Virtual Reality Programme Incorporating Psychology and Physiotherapy for Chronic Low Back Pain

NCT ID: NCT06757413

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-10
• Study Completion Date: 2025-01-31

Brief Summary

The main objective of this randomized controlled pilot trial is to investigate the efficacy of a 4-week multidisciplinary intervention for patients with chronic non-specific low back pain, combining a therapeutic exercise program in physiotherapy and a psychological intervention focused on positive body image in pain intensity, pain interference, emotional distress, kinesophobia and pain catastrophization. Both components are designed to operate in parallel over a 4-week period. The physiotherapy component consists of a therapeutic exercise program of 8 sessions, performed with virtual reality (VR) manipulating visual proprioceptive information during all lumbar movements in the different therapeutic exercises. The psychological positive body image-based intervention consists of 4 sessions approaching 5 different clinical modules: Pain Psychoeducation, Body Awareness, Pain Acceptance, Body Appreciation and Functionality and Gratitude. 2 sessions (Body Awareness and Pain Acceptancce) will include virtual reality environments to enhance the clinical outcomes.

Detailed Description

This study evaluates a 4-week multidisciplinary intervention for patients with chronic non-specific low back pain, combining physiotherapy and psychological approaches. Both components leverage virtual reality (VR) technology to address physical and psychological aspects of pain management, operating in parallel to maximize patient outcomes.

Physiotherapy Component The physiotherapy intervention consists of a therapeutic exercise program based on the principles of the "Back School," designed to improve strength, stability, mobility, and flexibility in the abdomino-lumbo-pelvic region and lower extremities. Over 8 sessions (2 per week), patients perform VR-guided exercises where visual-proprioceptive information is manipulated. The VR goggles alter the perceived degree of lumbar flexion and extension, creating a mismatch between actual and perceived movements to promote motor learning and reduce maladaptive movement patterns.

Exercises are performed in two sets, with intensity and repetitions individualized using the Borg 6-20 scale for Rating of Perceived Exertion (RPE). During the first two weeks, exercises are performed at an RPE of 14 without additional load, while in weeks three and four, intensity increases to an RPE of 15 with progressively added weights. This program aims to improve outcomes such as pain, disability, kinesiophobia, catastrophizing, quality of life, and physical fitness.

Psychological Component

The psychological intervention aims to enhance positive body image and emotional resilience while addressing pain interference and emotional distress. It consists of four weekly sessions, each lasting approximately one hour, structured as follows:

1. Session 1: Pain Psychoeducation. Participants learn about chronic pain, its influencing factors, and the role of body image, with an overview of the intervention modules.

2. Session 2: Body Awareness. A virtual reality body scan is introduced to increase awareness of body sensations and perceptions.

3. Session 3: Pain Acceptance. Participants explore strategies to accept pain and address variables contributing to chronic pain, such as paradoxical control and avoidance, using a VR environment.

4. Session 4: Body Appreciation and Gratitude. Exercises focus on fostering appreciation for body functionality and gratitude for its abilities.

Participants will first undergo eligibility screening and baseline assessments before starting the intervention. The study complies with the ethical principles outlined in the Declaration of Helsinki.

Conditions

Chronic Low Back Pain (CLBP)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Enhanced Virtual reality

This study evaluates a 4-week multidisciplinary intervention for patients with chronic non-specific low back pain, combining physiotherapy and psychological approaches. Both components leverage virtual reality (VR) technology to address physical and psychological aspects of pain management, operating in parallel to maximize patient outcomes.

Physiotherapy Component. The physiotherapy intervention consists of a therapeutic exercise program based on the principles of the "Back School," designed to improve strength, stability, mobility, and flexibility in the abdomino-lumbo-pelvic region and lower extremities. Over 8 sessions (2 per week), patients perform VR-guided exercises where visual-proprioceptive information is manipulated. The VR goggles alter the perceived degree of lumbar flexion and extension, creating a mismatch between actual and perceived movements to promote motor learning and reduce maladaptive movement patterns.

Group Type: EXPERIMENTAL

Enhanced Virtual reality

Intervention Type: OTHER

This study evaluates a 4-week multidisciplinary intervention for patients with chronic non-specific low back pain, combining physiotherapy and psychological approaches. Both components leverage virtual reality (VR) technology to address physical and psychological aspects of pain management, operating in parallel to maximize patient outcomes. The physiotherapy intervention consists of a therapeutic exercise program based on the principles of the "Back School". Over 8 sessions (2 per week), patients perform VR-guided exercises where visual-proprioceptive information is manipulated.

The psychological positive body image-based intervention consists of 4 sessions approaching 5 different clinical modules: Pain Psychoeducation, Body Awareness, Pain Acceptance, Body Appreciation and Functionality and Gratitude. 2 sessions (Body Awareness and Pain Acceptancce) will include virtual reality environments to enhance the clinical outcomes.

Control Group (treatment as usual)

Participants will receive the usual treatment applied at the hospital.

Group Type: ACTIVE_COMPARATOR

Active Comparator: Treatment as usual

Intervention Type: OTHER

Participants will receive the usual treatment applied at the hospital

Interventions

Enhanced Virtual reality

This study evaluates a 4-week multidisciplinary intervention for patients with chronic non-specific low back pain, combining physiotherapy and psychological approaches. Both components leverage virtual reality (VR) technology to address physical and psychological aspects of pain management, operating in parallel to maximize patient outcomes. The physiotherapy intervention consists of a therapeutic exercise program based on the principles of the "Back School". Over 8 sessions (2 per week), patients perform VR-guided exercises where visual-proprioceptive information is manipulated.

The psychological positive body image-based intervention consists of 4 sessions approaching 5 different clinical modules: Pain Psychoeducation, Body Awareness, Pain Acceptance, Body Appreciation and Functionality and Gratitude. 2 sessions (Body Awareness and Pain Acceptancce) will include virtual reality environments to enhance the clinical outcomes.

Intervention Type: OTHER

Active Comparator: Treatment as usual

Participants will receive the usual treatment applied at the hospital

Intervention Type: OTHER

Other Intervention Names

Virtual Reality Group; Experimental Group

Eligibility Criteria

Inclusion Criteria

• diagnosed with non-specific cLBP according to the COST B13 European guideline
• age older than 18
• an average pain score of 3 or higher on the 11-point Pain Numerical Rating Scale (PNRS-11; with 0 indicating no pain and 10 indicating the worst pain imaginable) in the 6 months prior.

Exclusion Criteria

• spinal tumour, infection, or fracture
• systemic disease
• fibromyalgia
• cauda equina syndrome
• previous spinal surgery
• musculoskeletal injuries in the lower extremities (e.g., sciatica or radiating lower extremity pain, numbness, or weakness symptoms).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinica Universidad de Navarra, Universidad de Navarra

OTHER

Sponsor Role: collaborator

University of Valencia

OTHER

Sponsor Role: collaborator

Cardenal Herrera University

OTHER

Sponsor Role: lead

Responsible Party

Juan F. Lisón Párraga, Dr

Chair Profesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clínica Universidad de Navarra

Pamplona, Navarre, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 30035583 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28348526 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26002149 (View on PubMed)

Harvie DS, Broecker M, Smith RT, Meulders A, Madden VJ, Moseley GL. Bogus visual feedback alters onset of movement-evoked pain in people with neck pain. Psychol Sci. 2015 Apr;26(4):385-92. doi: 10.1177/0956797614563339. Epub 2015 Feb 17.

Reference Type: BACKGROUND

PMID: 25691362 (View on PubMed)

Other Identifiers

PID2020-115609RB-C22

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Cardenal Herrera University 69

Identifier Type: -

Identifier Source: org_study_id