Trial Outcomes & Findings for Morphine After Radiofrequency Ablation of Painful Bone Metastases in Patients With Cancer (NCT NCT00712712)
NCT ID: NCT00712712
Last Updated: 2025-08-29
Results Overview
Difference in maximum pain scores between inclusion and 2 months after radiofrequency ablation (RFA) according to an 11-point numerical scale Rate of patients with a decrease of two or more points in their most intense pain, 2 months after the radiofrequency ablation. This rate is calculated for the evaluable population for the principal outcome measure. This rate is equal to the ratio of the number of patients with a decrease of two or more points in their maximum pain divided by the size of the evaluable population. The response rate considered acceptable is 50%, above this threshold the treatment will be considered potentially effective and may be proposed in phase III.
COMPLETED
PHASE2
78 participants
2 months after radiofrequency ablation (RFA)
2025-08-29
Participant Flow
Participant milestones
| Measure |
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases Localized Causing Pain
Bone metastases refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
|
|---|---|
|
Overall Study
STARTED
|
78
|
|
Overall Study
COMPLETED
|
55
|
|
Overall Study
NOT COMPLETED
|
23
|
Reasons for withdrawal
| Measure |
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases Localized Causing Pain
Bone metastases refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
|
|---|---|
|
Overall Study
Protocol Violation
|
11
|
|
Overall Study
Radiofrequency not done
|
3
|
|
Overall Study
Death
|
8
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
n=78 Participants
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
|
|---|---|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 11.7 • n=78 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=78 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=78 Participants
|
|
Region of Enrollment
France
|
78 participants
n=78 Participants
|
PRIMARY outcome
Timeframe: 2 months after radiofrequency ablation (RFA)Population: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency. If 25 patients or more are observed with pain reduction of 2 or more points, then the treatment will be considered potentially effective.
Difference in maximum pain scores between inclusion and 2 months after radiofrequency ablation (RFA) according to an 11-point numerical scale Rate of patients with a decrease of two or more points in their most intense pain, 2 months after the radiofrequency ablation. This rate is calculated for the evaluable population for the principal outcome measure. This rate is equal to the ratio of the number of patients with a decrease of two or more points in their maximum pain divided by the size of the evaluable population. The response rate considered acceptable is 50%, above this threshold the treatment will be considered potentially effective and may be proposed in phase III.
Outcome measures
| Measure |
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
n=55 Participants
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
|
|---|---|
|
Percentage of Participants With Maximum Pain Level Decreased by ≥ 2 Points at 2 Months After Radiofrequency Ablation (RFA)
|
83.6 percentage of participants
Interval 73.9 to 93.4
|
SECONDARY outcome
Timeframe: Inclusion and 2 months after radiofrequency ablation (RFA)Population: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
Difference in maximum pain scores between inclusion and 2 months after radiofrequency ablation (RFA) according to a discrete 11-points numerical scale. Increased/decreased pain is considered as a variation of at least one point on the numerical scale. If 25 patients or more are observed with pain reduction of 2 or more points, then the treatment will be considered potentially effective.
Outcome measures
| Measure |
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
n=55 Participants
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
|
|---|---|
|
Difference in Maximum Pain Scores Between Inclusion and 2 Months After Radiofrequency Ablation
Increased pain
|
4 Participants
|
|
Difference in Maximum Pain Scores Between Inclusion and 2 Months After Radiofrequency Ablation
Unchanged pain
|
2 Participants
|
|
Difference in Maximum Pain Scores Between Inclusion and 2 Months After Radiofrequency Ablation
Decreased pain
|
49 Participants
|
SECONDARY outcome
Timeframe: First algology assessment at pre-selection visitPopulation: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at: * Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation, * Inclusion visit: Second algology assessment (One week after the first algology assessment) * J-1: one day before radiofrequency * J+1: One day after radiofrequency * Discharge from hospital * 7 days after discharge from hospital * 1 month after radiofrequency * 2 months after radiofrequency * 3 months after radiofrequency Here, are presented only data collected at the pre-selection visit.
Outcome measures
| Measure |
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
n=55 Participants
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
|
|---|---|
|
Intensity of Pain (Minimum, Average, Maximum)
Minimal pain
|
0.5 score on a scale
Standard Deviation 1.9
|
|
Intensity of Pain (Minimum, Average, Maximum)
Average pain
|
5.0 score on a scale
Standard Deviation 1.9
|
|
Intensity of Pain (Minimum, Average, Maximum)
Maximum pain
|
8.0 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Second algology assessment at inclusion visitPopulation: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at: * Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation, * Inclusion visit: Second algology assessment (One week after the first algology assessment) * J-1: one day before radiofrequency * J+1: One day after radiofrequency * Discharge from hospital * 7 days after discharge from hospital * 1 month after radiofrequency * 2 months after radiofrequency * 3 months after radiofrequency Here, are presented only data collected at the inclusion visit.
Outcome measures
| Measure |
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
n=55 Participants
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
|
|---|---|
|
Intensity of Pain (Minimum, Average, Maximum)
Minimal pain
|
2.0 score on a scale
Standard Deviation 2.0
|
|
Intensity of Pain (Minimum, Average, Maximum)
Average pain
|
5.0 score on a scale
Standard Deviation 1.8
|
|
Intensity of Pain (Minimum, Average, Maximum)
Maximum pain
|
8.0 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Algology assessment one day before radiofrequency (J-1)Population: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at: * Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation, * Inclusion visit: Second algology assessment (One week after the first algology assessment) * J-1: one day before radiofrequency * J+1: One day after radiofrequency * Discharge from hospital * 7 days after discharge from hospital * 1 month after radiofrequency * 2 months after radiofrequency * 3 months after radiofrequency Here, are presented only data collected one day before radiofrequency (J-1).
Outcome measures
| Measure |
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
n=55 Participants
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
|
|---|---|
|
Intensity of Pain (Minimum, Average, Maximum)
Minimal pain
|
2.0 score on a scale
Standard Deviation 1.7
|
|
Intensity of Pain (Minimum, Average, Maximum)
Average pain
|
5.0 score on a scale
Standard Deviation 1.7
|
|
Intensity of Pain (Minimum, Average, Maximum)
Maximum pain
|
7.0 score on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Algology assessment one day after radiofrequency: J+1Population: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at: * Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation, * Inclusion visit: Second algology assessment (One week after the first algology assessment) * J-1: one day before radiofrequency * J+1: One day after radiofrequency * Discharge from hospital * 7 days after discharge from hospital * 1 month after radiofrequency * 2 months after radiofrequency * 3 months after radiofrequency Here, are presented only data collected one day after radiofrequency (J+1).
Outcome measures
| Measure |
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
n=55 Participants
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
|
|---|---|
|
Intensity of Pain (Minimum, Average, Maximum)
Minimal pain
|
0.0 score on a scale
Standard Deviation 1.6
|
|
Intensity of Pain (Minimum, Average, Maximum)
Average pain
|
2.0 score on a scale
Standard Deviation 2.0
|
|
Intensity of Pain (Minimum, Average, Maximum)
Maximum pain
|
4.0 score on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Algology assessment at the discharge from hospital visitPopulation: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at: * Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation, * Inclusion visit: Second algology assessment (One week after the first algology assessment) * J-1: one day before radiofrequency * J+1: One day after radiofrequency * Discharge from hospital * 7 days after discharge from hospital * 1 month after radiofrequency * 2 months after radiofrequency * 3 months after radiofrequency Here, are presented only data collected at the discharge from hospital visit.
Outcome measures
| Measure |
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
n=55 Participants
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
|
|---|---|
|
Intensity of Pain (Minimum, Average, Maximum)
Minimal pain
|
0.0 score on a scale
Standard Deviation 1.4
|
|
Intensity of Pain (Minimum, Average, Maximum)
Average pain
|
2.0 score on a scale
Standard Deviation 1.8
|
|
Intensity of Pain (Minimum, Average, Maximum)
Maximum pain
|
3.0 score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Algology assessment 7 days after discharge from hospitalPopulation: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at: * Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation, * Inclusion visit: Second algology assessment (One week after the first algology assessment) * J-1: one day before radiofrequency * J+1: One day after radiofrequency * Discharge from hospital * 7 days after discharge from hospital * 1 month after radiofrequency * 2 months after radiofrequency * 3 months after radiofrequency Here, are presented only data collected 7 days after discharge from hospital.
Outcome measures
| Measure |
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
n=55 Participants
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
|
|---|---|
|
Intensity of Pain (Minimum, Average, Maximum)
Minimal pain
|
0.0 score on a scale
Standard Deviation 2.0
|
|
Intensity of Pain (Minimum, Average, Maximum)
Average pain
|
2.0 score on a scale
Standard Deviation 2.7
|
|
Intensity of Pain (Minimum, Average, Maximum)
Maximum pain
|
6.0 score on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Algology assessment 1 month after radiofrequencyPopulation: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at: * Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation, * Inclusion visit: Second algology assessment (One week after the first algology assessment) * J-1: one day before radiofrequency * J+1: One day after radiofrequency * Discharge from hospital * 7 days after discharge from hospital * 1 month after radiofrequency * 2 months after radiofrequency * 3 months after radiofrequency Here, are presented only data collected 1 month after radiofrequency.
Outcome measures
| Measure |
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
n=55 Participants
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
|
|---|---|
|
Intensity of Pain (Minimum, Average, Maximum)
Minimal pain
|
0.0 score on a scale
Standard Deviation 1.1
|
|
Intensity of Pain (Minimum, Average, Maximum)
Average pain
|
2.0 score on a scale
Standard Deviation 2.0
|
|
Intensity of Pain (Minimum, Average, Maximum)
Maximum pain
|
3.0 score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Algology assessment 2 months after radiofrequencyPopulation: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at: * Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation, * Inclusion visit: Second algology assessment (One week after the first algology assessment) * J-1: one day before radiofrequency * J+1: One day after radiofrequency * Discharge from hospital * 7 days after discharge from hospital * 1 month after radiofrequency * 2 months after radiofrequency * 3 months after radiofrequency Here, are presented only data collected 2 months after radiofrequency.
Outcome measures
| Measure |
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
n=55 Participants
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
|
|---|---|
|
Intensity of Pain (Minimum, Average, Maximum)
Average pain
|
2.0 score on a scale
Standard Deviation 2.1
|
|
Intensity of Pain (Minimum, Average, Maximum)
Minimal pain
|
0.0 score on a scale
Standard Deviation 1.1
|
|
Intensity of Pain (Minimum, Average, Maximum)
Maximum pain
|
3.0 score on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Algology assessment 3 months after radiofrequencyPopulation: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
According to a discrete 11-points numerical scale which ranges from 0 (low pain) to 11 (intense pain), intensity of pain (Minimum, Average, Maximum) has been evaluated at different time point between pre-selection and up to 3 months after radiofrequency. Assessment of intensity of pain has been done in this order at: * Pre-selection visit: First algology assessment within a week (± 3 days) after the radiology consultation, * Inclusion visit: Second algology assessment (One week after the first algology assessment) * J-1: one day before radiofrequency * J+1: One day after radiofrequency * Discharge from hospital * 7 days after discharge from hospital * 1 month after radiofrequency * 2 months after radiofrequency * 3 months after radiofrequency Here, are presented only data collected 3 months after radiofrequency.
Outcome measures
| Measure |
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
n=55 Participants
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
|
|---|---|
|
Intensity of Pain (Minimum, Average, Maximum)
Minimal pain
|
0.0 score on a scale
Standard Deviation 1.2
|
|
Intensity of Pain (Minimum, Average, Maximum)
Average pain
|
1.0 score on a scale
Standard Deviation 2.3
|
|
Intensity of Pain (Minimum, Average, Maximum)
Maximum pain
|
2.5 score on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Preselection: First algology visit (within a week (± 3 days) after the radiology consultation)Population: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.
Outcome measures
| Measure |
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
n=55 Participants
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
|
|---|---|
|
Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
|
60.0 mg morphine equivalents/day
Standard Deviation 182.9
|
SECONDARY outcome
Timeframe: Inclusion: Second algology visit (One week after the first algology visit)Population: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.
Outcome measures
| Measure |
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
n=55 Participants
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
|
|---|---|
|
Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
|
60.0 mg morphine equivalents/day
Standard Deviation 182.9
|
SECONDARY outcome
Timeframe: J-1 (One day before radiofrequency)Population: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.
Outcome measures
| Measure |
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
n=55 Participants
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
|
|---|---|
|
Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
|
60.0 mg morphine equivalents/day
Standard Deviation 132.8
|
SECONDARY outcome
Timeframe: Discharge from hospitalPopulation: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.
Outcome measures
| Measure |
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
n=55 Participants
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
|
|---|---|
|
Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
|
60.0 mg morphine equivalents/day
Standard Deviation 115.3
|
SECONDARY outcome
Timeframe: 7 days after dischargePopulation: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.
Outcome measures
| Measure |
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
n=55 Participants
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
|
|---|---|
|
Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
|
60.0 mg morphine equivalents/day
Standard Deviation 103.1
|
SECONDARY outcome
Timeframe: 1 month after radiofrequencyPopulation: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.
Outcome measures
| Measure |
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
n=55 Participants
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
|
|---|---|
|
Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
|
60.0 mg morphine equivalents/day
Standard Deviation 148.0
|
SECONDARY outcome
Timeframe: 2 months after radiofrequencyPopulation: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.
Outcome measures
| Measure |
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
n=55 Participants
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
|
|---|---|
|
Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
|
60.0 mg morphine equivalents/day
Standard Deviation 148.0
|
SECONDARY outcome
Timeframe: 3 months after radiofrequencyPopulation: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
Patients were provided with a pain notebook. This notebook allowed the patient to describe the pain specific to the metastasis concerned. In particular, information about the dose of oral morphine consumption or oral morphine equivalent in mg per day. This pain notebook has been evaluated between the radiology consultation and three months after radiofrequency.
Outcome measures
| Measure |
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
n=55 Participants
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
|
|---|---|
|
Oral Morphine Consumption or Oral Morphine Equivalent (Immediate and Sustained Release Forms) (mg) Per Day
|
50.0 mg morphine equivalents/day
Standard Deviation 169.5
|
SECONDARY outcome
Timeframe: 24 hours after radiofrequencyPopulation: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
Total intravenous dose of morphine 24 hours after the radiofrequency was assessed during the patient's hospital stay. As a reminder, the post-operative analgesic treatment included intravenous paracetamol (4 g / 24h) and patient-controlled analgesia (PCA).
Outcome measures
| Measure |
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
n=55 Participants
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
|
|---|---|
|
Total Intravenous Morphine Dose (mg)
|
3.0 mg
Standard Deviation 72.4
|
SECONDARY outcome
Timeframe: 24 hours after radiofrequencyPopulation: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
As a reminder, the post-operative analgesic treatment included intravenous paracetamol (4 g / 24h) and patient-controlled analgesia (PCA).
Outcome measures
| Measure |
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
n=55 Participants
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
|
|---|---|
|
Bolus Dose in mg Administered by Patient-controlled Analgesia (PCA)
|
1.0 mg
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: InclusionPopulation: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
Quality of life Questionnaire -Core 30 (QLQ-C30) developed in 1986 by the European Organization for Research and Treatment of Cancer (EORTC) assesses quality of life across 15 dimensions : 5 functional dimensions : Physical functioning, Role functioning, Emotional, Cognitive functioning, Social functioning; 9 symptomatic dimensions: Fatigue, Nausea and vomiting, Pain, Dyspnea, Insomnia, Appetite loss, Diarrhoea, Financial difficulties; 1 global health dimension: Global health status/QoL Each dimension is a standardised score ranges from 0 to 100. A low score corresponds to a low functional level, an absence of symptoms or a low level of QoL/ overall health and, conversely, so that a high score corresponds to a high functional level, a high presence of symptoms or a high level of QoL/overall health.
Outcome measures
| Measure |
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
n=55 Participants
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
|
|---|---|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Physical functioning
|
46.7 score on a scale
Standard Deviation 23.7
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Role functioning
|
33.3 score on a scale
Standard Deviation 32.9
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Emotional functioning
|
58.3 score on a scale
Standard Deviation 24.2
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Cognitive functioning
|
66.7 score on a scale
Standard Deviation 25.6
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Social functioning
|
33.3 score on a scale
Standard Deviation 25.6
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Global health status/QoL
|
41.7 score on a scale
Standard Deviation 17.1
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Fatigue
|
66.7 score on a scale
Standard Deviation 23.1
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Nausea and vomiting
|
16.7 score on a scale
Standard Deviation 26.5
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Pain
|
83.3 score on a scale
Standard Deviation 24.4
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Dyspnoea
|
33.3 score on a scale
Standard Deviation 30.6
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Insomnia
|
33.3 score on a scale
Standard Deviation 31.5
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Appetite loss
|
0.0 score on a scale
Standard Deviation 36.0
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Constipation
|
33.3 score on a scale
Standard Deviation 33.1
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Diarrhoea
|
0.0 score on a scale
Standard Deviation 16.3
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Financial difficulties
|
0.0 score on a scale
Standard Deviation 26.3
|
SECONDARY outcome
Timeframe: 2 months after radiofrequencyPopulation: Pre-selected patients meeting the inclusion and exclusion criteria. Excluded patients who died, were lost to follow-up, or dropped out of the study within eight weeks after radiofrequency.
Quality of life Questionnaire -Core 30 (QLQ-C30) developed in 1986 by the European Organization for Research and Treatment of Cancer (EORTC) assesses quality of life across 15 dimensions : 5 functional dimensions : Physical functioning, Role functioning, Emotional, Cognitive functioning, Social functioning; 9 symptomatic dimensions: Fatigue, Nausea and vomiting, Pain, Dyspnea, Insomnia, Appetite loss, Diarrhoea, Financial difficulties; 1 global health dimension: Global health status/QoL Each dimension is a standardised score ranges from 0 to 100. A low score corresponds to a low functional level, an absence of symptoms or a low level of QoL/ overall health and, conversely, so that a high score corresponds to a high functional level, a high presence of symptoms or a high level of QoL/overall health.
Outcome measures
| Measure |
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
n=55 Participants
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
|
|---|---|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Physical functioning
|
60.0 score on a scale
Standard Deviation 23.9
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Role functioning
|
50.0 score on a scale
Standard Deviation 29.9
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Emotional functioning
|
62.5 score on a scale
Standard Deviation 20.8
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Cognitive functioning
|
50.0 score on a scale
Standard Deviation 25.5
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Social functioning
|
50.0 score on a scale
Standard Deviation 33.7
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Global health status/QoL
|
50.0 score on a scale
Standard Deviation 19.0
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Fatigue
|
55.6 score on a scale
Standard Deviation 25.7
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Nausea and vomiting
|
0.0 score on a scale
Standard Deviation 21.3
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Pain
|
50.0 score on a scale
Standard Deviation 28.2
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Dyspnoea
|
33.3 score on a scale
Standard Deviation 33.2
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Insomnia
|
33.3 score on a scale
Standard Deviation 35.0
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Appetite loss
|
33.3 score on a scale
Standard Deviation 35.0
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Constipation
|
33.3 score on a scale
Standard Deviation 37.4
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Diarrhoea
|
0.0 score on a scale
Standard Deviation 23.8
|
|
Standardised Quality of Life Scores (EORTC - QLQ-C30)
Financial difficulties
|
0.0 score on a scale
Standard Deviation 16.9
|
Adverse Events
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
Serious adverse events
| Measure |
Patient Who Has Undergone Radiofrequency Ablation of Bone Metastases
n=71 participants at risk
Patient who has undergone radiofrequency ablation of bone metastases, localized, causing pain refractory to radiotherapy or not accessible to new irradiation, biphosphonates and well-conducted morphine analgesic treatment.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile aplasia
|
1.4%
1/71 • Number of events 1 • All expected (SAE-E) and unexpected (SAE-U) serious adverse events, whether or not attributable to the research, that occur during the study or within 30 days afterwards. A serious adverse event report form (initial or follow-up) must be completed. According to the context Adverse Event (AE) not including serious has not been collected for this study.
Adverse Event (AE) not including serious has not been collected for this study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
15.5%
11/71 • Number of events 11 • All expected (SAE-E) and unexpected (SAE-U) serious adverse events, whether or not attributable to the research, that occur during the study or within 30 days afterwards. A serious adverse event report form (initial or follow-up) must be completed. According to the context Adverse Event (AE) not including serious has not been collected for this study.
Adverse Event (AE) not including serious has not been collected for this study.
|
|
General disorders
Alteration of the general condition
|
14.1%
10/71 • Number of events 10 • All expected (SAE-E) and unexpected (SAE-U) serious adverse events, whether or not attributable to the research, that occur during the study or within 30 days afterwards. A serious adverse event report form (initial or follow-up) must be completed. According to the context Adverse Event (AE) not including serious has not been collected for this study.
Adverse Event (AE) not including serious has not been collected for this study.
|
|
General disorders
Disease-related death
|
4.2%
3/71 • Number of events 3 • All expected (SAE-E) and unexpected (SAE-U) serious adverse events, whether or not attributable to the research, that occur during the study or within 30 days afterwards. A serious adverse event report form (initial or follow-up) must be completed. According to the context Adverse Event (AE) not including serious has not been collected for this study.
Adverse Event (AE) not including serious has not been collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
1.4%
1/71 • Number of events 1 • All expected (SAE-E) and unexpected (SAE-U) serious adverse events, whether or not attributable to the research, that occur during the study or within 30 days afterwards. A serious adverse event report form (initial or follow-up) must be completed. According to the context Adverse Event (AE) not including serious has not been collected for this study.
Adverse Event (AE) not including serious has not been collected for this study.
|
|
General disorders
Fever
|
1.4%
1/71 • Number of events 1 • All expected (SAE-E) and unexpected (SAE-U) serious adverse events, whether or not attributable to the research, that occur during the study or within 30 days afterwards. A serious adverse event report form (initial or follow-up) must be completed. According to the context Adverse Event (AE) not including serious has not been collected for this study.
Adverse Event (AE) not including serious has not been collected for this study.
|
|
Injury, poisoning and procedural complications
Fracture
|
8.5%
6/71 • Number of events 6 • All expected (SAE-E) and unexpected (SAE-U) serious adverse events, whether or not attributable to the research, that occur during the study or within 30 days afterwards. A serious adverse event report form (initial or follow-up) must be completed. According to the context Adverse Event (AE) not including serious has not been collected for this study.
Adverse Event (AE) not including serious has not been collected for this study.
|
|
Blood and lymphatic system disorders
Anemia
|
7.0%
5/71 • Number of events 9 • All expected (SAE-E) and unexpected (SAE-U) serious adverse events, whether or not attributable to the research, that occur during the study or within 30 days afterwards. A serious adverse event report form (initial or follow-up) must be completed. According to the context Adverse Event (AE) not including serious has not been collected for this study.
Adverse Event (AE) not including serious has not been collected for this study.
|
|
Hepatobiliary disorders
Jaundice
|
1.4%
1/71 • Number of events 1 • All expected (SAE-E) and unexpected (SAE-U) serious adverse events, whether or not attributable to the research, that occur during the study or within 30 days afterwards. A serious adverse event report form (initial or follow-up) must be completed. According to the context Adverse Event (AE) not including serious has not been collected for this study.
Adverse Event (AE) not including serious has not been collected for this study.
|
|
Nervous system disorders
Sciatalgy
|
2.8%
2/71 • Number of events 3 • All expected (SAE-E) and unexpected (SAE-U) serious adverse events, whether or not attributable to the research, that occur during the study or within 30 days afterwards. A serious adverse event report form (initial or follow-up) must be completed. According to the context Adverse Event (AE) not including serious has not been collected for this study.
Adverse Event (AE) not including serious has not been collected for this study.
|
|
Injury, poisoning and procedural complications
Immediate post-operative pain increase
|
1.4%
1/71 • Number of events 1 • All expected (SAE-E) and unexpected (SAE-U) serious adverse events, whether or not attributable to the research, that occur during the study or within 30 days afterwards. A serious adverse event report form (initial or follow-up) must be completed. According to the context Adverse Event (AE) not including serious has not been collected for this study.
Adverse Event (AE) not including serious has not been collected for this study.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
1.4%
1/71 • Number of events 1 • All expected (SAE-E) and unexpected (SAE-U) serious adverse events, whether or not attributable to the research, that occur during the study or within 30 days afterwards. A serious adverse event report form (initial or follow-up) must be completed. According to the context Adverse Event (AE) not including serious has not been collected for this study.
Adverse Event (AE) not including serious has not been collected for this study.
|
|
Renal and urinary disorders
Dysuric syndrome
|
1.4%
1/71 • Number of events 1 • All expected (SAE-E) and unexpected (SAE-U) serious adverse events, whether or not attributable to the research, that occur during the study or within 30 days afterwards. A serious adverse event report form (initial or follow-up) must be completed. According to the context Adverse Event (AE) not including serious has not been collected for this study.
Adverse Event (AE) not including serious has not been collected for this study.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place