Extraction form for project: Acute Pain Updates

Design Details

1. Setting
Column B
2. Country
Column C
3. Specific Pain Condition
Column D
4. Intervention Types Compared
Column E
5. Number randomized
Total
Intervention A
Intervention B
6. Number Analyzed
Total
Intervention A
Intervention B
7. Participants age (mean, years)
8. Participants sex (% Female)
9. Race (%)
Column L
10. History of Substance Use Disorder
Column N
11. Under Treatment for Opiate Use Disorder
Column O
12. History of Psychiatric Illness
Column P
13. Pregnant or Breastfeeding
Column R
14. Pain Duration
Column R
15. Overall Baseline Pain Standardized Scale 0 to 10
Column S
16. Treatment duration
Column T
17. Assessment Time Points
Column V
18. Duration of Followup Category
Column W

Arms

Arm NameArm Description
Intervention ATENS: Segmental and local stimulation with electrodes placed on both sides of surgical incision and in paraspinal area; biphasic at constant stimulation frequency of 100 Hz and pulse duration of 200 µs, intensity increased until maximal tolerable tingling sensation without discomfort, pain, or muscle contraction
Intervention BSham TENS: Intensity 0 to 0.5 mA without any sensations

Arm Details

N/A

Sample Characteristics

N/A

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
ContinuousPainPain relief at rest (mean [SD], 0 to 10 VAS)
  • All Participants
  • 48 hours after treatment
ContinuousPainPain relief on walking (mean [SD], 0 to 10 VAS)
  • All Participants
  • 48 hours after treatment
CategoricalPersistent Opioid Use and Prescribing RatesOpioid use:
  • All Participants
  • After Treatment

Outcome Details

N/A

Risk of Bias Assessment

1. Was randomization adequate?
2. Was allocation concealment adequate?
3. Were the groups similar at baseline?
4. Were the outcome assessor masked?
5. Were the care providers masked?
6. Was the patient masked?
7. Did the article report attrition, crossovers, adherence and/or contamination?
8. Loss to followup?
Differential
High
9. Was there intention-to-treat analysis?
10. Were there post-randomization exclusions?
11. Were the outcomes prespecified?
12. Quality rating

Results

Categorical


Persistent Opioid Use and Prescribing Rates (Opioid use:)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intervention AIntervention B
After Treatment
Percentage
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Intervention AIntervention B

Continuous


Pain (Pain relief at rest (mean [SD], 0 to 10 VAS))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intervention AIntervention B
48 hours after treatment
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Intervention AIntervention B

Pain (Pain relief on walking (mean [SD], 0 to 10 VAS))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intervention AIntervention B
48 hours after treatment
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Intervention AIntervention B