Potential of Virtual Reality in Primary Chronic Low Back Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Pain intensity
Study Overview
Brief Summary
This is a single-case experimental design study enrolling individuals with chronic low back pain who will be receiving pain science education and virtual reality over 3 weeks.
Detailed Description
The main objective of this study is to evaluate the potential of virtual reality in reducing pain intensity in individuals with primary chronic low back pain. Secondary objectives include analysing the impact of virtual reality on pain catastrophizing and fear of movement, as well as exploring participants' perspectives on the integration of virtual reality into the intervention plan.
The study will be divided into three phases: baseline assessment, intervention, and post-intervention assessment. The baseline assessment phase will have a different duration for each participant.
At baseline, participants will complete several paper-based questionnaires (sociodemographic and anthropometric data; pain location, intensity and characteristics; pain catastrophizing; fear of movement; pain during movement; and pain-related disability). After completing all questionnaires, participants will receive a paper diary to complete daily at home. This diary will record information such as pain intensity, fear of movement, and pain catastrophizing.
Participants will return to the office only on the first day of the intervention phase, which will coincide with the first session. Sessions will be individual, will last between 30 and 45 minutes, and will take place with an interval of one to two days. The intervention phase will end on the 29th day of the study for all participants and consists of pain science education and virtual reality.
On the final day of the study (i.e., the 35th day), participants will complete the same questionnaires administered at baseline, with the addition of the Global Perceived Effect scale. At that time, the diary provided at the beginning of the study will be collected.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Individuals with primary chronic low back pain aged ≥18 years, who present a moderate pain intensity (≥4 on the Numeric Pain Rating Scale) and a mild level of fear of movement.
Exclusion Criteria
- •have a diagnosis of spondylolisthesis or lumbar spinal stenosis;
- •are experiencing an exacerbation of low back pain symptoms at the time of screening;
- •present with constant and widespread nonspecific pain;
- •are in an active phase of rheumatoid arthritis;
- •have a progressive neurological disease;
- •are currently pregnant or within 6 months postpartum;
- •have a diagnosed psychiatric disorder;
- •have a malignant disease;
- •have serious cardiac conditions;
- •have contraindications to physical exercise in general;
Outcomes
Primary Outcomes
Pain intensity
Time Frame: Baseline (Day 1)
Measured using the numeric pain rating scale (end points: 0-10); 0 - minimum score, 10 - maximum score; higher scores mean higher pain intensity.
Pain intensity
Time Frame: Daily (from day 1 to day 35)
Measured using the numeric pain rating scale (end points: 0-10); 0 - minimum score, 10 - maximum score; higher scores mean higher pain intensity.
Pain intensity
Time Frame: End of the intervention (day 35)
Measured using the numeric pain rating scale (end points: 0-10); 0 - minimum score, 10 - maximum score; higher scores mean higher pain intensity.
Secondary Outcomes
- pain mechanism(Baseline (day 1))
- pain mechanism(End of the intervention (day 35))
- Pain intensity during movement(Baseline (day 1))
- Pain intensity during movement(End of the intervention (day 35))
- Perceived disability(Baseline (day 1))
- Perceived disability(End of the intervention (day 35))
- Catastrophizing(Baseline (day 1))
- Catastrophizing(End of the intervention (day 35))
- Fear of movement(Baseline (day 1))
- Fear of movement(End of the intervention (day 35))
- Knowledge on pain neurophysiology(Baseline (day 1))
- Knowledge on pain neurophysiology(End of the intervention (day 35))
- Global perception of change(End of the intervention (day 35))
Investigators
Anabela G Silva
Professor
Aveiro University