18 and older, any sex, with Phantom Limb Pain or Neuroma Amputation. 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.
Numeric Rating Scale (NRS) for Pain at 6 MonthsPrimary· 6 months
Presented here is the proportion of participants reporting ≥50% improvement in Numeric Rating Scale pain score at 6 months after their cooled radiofrequency ablation procedure. The Numeric Rating Scale was used to quantify neuroma-associated residual limb pain by asking patients to rate their pain intensity on an 11-point scale ranging from 0 to 10, with 0 representing "no pain at all" and 10 representing "the worst pain imaginable".
Group
Value
95% CI
Residual Limb Pain in Affected Amputated Limb
4
Median Change in Numeric Rating Scale (NRS) Scores for PainSecondary· 1, 3, 6, and 12 months
Patients rated their residual limb pain intensity at baseline and the designated follow-up timepoints using an 11-point Numeric Rating Scale (NRS) ranging from 0 to 10, with 0 representing "no pain at all" and 10 representing "the worst pain imaginable". Change scores were calculated by subtracting follow-up scores from baseline scores. Median change scores and their interquartile ranges are reported here. Positive median change scores indicate pain improvement from baseline, with greater values corresponding to greater pain relief. Similarly, negative change scores indicate worsening pain fro
1 month
Group
Value
95% CI
Residual Limb Pain in Affected Amputated Limb
1.0
0.5 – 3.0
3 months
Group
Value
95% CI
Residual Limb Pain in Affected Amputated Limb
2.0
1.5 – 2.5
6 months
Group
Value
95% CI
Residual Limb Pain in Affected Amputated Limb
1.0
-1.5 – 3.0
12 months
Group
Value
95% CI
Residual Limb Pain in Affected Amputated Limb
3.0
1.3 – 4.0
Medication Quantification Scale III Mean ScoreSecondary· 1, 3, 6 and 12 Months
The Medication Quantification Scale (MQS) is calculated using a pain-related medication detriment score based on drug class, which ranges from 1.1 to 4.5, and multiplying it by a usage score: 1 = subtherapeutic or occasional dose/2 = lower 50% of a therapeutic dose/ 3 = upper 50% of a therapeutic dose/ 4 = supratherapeutic dose. The higher the score, the more pain-related medication the participant takes to control their pain. The resulting score is useful in research for tracking individual or group pain medication use over time.
1 Month
Group
Value
95% CI
Residual Limb Pain in Affected Amputated Limb
8.3
6.1 – 10.0
3 Months
Group
Value
95% CI
Residual Limb Pain in Affected Amputated Limb
6.9
4.6 – 8.1
6 Months
Group
Value
95% CI
Residual Limb Pain in Affected Amputated Limb
7.1
3.6 – 8.5
12 Months
Group
Value
95% CI
Residual Limb Pain in Affected Amputated Limb
7.1
2.4 – 9.7
Proportion of Patients With a ≥6 Score on Patient Global Impression of Change (PGIC)Secondary· 1, 3, 6, and 12 months
Patient Global Impression of Change is a scale which measures participant reported satisfaction after an intervention. The outcome was measured as the percent of patients reporting a PGIC score of 6-7 (indicating "much improved" and "very much improved").
1 month
Group
Value
95% CI
Residual Limb Pain in Affected Amputated Limb
3
3 months
Group
Value
95% CI
Residual Limb Pain in Affected Amputated Limb
3
6 months
Group
Value
95% CI
Residual Limb Pain in Affected Amputated Limb
1
12 months
Group
Value
95% CI
Residual Limb Pain in Affected Amputated Limb
1
Sponsor's own description
To assess changes in pain, physical function, and health-related quality of life in patients with post-amputation neuroma-associated residual limb pain after cooled radiofrequency ablation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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 Utah
Last refreshed: 8 January 2025
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/NCT04538417.