"Psychological Intervention Enhanced by Virtual Reality for the Improvement of Appreciation of Body Functionality in Patients With Chronic Low-back-pain".

NCT06506604 | Completed

• 1 other identifier: PID2020-115609RB-C21
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Fear of movement

  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

  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 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

  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

  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.

Other Outcomes (2)

• Negative affect

  This item will be administered daily for 43 days via MPATH

• Positive affect

  This item will be administered daily for 43 days via MPATH

Study Arms (4)

Participants with low back pain. Multiple Base Line Single Case Design - 7 days wait

EXPERIMENTAL

Positive body image-based intervention. Main Components: Psychoeducation, Body Awareness, Acceptance, Functionality Appreciation and Gratitude toward the body.

Behavioral: CLEVER

Participants with low back pain. Multiple Base Line Single Case Design - 10 days wait

EXPERIMENTAL

Positive body image-based intervention. Main Components: Psychoeducation, Body Awareness, Acceptance, Functionality Appreciation and Gratitude toward the body.

Behavioral: CLEVER

Participants with low back pain. Multiple Base Line Single Case Design - 14 days wait

EXPERIMENTAL

Positive body image-based intervention. Main Components: Psychoeducation, Body Awareness, Acceptance, Functionality Appreciation and Gratitude toward the body.

Behavioral: CLEVER

Participants with low back pain. Multiple Base Line Single Case Design - 11 days wait

EXPERIMENTAL

Positive body image-based intervention. Main Components: Psychoeducation, Body Awareness, Acceptance, Functionality Appreciation and Gratitude toward the body.

Behavioral: CLEVER

Interventions

CLEVER BEHAVIORAL

CLEVER: A positive body image-based intervention for Chronic Low Back Pain. Patients will receive 4 sessions to approach 5 clinical modules: Pain Psychoeducation, Body Awareness, Pain Acceptance, Body Appreciation and Functionality and Gratitude. virtual reality environments will be used to enhance the clinical outcomes in two sessions. Each session will last 60 minutes.

Participants with low back pain. Multiple Base Line Single Case Design - 10 days wait; Participants with low back pain. Multiple Base Line Single Case Design - 11 days wait; Participants with low back pain. Multiple Base Line Single Case Design - 14 days wait; Participants with low back pain. Multiple Base Line Single Case Design - 7 days wait

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with low back pain.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Arnau de Vilanova Hospital

Valencia, Valencia, 46015, Spain

Location

Related Publications (4)

• 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.

  PMID: 28348526 BACKGROUND

• 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.

  PMID: 26002149 BACKGROUND

• 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.

  PMID: 30035583 BACKGROUND

• 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.

  PMID: 20515235 BACKGROUND

Study Officials

• Rosa M. Baños, PhD

  University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blind to the variables of change.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: Multiple Baseline Single Case Design

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 17, 2024
• Study Start: June 3, 2024
• Primary Completion: June 3, 2024
• Study Completion: July 15, 2024
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)