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 A Cryotherapy: Cooling brace worn day of surgery for 6 hours at 6 degrees C, then day 1 for 4 hours at 8 degrees C three times daily, then days 2 to 7 for 2 hours in the morning at 8 degrees C, optional use mid-day, and 2 hours at 10 degrees C in the evening, plus usual rapid recovery care and rehabilitation program.
Intervention BUsual care: Rapid recovery care and rehabilitation program

Arm Details

N/A

Sample Characteristics

N/A

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
ContinuousPainPain Intensity at rest (mean [SD], 0 to 10 NRS, estimated from figure)
  • All Participants
  • Day 1 after treatment
  • Day 14 after treatment
  • Day 7 after treatment
  • Day 6 after treatment
  • 6 weeks after treatment
ContinuousPainPain Intensity while loading (mean [SD], 0 to 10 NRS, estimated from figure)
  • All Participants
  • Day 1 after treatment
  • Day 14 after treatment
  • Day 7 after treatment
  • Day 6 after treatment
  • 6 weeks after treatment
ContinuousFunctionKnee Injury and Osteoarthritis Outcome Score- Activities of Daily Living (mean [SD], 0 to 100 scale, higher score=better outcome)
  • All Participants
  • Day 14 after treatment
  • 6 weeks after treatment
CategoricalPersistent Opioid Use and Prescribing RatesOxycodone 10 mg use
  • All Participants
  • Day 1 after treatment
  • Day 7 after treatment
  • Day 6 after treatment
CategoricalPersistent Opioid Use and Prescribing RatesOxycodone 5 mg use
  • All Participants
  • Day 1 after treatment
  • Day 7 after treatment
  • Day 6 after treatment
CategoricalAdverse EventsInfection
  • All Participants
  • After Treatment
CategoricalAdverse EventsConfused after surgery
  • All Participants
  • After Treatment
ContinuousQOL and Satisfaction With Pain ReliefKnee Injury and Osteoarthritis Outcome Score- knee related QOL (mean [SD], 0 to 100 scale, higher score=better outcome)
  • All Participants
  • 2 weeks after treatment (wk)
  • 6 weeks after treatment (wk)

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 (Oxycodone 10 mg use)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intervention A Intervention B
Day 1 after treatment
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Day 7 after treatment
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Day 6 after treatment
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Intervention A Intervention B

Persistent Opioid Use and Prescribing Rates (Oxycodone 5 mg use)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intervention A Intervention B
Day 1 after treatment
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Day 7 after treatment
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Day 6 after treatment
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Intervention A Intervention B

Adverse Events (Infection)

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

Adverse Events (Confused after surgery)

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

Continuous


Pain (Pain Intensity at rest (mean [SD], 0 to 10 NRS, estimated from figure))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intervention A Intervention B
Day 1 after treatment
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Day 14 after treatment
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Day 7 after treatment
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Day 6 after treatment
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
6 weeks 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 A Intervention B

Pain (Pain Intensity while loading (mean [SD], 0 to 10 NRS, estimated from figure))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intervention A Intervention B
Day 1 after treatment
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Day 14 after treatment
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Day 7 after treatment
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Day 6 after treatment
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
6 weeks 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 A Intervention B

Function (Knee Injury and Osteoarthritis Outcome Score- Activities of Daily Living (mean [SD], 0 to 100 scale, higher score=better outcome))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intervention A Intervention B
Day 14 after treatment
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
6 weeks 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 A Intervention B

QOL and Satisfaction With Pain Relief (Knee Injury and Osteoarthritis Outcome Score- knee related QOL (mean [SD], 0 to 100 scale, higher score=better outcome))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Intervention A Intervention B
2 weeks after treatment (wk)
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
6 weeks after treatment (wk)
Mean
Mean Difference (MD)
SD
95% CI low (MD)
95% CI high (MD)
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Intervention A Intervention B