"Psychological Intervention Enhanced by Virtual Reality for the Improvement of Appreciation of Body Functionality in Patients With Chronic Low-back-pain".
NCT Number: NCT06506604
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Low-back Pain
Interventions: DEVICE: CLEVER
Sponsor: University of Valencia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 13
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-06-03
Completion Date: 2024-07-15
Locations: Arnau de Vilanova Hospital, Valencia, Valencia, Spain, 46015, Spain

Summary:
The purpose of this study is to test whether a positive body image-based intervention is able to improve pain, disability, interference and emotional distress in people with chronic low back pain.

Patients will receive 4 sessions approaching 5 different clinical modules: Pain Psychoeducation, Body Awareness, Pain Acceptance, Body Appreciation and Functionality and Gratitude. 2 sessions will include virtual reality (VR) environments to enhance the clinical outcomes.

Researchers will analyse changes in the variables of interest after intervention compared to baseline.

Primary Outcome Measures: Body Disability, Roland-Morris Questionnaire (RMQ) is a 24-item patient-reported outcome measure those inquiries about pain-related disability. Items are scored 0 if left blank or 1 if endorsed, for a total RMQ score ranging from 0 to 24., The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).|Emotional Distress, The 4-item Brief Assessment of Distress about Pain (BADP) scale was developed to assess anxiety, fear, and depression related to pain, as well as an overall evaluation of distress about pain. Items are scored from 0 ("Not at all") to 4 ("Extreme"), for a total BADP score ranging from 0 to 16., The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).|Pain Interference and Pain Intensity, The Brief Pain Inventory (BPI) scale was developed to assess the severity of pain and its impact on functioning. The scale consists of 9 items with qualitative and quantitative data on the following dimensions: "Worst pain in last 24 hours", "Least pain in last 24 hours", "Pain on average" and "Pain right now"., The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).|Level of Quality of Life, The EuroQol-5D (EQ-5D) scale is a 5-item scale to assess the quality of life of patients with several pathologies, chronic pain included. The individual assesses his or her own state of health, first in levels of severity by dimensions (descriptive system) and then on a more general visual analogue scale (VAS)., The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
Secondary Outcome Measures: Fear of movement, The Tampa Scale for Kinesophobia (TSK-11SV) is an 11-item scale that measures kinesophobia with statements asking the subject to answer from 1 ("Strongly disagree"), to 4 ("Strongly agree").

Two items: 'I'M AFRAID OF UNINTENTIONALLY INJURING MYSELF', ´PHYSICAL ACTIVITY AGGRAVATES MY PAIN´ will be administered daily for 43 days via MPATH, The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).|Body Awareness, Dimensions of "Not Worrying" (items 9, 10 and 11), "Not distracting" (items 5, 6 and 7) and "Trusting" (items 30, 31 and 32) from the Multidimensional Assessment of Interoceptive Awareness (MAIA) will be used. This scale is a state-trait self-report questionnaire to measure multiple dimensions of interoception (awareness of bodily sensations). These dimensions have been chosen for their relationship to the intervention components and for their good psychometric quality. The scores range from 0 to 5, where higher scores indicate a higher level in that dimension., The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43) and one of the items of the scale: 'I NOTICE WHEN I FEEL UNCOMFORTABLE IN MY BODY´ will be administered daily for 43 days via MPATH.|Body Awareness, The following items have been created ad-hoc for this experiment:

1. In general, I am able to pay attention to both pleasant and unpleasant bodily sensations.
2. When I feel pain, I am also able to notice pleasant bodily sensations.
3. Today I have noticed pleasant bodily sensations.
4. Today I have noticed unpleasant bodily sensations.
5. I am able to notice and differentiate the various sensations I experience in my body, regardless of whether they are pleasant or unpleasant (examples).
6. I have the ability to pay attention to body signals, whether positive or negative.
7. I am aware of physical sensations in my body, whether pleasant or uncomfortable.

One of the items of the scale: 'TODAY I HAVE NOTICED PLEASANT BODILY SENSATIONS´ and 'TODAY I HAVE NOTICED UNPLEASANT BODILY SENSATIONS´ will be administered daily for 43 days via MPATH., The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).|Chronic Pain Acceptance, Chronic Pain Acceptance Questionnaire 8 (CPAQ-8). Numerical rating scale ranging from 0 "Never true" to 6 "Always true" where higher scores indicate a higher Chronic Pain Acceptance (Pain Willingness and Activity Engagement).

Two items: 'WHETHER I FELT PAIN OR NOT, I HAD A SATISFACTORY DAY´ and 'WHETHER I FELT PAIN OR NOT, I HAVE HAD A SATISFYING DAY TODAY´ will be administered daily for 43 days via MPATH., The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).|Body Appreciation, Body Appreciation Scale 2 (BAS-2). Numerical rating scale ranging from 1 "Never" to 5 "Always", 10 items where higher scores indicate a higher Appreciation of the body., The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43) and one of the items of the scale -'I FEEL LOVE AND RESPECT FOR MY BODY'- will be administered daily for 43 days via MPATH.|Appreciation of Body Functionality, Functionality Appreciation Scale (FAS). The scores range from 1 to 5, where higher scores indicate higher levels of appreciation of body functionality.

Two items of the scale -'I APPRECIATE MY BODY FOR WHAT IT IS ABLE TO DO'- and -'I AM GRATEFUL THAT MY BODY ALLOWS ME TO BE INVOLVED IN ACTIVITIES THAT I ENJOY OR THAT SEEM IMPORTANT TO ME´ will be administered daily for 43 days via MPATH, The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).|Pain Catastrophizing, The Pain Catastrophizing Scale (PCS) consists of 13 statements containing a number of thoughts and feelings typically present in the experience of pain. The items are divided into 3 categories: rumination, magnification and helplessness, with each item scored on a 5-point scale. The patient is asked to indicate the frequency with which these feelings or thoughts appear from 0 ("Not at all") to 4 ("All the time").

Two of the items of the scale: -'I'M AFRAID THE PAIN WILL GET WORSE'- and -'I CAN'T STOP THINKING ABOUT HOW MUCH IT HURTS'- will be administered daily for 43 days via MPATH, The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).|Depression, The Patient Health Questionnaire (PHQ-9). The scale is composed of 9 items to assess depressive symptoms and the patient is asked to indicate the frequency with which these feelings, thoughts or states appear from 0 ("Not at all) to 3 ("Nearly every day")., The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).|Anxiety, The Generalised Anxiety Disorder-7 (GAD-7) scale is composed of 7 items to assess the different dimensions of the Generalised Anxiety Disorder and the patient is asked to mark the frequency from 'Never' to 'almost every day' in the last two weeks., The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
Other Outcome Measures: Negative affect, How do you feel today? 0 = Not negative at all; 100 = Very negative, This item will be administered daily for 43 days via MPATH|Positive affect, How do you feel today? 0 = Not positive at all; 100 = Very positive, This item will be administered daily for 43 days via MPATH