| Protocol ID | NCT04273919 |
| Registration Date | 2020-02-18 |
| Status | Withdrawn |
| Sponsor | University of Pennsylvania |
| Country | United States |
| Industry | not industry |
| Blinding | blinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2020-08-01 |
| Last Patient Out | 2022-02-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT04273919
A Pilot Study to Evaluate the Safety and Efficacy of the Karuna Virtual Reality Program for the Treatment of Chronic Low Back Pain
| Field |
GLM
glm-5.1 8962ms / 8922 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5335ms / 10191 tok |
OPENAI
gpt-4o Thinking: o3 2533ms / 8789 tok |
Review |
|---|---|---|---|---|
| rct_type | parallel RCT | parallel RCT | parallel RCT | OK |
| cancer_status | non-cancer | non-cancer | non-cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient | outpatient | outpatient | outpatient | OK |
| setting_place | other | other | other | OK |
| feasibility | feasibility RCT | feasibility RCT | feasibility RCT | OK |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary |
yes
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The clinical trial evaluates a virtual reality program and devices, which do not fall under the specified CAM modalities.
|
yes
yes → yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The study includes mindfulness meditation as one of the virtual reality interventions, which is a complementary and alternative medicine modality.
Thinking: yes — Study group 1 participates in mindfulness meditation sessions, and meditation is listed as a complementary intervention.
|
yes
no → no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The trial evaluates a virtual reality program, which is not considered a complementary CAM modality.
Thinking: yes — One study arm delivers mindfulness meditation, and meditation is listed as a complementary modality.
|
OK |
| intervention_device | yes | yes | yes | OK |
| intervention_psychological |
no
no → no
shaky reasoning✗ No consensus
Initial: no
Requery: no — The interventions consist of virtual reality programs using either graded motor imagery or mindfulness meditation, which are behavioral and physical techniques rather than structured psychotherapy (e.g., CBT, ACT).
|
yes
yes → yes → no
shaky reasoning✗ No consensus
Initial: yes
Requery: yes — The study includes mindfulness meditation as one intervention arm, which is a structured psychological therapeutic approach.
Thinking: no — While the study includes mindfulness meditation via VR, it is not described as a named structured psychological therapy like MBSR, CBT, or psychotherapy.
|
yes
yes → no → yes
shaky reasoning✗ No consensus
Initial: yes
Requery: no — The trial focuses on virtual reality interventions, including mindfulness mediation and graded motor imagery, which do not qualify as structured psychological therapies.
Thinking: yes — Interventions include structured mindfulness meditation and graded exposure/motor imagery, which are named psychological therapies delivered via VR.
|
|
| intervention_complex |
no
no
shaky reasoning✓ Unanimous
Initial: no
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — This is a single-modality virtual reality intervention comparing two different VR programs (mindfulness meditation vs graded motor imagery), not a multi-component intervention combining distinct categories of treatment.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention involves a single-type virtual reality intervention with multiple sessions, which does not combine different categories such as psychological, educational, or pharmacological components.
|
OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | no | no | no | OK |
| intervention_education | no | no | no | OK |
| intervention_digital | yes | yes | yes | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | yes | yes | yes | OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |