Table 1.
Summary of randomized controlled trials of digital interventions in patients with acute or chronic pain.
| Author | Study design; Duration or number of sessions |
Pain type;
Pain scale |
Population (n), intervention, and comparator description | Concomitant medication(s) | Results |
|---|---|---|---|---|---|
| Bani Mohammed et al. (42) | Prospective RCT 40 sessions | Cancer Pain VASa |
Population (n
=
80): Women (ages 30–70 years) with breast cancer Intervention (n
=
40): VR (Ocean Rift interactive game or Happy Place non-interactive video) plus morphine Comparator (n = 40): Oral or intravenous morphine alone |
IV or oral morphine | One session of adjunct VR resulted in a significant reduction in pain scores when compared to morphine alone (mean post-VAS score: iVR 0.33 vs. control 4.84; p <0.001) |
| Carrougher et al. (19) | Within-subject RCT 78 sessions | Burn Pain GRSb |
Population (n
=
39): Adult burn patients (ages 21–57 years) who required PT Intervention: VR (SnowWorld) with pharmacological analgesia during PT Comparator: Pharmacological analgesia alone |
Oral methadone or OxyContin and a preprocedural short-acting opioid (e.g., oxycodone) | Adjunctive VR significantly reduced worst pain scores by 27% (VR 40 ± 30 vs. control 55 ± 25; p = 0.004) |
| Hoffman et al. (43) | Within-subject RCT 22 sessions | Burn Pain GRSa |
Population (n
=
11): Pediatric and adult patients (ages 9–40 years) with burns requiring hospitalization Intervention: VR (SnowWorld) with pharmacological analgesia during dressing changes Comparator: Pharmacological analgesia alone |
Standard opioid analgesics and benzodiazepines | Mean pain ratings were lower with adjunct iVR when compared to the control group for all 3 pain measures (worst pain, time spent thinking about pain, and pain unpleasantness); differences were all statistically significant (p <0.05) |
| Hoffman et al. (44) | Within-subject RCT 24 sessions | Burn Pain VASb |
Population (n
=
12): Adult burn patients (ages 19–47 years) Intervention: VR (SpiderWorld) with pharmacological analgesia during PT Comparator: Pharmacological analgesia alone |
Long-acting opioids (typically OxyContin) | All 12 participants reported statistically significant less pain with adjunct VR distraction (worst pain: VR 19.92 vs. control 42, p = 0.002; average pain: VR 14.67 vs. control 36.33, p = 0.002) |
| Maani et al. (45) | Within-subject RCT 24 sessions | Burn Pain GRSa |
Population (n
=
12): US soldiers (ages 20–27 years) with burn wounds Intervention: VR (SnowWorld) with pharmacological analgesia during wound debridement Comparator: Pharmacological analgesia alone |
Fast acting opioids and/or ketamine | Significant difference in mean worst pain scores >7 (iVR 5.67 vs. control 8.33; p = 0.043); no significant difference between groups for mild to moderate pain (VR 4.17 vs. control 3.33) |
| Morris et al. (46) | Within-subject RCT 22 sessions | Burn Pain NRSa |
Population (n
=
11): Adult burn patients (ages 23–54 years) undergoing physiotherapy Intervention: VR (eMagin Z800 3DVisor; game: Chicken Little) with pharmacological analgesia during PT Comparator: Pharmacological analgesia alone |
Morphine and acetaminophen/ codeine (Dolorol Forte) to all eligible subjects; ibuprofen was given to two subjects | No significant difference in pain reduction between both groups (mean difference = 2.09; 95% CI-0.67 to 4.85, p = 0.13) |
| Schmitt et al. (47) | Within-subject RCT 1 to 5 days | Burn Pain GRSb |
Population (n
=
54): Hospitalized pediatric (ages 6–19 years) burn patients undergoing physical therapy Intervention: VR (SnowWorld) with pharmacological analgesia during PT Comparator: Pharmacological analgesia/sedation alone |
Oral opioid (e.g., hydromorphone, fentanyl lozenge) +/− oral benzodiazepine (e.g., midazolam) | Significant reduction in cognitive (decreased by 44%), affective (decreased by 32%), and sensory pain (decreased by 27%) with adjunct immersive VR (p <0.05) |
| Sharar et al. (48) | Within-subject RCT 146 sessions | Burn Pain GRSb |
Population (n
=
88): Pediatric and adult patients (ages 6–65 years) who required postburn PT Intervention: VR (SnowWorld) with pharmacological analgesia during PT Comparator: Pharmacological analgesia alone |
Systemic opioid and/or benzodiazepine | Significant decrease in worst pain intensity scores in the VR group (VR 43.5 ± 3.5 vs. control 54.2 ± 3.1; p = 0.003) |
| Yang et al. (49) | Prospective RCT 4 weeks | Cancer Pain NRSa |
Population (n
=
58): Adults (ages 18–75 years) with cancer-related pain Intervention (n
=
31): Pain Guard mobile app Comparator (n = 27): Standard pharmaceutical care |
Oxycodone, morphine, methadone, and/or tramadol | Pain Guard significantly decreased the frequency of breakthrough cancer pain (Pain Guard: median 3, IQR 2–7 vs. control: median 13, IQR 9.5–14, p <0.001) and lead to a higher rate of pain remission (p <0.001) with fewer adverse events reported |
Only RCTs which compared digital interventions with pharmacological interventions alone are included in this table.
GRS, graphic rating scale; IQR, interquartile range; iVR, immersive virtual reality; n, number of participants; NRS, numerical rating scale; PT, physical therapy; RCT, randomized controlled trial; VAS, visual analog scale; VR, virtual reality; vs., versus.
aMeasured on a 0- to 10-cm scale.
bMeasured on a 0- to 100-mm scale.