Trial Outcomes & Findings for Dorsal Root Ganglion Thermal Radiofrequency Versus Pulsed Radiofrequency for Metastatic Pain in Thoracic Vertebral Body (NCT NCT03204942)
NCT ID: NCT03204942
Last Updated: 2020-07-07
Results Overview
The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems e.g. a higher score in " Financial difficulties" represents a greater difficulty
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
69 participants
Primary outcome timeframe
Assessment done at 3 months after the procedure.
Results posted on
2020-07-07
Participant Flow
140 patients were assessed for primary eligibility using Visual Analogue Scale(VAS).Of which81 only met the inclusion and exclusion criteria. Those 81 were assessed for final eligibility using MRI, CT and bone scan. 69 were included and12 were excluded before randomization due to4 died,4 declined to participate and4 had severe health deterioration
Participant milestones
| Measure |
PRF on DRG
Patients will receive Pulsed Radiofrequency (PRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 42°C for 480 sec.,2 active cycles per second of 20 milliseconds each , with a voltage output 40 to 60-V range, impedance ranges between 150 and 400 Ohms at all levels using Fluroscopic guidance(FG).
PRF on DRG: RF will be performed with the patient in a prone position with mild flexion of the spine. Fluoroscopy beam positioned in an antero-posterior direction. A 10 cm RF needle 20 G with a 10 mm active tip.The needle is inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walking into the thoracic intervertebral foramen. So the location of the needle tip confirmed by sensory stimulation at 50 Hz. The point of maximum stimulation is at 0.5 V intensity and this is designated to be the location of the DRG. Slight redirection can be done to optimize the st
|
TRF on DRG
Patients will receive Thermal Radiofrequency (TRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 80°C for 90 sec.,2 cycles, using Fluoroscopic guidance (FG) .
TRF on DRG: Similar to the group of " PRF on DRG", but the types of the waves will be different as previously described
|
Control Group
The control group will have identical needle placement and preparation like the 2 previous groups without the RF lesion, but with the injection of particulate Betamethasone steroids and local anesthetic on DRG of the selected metastatic painful dorsal vertebrae, using Fluoroscopic guidance (FG).
Corticosteroid injection: Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described
|
|---|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
23
|
|
Overall Study
COMPLETED
|
23
|
23
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dorsal Root Ganglion Thermal Radiofrequency Versus Pulsed Radiofrequency for Metastatic Pain in Thoracic Vertebral Body
Baseline characteristics by cohort
| Measure |
PRF on DRG
n=23 Participants
Patients received Pulsed Radiofrequency (PRF)on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 42°C for 480 sec.2 active cycles per second of 20 milliseconds each , with a voltage output 40-60-V ,impedance between 150-400 Ohms at all levels using Fluroscopic guidance. RF was performed with the patient in a prone position with mild flexion of the spine. Fluoroscopy beam positioned in an AP direction. A 10 cm RF needle 20 G with a 10 mm active tip.The needle was inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walking into the thoracic intervertebral foramen. The location of the needle tip confirmed by sensory stimulation at 50 Hz. The point of maximum stimulation was at 0.5 V . injection of contrast reveals epidural uptake. After establishing the site for the RF, 1 ml 2% lidocaine was injected through the needle.
|
TRF on DRG
n=23 Participants
Patients received Thermal Radiofrequency (TRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 80°C for 90 sec.,2 cycles, using Fluoroscopic guidance (FG) .
TRF on DRG: Similar to the group of " PRF on DRG", but the types of the waves was different as previously described
|
Control Group
n=23 Participants
The control group had identical needle placement and preparation like the 2 previous groups without the RF lesion, but with the injection of particulate Betamethasone steroids and local anesthetic on DRG of the selected metastatic painful dorsal vertebrae, using Fluoroscopic guidance (FG).
Corticosteroid injection: Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.87 years
STANDARD_DEVIATION 10.55 • n=5 Participants
|
55.78 years
STANDARD_DEVIATION 7.34 • n=7 Participants
|
59.39 years
STANDARD_DEVIATION 13.72 • n=5 Participants
|
55.8 years
STANDARD_DEVIATION 10.94 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Region of Enrollment
Egypt
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
23 participants
n=5 Participants
|
69 participants
n=4 Participants
|
|
Interventional Level
Dorsal vertebrae 3
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Interventional Level
Dorsal vertebrae 4
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Interventional Level
Dorsal vertebrae 5
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
4 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Interventional Level
Dorsal vertebrae 6
|
5 participants
n=5 Participants
|
9 participants
n=7 Participants
|
3 participants
n=5 Participants
|
17 participants
n=4 Participants
|
|
Interventional Level
Dorsal vertebrae 7
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
3 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Interventional Level
Dorsal vertebrae 8
|
2 participants
n=5 Participants
|
8 participants
n=7 Participants
|
4 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Interventional Level
Dorsal vertebrae 9
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Interventional Level
Dorsal vertebrae 10
|
7 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Interventional Level
Dorsal vertebrae 11
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Interventional Level
Dorsal vertebrae 12
|
6 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Cancer Origin
Bladder
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Cancer Origin
Breast
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Cancer Origin
Chest Wall
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Cancer Origin
Colon
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Cancer Origin
Endometrial
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Cancer Origin
Liver
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Cancer Origin
Lung
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Cancer Origin
Lymphoma non-Hodgikin
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Cancer Origin
Lymphoma Hodgikin
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Cancer Origin
Multiple Myeloma
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Cancer Origin
Ovaries
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Cancer Origin
Prostate
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Cancer Origin
Stomach
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Cancer Origin
Unknown
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Body Mass Index
|
27.54 weight in kg divided by length in m2
STANDARD_DEVIATION 5.19 • n=5 Participants
|
29.55 weight in kg divided by length in m2
STANDARD_DEVIATION 6.08 • n=7 Participants
|
28.50 weight in kg divided by length in m2
STANDARD_DEVIATION 6.41 • n=5 Participants
|
28.829 weight in kg divided by length in m2
STANDARD_DEVIATION 5.78117 • n=4 Participants
|
PRIMARY outcome
Timeframe: Assessment done at 3 months after the procedure.Population: At 3 months post intervention, there are changes in all groups in the Global health of the QLQ-C30 questionnaire.
The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems e.g. a higher score in " Financial difficulties" represents a greater difficulty
Outcome measures
| Measure |
PRF on DRG
n=23 Participants
Patients will receive Pulsed Radiofrequency (PRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 42°C for 480 sec.,2 active cycles per second of 20 milliseconds each , with a voltage output 40 to 60-V range, impedance ranges between 150 and 400 Ohms at all levels using Fluroscopic guidance(FG).
PRF on DRG: RF will be performed with the patient in a prone position with mild flexion of the spine. Fluoroscopy beam positioned in an antero-posterior direction. A 10 cm RF needle 20 G with a 10 mm active tip.The needle is inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walking into the thoracic intervertebral foramen. So the location of the needle tip confirmed by sensory stimulation at 50 Hz. The point of maximum stimulation is at 0.5 V intensity and this is designated to be the location of the DRG. Slight redirection can be done to optimize the st
|
TRF on DRG
n=23 Participants
Patients will receive Thermal Radiofrequency (TRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 80°C for 90 sec.,2 cycles, using Fluoroscopic guidance (FG) .
TRF on DRG: Similar to the group of " PRF on DRG", but the types of the waves will be different as previously described
|
Control Group
n=23 Participants
The control group will have identical needle placement and preparation like the 2 previous groups without the RF lesion, but with the injection of particulate Betamethasone steroids and local anesthetic on DRG of the selected metastatic painful dorsal vertebrae, using Fluoroscopic guidance (FG).
Corticosteroid injection: Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described
|
|---|---|---|---|
|
The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30
Social functioning
|
65.67 score on a scale
Standard Deviation 22.47
|
62.05 score on a scale
Standard Deviation 24.60
|
67.85 score on a scale
Standard Deviation 25.28
|
|
The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30
Pain
|
57.25 score on a scale
Standard Deviation 18.01
|
45.64 score on a scale
Standard Deviation 17.58
|
62.32 score on a scale
Standard Deviation 14.40
|
|
The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30
Global health status/QoL
|
41.30 score on a scale
Standard Deviation 9.56
|
51.08 score on a scale
Standard Deviation 9.51
|
38.76 score on a scale
Standard Deviation 12.47
|
|
The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30
Physical functioning
|
42.48 score on a scale
Standard Deviation 20.77
|
46.53 score on a scale
Standard Deviation 19.10
|
54.96 score on a scale
Standard Deviation 15.92
|
|
The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30
Role functioning
|
59.16 score on a scale
Standard Deviation 25.99
|
62.06 score on a scale
Standard Deviation 21.89
|
65.67 score on a scale
Standard Deviation 23.57
|
|
The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30
Emotional functioning
|
33.42 score on a scale
Standard Deviation 24.53
|
29.43 score on a scale
Standard Deviation 22.83
|
50.09 score on a scale
Standard Deviation 22.93
|
|
The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30
Cognitive functioning
|
26.54 score on a scale
Standard Deviation 25.44
|
30.16 score on a scale
Standard Deviation 20.29
|
38.84 score on a scale
Standard Deviation 18.62
|
|
The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30
Fatigue
|
52.67 score on a scale
Standard Deviation 16.51
|
49.27 score on a scale
Standard Deviation 14.94
|
62.33 score on a scale
Standard Deviation 13.72
|
|
The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30
Nausea and vomiting
|
24.64 score on a scale
Standard Deviation 23.49
|
28.26 score on a scale
Standard Deviation 16.22
|
37.68 score on a scale
Standard Deviation 23.69
|
|
The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30
Dyspnea
|
31.87 score on a scale
Standard Deviation 23.53
|
28.97 score on a scale
Standard Deviation 23.15
|
43.47 score on a scale
Standard Deviation 23.45
|
|
The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30
Insomnia
|
52.17 score on a scale
Standard Deviation 19.69
|
49.28 score on a scale
Standard Deviation 24.37
|
55.07 score on a scale
Standard Deviation 23.82
|
|
The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30
Appetite loss
|
43.47 score on a scale
Standard Deviation 27.42
|
37.67 score on a scale
Standard Deviation 20.87
|
57.97 score on a scale
Standard Deviation 25.08
|
|
The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30
Constipation
|
30.43 score on a scale
Standard Deviation 31.65
|
23.17 score on a scale
Standard Deviation 21.16
|
34.77 score on a scale
Standard Deviation 30.95
|
|
The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30
Diarrhea
|
11.59 score on a scale
Standard Deviation 19.09
|
11.58 score on a scale
Standard Deviation 16.22
|
11.58 score on a scale
Standard Deviation 16.22
|
|
The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30
Financial difficulties
|
85.51 score on a scale
Standard Deviation 24.26
|
82.61 score on a scale
Standard Deviation 28.20
|
85.51 score on a scale
Standard Deviation 26.26
|
PRIMARY outcome
Timeframe: Assessment done at 3 months after the procedure.Population: The QLQ-BM22 at 3 months post intervention there were changes in terms of Painful sites and Pain characteristics.
The scoring procedure for the QLQ-BM22 module is identical in principle to that for the function and symptom scales/items of the QLQ-C30. Each sub scale is then linearly converted to a score from 0 to 100. For the QLQ-BM22, a higher score indicates worse symptom burden for painful sites and pain characteristics, and better functioning for functional interference and psychosocial aspects. With regards to the positive phrasing of questions 21 and 22, the scoring must be reversed prior to statistical analysis. The item range for each scale/item is 3.
Outcome measures
| Measure |
PRF on DRG
n=23 Participants
Patients will receive Pulsed Radiofrequency (PRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 42°C for 480 sec.,2 active cycles per second of 20 milliseconds each , with a voltage output 40 to 60-V range, impedance ranges between 150 and 400 Ohms at all levels using Fluroscopic guidance(FG).
PRF on DRG: RF will be performed with the patient in a prone position with mild flexion of the spine. Fluoroscopy beam positioned in an antero-posterior direction. A 10 cm RF needle 20 G with a 10 mm active tip.The needle is inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walking into the thoracic intervertebral foramen. So the location of the needle tip confirmed by sensory stimulation at 50 Hz. The point of maximum stimulation is at 0.5 V intensity and this is designated to be the location of the DRG. Slight redirection can be done to optimize the st
|
TRF on DRG
n=23 Participants
Patients will receive Thermal Radiofrequency (TRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 80°C for 90 sec.,2 cycles, using Fluoroscopic guidance (FG) .
TRF on DRG: Similar to the group of " PRF on DRG", but the types of the waves will be different as previously described
|
Control Group
n=23 Participants
The control group will have identical needle placement and preparation like the 2 previous groups without the RF lesion, but with the injection of particulate Betamethasone steroids and local anesthetic on DRG of the selected metastatic painful dorsal vertebrae, using Fluoroscopic guidance (FG).
Corticosteroid injection: Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described
|
|---|---|---|---|
|
EORTC QLQ-BM22
Painful Sites
|
50.43 score on a scale
Standard Deviation 16.80
|
35.07 score on a scale
Standard Deviation 12.10
|
44.36 score on a scale
Standard Deviation 16.65
|
|
EORTC QLQ-BM22
Pain Characteristics
|
41.54 score on a scale
Standard Deviation 15.09
|
30.41 score on a scale
Standard Deviation 13.90
|
34.75 score on a scale
Standard Deviation 10.75
|
|
EORTC QLQ-BM22
Functional Interference
|
54.43 score on a scale
Standard Deviation 22.62
|
52.08 score on a scale
Standard Deviation 16.33
|
59.88 score on a scale
Standard Deviation 14.64
|
|
EORTC QLQ-BM22
Psychosocial Aspects
|
51.90 score on a scale
Standard Deviation 26.31
|
56.49 score on a scale
Standard Deviation 20.42
|
51.41 score on a scale
Standard Deviation 24.03
|
PRIMARY outcome
Timeframe: Assessment of pain done at 3 months after the procedure.Population: Patients receiving PRF treatment changes in VAS% at 3 months.
The VAS is a horizontal line,from 0 to 100 mm in length, anchored by word descriptors at each end such as "no pain" on the left and "severe pain" on the right. The patient marks on the line three pain ratings, corresponding to current, best and worst intensity of pain experienced over the past 24 hours.High VAS means worsening of pain. The average of the 3 ratings will be used to represent the patient's level of pain over the previous 24 hours. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.The VAS has consistently demonstrated sensitivity to changes in cancer pain associated with treatment or time ) and usually shows strong associations with other pain intensity ratings, it appears adequately valid and reliable as measures of pain intensity among the many different samples of persons with cancer
Outcome measures
| Measure |
PRF on DRG
n=23 Participants
Patients will receive Pulsed Radiofrequency (PRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 42°C for 480 sec.,2 active cycles per second of 20 milliseconds each , with a voltage output 40 to 60-V range, impedance ranges between 150 and 400 Ohms at all levels using Fluroscopic guidance(FG).
PRF on DRG: RF will be performed with the patient in a prone position with mild flexion of the spine. Fluoroscopy beam positioned in an antero-posterior direction. A 10 cm RF needle 20 G with a 10 mm active tip.The needle is inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walking into the thoracic intervertebral foramen. So the location of the needle tip confirmed by sensory stimulation at 50 Hz. The point of maximum stimulation is at 0.5 V intensity and this is designated to be the location of the DRG. Slight redirection can be done to optimize the st
|
TRF on DRG
n=23 Participants
Patients will receive Thermal Radiofrequency (TRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 80°C for 90 sec.,2 cycles, using Fluoroscopic guidance (FG) .
TRF on DRG: Similar to the group of " PRF on DRG", but the types of the waves will be different as previously described
|
Control Group
n=23 Participants
The control group will have identical needle placement and preparation like the 2 previous groups without the RF lesion, but with the injection of particulate Betamethasone steroids and local anesthetic on DRG of the selected metastatic painful dorsal vertebrae, using Fluoroscopic guidance (FG).
Corticosteroid injection: Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described
|
|---|---|---|---|
|
Visual Analog Scale (VAS), to Evaluate Pain
|
68.57 units on a scale
Standard Deviation 9.06
|
48.78 units on a scale
Standard Deviation 9.55
|
66.17 units on a scale
Standard Deviation 6.67
|
PRIMARY outcome
Timeframe: Assessment of pain done at 3 months after the procedure.Population: TRF group showed changes in pain and ODI% at 3 months.
ODI is a self-administered questionnaire divided into ten sections, each with six items designed to assess limitations of various activities of daily living. Each section is scored on a 0 to 5 scale, with 5 representing the greatest disability.If a patient marked more than one statement for a question, the highest scoring statement is recorded as the true indication of disability. The scores are assessed from 0% to 20% to indicate minimal disability, 20% to 40%, to indicate moderate disability, 40% to 60% to indicate severe disability, 60% to 80% to indicate crippled, and 80% to 100% to indicate bed bound or exaggerating their symptoms
Outcome measures
| Measure |
PRF on DRG
n=23 Participants
Patients will receive Pulsed Radiofrequency (PRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 42°C for 480 sec.,2 active cycles per second of 20 milliseconds each , with a voltage output 40 to 60-V range, impedance ranges between 150 and 400 Ohms at all levels using Fluroscopic guidance(FG).
PRF on DRG: RF will be performed with the patient in a prone position with mild flexion of the spine. Fluoroscopy beam positioned in an antero-posterior direction. A 10 cm RF needle 20 G with a 10 mm active tip.The needle is inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walking into the thoracic intervertebral foramen. So the location of the needle tip confirmed by sensory stimulation at 50 Hz. The point of maximum stimulation is at 0.5 V intensity and this is designated to be the location of the DRG. Slight redirection can be done to optimize the st
|
TRF on DRG
n=23 Participants
Patients will receive Thermal Radiofrequency (TRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 80°C for 90 sec.,2 cycles, using Fluoroscopic guidance (FG) .
TRF on DRG: Similar to the group of " PRF on DRG", but the types of the waves will be different as previously described
|
Control Group
n=23 Participants
The control group will have identical needle placement and preparation like the 2 previous groups without the RF lesion, but with the injection of particulate Betamethasone steroids and local anesthetic on DRG of the selected metastatic painful dorsal vertebrae, using Fluoroscopic guidance (FG).
Corticosteroid injection: Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described
|
|---|---|---|---|
|
Oswestry Low Back Pain Disability Questionnaire (ODI),
|
62.52 score on a scale
Standard Deviation 12.89
|
52.87 score on a scale
Standard Deviation 11.86
|
61.61 score on a scale
Standard Deviation 8.45
|
SECONDARY outcome
Timeframe: Assessment done at 3 months after the procedurePopulation: In the TRF group there were some changes
from either the technique as pneumothorax, Neurological defects, Dysthesia and hypoesthesia, anesthesia dolorosa and burning pain or local anesthetic complications.
Outcome measures
| Measure |
PRF on DRG
n=23 Participants
Patients will receive Pulsed Radiofrequency (PRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 42°C for 480 sec.,2 active cycles per second of 20 milliseconds each , with a voltage output 40 to 60-V range, impedance ranges between 150 and 400 Ohms at all levels using Fluroscopic guidance(FG).
PRF on DRG: RF will be performed with the patient in a prone position with mild flexion of the spine. Fluoroscopy beam positioned in an antero-posterior direction. A 10 cm RF needle 20 G with a 10 mm active tip.The needle is inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walking into the thoracic intervertebral foramen. So the location of the needle tip confirmed by sensory stimulation at 50 Hz. The point of maximum stimulation is at 0.5 V intensity and this is designated to be the location of the DRG. Slight redirection can be done to optimize the st
|
TRF on DRG
n=23 Participants
Patients will receive Thermal Radiofrequency (TRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 80°C for 90 sec.,2 cycles, using Fluoroscopic guidance (FG) .
TRF on DRG: Similar to the group of " PRF on DRG", but the types of the waves will be different as previously described
|
Control Group
n=23 Participants
The control group will have identical needle placement and preparation like the 2 previous groups without the RF lesion, but with the injection of particulate Betamethasone steroids and local anesthetic on DRG of the selected metastatic painful dorsal vertebrae, using Fluoroscopic guidance (FG).
Corticosteroid injection: Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described
|
|---|---|---|---|
|
Number of Participants With Any Complications
|
0 participants
|
7 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Assessment was done before intervention and at at 3 months after the procedure.Population: Opioid consumption varied in the 3 groups
The change in the pre procedure use of different analgesics in comparison to 3 months later, using Analgesic Quantification Algorithm (AQA).0 No analgesic, 1 Non-opioid analgesics, 2 Weak opioids, 3 Strong opioids ≤75 mg OME per day, 4 Strong opioids \>75-150 mg OME per day, 5 Strong opioids \>150-300 mg OME per day, 6 Strong opioids \>300-600 mg OME per day, 7 Strong opioids \>600 mg OME per day.
Outcome measures
| Measure |
PRF on DRG
n=23 Participants
Patients will receive Pulsed Radiofrequency (PRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 42°C for 480 sec.,2 active cycles per second of 20 milliseconds each , with a voltage output 40 to 60-V range, impedance ranges between 150 and 400 Ohms at all levels using Fluroscopic guidance(FG).
PRF on DRG: RF will be performed with the patient in a prone position with mild flexion of the spine. Fluoroscopy beam positioned in an antero-posterior direction. A 10 cm RF needle 20 G with a 10 mm active tip.The needle is inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walking into the thoracic intervertebral foramen. So the location of the needle tip confirmed by sensory stimulation at 50 Hz. The point of maximum stimulation is at 0.5 V intensity and this is designated to be the location of the DRG. Slight redirection can be done to optimize the st
|
TRF on DRG
n=23 Participants
Patients will receive Thermal Radiofrequency (TRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 80°C for 90 sec.,2 cycles, using Fluoroscopic guidance (FG) .
TRF on DRG: Similar to the group of " PRF on DRG", but the types of the waves will be different as previously described
|
Control Group
n=23 Participants
The control group will have identical needle placement and preparation like the 2 previous groups without the RF lesion, but with the injection of particulate Betamethasone steroids and local anesthetic on DRG of the selected metastatic painful dorsal vertebrae, using Fluoroscopic guidance (FG).
Corticosteroid injection: Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described
|
|---|---|---|---|
|
To Measure Change in Analgesic Usage
Before intervention
|
4.30 score on a scale
Standard Deviation 1.11
|
4.57 score on a scale
Standard Deviation 1.12
|
3.87 score on a scale
Standard Deviation 0.87
|
|
To Measure Change in Analgesic Usage
After 3 months
|
3.43 score on a scale
Standard Deviation 1.12
|
2.70 score on a scale
Standard Deviation 1.26
|
3.52 score on a scale
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: a week after procedurePopulation: improvement at 5-level Likert Scale was measured in all groups.
Patients' satisfaction with analgesia through a phone call on 5-level likert scale, (not satisfied at all, only slightly satisfied, somewhat or partly satisfied, very satisfied, perfectly satisfied )
Outcome measures
| Measure |
PRF on DRG
n=23 Participants
Patients will receive Pulsed Radiofrequency (PRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 42°C for 480 sec.,2 active cycles per second of 20 milliseconds each , with a voltage output 40 to 60-V range, impedance ranges between 150 and 400 Ohms at all levels using Fluroscopic guidance(FG).
PRF on DRG: RF will be performed with the patient in a prone position with mild flexion of the spine. Fluoroscopy beam positioned in an antero-posterior direction. A 10 cm RF needle 20 G with a 10 mm active tip.The needle is inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walking into the thoracic intervertebral foramen. So the location of the needle tip confirmed by sensory stimulation at 50 Hz. The point of maximum stimulation is at 0.5 V intensity and this is designated to be the location of the DRG. Slight redirection can be done to optimize the st
|
TRF on DRG
n=23 Participants
Patients will receive Thermal Radiofrequency (TRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 80°C for 90 sec.,2 cycles, using Fluoroscopic guidance (FG) .
TRF on DRG: Similar to the group of " PRF on DRG", but the types of the waves will be different as previously described
|
Control Group
n=23 Participants
The control group will have identical needle placement and preparation like the 2 previous groups without the RF lesion, but with the injection of particulate Betamethasone steroids and local anesthetic on DRG of the selected metastatic painful dorsal vertebrae, using Fluoroscopic guidance (FG).
Corticosteroid injection: Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described
|
|---|---|---|---|
|
Patients' Satisfaction, Descriptive Scale
Neutral
|
9 Participants
|
4 Participants
|
4 Participants
|
|
Patients' Satisfaction, Descriptive Scale
Very satisfied, perfectly satisfied
|
1 Participants
|
16 Participants
|
0 Participants
|
|
Patients' Satisfaction, Descriptive Scale
Somewhat or partly satisfied
|
5 Participants
|
2 Participants
|
6 Participants
|
|
Patients' Satisfaction, Descriptive Scale
Only slightly satisfied
|
7 Participants
|
1 Participants
|
13 Participants
|
|
Patients' Satisfaction, Descriptive Scale
Not satisfied at all
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
PRF on DRG
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TRF on DRG
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PRF on DRG
n=23 participants at risk
Patients received Pulsed Radiofrequency (PRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 42°C for 480 sec.,2 active cycles per second of 20 milliseconds each , with a voltage output 40 to 60-V range, impedance ranges between 150 and 400 Ohms at all levels using Fluroscopic guidance (FG).
A 10 cm RF needle 20 G with a 10 mm active tip.The needle was inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walking into the thoracic intervertebral foramen. So the location of the needle tip confirmed by sensory stimulation at 50 Hz. The point of maximum stimulation was at 0.5 V intensity and this is designated to be the location of the DRG. After establishing the site for the RF, 1 ml 2% lidocaine was injected through the needle.
|
TRF on DRG
n=23 participants at risk
Patients received Thermal Radiofrequency (TRF) on Dorsal root ganglion(DRG) of the selected metastatic painful dorsal vertebrae, with temperature 80°C for 90 sec.,2 cycles, using Fluoroscopic guidance (FG) .
TRF on DRG: Similar to the group of " PRF on DRG", but the types of the waves was different as previously described
|
Control Group
n=23 participants at risk
The control group had identical needle placement and preparation like the 2 previous groups without the RF lesion, but with the injection of particulate Betamethasone steroids and local anesthetic on DRG of the selected metastatic painful dorsal vertebrae, using Fluoroscopic guidance (FG).
Corticosteroid injection: Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described
|
|---|---|---|---|
|
Nervous system disorders
Neuritis
|
0.00%
0/23 • Adverse event data were collected over the study course ( 3 months)
Adverse event were collected just post procedure by clinical examination then at 3 months post procedure.
|
17.4%
4/23 • Adverse event data were collected over the study course ( 3 months)
Adverse event were collected just post procedure by clinical examination then at 3 months post procedure.
|
0.00%
0/23 • Adverse event data were collected over the study course ( 3 months)
Adverse event were collected just post procedure by clinical examination then at 3 months post procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/23 • Adverse event data were collected over the study course ( 3 months)
Adverse event were collected just post procedure by clinical examination then at 3 months post procedure.
|
0.00%
0/23 • Adverse event data were collected over the study course ( 3 months)
Adverse event were collected just post procedure by clinical examination then at 3 months post procedure.
|
4.3%
1/23 • Adverse event data were collected over the study course ( 3 months)
Adverse event were collected just post procedure by clinical examination then at 3 months post procedure.
|
|
Nervous system disorders
Numbness
|
0.00%
0/23 • Adverse event data were collected over the study course ( 3 months)
Adverse event were collected just post procedure by clinical examination then at 3 months post procedure.
|
8.7%
2/23 • Adverse event data were collected over the study course ( 3 months)
Adverse event were collected just post procedure by clinical examination then at 3 months post procedure.
|
0.00%
0/23 • Adverse event data were collected over the study course ( 3 months)
Adverse event were collected just post procedure by clinical examination then at 3 months post procedure.
|
|
Nervous system disorders
Dysethsia
|
0.00%
0/23 • Adverse event data were collected over the study course ( 3 months)
Adverse event were collected just post procedure by clinical examination then at 3 months post procedure.
|
4.3%
1/23 • Adverse event data were collected over the study course ( 3 months)
Adverse event were collected just post procedure by clinical examination then at 3 months post procedure.
|
0.00%
0/23 • Adverse event data were collected over the study course ( 3 months)
Adverse event were collected just post procedure by clinical examination then at 3 months post procedure.
|
Additional Information
Director of Ethical Committee
National Cancer Institute
Phone: +201224276580
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place