Chronic Low Back Pain Graded - Exposure Psychoeducation Intervention

Chronic Low Back Pain Clinical Trial

— VRGE  

Official title:

Chronic Low Back Pain Graded - Exposure Psychoeducation Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03909048
• Other study ID #: 300002878
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: September 1, 2019

Study information

• Verified date: October 2019
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

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.
• Non-interactive Psychoeducation
Individuals will receive non-interactive psychoeducation over the course of a week period. Each session will take approximately 30 minutes.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	Video Game History	History of playing video games.	Baseline Only
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)