Chronic Low Back Pain Graded - Exposure Psychoeducation Intervention (VRGE)

This study will examine the effectiveness of one of two psychoeducation treatments on chronic low back pain.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Behavioral: Interactive - Psychoeducation; Behavioral: Non-interactive Psychoeducation

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Interactive Psycho-education; Interactive psycho-education using interactive dashboard.	Behavioral: Interactive - Psychoeducation; Individuals will receive interactive psychoeducation in the lab over the course of a week period. Each session will take approximately 30 minutes.
PLACEBO_COMPARATOR: Psycho-education; Non-interactive psycho-education not using interactive dashboard.	Behavioral: Non-interactive Psychoeducation; Individuals will receive non-interactive psychoeducation over the course of a week period. Each session will take approximately 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline - Final assessment (average 1 week post treatment)
Present Pain Intensity	Present Pain Intensity (PPI) assesses present pain intensity on a scale of 0 (no pain) to 5 (excruciating)	Baseline - Final assessment (average 1 week post treatment)
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	Baseline - Final assessment (average 1 week post treatment)
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.	Baseline - Final assessment (average 1 week post treatment)
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)"	Baseline - Final assessment (average 1 week post treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Final assessment (average 1 week post treatment)
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.	Baseline - Final assessment (average 1 week post treatment)
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.	Baseline - Final assessment (average 1 week post treatment)
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).	Baseline - Final assessment (average 1 week post treatment)
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	Baseline - Final assessment (average 1 week post treatment)
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	Baseline - Final assessment (average 1 week post treatment)
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.	Baseline only
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.	Baseline Only
Video Game History	History of playing video games.	Baseline Only
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.	Final assessment (average 1 week post treatment)
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.	Baseline - Final assessment (average 1 week post treatment)
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.	Final assessment (average 1 week post treatment)
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	Final assessment (average 1 week post treatment)
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.	Final assessment (average 1 week post treatment)

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2019
• Primary Completion (ACTUAL): September 1, 2019
• Study Completion (ACTUAL): September 1, 2019

Study Registration Dates

• First Submitted: April 5, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (ACTUAL): April 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 31, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Chronic Pain; Low Back Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 300002878

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No