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Back pain is the #1 contributor to disability in the United States (US), and second only to hearing problems as a reason for new Veteran disability compensation. The societal burden of back pain is driven mainly by chronic low back pain (CLBP), defined as low back pain persisting for 3 months. Since most individual treatments for CLBP have only small effects on functional recovery, combining CLBP treatments has recently been recommended as a priority area for research. However, few prior studies of CLBP have been properly designed to evaluate the effects of treatment combinations. Large effects on functional recovery from CLBP may require combining interventions that each target different points on a theoretical pathway to functional recovery. Procedural treatments for CLBP aim primarily to address early stages in the pathway to functional recovery, such as problems with the lumbar spinal structures or low back pain itself. In contrast, behavioral interventions for CLBP generally have effects not only on pain itself, but also work by mitigating the degree to which the sensation of low back pain impacts function, well-being, and quality of life. These represent later stages in the pathway to functional recovery from CLBP. Combining procedural and behavioral treatments may have great potential for achieving large magnitude treatment effects for CLBP in Veterans.
The proposed research assesses the feasibility of using a 2 x 2 factorial randomized controlled trial (RCT) design to examine the individual and combined effects of 1) lumbar medial branch nerve radiofrequency ablation (LRFA), a commonly used procedural intervention to target low back pain severity, and 2) a novel video telehealth tablet- and personal computer (PC)-based Activity Tracker-Informed Video-Enabled Cognitive Behavioral Therapy program ("AcTIVE-CBT"), a behavioral intervention designed primarily to target functional limitations both secondary to, and independent of, improvements in pain. The LRFA treatment to be used in the proposed study addresses the major patient selection, procedural/technical, methodologic and reporting limitations of prior studies. AcTIVE-CBT addresses problems with Veteran access and compliance associated with conventional cognitive behavioral therapy (CBT) delivered in clinic, and uses currently available activity tracking technology to better promote activity and behavior change as compared to conventional CBT. This pilot RCT involves recruitment of up to 30 Veterans with CLBP who will be followed to evaluate functional recovery for up to 3 months, to reach a goal of 20 Veterans completing the 3-month primary outcome. The primary outcome is participant-reported back-related functional limitations (mobility and ADLs) at 3 months, as measured by the validated Roland-Morris Disability Questionnaire. Secondary outcomes include activity tracker-assessed step counts, back pain intensity, reduction in opioid use, and quality of life. Although the proposed pilot study is unlikely to definitively address whether these treatments alone or in combination have significant effects on functional recovery, it will inform a future large-scale multicenter RCT to determine the efficacy of LRFA, AcTIVE-CBT, or combined LRFA + AcTIVE-CBT, for Veterans with CLBP.
The proposed research assesses the feasibility of using an innovative application of the 2 x 2 factorial randomized controlled trial (RCT) design to examine the individual and combined effects of 1) lumbar medial branch nerve radiofrequency ablation (LRFA), a commonly used procedural intervention to target low back pain severity, and 2) a novel video telehealth tablet- and personal computer (PC)-based Activity Tracker-Informed Video-Enabled Cognitive Behavioral Therapy program ("AcTIVE-CBT"), a behavioral intervention designed primarily to target functional limitations both secondary to, and independent of, improvements in pain. The LRFA treatment to be used in the proposed study addresses the major patient selection, procedural/technical, methodologic and reporting limitations of prior studies. AcTIVE-CBT addresses problems with Veteran access and compliance associated with conventional cognitive behavioral therapy (CBT) delivered in clinic, and uses currently available activity tracking technology to better promote activity and behavior change as compared to conventional CBT. This pilot RCT involves recruitment of up to 30 Veterans with CLBP who will be followed to evaluate functional recovery for up to 3 months, to reach a goal of 20 Veterans completing the 3-month primary outcome. The primary outcome is participant-reported back-related functional limitations (mobility and ADLs) at 3 months, as measured by the validated Roland-Morris Disability Questionnaire. Secondary outcomes include activity tracker-assessed step counts, back pain intensity, reduction in opioid use, and quality of life. The investigators hypothesize that 1) each individual treatment will result in improvements in back-related functional limitations and secondary outcomes compared to control, and 2) combined treatment will produce greater treatment effects than each of the individual treatments alone. Although the proposed pilot study is unlikely to definitively address whether these treatments alone or in combination have significant effects on functional recovery, it will inform a future large-scale multicenter RCT to determine the efficacy of LRFA, AcTIVE-CBT, or combined LRFA + AcTIVE-CBT, for Veterans with CLBP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumbar medial branch nerve radiofrequency ablation (LRFA) | Experimental | Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves |
|
| Simulated lumbar radiofrequency ablation (simulated LRFA) | Active Comparator | Simulated radiofrequency ablation of the dorsal rami of the lumbar spinal nerves(simulated LRFA), with targeted steroid injections |
|
| AcTIVE-CBT | Experimental | Activity-Tracker Informed Video-enabled Cognitive Behavioral Therapy (AcTIVE-CBT) |
|
| TBSCE | Active Comparator | Telephone-based self-directed CBT and education (TBSCE) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumbar medial branch nerve radiofrequency ablation (LRFA) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Roland-Morris Disability Questionnaire | 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). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Activity Tracker-assessed Average Daily Step Counts (Change Scores) | Change scores will be calculated as compared to average daily step count pre-randomization. | 3 months |
| Low Back Pain Intensity (0-10 Numerical Pain Rating Scale) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pradeep Suri, MD | VA Puget Sound Health Care System Seattle Division, Seattle, WA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington | 98108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39902653 | Derived | Tanus AD, Nishio I, Williams R, Friedly J, Soares B, Anderson D, Bambara J, Dawson T, Hsu A, Kim PY, Krashin D, Del Piero L, Korpak A, Timmons A, Suri P. Combining procedural and behavioral treatments for chronic low back pain: A pilot feasibility randomized controlled trial. PM R. 2025 Apr;17(4):431-444. doi: 10.1002/pmrj.13323. Epub 2025 Feb 4. |
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Only completely deidentified/anonymized versions of datasets would be shared, provided that appropriate enterprise-level procedures permit this and are in place. Sharing would only take place under a written agreement prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset, including a properly submitted FOIA request. Electronic versions of final data sets will be maintained locally in a secure manner until enterprise-level resources become available for long-term storage.
The investigators will endeavor to share IPD when requested by 6 months after the time of publication of the main study findings and publication of longer-term results of the study, provided that appropriate enterprise-level procedures permit this and are in place at the time of.
The study team and PI will review each request for IPD, with involvement of local administrative officials as appropriate. Requests will be evaluated for criteria including data safety, the purpose of analyses warranting potential risks of transferring data, security of the transfer. An agreement will specify the duration of time for data to be held before being destroyed at the destination site.
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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).
Recruitment dates: 11/15/2018 to 03/17/2020 at the VA Puget Sound Health Care System
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Group A (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + AcTIVE-CBT) | Participants received both:
|
| FG002 | Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT) | Participants received both:
|
| FG003 | Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE) | Participants received both:
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| FG004 | Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE) | Participants received both:
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| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-Randomization |
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| ||||||||||||||||||
| Randomized |
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At randomization, participants are randomized to 1 the 4 treatment groups above; thus there are 0 participants in the "Pre-Randomization Run-In Period" group. Although baseline characteristics presented for each cell of the 2 x 2 contingency table in this factorial pilot trial, the primary analysis as originally planned focused on the main effects of (1) LRFA vs. simulated LRFA and (2) AcTIVE-CBT vs. TBSCE, unless there were indications of strong interactions between the two types of treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Roland-Morris Disability Questionnaire | 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). | 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). | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-Randomizaton 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgery | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pradeep Suri, MD | VA Puget Sound Health Care System Seattle Division, Seattle, WA | 206-764-2673 | Pradeep.Suri@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 12, 2020 | Jun 9, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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The proposed research assesses the feasibility of using a 2 x 2 factorial randomized controlled trial (RCT) design to examine the individual and combined effects of 1) lumbar medial branch nerve radiofrequency ablation (LRFA) (vs. simulated LRFA control), and 2) a novel video telehealth tablet- and personal computer (PC)-based Activity Tracker-Informed Video-Enabled Cognitive Behavioral Therapy program ("AcTIVE-CBT") (vs. a telephone-based self-directed CBT and education control). This pilot RCT will involve 30 Veterans with chronic low back pain (CLBP) who will be followed to evaluate functional recovery for 3 months.
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Some investigators are not masked, for safety monitoring purposes.
| Simulated LRFA with targeted steroid injections | Procedure | 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. |
|
|
| AcTIVE-CBT | Behavioral | 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. |
|
|
| TBSCE | Behavioral | 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. |
|
|
Higher numerical pain ratings reflect greater pain intensity.
| 3 months |
| PROMIS Global Health Short Form 10 | 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 | 3 months |
| Average Morphine Equivalent Daily Dose | Self-reported average morphine equivalent daily dose over the past 3 days. | 3 months |
| Global Perceived Effect (How Back Pain Has Changed Since Baseline) | 7-point Likert scale where 3 represents 'complete recovery', 0 represents 'not changed', and -3 represents 'become worse than ever' | 3 months |
| Expected Low Back Pain Intensity (0-10 Numerical Pain Rating Scale) if Not Using Pain Medications | Higher numerical pain ratings reflect greater pain intensity. | 3 months |
| Participant-reported Satisfaction | 5-point Likert scale where 2 represents 'completely satisfied', 0 represents 'neutral', and -2 represents 'completely dissatisfied' | 3 months |
| BRFSS Self-reported Physical Activity Per Week | Self-reported activity equivalent minutes per week | 3 months |
| Failed eligibility criteria or run-in period criteria |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Lumbar Medial Branch Nerve Radiofrequency Ablation (LRFA) + AcTIVE-CBT | Participants received both:
|
| BG002 | Simulated Lumbar Radiofrequency Ablation (Simulated LRFA) + AcTIVE-CBT | Participants received both:
|
| BG003 | Lumbar Medial Branch Nerve Radiofrequency Ablation (LRFA) + TBSCE | Participants received both:
|
| BG004 | Simulated Lumbar Radiofrequency Ablation (Simulated LRFA) + TBSCE | Participants received both:
|
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Back-related functional limitations, RMDQ (pre-randomization) | The Roland-Morris Disability Questionnaire (RMDQ) is a validated, commonly used, and widely accepted measure of back-related functional limitations. Scores range from 0 to 24, with higher numbers reflecting greater functional limitations. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Group B (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + AcTIVE-CBT) | Participants received both:
|
| OG002 | Group C (Lumbar Medial Branch Nerve Radiofrequency Ablation [LRFA] + TBSCE) | Participants received both:
|
| OG003 | Group D (Simulated Lumbar Radiofrequency Ablation [Simulated LRFA] + TBSCE) | Participants received both:
|
|
|
|
| Secondary | Activity Tracker-assessed Average Daily Step Counts (Change Scores) | Change scores will be calculated as compared to average daily step count pre-randomization. | 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). | Posted | Mean | Standard Deviation | average daily step count change score | 3 months |
|
|
|
|
| Secondary | Low Back Pain Intensity (0-10 Numerical Pain Rating Scale) | Higher numerical pain ratings reflect greater pain intensity. | 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). | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
|
| Secondary | PROMIS Global Health Short Form 10 | 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 | 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). | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
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|
|
| Secondary | Average Morphine Equivalent Daily Dose | Self-reported average morphine equivalent daily dose over the past 3 days. | 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). | Posted | Mean | Standard Deviation | average morphine milligram equivalents | 3 months |
|
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|
|
| Secondary | Global Perceived Effect (How Back Pain Has Changed Since Baseline) | 7-point Likert scale where 3 represents 'complete recovery', 0 represents 'not changed', and -3 represents 'become worse than ever' | 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). | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
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|
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| Secondary | Expected Low Back Pain Intensity (0-10 Numerical Pain Rating Scale) if Not Using Pain Medications | Higher numerical pain ratings reflect greater pain intensity. | 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). | Posted | Mean | Standard Deviation | units on a scale | 3 months |
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|
| Secondary | Participant-reported Satisfaction | 5-point Likert scale where 2 represents 'completely satisfied', 0 represents 'neutral', and -2 represents 'completely dissatisfied' | 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). | Posted | Mean | Standard Deviation | units on a scale | 3 months |
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| Secondary | BRFSS Self-reported Physical Activity Per Week | Self-reported activity equivalent minutes per week | 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). | Posted | Mean | Standard Deviation | activity minutes per week | 3 months |
|
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 5 |
| 16 |
| EG001 | Lumbar Medial Branch Nerve Radiofrequency Ablation (LRFA) + AcTIVE-CBT | Participants received both:
| 0 | 4 | 0 | 4 | 3 | 4 |
| EG002 | Simulated Lumbar Radiofrequency Ablation (Simulated LRFA) + AcTIVE-CBT | Participants received both:
| 0 | 3 | 0 | 3 | 1 | 3 |
| EG003 | Lumbar Medial Branch Nerve Radiofrequency Ablation (LRFA) + TBSCE | Participants received both:
| 0 | 3 | 0 | 3 | 3 | 3 |
| EG004 | Simulated Lumbar Radiofrequency Ablation (Simulated LRFA) + TBSCE | Participants received both:
| 0 | 3 | 0 | 3 | 0 | 3 |
| ED/Urgent Care | Surgical and medical procedures | Systematic Assessment |
|
| Hospitalization | Surgical and medical procedures | Systematic Assessment |
|
| ICU | Surgical and medical procedures | Systematic Assessment |
|
| Allergic Reaction | Immune system disorders | Systematic Assessment |
|
| Other Complications | General disorders | Systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Mean Difference (Final Values) |
| 2081.9 |
| Standard Error of the Mean |
| 2983.2 |
| 2-Sided |
| 95 |
| -4666.6 |
| 8830.4 |
This is an analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on CHANGE in step counts, after adjustment for age and baseline step counts.Positive values show increased steps with AcTIVE-CBT over TBSCE. |
| Superiority |
| Mean Difference (Final Values) |
| -0.3 |
| Standard Error of the Mean |
| 1.7 |
| 2-Sided |
| 95 |
| -4.2 |
| 3.6 |
Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate benefit with AcTIVE-CBT over TBSCE. |
| Superiority |
| PROMIS mental health |
|
| PROMIS physical health scores | Mean Difference (Final Values) | 6.2 | Standard Error of the Mean | 2.9 | 2-Sided | 95 | -0.4 | 12.9 | Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Positive scores indicate better health with AcTIVE-CBT vs. TBSCE | Superiority |
| PROMIS mental health scores | Mean Difference (Final Values) | 3.7 | Standard Error of the Mean | 4.0 | 2-Sided | 95 | -5.4 | 12.7 | Analysis of the MAIN EFFECT of LRFA (Group A + Group C) vs. simulated LRFA (Group B + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Positive scores indicate better health with LRFA vs. simulated LRFA. | Superiority |
| PROMIS mental health scores | Mean Difference (Final Values) | 1.8 | Standard Error of the Mean | 3.9 | 2-Sided | 95 | -7.0 | 10.6 | Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Positive scores indicate better health with AcTIVE-CBT vs. TBSCE | Superiority |
| Mean Difference (Final Values) |
| -3.3 |
| Standard Error of the Mean |
| 1.9 |
| 2-Sided |
| 95 |
| -7.5 |
| 1.0 |
Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Negative scores indicate lower doses with AcTIVE-CBT over TBSCE. |
| Superiority |
| Mean Difference (Final Values) |
| 0.1 |
| Standard Error of the Mean |
| 0.6 |
| 2-Sided |
| 95 |
| -1.3 |
| 1.5 |
Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months, after adjustment for age and baseline value of the outcome. Positive scores indicate perceived benefit with AcTIVE-CBT over TBSCE. |
| Superiority |
| Mean Difference (Final Values) |
| -1.4 |
| Standard Error of the Mean |
| 1.8 |
| 2-Sided |
| 95 |
| -5.4 |
| 2.6 |
Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months after adjustment for age and baseline value of the outcome. Negative scores indicate less pain with AcTIVE-CBT vs. TBSCE |
| Superiority |
| Mean Difference (Final Values) |
| 1.2 |
| Standard Error of the Mean |
| 0.7 |
| 2-Sided |
| 95 |
| -0.4 |
| 2.8 |
Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months, after adjustment for age. Positive scores indicate more satisfaction with AcTIVE-CBT over TBSCE. |
| Superiority |
| Mean Difference (Final Values) |
| 572.2 |
| Standard Error of the Mean |
| 334.5 |
| 2-Sided |
| 95 |
| -199.3 |
| 1343.6 |
Analysis of the MAIN EFFECT of AcTIVE-CBT (Group A + Group B) vs. TBSCE (Group C + Group D) on the outcome at 3 months adjusting for age and baseline value of the outcome. Positive scores indicate more satisfaction with AcTIVE-CBT over TBSCE. |
| Superiority |