
|
0
|
0
|
0
|
0
|
|
Randomized
STARTED
|
0
|
4
|
3
|
3
|
3
|
|
Randomized
COMPLETED
|
0
|
4
|
3
|
3
|
3
|
|
Randomized
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Pre-Randomization Run-In Period
The pre-randomization run-in period was designed to exclude subjects who no longer met study criteria by the day of randomization, and those who were unlikely to be able to complete the study processes such as the telephone assessments used for data collection and the use of technology (synchronizing activity trackers). Of those who began the run-in period (n=16), 3 were withdrawn during the run-in period and prior to randomization, leaving 13 who were randomized.
|
Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT)
Participants received both:
1. Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.
and
2. Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress.
|
Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT)
Participants received both:
1. Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and 2) the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.
and
2. Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress.
|
Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE)
Participants received both:
1. Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.
and
2. Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook.
|
Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE)
Participants received both:
1. Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.
and
2. Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook.
|
|---|---|---|---|---|---|
|
Pre-Randomization
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
|
Pre-Randomization
Failed eligibility criteria or run-in period criteria
|
2
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Selecting Effective Combinations of Treatment for Low Back Pain
Baseline characteristics by cohort
| Measure |
Pre-Randomization Run-In Period
The pre-randomization run-in period was designed to exclude subjects who no longer met study criteria by the day of randomization, and those who were unlikely to be able to complete the study processes such as the telephone assessments used for data collection and the use of technology (synchronizing activity trackers). Of those who began the run-in period (n=16), 3 were withdrawn during the run-in period and prior to randomization, leaving 13 who were randomized. There are no participants in this group after randomization.
|
Lumbar Medial Branch Nerve Radiofrequency Ablation (LRFA) + AcTIVE-CBT
n=4 Participants
Participants received both:
1. Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.
and
2. Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress.
|
Simulated Lumbar Radiofrequency Ablation (Simulated LRFA) + AcTIVE-CBT
n=3 Participants
Participants received both:
1. Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and 2) the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.
and
2. Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress.
|
Lumbar Medial Branch Nerve Radiofrequency Ablation (LRFA) + TBSCE
n=3 Participants
Participants received both:
1. Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.
and
2. Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook.
|
Simulated Lumbar Radiofrequency Ablation (Simulated LRFA) + TBSCE
n=3 Participants
Participants received both:
1. Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.
and
2. Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
—
|
59.3 years
STANDARD_DEVIATION 14.6 • n=7 Participants
|
57.7 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
66.0 years
STANDARD_DEVIATION 14.1 • n=4 Participants
|
49.3 years
STANDARD_DEVIATION 3.5 • n=21 Participants
|
58.2 years
STANDARD_DEVIATION 12.6 • n=10 Participants
|
|
Sex: Female, Male
Female
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
—
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
—
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Back-related functional limitations, RMDQ (pre-randomization)
|
—
|
16.3 units on a scale
STANDARD_DEVIATION 3.6 • n=7 Participants
|
10.0 units on a scale
STANDARD_DEVIATION 3.6 • n=5 Participants
|
14.0 units on a scale
STANDARD_DEVIATION 1.0 • n=4 Participants
|
16.0 units on a scale
STANDARD_DEVIATION 2.7 • n=21 Participants
|
14.2 units on a scale
STANDARD_DEVIATION 3.7 • n=10 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Note that this outcome reporting does not include the "Pre-Randomization Run-In Period Arm/Group", because that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization).
The RMDQ is a validated, commonly used, and widely accepted 'legacy' measure of back-related functional limitations (range 0 to 24, with higher scores representing greater functional limitations).
Outcome measures
| Measure |
Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT)
n=4 Participants
Participants received both:
1. Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.
and
2. Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress.
|
Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT)
n=3 Participants
Participants received both:
1. Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and 2) the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.
and
2. Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress.
|
Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE)
n=3 Participants
Participants received both:
1. Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.
and
2. Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook.
|
Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE)
n=3 Participants
Participants received both:
1. Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.
and
2. Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook.
|
|---|---|---|---|---|
|
Roland-Morris Disability Questionnaire
|
9.8 units on a scale
Standard Deviation 4.1
|
5.3 units on a scale
Standard Deviation 5.9
|
13.3 units on a scale
Standard Deviation 3.1
|
16.7 units on a scale
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Note that this outcome reporting does not include the "Pre-Randomization Run-In Period Arm/Group", because that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization).
Change scores will be calculated as compared to average daily step count pre-randomization.
Outcome measures
| Measure |
Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT)
n=4 Participants
Participants received both:
1. Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.
and
2. Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress.
|
Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT)
n=3 Participants
Participants received both:
1. Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and 2) the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.
and
2. Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress.
|
Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE)
n=3 Participants
Participants received both:
1. Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.
and
2. Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook.
|
Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE)
n=3 Participants
Participants received both:
1. Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.
and
2. Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook.
|
|---|---|---|---|---|
|
Activity Tracker-assessed Average Daily Step Counts (Change Scores)
|
-1445.8 average daily step count change score
Standard Deviation 5984.0
|
5617.2 average daily step count change score
Standard Deviation 5963.4
|
42.02 average daily step count change score
Standard Deviation 448.3
|
-842.4 average daily step count change score
Standard Deviation 3105.5
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Note that this outcome reporting does not include the "Pre-Randomization Run-In Period Arm/Group", because that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization).
Higher numerical pain ratings reflect greater pain intensity.
Outcome measures
| Measure |
Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT)
n=4 Participants
Participants received both:
1. Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.
and
2. Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress.
|
Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT)
n=3 Participants
Participants received both:
1. Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and 2) the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.
and
2. Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress.
|
Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE)
n=3 Participants
Participants received both:
1. Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.
and
2. Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook.
|
Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE)
n=3 Participants
Participants received both:
1. Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.
and
2. Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook.
|
|---|---|---|---|---|
|
Low Back Pain Intensity (0-10 Numerical Pain Rating Scale)
|
4.8 units on a scale
Standard Deviation 4.5
|
4.7 units on a scale
Standard Deviation 1.2
|
4.7 units on a scale
Standard Deviation 3.5
|
5.3 units on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Note that this outcome reporting does not include the "Pre-Randomization Run-In Period Arm/Group", because that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization).
Global quality of life measure. There are two subscales, the physical component summary score and the mental component summary score. Each range from 4-20, with higher scores reflecting greater quality of life
Outcome measures
| Measure |
Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT)
n=4 Participants
Participants received both:
1. Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.
and
2. Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress.
|
Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT)
n=3 Participants
Participants received both:
1. Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and 2) the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.
and
2. Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress.
|
Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE)
n=3 Participants
Participants received both:
1. Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.
and
2. Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook.
|
Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE)
n=3 Participants
Participants received both:
1. Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.
and
2. Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook.
|
|---|---|---|---|---|
|
PROMIS Global Health Short Form 10
PROMIS physical health
|
40.5 units on a scale
Standard Deviation 5.2
|
44.3 units on a scale
Standard Deviation 5.8
|
37.4 units on a scale
Standard Deviation 9.3
|
38.2 units on a scale
Standard Deviation 3.8
|
|
PROMIS Global Health Short Form 10
PROMIS mental health
|
47.8 units on a scale
Standard Deviation 5.4
|
50.9 units on a scale
Standard Deviation 5.1
|
55.3 units on a scale
Standard Deviation 4.2
|
38.6 units on a scale
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Note that this outcome reporting does not include the "Pre-Randomization Run-In Period Arm/Group", because that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization).
Self-reported average morphine equivalent daily dose over the past 3 days.
Outcome measures
| Measure |
Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT)
n=4 Participants
Participants received both:
1. Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.
and
2. Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress.
|
Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT)
n=3 Participants
Participants received both:
1. Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and 2) the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.
and
2. Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress.
|
Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE)
n=3 Participants
Participants received both:
1. Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.
and
2. Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook.
|
Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE)
n=3 Participants
Participants received both:
1. Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.
and
2. Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook.
|
|---|---|---|---|---|
|
Average Morphine Equivalent Daily Dose
|
0 average morphine milligram equivalents
Standard Deviation 0
|
0 average morphine milligram equivalents
Standard Deviation 0
|
0 average morphine milligram equivalents
Standard Deviation 0
|
6.7 average morphine milligram equivalents
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Note that this outcome reporting does not include the "Pre-Randomization Run-In Period Arm/Group", because that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization).
7-point Likert scale where 3 represents 'complete recovery', 0 represents 'not changed', and -3 represents 'become worse than ever'
Outcome measures
| Measure |
Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT)
n=4 Participants
Participants received both:
1. Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.
and
2. Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress.
|
Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT)
n=3 Participants
Participants received both:
1. Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and 2) the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.
and
2. Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress.
|
Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE)
n=3 Participants
Participants received both:
1. Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.
and
2. Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook.
|
Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE)
n=3 Participants
Participants received both:
1. Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.
and
2. Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook.
|
|---|---|---|---|---|
|
Global Perceived Effect (How Back Pain Has Changed Since Baseline)
|
0.3 units on a scale
Standard Deviation 1.7
|
0.7 units on a scale
Standard Deviation 0.6
|
0.7 units on a scale
Standard Deviation 1.2
|
0 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Note that this outcome reporting does not include the "Pre-Randomization Run-In Period Arm/Group", because that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization).
Higher numerical pain ratings reflect greater pain intensity.
Outcome measures
| Measure |
Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT)
n=4 Participants
Participants received both:
1. Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.
and
2. Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress.
|
Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT)
n=3 Participants
Participants received both:
1. Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and 2) the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.
and
2. Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress.
|
Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE)
n=3 Participants
Participants received both:
1. Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.
and
2. Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook.
|
Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE)
n=3 Participants
Participants received both:
1. Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.
and
2. Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook.
|
|---|---|---|---|---|
|
Expected Low Back Pain Intensity (0-10 Numerical Pain Rating Scale) if Not Using Pain Medications
|
5.0 units on a scale
Standard Deviation 4.2
|
5.0 units on a scale
Standard Deviation 1.7
|
5.7 units on a scale
Standard Deviation 4.0
|
7.0 units on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Note that this outcome reporting does not include the "Pre-Randomization Run-In Period Arm/Group", because that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization).
5-point Likert scale where 2 represents 'completely satisfied', 0 represents 'neutral', and -2 represents 'completely dissatisfied'
Outcome measures
| Measure |
Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT)
n=4 Participants
Participants received both:
1. Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.
and
2. Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress.
|
Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT)
n=3 Participants
Participants received both:
1. Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and 2) the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.
and
2. Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress.
|
Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE)
n=3 Participants
Participants received both:
1. Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.
and
2. Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook.
|
Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE)
n=3 Participants
Participants received both:
1. Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.
and
2. Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook.
|
|---|---|---|---|---|
|
Participant-reported Satisfaction
|
1.0 units on a scale
Standard Deviation 1.4
|
0.3 units on a scale
Standard Deviation 0.6
|
0.3 units on a scale
Standard Deviation 1.5
|
-1.3 units on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Note that this outcome reporting does not include the "Pre-Randomization Run-In Period Arm/Group", because that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization).
Self-reported activity equivalent minutes per week
Outcome measures
| Measure |
Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT)
n=4 Participants
Participants received both:
1. Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.
and
2. Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress.
|
Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT)
n=3 Participants
Participants received both:
1. Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and 2) the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.
and
2. Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress.
|
Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE)
n=3 Participants
Participants received both:
1. Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.
and
2. Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook.
|
Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE)
n=3 Participants
Participants received both:
1. Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.
and
2. Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook.
|
|---|---|---|---|---|
|
BRFSS Self-reported Physical Activity Per Week
|
487.5 activity minutes per week
Standard Deviation 306.2
|
1650.0 activity minutes per week
Standard Deviation 297.0
|
201.7 activity minutes per week
Standard Deviation 97.8
|
398.3 activity minutes per week
Standard Deviation 530.1
|
Adverse Events
Pre-Randomizaton Run-In Period
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Lumbar Medial Branch Nerve Radiofrequency Ablation (LRFA) + AcTIVE-CBT
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Simulated Lumbar Radiofrequency Ablation (Simulated LRFA) + AcTIVE-CBT
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Lumbar Medial Branch Nerve Radiofrequency Ablation (LRFA) + TBSCE
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Simulated Lumbar Radiofrequency Ablation (Simulated LRFA) + TBSCE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pre-Randomizaton Run-In Period
n=16 participants at risk
The pre-randomization run-in period was designed to exclude subjects who no longer met study criteria by the day of randomization, and those who were unlikely to be able to complete the study processes such as the telephone assessments used for data collection and the use of technology (synchronizing activity trackers). Of those who began the run-in period (n=16), 3 were withdrawn during the run-in period and prior to randomization, leaving 13 who were randomized. There are no participants in this group after randomization.
|
Lumbar Medial Branch Nerve Radiofrequency Ablation (LRFA) + AcTIVE-CBT
n=4 participants at risk
Participants received both:
1. Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.
and
2. Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress.
|
Simulated Lumbar Radiofrequency Ablation (Simulated LRFA) + AcTIVE-CBT
n=3 participants at risk
Participants received both:
1. Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and 2) the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.
and
2. Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT): AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress.
|
Lumbar Medial Branch Nerve Radiofrequency Ablation (LRFA) + TBSCE
n=3 participants at risk
Participants received both:
1. Lumbar medial branch nerve radiofrequency ablation (LRFA): Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.
and
2. Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook.
|
Simulated Lumbar Radiofrequency Ablation (Simulated LRFA) + TBSCE
n=3 participants at risk
Participants received both:
1. Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves (simulated LRFA), with targeted steroid injections: Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.
and
2. Telephone-based self-directed CBT and education (TBSCE): TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook.
|
|---|---|---|---|---|---|
|
Surgical and medical procedures
Surgery
|
0.00%
0/16 • 3 months
Note that AE reporting includes the "Pre-Randomization Run-In Period Arm/Group", although that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization). We corresponded with the PRS Results Team who recommend this approach on 8/9/2021.
|
25.0%
1/4 • Number of events 1 • 3 months
Note that AE reporting includes the "Pre-Randomization Run-In Period Arm/Group", although that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization). We corresponded with the PRS Results Team who recommend this approach on 8/9/2021.
|
0.00%
0/3 • 3 months
Note that AE reporting includes the "Pre-Randomization Run-In Period Arm/Group", although that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization). We corresponded with the PRS Results Team who recommend this approach on 8/9/2021.
|
0.00%
0/3 • 3 months
Note that AE reporting includes the "Pre-Randomization Run-In Period Arm/Group", although that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization). We corresponded with the PRS Results Team who recommend this approach on 8/9/2021.
|
0.00%
0/3 • 3 months
Note that AE reporting includes the "Pre-Randomization Run-In Period Arm/Group", although that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization). We corresponded with the PRS Results Team who recommend this approach on 8/9/2021.
|
|
Surgical and medical procedures
ED/Urgent Care
|
31.2%
5/16 • Number of events 5 • 3 months
Note that AE reporting includes the "Pre-Randomization Run-In Period Arm/Group", although that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization). We corresponded with the PRS Results Team who recommend this approach on 8/9/2021.
|
0.00%
0/4 • 3 months
Note that AE reporting includes the "Pre-Randomization Run-In Period Arm/Group", although that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization). We corresponded with the PRS Results Team who recommend this approach on 8/9/2021.
|
33.3%
1/3 • Number of events 1 • 3 months
Note that AE reporting includes the "Pre-Randomization Run-In Period Arm/Group", although that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization). We corresponded with the PRS Results Team who recommend this approach on 8/9/2021.
|
66.7%
2/3 • Number of events 2 • 3 months
Note that AE reporting includes the "Pre-Randomization Run-In Period Arm/Group", although that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization). We corresponded with the PRS Results Team who recommend this approach on 8/9/2021.
|
0.00%
0/3 • 3 months
Note that AE reporting includes the "Pre-Randomization Run-In Period Arm/Group", although that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization). We corresponded with the PRS Results Team who recommend this approach on 8/9/2021.
|
|
Surgical and medical procedures
Hospitalization
|
0.00%
0/16 • 3 months
Note that AE reporting includes the "Pre-Randomization Run-In Period Arm/Group", although that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization). We corresponded with the PRS Results Team who recommend this approach on 8/9/2021.
|
0.00%
0/4 • 3 months
Note that AE reporting includes the "Pre-Randomization Run-In Period Arm/Group", although that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization). We corresponded with the PRS Results Team who recommend this approach on 8/9/2021.
|
0.00%
0/3 • 3 months
Note that AE reporting includes the "Pre-Randomization Run-In Period Arm/Group", although that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization). We corresponded with the PRS Results Team who recommend this approach on 8/9/2021.
|
0.00%
0/3 • 3 months
Note that AE reporting includes the "Pre-Randomization Run-In Period Arm/Group", although that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization). We corresponded with the PRS Results Team who recommend this approach on 8/9/2021.
|
0.00%
0/3 • 3 months
Note that AE reporting includes the "Pre-Randomization Run-In Period Arm/Group", although that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization). We corresponded with the PRS Results Team who recommend this approach on 8/9/2021.
|
|
Surgical and medical procedures
ICU
|
0.00%
0/16 • 3 months
Note that AE reporting includes the "Pre-Randomization Run-In Period Arm/Group", although that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization). We corresponded with the PRS Results Team who recommend this approach on 8/9/2021.
|
0.00%
0/4 • 3 months
Note that AE reporting includes the "Pre-Randomization Run-In Period Arm/Group", although that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization). We corresponded with the PRS Results Team who recommend this approach on 8/9/2021.
|
0.00%
0/3 • 3 months
Note that AE reporting includes the "Pre-Randomization Run-In Period Arm/Group", although that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization). We corresponded with the PRS Results Team who recommend this approach on 8/9/2021.
|
0.00%
0/3 • 3 months
Note that AE reporting includes the "Pre-Randomization Run-In Period Arm/Group", although that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization). We corresponded with the PRS Results Team who recommend this approach on 8/9/2021.
|
0.00%
0/3 • 3 months
Note that AE reporting includes the "Pre-Randomization Run-In Period Arm/Group", although that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization). We corresponded with the PRS Results Team who recommend this approach on 8/9/2021.
|
|
Immune system disorders
Allergic Reaction
|
0.00%
0/16 • 3 months
Note that AE reporting includes the "Pre-Randomization Run-In Period Arm/Group", although that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization). We corresponded with the PRS Results Team who recommend this approach on 8/9/2021.
|
75.0%
3/4 • Number of events 3 • 3 months
Note that AE reporting includes the "Pre-Randomization Run-In Period Arm/Group", although that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization). We corresponded with the PRS Results Team who recommend this approach on 8/9/2021.
|
0.00%
0/3 • 3 months
Note that AE reporting includes the "Pre-Randomization Run-In Period Arm/Group", although that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization). We corresponded with the PRS Results Team who recommend this approach on 8/9/2021.
|
0.00%
0/3 • 3 months
Note that AE reporting includes the "Pre-Randomization Run-In Period Arm/Group", although that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization). We corresponded with the PRS Results Team who recommend this approach on 8/9/2021.
|
0.00%
0/3 • 3 months
Note that AE reporting includes the "Pre-Randomization Run-In Period Arm/Group", although that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization). We corresponded with the PRS Results Team who recommend this approach on 8/9/2021.
|
|
General disorders
Other Complications
|
0.00%
0/16 • 3 months
Note that AE reporting includes the "Pre-Randomization Run-In Period Arm/Group", although that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization). We corresponded with the PRS Results Team who recommend this approach on 8/9/2021.
|
25.0%
1/4 • Number of events 1 • 3 months
Note that AE reporting includes the "Pre-Randomization Run-In Period Arm/Group", although that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization). We corresponded with the PRS Results Team who recommend this approach on 8/9/2021.
|
33.3%
1/3 • Number of events 1 • 3 months
Note that AE reporting includes the "Pre-Randomization Run-In Period Arm/Group", although that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization). We corresponded with the PRS Results Team who recommend this approach on 8/9/2021.
|
33.3%
1/3 • Number of events 1 • 3 months
Note that AE reporting includes the "Pre-Randomization Run-In Period Arm/Group", although that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization). We corresponded with the PRS Results Team who recommend this approach on 8/9/2021.
|
0.00%
0/3 • 3 months
Note that AE reporting includes the "Pre-Randomization Run-In Period Arm/Group", although that group is not mutually exclusive from the 4 groups presented here (it includes the same participants, but prior to randomization). We corresponded with the PRS Results Team who recommend this approach on 8/9/2021.
|
Additional Information
Pradeep Suri, MD
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Phone: 206-764-2673
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place