Who is sponsoring NCT04849897?

NCT04849897 is sponsored by University of Southern California.

What drugs are being tested in NCT04849897?

Interventions in NCT04849897: Experimental: Virtual Reality Guided Imagery, Active Comparator: Audio Only Guided Imagery.

What condition does NCT04849897 study?

NCT04849897 studies Complex Regional Pain Syndromes, Back Pain.

Is NCT04849897 still recruiting?

NCT04849897 is currently completed. Last updated 21 August 2024.

Are results published for NCT04849897?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-08-21 · How we verify

NCT04849897: VRGI

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Virtual Reality Guided Imagery for Chronic Pain

Completed NA Results posted Last updated 21 August 2024

What this trial tests

NA trial testing Experimental: Virtual Reality Guided Imagery in Complex Regional Pain Syndromes in 36 participants. Completed in 30 April 2022.

Timeline

22 March 2021

Primary endpoint
30 April 2022

30 April 2022

Quick facts

Lead sponsor	University of Southern California
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	22 March 2021
Primary completion	30 April 2022
Estimated completion	30 April 2022
Sites	1 location across United States

Drugs / interventions tested

Experimental: Virtual Reality Guided Imagery
Active Comparator: Audio Only Guided Imagery

Conditions studied

Complex Regional Pain Syndromes — all drugs for Complex Regional Pain Syndromes →
Back Pain — all drugs for Back Pain →

Sponsor

University of Southern California

Who can join

18 and older, any sex, with Complex Regional Pain Syndromes or Back Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Are Recruited But Not Enrolled as Documented in Participant Log Primary · Baseline

Participant log tracks number of recruited participants who are ineligible to participate and/or decline to enroll

Group	Value	95% CI
Total Recruited	60

Number of Enrolled Participants Who do Not Complete the Study as Documented in Log Primary · Baseline to 2 week follow up

Participant log tracks the number of enrolled participants who discontinue intervention, are lost to follow-up and/or experience adverse events.

Group	Value	95% CI
Virtual Reality Guided Imagery (VR-GI)	3
Audio Only Guided Imagery (AO-GI)	1

Number of Practice Sessions Completed by Participants as Documented in Spread Sheet Primary · Baseline to 2 week follow up

Spread sheet documenting proportion of at-home daily GI practice completed over 2-week intervention

Group	Value	95% CI
Virtual Reality Guided Imagery (VR-GI)	10.8	± 3.58
Audio Only Guided Imagery (AO-GI)	11.4	± 4.27

Pain Assessed by Pain Numeric Rating Scale Primary · Baseline to 2 week follow up

Numeric Rating Scale of self-reported highest, lowest, and average pain scores (0-10) over the last 7 days. Higher scores indicate worse pain outcomes.

Change in Lowest Score Follow up Baseline

Group	Value	95% CI
Virtual Reality Guided Imagery (VR-GI)	0.381	± 1.36
Audio Only Guided Imagery (AO-GI)	0.091	± 1.04

Lowest Score Baseline

Group	Value	95% CI
Virtual Reality Guided Imagery (VR-GI)	4	± 1.82
Audio Only Guided Imagery (AO-GI)	3.92	± 1.51

Lowest Score Follow up

Group	Value	95% CI
Virtual Reality Guided Imagery (VR-GI)	3.71	± 1.95
Audio Only Guided Imagery (AO-GI)	3.64	± 1.63

Change in Highest Score Follow-up-Baseline

Group	Value	95% CI
Virtual Reality Guided Imagery (VR-GI)	0.619	± .973
Audio Only Guided Imagery (AO-GI)	0.100	± 1.37

Highest Score Baseline

Group	Value	95% CI
Virtual Reality Guided Imagery (VR-GI)	8.42	± 0.83
Audio Only Guided Imagery (AO-GI)	7.75	± 1.36

Highest Score Follow-up

Group	Value	95% CI
Virtual Reality Guided Imagery (VR-GI)	7.86	± 1.01
Audio Only Guided Imagery (AO-GI)	7.4	± 0.97

Change in Average Score Follow-up-baseline

Group	Value	95% CI
Virtual Reality Guided Imagery (VR-GI)	0.524	± 1.08
Audio Only Guided Imagery (AO-GI)	0.182	± 1.08

Average Score Baseline

Group	Value	95% CI
Virtual Reality Guided Imagery (VR-GI)	6.08	± 1.18
Audio Only Guided Imagery (AO-GI)	5.75	± 1.42

Opioid Medication Usage Assessed by Frequency of Use Log Primary · Baseline to 2 week follow up

Log with list of medications taken, dosages and frequency of use. Lower frequency indicates better outcomes.

Group	Value	95% CI
Virtual Reality Guided Imagery (VR-GI)	0
Audio Only Guided Imagery (AO-GI)	1

Non-opioid Pain Medication Usage Assessed by Frequency of Use Log Primary · Baseline to 2 week follow up

Log with list of non-opioid pain mediction taken, dosages and frequency of use. Lower frequency of use indicates better outcomes

Group	Value	95% CI
Virtual Reality Guided Imagery (VR-GI)	6
Audio Only Guided Imagery (AO-GI)	3

Anxiety Assessed by Generalized Anxiety Disorder Assessment: GAD-2 (GAD-7) Secondary · Baseline to 2 week follow up

Generalized Anxiety Disorder Assessment is calculated by assigning scores of 1,2,3 and 4, to the response categories of Not at all sure, Several Days,Over half the days, Nearly every day , respectively. Total score for the two ranges from 0-6 with higher number indicating worse anxiety outcome.

Change in GAD (Follow up-Baseline

Group	Value	95% CI
Virtual Reality Guided Imagery (VR-GI)	-1.2	± 1.20
Audio Only Guided Imagery (AO-GI)	-.06	± 1.17

GAD Baseline

Group	Value	95% CI
Virtual Reality Guided Imagery (VR-GI)	1.83	± 1.86
Audio Only Guided Imagery (AO-GI)	1.58	± 1.68

GAD Follow-up

Group	Value	95% CI
Virtual Reality Guided Imagery (VR-GI)	0.9	± 1.17
Audio Only Guided Imagery (AO-GI)	1.2	± 1.55

Depression Assessed by the Patient Health Questionnaire PHQ-2 Secondary · Baseline to 2 week follow up

Patient Health Questionnaire is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of not at all, several days more than half the days, and-nearly every day, respectively. Total score for the two ranges from 0 to 6 with higher number worse depression outcome.

Change in PHQ (Follow up-Baseline)

Group	Value	95% CI
Virtual Reality Guided Imagery (VR-GI)	-1.10	± 1.34
Audio Only Guided Imagery (AO-GI)	0	± 0.47

PHQ Baseline

Group	Value	95% CI
Virtual Reality Guided Imagery (VR-GI)	2	± 1.53
Audio Only Guided Imagery (AO-GI)	1.33	± 1.44

PHQ Follow-up

Group	Value	95% CI
Virtual Reality Guided Imagery (VR-GI)	0.86	± 1.39
Audio Only Guided Imagery (AO-GI)	1.3	± 1.7

Short Form Health Survey (SF12v12) Secondary · Baseline to 2 week follow up

Health-related quality of life assessment Short Form Health Survey 12 has two composite scores (Physical composite score and Mental composite score). Each score has a range of 0 to 100 with higher scores indicating better health outcomes.

Change in Physical Score (Follow-up- Baseline)

Group	Value	95% CI
Virtual Reality Guided Imagery (VR-GI)	7.3	± 6.42
Audio Only Guided Imagery (AO-GI)	-1.85	± 6.81

Physical Score Baseline

Group	Value	95% CI
Virtual Reality Guided Imagery (VR-GI)	27.0	± 6.87
Audio Only Guided Imagery (AO-GI)	29.1	± 4.80

Physical Score Follow up

Group	Value	95% CI
Virtual Reality Guided Imagery (VR-GI)	27.9	± 8.61
Audio Only Guided Imagery (AO-GI)	27.7	± 7.22

Change in Mental Score (Follow-up - Baseline)

Group	Value	95% CI
Virtual Reality Guided Imagery (VR-GI)	6.56	± 7.25
Audio Only Guided Imagery (AO-GI)	5.65	± 7.89

Mental Score Baseline

Group	Value	95% CI
Virtual Reality Guided Imagery (VR-GI)	43.6	± 12.3
Audio Only Guided Imagery (AO-GI)	43.5	± 13.1

Mental Score Follow up

Group	Value	95% CI
Virtual Reality Guided Imagery (VR-GI)	50.4	± 10.2
Audio Only Guided Imagery (AO-GI)	48.6	± 16.2

Back Pain Disability Assessed by the Back Pain Oswestry Disability Index (ODI) Secondary · Baseline to 2 week follow up

Pain Management assessments for patients with back pain. Oswestry Disability Index For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5 with 50 as a highest score; higher scores indicating a worse disability outcome from back pain. Scale is 0-50.

Change in ODI (Follow-up - Baseline)

Group	Value	95% CI
Virtual Reality Guided Imagery (VR-GI)	-3.44	± 3.40
Audio Only Guided Imagery (AO-GI)	-4.83	± 7.65

ODI Baseline

Group	Value	95% CI
Virtual Reality Guided Imagery (VR-GI)	24.6	± 5.66
Audio Only Guided Imagery (AO-GI)	25.8	± 8.98

ODI Follow up

Group	Value	95% CI
Virtual Reality Guided Imagery (VR-GI)	20.8	± 5.65
Audio Only Guided Imagery (AO-GI)	21	± 9.07

Daily Pain Numerical Rating Scale Secondary · Baseline to 2 week follow up

Rating of current pain intensity from 0-10 with higher number indicated worse pain outcomes

Change in Pain Score (Follow-up - Baseline)

Group	Value	95% CI
Virtual Reality Guided Imagery (VR-GI)	-0.906	± 0.851
Audio Only Guided Imagery (AO-GI)	-.757	± 0.489

Pre Pain Score

Group	Value	95% CI
Virtual Reality Guided Imagery (VR-GI)	5.75	± 1.5
Audio Only Guided Imagery (AO-GI)	5.49	± 1.41

Post pain Score

Group	Value	95% CI
Virtual Reality Guided Imagery (VR-GI)	4.82	± 1.48
Audio Only Guided Imagery (AO-GI)	4.8	± 1.47

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 weeks. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Virtual Reality Guided Imagery (VR-GI)

Serious: 0/23 (0%)

Deaths: 0/23

Audio Only Guided Imagery (AO-GI)

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (1 terms — click to expand)

Reaction	System	Virtual Reality Guided Ima…	Audio Only Guided Imagery …
device usage	Product Issues	—	—

Data from ClinicalTrials.gov NCT04849897 adverse events section.

Sponsor's own description

To assess treatment with an at-home Virtual Reality Guided Imagery (VR-GI) intervention, 36 patients with chronic pain (18 with chronic back pain, CBP, and 18 with complex regional pain syndrome, CRPS) will complete a 2-week intervention with at-home daily practice of VR-GI (n = 24) or audio-only GI (n = 12). Pre-post treatment measures of pain intensity, opioid use, functional outcomes, and mood will be collected. Intervention feasibility and patient satisfaction will be evaluated post-treatment via questionnaire and qualitative interview.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Mechanism-based nonopioid analgesic targets.
Zeng X, Powell R, Woolf CJ. · · 2025 · cited 11× · PMID 40454476 · DOI 10.1172/jci191346
Feasibility, acceptability, patient experience, and preliminary efficacy of a virtual reality guided imagery intervention for chronic pain.
Doan L, Recasens M, Lake J, Miller I, et al · · 2025 · cited 1× · PMID 40630049 · DOI 10.3389/fdgth.2025.1505861

Verify or expand the search:

Other recruiting trials for Complex Regional Pain Syndromes

Currently open trials in the same condition.

NCT05986461 — Spatially Transcriptomics Reveals Molecular Signatures in CRPS · recruiting
NCT05814497 — Supraspinal Processing of Sensory Aspects of Pain · NA · recruiting
NCT05593237 — Transcranial Magnetic Stimulation for Chronic Neuropathic Pain · NA · active not recruiting
NCT05337501 — Prognostic Factors for Complex Regional Pain Syndrome · NA · active not recruiting
NCT04144972 — Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain · NA · recruiting

Other University of Southern California trials

Trials by the same sponsor.

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NCT07332312 — A Culturally Informed Patient Navigation Program (CFPN) to Reduce Delays Between Diagnosis and Treatment in American Ind · NA · not yet recruiting
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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04849897 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Southern California
Last refreshed: 21 August 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04849897.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing