Chronic Low Back PainVRGENCT03909048
Chronic Low Back Pain Graded - Exposure Psychoeducation Intervention
A study testing Interactive - Psychoeducation and Non-interactive Psychoeducation in people with Chronic Low Back Pain, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study will examine the effectiveness of one of two psychoeducation treatments on chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Interactive - Psychoeducation and Non-interactive Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
This study will examine the effectiveness of one of two psychoeducation treatments on chronic low back pain.
Read the 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- Interactive - Psychoeducation, Non-interactive Psychoeducation
- Keywords
- Chronic Pain, Low Back Pain
- Medical subject headings
- Chronic Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive - PsychoeducationBehavioural
Individuals will receive interactive psychoeducation in the lab over the course of a week period. Each session will take approximately 30 minutes.
Non-interactive PsychoeducationBehavioural
Individuals will receive non-interactive psychoeducation over the course of a week period. Each session will take approximately 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Interactive Psycho-education | Experimental | Interactive psycho-education using interactive dashboard. Receives: Behavioral: Interactive - Psychoeducation |
| Psycho-education | Placebo comparator | Non-interactive psycho-education not using interactive dashboard. Receives: Behavioral: Non-interactive Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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)"
Measured: Baseline - Final assessment (average 1 week post treatment)
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline Only
Video Game History
History of playing video games.
Measured: Baseline Only
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.
Measured: Final assessment (average 1 week post 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Final assessment (average 1 week post treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start1 May 2019
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zina Trost, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909048
- Sponsor's protocol ID
- 300002878
- Acronym
- VRGE
- Status last verified
- Oct 2019
- First submitted
- 5 Apr 2019
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Low Back Pain Graded - Exposure Psychoeducation Intervention
- ClinicalTrials.gov ID
- NCT03909048
- Acronym / sponsor ID
- VRGE / 300002878
- Conditions
- Chronic Low Back Pain
- Keywords
- Chronic Pain, Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive Psycho-education | Experimental | Behavioral: Interactive - PsychoeducationInteractive psycho-education using interactive dashboard. |
| Psycho-education | Placebo comparator | Behavioral: Non-interactive PsychoeducationNon-interactive psycho-education not using interactive dashboard. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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,
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive - PsychoeducationIndividuals will receive interactive psychoeducation in the lab over the course of a week period. Each session will take approximately 30 minutes. | Behavioural | Interactive Psycho-education |
| Non-interactive PsychoeducationIndividuals will receive non-interactive psychoeducation over the course of a week period. Each session will take approximately 30 minutes. | Behavioural | Psycho-education |
Primary outcome
Pain Intensity as assessed by Numeric Rating Scale
Time frame: Baseline - Final assessment (average 1 week post treatment)
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
Time frame: Baseline - Final assessment (average 1 week post treatment)
Present Pain Intensity (PPI) assesses present pain intensity on a scale of 0 (no pain) to 5 (excruciating)
Present Pain Rating
Time frame: Baseline - Final assessment (average 1 week post treatment)
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
Time frame: Baseline - Final assessment (average 1 week post treatment)
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
Time frame: Baseline - Final assessment (average 1 week post treatment)
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)"
14 secondary outcomes
Back Disability as assessed by the Roland Morris Disability Questionnaire
Time frame: Baseline - Final assessment (average 1 week post treatment)
Depressive symptoms as assessed by the Center for Epidemiologic Studies Depression Scale
Time frame: Baseline - Final assessment (average 1 week post treatment)
Pain Catastrophizing as assessed by the Pain Catastrophizing Scale
Time frame: Baseline - Final assessment (average 1 week post treatment)
Pain-related fear of movement as assessed by the Tampa Scale Kinesiophobia
Time frame: Baseline - Final assessment (average 1 week post treatment)
Mood and Affect as assessed by the Positive and Negative Affect Scale
Time frame: Baseline - Final assessment (average 1 week post treatment)
Immersive Tendencies
Time frame: Baseline only
Absorption Tendencies
Time frame: Baseline Only
Video Game History
Time frame: Baseline Only
Patient Treatment Evaluation as assessed by the Modified Treatment Evaluation Inventory
Time frame: Final assessment (average 1 week post treatment)
Patient Treatment Evaluation as assessed by Semi-structured Qualitative interviewing
Time frame: Final assessment (average 1 week post treatment)
Daily intervention feedback questions
Time frame: Baseline - Final assessment (average 1 week post treatment)
Patient Treatment Evaluation as assessed by the Usefulness, Satisfaction, and Ease of Use Questionnaire
Time frame: Final assessment (average 1 week post treatment)
Patient Treatment Evaluation as assessed by the Patient Global Impression of Change Scale
Time frame: Final assessment (average 1 week post treatment)
Video Game Preferences as assessed by the BrainHex
Time frame: Final assessment (average 1 week post treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive - Psychoeducation and Non-interactive Psychoeducation in people with Chronic Low Back Pain, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity as assessed by Numeric Rating Scale (time frame: Baseline - Final assessment (average 1 week post treatment)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2019.