Chronic Low Back Pain Graded - Exposure Psychoeducation Intervention (VRGE)
Primary Purpose
Chronic Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interactive - Psychoeducation
Non-interactive Psychoeducation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Chronic Pain, Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- report having low back pain for more than three months and at least half the days in the past 6 months
- be 18-65 years of age,
- have scores higher than 37 on the Tampa Scale of Kinesiophobia,
Exclusion Criteria:
- medical conditions other than back pain that significantly impair movement (e.g., arthritis)
- confirmed/suspected pregnancy
- pending litigation related to an episode of low back pain
- significant impairment in vision
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Interactive Psycho-education
Psycho-education
Arm Description
Interactive psycho-education using interactive dashboard.
Non-interactive psycho-education not using interactive dashboard.
Outcomes
Primary Outcome Measures
Pain Intensity as assessed by Numeric Rating Scale
The Numeric Rating Scale (NRS) measures pain intensity measured via 0-10 numeric rating scale.
0 = No Pain - 10 = Worst Possible Pain Range of scores: 0-10
Present Pain Intensity
Present Pain Intensity (PPI) assesses present pain intensity on a scale of 0 (no pain) to 5 (excruciating)
Present Pain Rating
Pain Rating Index (PRI) is assessed by 15 questions assessing pain in the sensory and affective dimensions.
Items rate from 0 (none) to 3 (severe) on degree to which the words apply to pain.
Score Range: 0-45
Pain Chronicity assessed by the Graded Chronic Pain Scale
Pain Chronicity is assessed by the Graded Chronic Pain Scale (GCPS). The GCPS is 7 questions with 3 sub-scales (Characteristic pain intensity, disability score, and disability points).
Scoring:
Characteristic Pain Intensity: is a 0 to 100 score derived from Questions 1 through 3: Mean (Pain Right Now, Worst Pain, Average Pain) X 10.
Disability Score: is 0 to 100 score derived from Questions 4 through 6: Mean (Daily Activities, Social Activities, Work Activities) X 10 Disability Points: Add the indicated points for Disability Days (Question 7) and for Disability Score (0-6).
Items rate from 0 to 10 with 0 referencing no pain/interference/change and 10 referencing pain as bad as could be/unable to carry out any activities/extreme change.
Daily Pain Monitoring: 10 point scale
Daily pain monitoring defined as daily pain intensity and daily pain interference monitoring is two questions asked daily on a 10 point scale assessing daily pain and how much pain had interfered with day to day activities.
Pain: Over the past 24 hours, how would you rate your back pain on average? (0=No Pain; 10=Worst Imaginable Pain)
Interference: Over the past 24 hours, how much did pain interfere with your day-to-day activities? (0=No Interference; 10 = A great deal of interference)"
Secondary Outcome Measures
Back Disability as assessed by the Roland Morris Disability Questionnaire
The Roland Morris Disability Questionnaire (RMDQ) assesses disability due to low back pain.
The RMDQ is a 24 item survey with yes/no response options. Score 0 -24 with ower scores indicate more impairment.
Depressive symptoms as assessed by the Center for Epidemiologic Studies Depression Scale
The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20 item survey tool. The items are a 4 pt Likert response items.
Scores range from 0-60 with higher scores indicate greater levels of depressive symptoms.
Pain Catastrophizing as assessed by the Pain Catastrophizing Scale
The Pain Catastrophizing Scale (PCS) is a 13 item survey assessing catastrophizing in context to pain. There are 13 items with 5-pt Likert responses.
There are several subscales. Scoring Procedure: The PCS total score is computed by summing responses to all 13 items (0-52).
Subscales:
Rumination: Sum of items 8, 9, 10, 11 (0-16). Magnification: Sum of items 6, 7, 13 (0-12). Helplessness: Sum of items 1, 2, 3, 4, 5, 12 (0-24).
Pain-related fear of movement as assessed by the Tampa Scale Kinesiophobia
The Tampa Scale Kinesiophobia (TSK) is a 17 item assessment of fear of movement. This uses a 5-pt Likert scale from 1 = Strongly Disagree to 4 = Strongly Agree.
Scoring Procedure: Sum items Range: 17-68 Subscale Harm/Somatic Items: 3, 5, 6, 9, 11, 15 Subscale Avoidance Items: 1, 2, 7, 10, 13, 14, 17
Mood and Affect as assessed by the Positive and Negative Affect Scale
The Positive and Negative Affect Scale (PANAS) measures mood of participants. This is a 20 item survey with 5 pt Likert response indicating to what degree the participant feels those emotions. There is a positive and negative subscale.
Higher positive affect score indicates greater positive emotions; higher negative affect score indicates greater negative emotions.
Range of Scores: 0-40
Immersive Tendencies
Immersive Tendencies are assessed by the Immersive Tendencies Questionnaire (ITQ). This is an 18-item survey. Item responses use a 7 point Likert scale. Subscales include: focus, involvement, emotions, and play. Each subscale is scored by summing items. A total score is scored by summing all items.
Range of total score: 18-126 Focus range of scores: 5-35 Involvement range of scores: 5-35 Emotions range of scores: 4-28 Play range of scores: 3-21 Higher scores indicate higher immersive tendencies overall and in each sub-scale.
Absorption Tendencies
Tellegen Absorption Scale is a 34-item multi-dimensional measure that assesses imaginative involvement and the tendency to become mentally absorbed in everyday activities. Item responses are on a 5-point Likert scale. Items are summed to score.
Range of scores: 0-136. Higher scores indicate greater levels of absorption.
Video Game History
History of playing video games.
Patient Treatment Evaluation as assessed by the Modified Treatment Evaluation Inventory
Patient treatment evaluation is assessed by Treatment Evaluation Inventory. This is a 9 item scale with a 5-point Likert responses for each question. The items are scored by summing all items.
Range of scores: 9-45. A higher score indicates greater acceptance of treatment.
Patient Treatment Evaluation as assessed by Semi-structured Qualitative interviewing
Patient treatment evaluation is assessed by semi-structured interviewing. Qualitative feedback from participant experience will be assessed by thematic analyses.
Daily intervention feedback questions
The daily intervention feedback questions are 7 items that assess the individuals feelings and experiences during that daily intervention session.
0-10 Likert scale
Each item is it's own scale.
Higher scores indicate more enjoyment/usefulness/demand/awareness/concern/mood.
Patient Treatment Evaluation as assessed by the Usefulness, Satisfaction, and Ease of Use Questionnaire
The Usefulness, Satisfaction, and Ease of Use Questionnaire (USE, Lund, 2001) measures the subjective usability of a product or service. It is a 30-item survey that examines four dimensions of usability: usefulness, ease of use, ease of learning, and satisfaction. This metric can be applied to various scenarios of usability assessment because it is non-proprietary and technology-agnostic. is a 30 item survey.
Each item is presented on a 7-point Likert scale from strongly disagree = 1 to strongly agree. = 7
Each subscale is calculated by averaging all items in subscale. Usefulness: items 1-8 Ease of use: items 9-19 Ease of Learning: items 20-23 Satisfaction: items 24-30
Range of scores for each subscale: 1-7 Scoring Interpretation: Higher score indicates greater usefulness, satisfaction, and ease of use.
Patient Treatment Evaluation as assessed by the Patient Global Impression of Change Scale
Patient treatment evaluation is assessed by the Patient Global Impression of Change. This is a one item 7 point Likert item assessing improvement of the participants overall status.
Item responses:
1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse
Video Game Preferences as assessed by the BrainHex
Video game preferences will be assessed by the BrainHex. The BrainHex provides a tool for designing gameplay and understanding motivations for play.
Full Information
NCT ID
NCT03909048
First Posted
April 5, 2019
Last Updated
October 30, 2019
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT03909048
Brief Title
Chronic Low Back Pain Graded - Exposure Psychoeducation Intervention
Acronym
VRGE
Official Title
Chronic Low Back Pain Graded - Exposure Psychoeducation Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will examine the effectiveness of one of two psychoeducation treatments on chronic low back pain.
Detailed Description
This study will examine the effectiveness of one of two psychoeducation treatments on chronic low back pain. Participants will be randomized to one of these two treatments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Chronic Pain, Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Participant, statistician, and outcomes assessor are blinded.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interactive Psycho-education
Arm Type
Experimental
Arm Description
Interactive psycho-education using interactive dashboard.
Arm Title
Psycho-education
Arm Type
Placebo Comparator
Arm Description
Non-interactive psycho-education not using interactive dashboard.
Intervention Type
Behavioral
Intervention Name(s)
Interactive - Psychoeducation
Intervention Description
Individuals will receive interactive psychoeducation in the lab over the course of a week period. Each session will take approximately 30 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Non-interactive Psychoeducation
Intervention Description
Individuals will receive non-interactive psychoeducation over the course of a week period. Each session will take approximately 30 minutes.
Primary Outcome Measure Information:
Title
Pain Intensity as assessed by Numeric Rating Scale
Description
The Numeric Rating Scale (NRS) measures pain intensity measured via 0-10 numeric rating scale.
0 = No Pain - 10 = Worst Possible Pain Range of scores: 0-10
Time Frame
Baseline - Final assessment (average 1 week post treatment)
Title
Present Pain Intensity
Description
Present Pain Intensity (PPI) assesses present pain intensity on a scale of 0 (no pain) to 5 (excruciating)
Time Frame
Baseline - Final assessment (average 1 week post treatment)
Title
Present Pain Rating
Description
Pain Rating Index (PRI) is assessed by 15 questions assessing pain in the sensory and affective dimensions.
Items rate from 0 (none) to 3 (severe) on degree to which the words apply to pain.
Score Range: 0-45
Time Frame
Baseline - Final assessment (average 1 week post treatment)
Title
Pain Chronicity assessed by the Graded Chronic Pain Scale
Description
Pain Chronicity is assessed by the Graded Chronic Pain Scale (GCPS). The GCPS is 7 questions with 3 sub-scales (Characteristic pain intensity, disability score, and disability points).
Scoring:
Characteristic Pain Intensity: is a 0 to 100 score derived from Questions 1 through 3: Mean (Pain Right Now, Worst Pain, Average Pain) X 10.
Disability Score: is 0 to 100 score derived from Questions 4 through 6: Mean (Daily Activities, Social Activities, Work Activities) X 10 Disability Points: Add the indicated points for Disability Days (Question 7) and for Disability Score (0-6).
Items rate from 0 to 10 with 0 referencing no pain/interference/change and 10 referencing pain as bad as could be/unable to carry out any activities/extreme change.
Time Frame
Baseline - Final assessment (average 1 week post treatment)
Title
Daily Pain Monitoring: 10 point scale
Description
Daily pain monitoring defined as daily pain intensity and daily pain interference monitoring is two questions asked daily on a 10 point scale assessing daily pain and how much pain had interfered with day to day activities.
Pain: Over the past 24 hours, how would you rate your back pain on average? (0=No Pain; 10=Worst Imaginable Pain)
Interference: Over the past 24 hours, how much did pain interfere with your day-to-day activities? (0=No Interference; 10 = A great deal of interference)"
Time Frame
Baseline - Final assessment (average 1 week post treatment)
Secondary Outcome Measure Information:
Title
Back Disability as assessed by the Roland Morris Disability Questionnaire
Description
The Roland Morris Disability Questionnaire (RMDQ) assesses disability due to low back pain.
The RMDQ is a 24 item survey with yes/no response options. Score 0 -24 with ower scores indicate more impairment.
Time Frame
Baseline - Final assessment (average 1 week post treatment)
Title
Depressive symptoms as assessed by the Center for Epidemiologic Studies Depression Scale
Description
The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20 item survey tool. The items are a 4 pt Likert response items.
Scores range from 0-60 with higher scores indicate greater levels of depressive symptoms.
Time Frame
Baseline - Final assessment (average 1 week post treatment)
Title
Pain Catastrophizing as assessed by the Pain Catastrophizing Scale
Description
The Pain Catastrophizing Scale (PCS) is a 13 item survey assessing catastrophizing in context to pain. There are 13 items with 5-pt Likert responses.
There are several subscales. Scoring Procedure: The PCS total score is computed by summing responses to all 13 items (0-52).
Subscales:
Rumination: Sum of items 8, 9, 10, 11 (0-16). Magnification: Sum of items 6, 7, 13 (0-12). Helplessness: Sum of items 1, 2, 3, 4, 5, 12 (0-24).
Time Frame
Baseline - Final assessment (average 1 week post treatment)
Title
Pain-related fear of movement as assessed by the Tampa Scale Kinesiophobia
Description
The Tampa Scale Kinesiophobia (TSK) is a 17 item assessment of fear of movement. This uses a 5-pt Likert scale from 1 = Strongly Disagree to 4 = Strongly Agree.
Scoring Procedure: Sum items Range: 17-68 Subscale Harm/Somatic Items: 3, 5, 6, 9, 11, 15 Subscale Avoidance Items: 1, 2, 7, 10, 13, 14, 17
Time Frame
Baseline - Final assessment (average 1 week post treatment)
Title
Mood and Affect as assessed by the Positive and Negative Affect Scale
Description
The Positive and Negative Affect Scale (PANAS) measures mood of participants. This is a 20 item survey with 5 pt Likert response indicating to what degree the participant feels those emotions. There is a positive and negative subscale.
Higher positive affect score indicates greater positive emotions; higher negative affect score indicates greater negative emotions.
Range of Scores: 0-40
Time Frame
Baseline - Final assessment (average 1 week post treatment)
Title
Immersive Tendencies
Description
Immersive Tendencies are assessed by the Immersive Tendencies Questionnaire (ITQ). This is an 18-item survey. Item responses use a 7 point Likert scale. Subscales include: focus, involvement, emotions, and play. Each subscale is scored by summing items. A total score is scored by summing all items.
Range of total score: 18-126 Focus range of scores: 5-35 Involvement range of scores: 5-35 Emotions range of scores: 4-28 Play range of scores: 3-21 Higher scores indicate higher immersive tendencies overall and in each sub-scale.
Time Frame
Baseline only
Title
Absorption Tendencies
Description
Tellegen Absorption Scale is a 34-item multi-dimensional measure that assesses imaginative involvement and the tendency to become mentally absorbed in everyday activities. Item responses are on a 5-point Likert scale. Items are summed to score.
Range of scores: 0-136. Higher scores indicate greater levels of absorption.
Time Frame
Baseline Only
Title
Video Game History
Description
History of playing video games.
Time Frame
Baseline Only
Title
Patient Treatment Evaluation as assessed by the Modified Treatment Evaluation Inventory
Description
Patient treatment evaluation is assessed by Treatment Evaluation Inventory. This is a 9 item scale with a 5-point Likert responses for each question. The items are scored by summing all items.
Range of scores: 9-45. A higher score indicates greater acceptance of treatment.
Time Frame
Final assessment (average 1 week post treatment)
Title
Patient Treatment Evaluation as assessed by Semi-structured Qualitative interviewing
Description
Patient treatment evaluation is assessed by semi-structured interviewing. Qualitative feedback from participant experience will be assessed by thematic analyses.
Time Frame
Final assessment (average 1 week post treatment)
Title
Daily intervention feedback questions
Description
The daily intervention feedback questions are 7 items that assess the individuals feelings and experiences during that daily intervention session.
0-10 Likert scale
Each item is it's own scale.
Higher scores indicate more enjoyment/usefulness/demand/awareness/concern/mood.
Time Frame
Baseline - Final assessment (average 1 week post treatment)
Title
Patient Treatment Evaluation as assessed by the Usefulness, Satisfaction, and Ease of Use Questionnaire
Description
The Usefulness, Satisfaction, and Ease of Use Questionnaire (USE, Lund, 2001) measures the subjective usability of a product or service. It is a 30-item survey that examines four dimensions of usability: usefulness, ease of use, ease of learning, and satisfaction. This metric can be applied to various scenarios of usability assessment because it is non-proprietary and technology-agnostic. is a 30 item survey.
Each item is presented on a 7-point Likert scale from strongly disagree = 1 to strongly agree. = 7
Each subscale is calculated by averaging all items in subscale. Usefulness: items 1-8 Ease of use: items 9-19 Ease of Learning: items 20-23 Satisfaction: items 24-30
Range of scores for each subscale: 1-7 Scoring Interpretation: Higher score indicates greater usefulness, satisfaction, and ease of use.
Time Frame
Final assessment (average 1 week post treatment)
Title
Patient Treatment Evaluation as assessed by the Patient Global Impression of Change Scale
Description
Patient treatment evaluation is assessed by the Patient Global Impression of Change. This is a one item 7 point Likert item assessing improvement of the participants overall status.
Item responses:
1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse
Time Frame
Final assessment (average 1 week post treatment)
Title
Video Game Preferences as assessed by the BrainHex
Description
Video game preferences will be assessed by the BrainHex. The BrainHex provides a tool for designing gameplay and understanding motivations for play.
Time Frame
Final assessment (average 1 week post treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
report having low back pain for more than three months and at least half the days in the past 6 months
be 18-65 years of age,
have scores higher than 37 on the Tampa Scale of Kinesiophobia,
Exclusion Criteria:
medical conditions other than back pain that significantly impair movement (e.g., arthritis)
confirmed/suspected pregnancy
pending litigation related to an episode of low back pain
significant impairment in vision
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Chronic Low Back Pain Graded - Exposure Psychoeducation Intervention
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