Clinical trial NCT06506604: "Psychological Intervention Enhanced by Virtual Reality for the Improvement of Appreciation of Body Functionality in Patients With Chronic Low-back-pain".
Official title: "Psychological Intervention Enhanced by Virtual Reality for the Improvement of Appreciation of Body Functionality in Patients With Chronic Low-back-pain".
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multiple Baseline Single Case Design
Primary purpose: TREATMENT

Brief 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.

Detailed description: The purpose of this intervention is to examine the effects of a positive body image-based intervention using virtual reality to improve pain, interference and emotional distress.

The first session will be dedicated to psychoeducation about pain. Investigators will discuss what chronic pain is, what factors influence pain, chronification, body image and a brief presentation of the modules.

In the second session, a brief introduction to body awareness will be given and a VR environment will be used to carry out a body scan.

In the third session, Acceptance of pain will be worked on and a VR environment will be used to work on some variables related to the chronification of pain, such as paradoxical control or avoidance.

In the fourth session, the modules of Appreciation and Gratitude will be addressed.

Each session will last approximately one hour. First, participants will be screened to check eligibility inclusion/exclusion criteria. Second, eligible participants will complete baseline measures.

The study will be conducted following the principles stated in the Declaration of Helsinki.

The design chosen for the intervention will be a Multiple Baseline Single Case Design (SCD-MB). Data will be analysed by visual and statistical analysis. For visual analysis, the mean and/or median will be used to report the level, trend and stability of the 'within phase' data. For "between-phase" data, "Nonoverlap Statistics" such as "Nonoverlap of All Pairs" (NAP) will be used. For statistical analyses a Cohen's Difference of Means (Cohen's d) will be used to estimate the effect size at the individual level and multilevel analyses for across-case effect sizes.

Eligibility criteria: Inclusion Criteria:

* Individuals with low back pain.

Exclusion Criteria:

* Meeting any of the following medical conditions:

  * Spinal tumor, infection or fracture
  * Systemic disease (autoimmune, infectious, vascular, endocrine, metabolic...)
  * Fibromyalgia
  * Cauda equina syndrome
  * History of spinal surgery
  * Musculoskeletal injury of lower extremities

Primary outcomes:
measure: Body Disability
timeFrame: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
measure: Emotional Distress
timeFrame: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
measure: Pain Interference and Pain Intensity
timeFrame: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
measure: Level of Quality of Life
timeFrame: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
Secondary outcomes:
measure: Fear of movement
timeFrame: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
measure: Body Awareness
timeFrame: 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.
measure: Body Awareness
timeFrame: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
measure: Chronic Pain Acceptance
timeFrame: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
measure: Body Appreciation
timeFrame: 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.
measure: Appreciation of Body Functionality
timeFrame: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
measure: Pain Catastrophizing
timeFrame: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
measure: Depression
timeFrame: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
measure: Anxiety
timeFrame: The whole scale will be administered at the beginning (day 1 of 43) and the end of the intervention (day 43 of 43).
Other outcomes:
measure: Negative affect
timeFrame: This item will be administered daily for 43 days via MPATH
measure: Positive affect
timeFrame: This item will be administered daily for 43 days via MPATH
Locations:
city: Valencia
country: Spain
facility: Arnau de Vilanova Hospital
state: Comunidad Valenciana
Study officials:
affiliation: University of Valencia
name: Rosa M. Baños, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Valenzuela-Moguillansky C, Reyes-Reyes A, Gaete MI. Exteroceptive and Interoceptive Body-Self Awareness in Fibromyalgia Patients. Front Hum Neurosci. 2017 Mar 13;11:117. doi: 10.3389/fnhum.2017.00117. eCollection 2017.
citation: Bailey KA, Gammage KL, van Ingen C, Ditor DS. "It's all about acceptance": A qualitative study exploring a model of positive body image for people with spinal cord injury. Body Image. 2015 Sep;15:24-34. doi: 10.1016/j.bodyim.2015.04.010. Epub 2015 May 21.
citation: Alleva JM, Diedrichs PC, Halliwell E, Peters ML, Dures E, Stuijfzand BG, Rumsey N. More than my RA: A randomized trial investigating body image improvement among women with rheumatoid arthritis using a functionality-focused intervention program. J Consult Clin Psychol. 2018 Aug;86(8):666-676. doi: 10.1037/ccp0000317.
citation: Kratochwill TR, Levin JR. Enhancing the scientific credibility of single-case intervention research: randomization to the rescue. Psychol Methods. 2010 Jun;15(2):124-44. doi: 10.1037/a0017736.