Bone Neoplasm,Malignant Vertebral Column Thoracic Secondary
Conditions
Keywords
Bone metastasis,Thoracic secondary, Cancer Pain,
Brief summary
AIM OF THE WORK To evaluate the effectiveness and safety of Pulsed and Thermal Radiofrequency lesion of the dorsal root ganglion (RF-DRG) on a consecutive group of patients presenting with chronic thoracic pain due to vertebral bone metastasis.
Detailed description
STUDY DESIGN This is a Prospective Randomized Controlled trial that will be conducted at the National Cancer Institute. All patients who are eligible for the study will be included and randomized into 3 equal groups. PATIENTS AND METHODS After approval from the Ethics Committee at the National Cancer Institute, Cairo University, and obtaining written informed consent, eighty-one patients with thoracic segmental pain due to metastasis, unresponsive to conventional therapy and meeting the inclusion criteria will be randomly assigned to either one of the two types of treatment, PRF or TRF lesioning of the DRG or the control group. Patients will be carefully evaluated for neurologic deficits and side effects. Assessment of pain will be done at baseline then at 1, 3, 6 months after the procedure. Randomization will be done using randomized permuted block design. Randomization list will be generated through random.org online site. Patients will be randomly assigned and divided into 3 equal comparable groups. Before the procedure, laboratory investigations, Dorsal X-ray, CT and MRI will be done. All Patients will be interviewed and examined by physicians trained in interventional pain management. Patients will be carefully assessed on physical exam for sensory, motor, or reflex deficit and carefully documented. Patients will be informed about the technique of the blocks, and written informed consents will be obtained. The types of measures used to assess pain relief will include single rating scales; VAS, and multiple-dimension composite measures; Oswestry Low Back Pain Disability Questionnaire (ODI), The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-BM22.
Interventions
DEVICEPRF 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 stimulation; injection of contrast reveals epidural uptake. After establishing the site for the RF, 1 ml 2% lidocaine should be injected through the needle.
DEVICETRF on DRG
Similar to the group of PRF on DRG, but the types of the waves will be different as previously described
DRUGCorticosteroid injection
Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described
Sponsors
National Cancer Institute, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. A greater than 6-month history of segmental pain of thoracic vertebral body metastasis origin. 2. Unsatisfactory pain control with oral pharmacotherapy including strong opioid with VAS \>5 . 3. Absence of a chronic or progressive motor deficit. 4. Absence of significant sensory deficit. 5. No indication for percutaneous or open surgical intervention. 6. Magnetic resonance imaging and Computed Tomogrophy evidence of thoracic involvement. 7. ASA status of II to III . 8. Age \> 18 . 9. Body mass index (BMI) :less than forty and more than twenty . 10. Informed consent
Exclusion criteria
1. Known sensitivity or contraindication to injected materials: local anesthetics. 2. History of psychological disorders. 3. Evidence of significant neurological deficit. 4. Inability to lie prone. 5. Local contraindication to procedure e.g. local sepsis at the site of intervention, coagulopathy. 6. Patient refusal.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 | Assessment done at 3 months after the procedure. | 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 |
| EORTC QLQ-BM22 | Assessment done at 3 months after the procedure. | 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. |
| Visual Analog Scale (VAS), to Evaluate Pain | Assessment of pain done at 3 months after the procedure. | 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 |
| Oswestry Low Back Pain Disability Questionnaire (ODI), | Assessment of pain done at 3 months after the procedure. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Measure Change in Analgesic Usage | Assessment was done before intervention and at at 3 months after the procedure. | 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. |
| Patients' Satisfaction, Descriptive Scale | a week after procedure | 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 ) |
| Number of Participants With Any Complications | Assessment done at 3 months after the procedure | from either the technique as pneumothorax, Neurological defects, Dysthesia and hypoesthesia, anesthesia dolorosa and burning pain or local anesthetic complications. |
Countries
Egypt
Participant flow
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| PRF on DRG 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. | 23 |
| TRF on DRG 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 | 23 |
| Control Group 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 | 23 |
| Total | 69 |
Baseline characteristics
| Characteristic | Total | Control Group | TRF on DRG | PRF on DRG |
|---|---|---|---|---|
| Age, Continuous | 55.8 years STANDARD_DEVIATION 10.94 | 59.39 years STANDARD_DEVIATION 13.72 | 55.78 years STANDARD_DEVIATION 7.34 | 53.87 years STANDARD_DEVIATION 10.55 |
| Body Mass Index | 28.829 weight in kg divided by length in m2 STANDARD_DEVIATION 5.78117 | 28.50 weight in kg divided by length in m2 STANDARD_DEVIATION 6.41 | 29.55 weight in kg divided by length in m2 STANDARD_DEVIATION 6.08 | 27.54 weight in kg divided by length in m2 STANDARD_DEVIATION 5.19 |
| Cancer Origin Bladder | 2 Participants | 1 Participants | 0 Participants | 1 Participants |
| Cancer Origin Breast | 34 Participants | 12 Participants | 12 Participants | 10 Participants |
| Cancer Origin Chest Wall | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Cancer Origin Colon | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cancer Origin Endometrial | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cancer Origin Liver | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Cancer Origin Lung | 5 Participants | 1 Participants | 2 Participants | 2 Participants |
| Cancer Origin Lymphoma Hodgikin | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Cancer Origin Lymphoma non-Hodgikin | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Cancer Origin Multiple Myeloma | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Cancer Origin Ovaries | 4 Participants | 1 Participants | 1 Participants | 2 Participants |
| Cancer Origin Prostate | 10 Participants | 4 Participants | 3 Participants | 3 Participants |
| Cancer Origin Stomach | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Cancer Origin Unknown | 3 Participants | 2 Participants | 1 Participants | 0 Participants |
| Interventional Level Dorsal vertebrae 10 | 12 participants | 4 participants | 1 participants | 7 participants |
| Interventional Level Dorsal vertebrae 11 | 4 participants | 1 participants | 0 participants | 3 participants |
| Interventional Level Dorsal vertebrae 12 | 10 participants | 4 participants | 0 participants | 6 participants |
| Interventional Level Dorsal vertebrae 3 | 4 participants | 2 participants | 1 participants | 1 participants |
| Interventional Level Dorsal vertebrae 4 | 7 participants | 2 participants | 4 participants | 1 participants |
| Interventional Level Dorsal vertebrae 5 | 14 participants | 4 participants | 6 participants | 4 participants |
| Interventional Level Dorsal vertebrae 6 | 17 participants | 3 participants | 9 participants | 5 participants |
| Interventional Level Dorsal vertebrae 7 | 14 participants | 3 participants | 7 participants | 4 participants |
| Interventional Level Dorsal vertebrae 8 | 14 participants | 4 participants | 8 participants | 2 participants |
| Interventional Level Dorsal vertebrae 9 | 14 participants | 6 participants | 4 participants | 4 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 69 Participants | 23 Participants | 23 Participants | 23 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Egypt | 69 participants | 23 participants | 23 participants | 23 participants |
| Sex: Female, Male Female | 41 Participants | 13 Participants | 15 Participants | 13 Participants |
| Sex: Female, Male Male | 28 Participants | 10 Participants | 8 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 23 | 0 / 23 |
| other Total, other adverse events | 0 / 23 | 7 / 23 | 1 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 | 0 / 23 |
Outcome results
Primary
EORTC QLQ-BM22
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRF on DRG | EORTC QLQ-BM22 | Functional Interference | 54.43 score on a scale | Standard Deviation 22.62 |
| PRF on DRG | EORTC QLQ-BM22 | Psychosocial Aspects | 51.90 score on a scale | Standard Deviation 26.31 |
| PRF on DRG | EORTC QLQ-BM22 | Painful Sites | 50.43 score on a scale | Standard Deviation 16.8 |
| PRF on DRG | EORTC QLQ-BM22 | Pain Characteristics | 41.54 score on a scale | Standard Deviation 15.09 |
| TRF on DRG | EORTC QLQ-BM22 | Functional Interference | 52.08 score on a scale | Standard Deviation 16.33 |
| TRF on DRG | EORTC QLQ-BM22 | Pain Characteristics | 30.41 score on a scale | Standard Deviation 13.9 |
| TRF on DRG | EORTC QLQ-BM22 | Psychosocial Aspects | 56.49 score on a scale | Standard Deviation 20.42 |
| TRF on DRG | EORTC QLQ-BM22 | Painful Sites | 35.07 score on a scale | Standard Deviation 12.1 |
| Control Group | EORTC QLQ-BM22 | Psychosocial Aspects | 51.41 score on a scale | Standard Deviation 24.03 |
| Control Group | EORTC QLQ-BM22 | Painful Sites | 44.36 score on a scale | Standard Deviation 16.65 |
| Control Group | EORTC QLQ-BM22 | Pain Characteristics | 34.75 score on a scale | Standard Deviation 10.75 |
| Control Group | EORTC QLQ-BM22 | Functional Interference | 59.88 score on a scale | Standard Deviation 14.64 |
Primary
Oswestry Low Back Pain Disability Questionnaire (ODI),
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
Time frame: Assessment of pain done at 3 months after the procedure.
Population: TRF group showed changes in pain and ODI% at 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRF on DRG | Oswestry Low Back Pain Disability Questionnaire (ODI), | 62.52 score on a scale | Standard Deviation 12.89 |
| TRF on DRG | Oswestry Low Back Pain Disability Questionnaire (ODI), | 52.87 score on a scale | Standard Deviation 11.86 |
| Control Group | Oswestry Low Back Pain Disability Questionnaire (ODI), | 61.61 score on a scale | Standard Deviation 8.45 |
Primary
The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30
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
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRF on DRG | 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 |
| PRF on DRG | 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 |
| PRF on DRG | 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 |
| PRF on DRG | 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 |
| PRF on DRG | 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 |
| PRF on DRG | 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 |
| PRF on DRG | 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 |
| PRF on DRG | 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 |
| PRF on DRG | 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 |
| PRF on DRG | 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 |
| PRF on DRG | 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 |
| PRF on DRG | 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 |
| PRF on DRG | 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 |
| PRF on DRG | 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 |
| PRF on DRG | 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 |
| TRF on DRG | The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 | Appetite loss | 37.67 score on a scale | Standard Deviation 20.87 |
| TRF on DRG | 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 | 51.08 score on a scale | Standard Deviation 9.51 |
| TRF on DRG | The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 | Physical functioning | 46.53 score on a scale | Standard Deviation 19.1 |
| TRF on DRG | The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 | Role functioning | 62.06 score on a scale | Standard Deviation 21.89 |
| TRF on DRG | The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 | Emotional functioning | 29.43 score on a scale | Standard Deviation 22.83 |
| TRF on DRG | The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 | Cognitive functioning | 30.16 score on a scale | Standard Deviation 20.29 |
| TRF on DRG | The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 | Social functioning | 62.05 score on a scale | Standard Deviation 24.6 |
| TRF on DRG | The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 | Fatigue | 49.27 score on a scale | Standard Deviation 14.94 |
| TRF on DRG | The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 | Nausea and vomiting | 28.26 score on a scale | Standard Deviation 16.22 |
| TRF on DRG | The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 | Pain | 45.64 score on a scale | Standard Deviation 17.58 |
| TRF on DRG | The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 | Dyspnea | 28.97 score on a scale | Standard Deviation 23.15 |
| TRF on DRG | The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 | Insomnia | 49.28 score on a scale | Standard Deviation 24.37 |
| TRF on DRG | The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 | Constipation | 23.17 score on a scale | Standard Deviation 21.16 |
| TRF on DRG | The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 | Diarrhea | 11.58 score on a scale | Standard Deviation 16.22 |
| TRF on DRG | The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 | Financial difficulties | 82.61 score on a scale | Standard Deviation 28.2 |
| Control Group | The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 | Social functioning | 67.85 score on a scale | Standard Deviation 25.28 |
| Control Group | The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 | Diarrhea | 11.58 score on a scale | Standard Deviation 16.22 |
| Control Group | The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 | Insomnia | 55.07 score on a scale | Standard Deviation 23.82 |
| Control Group | The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 | Cognitive functioning | 38.84 score on a scale | Standard Deviation 18.62 |
| Control Group | The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 | Emotional functioning | 50.09 score on a scale | Standard Deviation 22.93 |
| Control Group | The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 | Appetite loss | 57.97 score on a scale | Standard Deviation 25.08 |
| Control Group | The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 | Role functioning | 65.67 score on a scale | Standard Deviation 23.57 |
| Control Group | 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 | 38.76 score on a scale | Standard Deviation 12.47 |
| Control Group | The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 | Constipation | 34.77 score on a scale | Standard Deviation 30.95 |
| Control Group | The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 | Nausea and vomiting | 37.68 score on a scale | Standard Deviation 23.69 |
| Control Group | The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 | Physical functioning | 54.96 score on a scale | Standard Deviation 15.92 |
| Control Group | The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 | Pain | 62.32 score on a scale | Standard Deviation 14.4 |
| Control Group | The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 | Fatigue | 62.33 score on a scale | Standard Deviation 13.72 |
| Control Group | 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 26.26 |
| Control Group | The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 | Dyspnea | 43.47 score on a scale | Standard Deviation 23.45 |
Primary
Visual Analog Scale (VAS), to Evaluate Pain
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
Time frame: Assessment of pain done at 3 months after the procedure.
Population: Patients receiving PRF treatment changes in VAS% at 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRF on DRG | Visual Analog Scale (VAS), to Evaluate Pain | 68.57 units on a scale | Standard Deviation 9.06 |
| TRF on DRG | Visual Analog Scale (VAS), to Evaluate Pain | 48.78 units on a scale | Standard Deviation 9.55 |
| Control Group | Visual Analog Scale (VAS), to Evaluate Pain | 66.17 units on a scale | Standard Deviation 6.67 |
Secondary
Number of Participants With Any Complications
from either the technique as pneumothorax, Neurological defects, Dysthesia and hypoesthesia, anesthesia dolorosa and burning pain or local anesthetic complications.
Time frame: Assessment done at 3 months after the procedure
Population: In the TRF group there were some changes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PRF on DRG | Number of Participants With Any Complications | 0 participants |
| TRF on DRG | Number of Participants With Any Complications | 7 participants |
| Control Group | Number of Participants With Any Complications | 1 participants |
Secondary
Patients' Satisfaction, Descriptive Scale
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 )
Time frame: a week after procedure
Population: improvement at 5-level Likert Scale was measured in all groups.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PRF on DRG | Patients' Satisfaction, Descriptive Scale | Only slightly satisfied | 7 Participants |
| PRF on DRG | Patients' Satisfaction, Descriptive Scale | Neutral | 9 Participants |
| PRF on DRG | Patients' Satisfaction, Descriptive Scale | Very satisfied, perfectly satisfied | 1 Participants |
| PRF on DRG | Patients' Satisfaction, Descriptive Scale | Somewhat or partly satisfied | 5 Participants |
| PRF on DRG | Patients' Satisfaction, Descriptive Scale | Not satisfied at all | 1 Participants |
| TRF on DRG | Patients' Satisfaction, Descriptive Scale | Very satisfied, perfectly satisfied | 16 Participants |
| TRF on DRG | Patients' Satisfaction, Descriptive Scale | Somewhat or partly satisfied | 2 Participants |
| TRF on DRG | Patients' Satisfaction, Descriptive Scale | Neutral | 4 Participants |
| TRF on DRG | Patients' Satisfaction, Descriptive Scale | Only slightly satisfied | 1 Participants |
| TRF on DRG | Patients' Satisfaction, Descriptive Scale | Not satisfied at all | 0 Participants |
| Control Group | Patients' Satisfaction, Descriptive Scale | Not satisfied at all | 0 Participants |
| Control Group | Patients' Satisfaction, Descriptive Scale | Only slightly satisfied | 13 Participants |
| Control Group | Patients' Satisfaction, Descriptive Scale | Very satisfied, perfectly satisfied | 0 Participants |
| Control Group | Patients' Satisfaction, Descriptive Scale | Neutral | 4 Participants |
| Control Group | Patients' Satisfaction, Descriptive Scale | Somewhat or partly satisfied | 6 Participants |
Secondary
To Measure Change in Analgesic Usage
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.
Time frame: Assessment was done before intervention and at at 3 months after the procedure.
Population: Opioid consumption varied in the 3 groups
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRF on DRG | To Measure Change in Analgesic Usage | Before intervention | 4.30 score on a scale | Standard Deviation 1.11 |
| PRF on DRG | To Measure Change in Analgesic Usage | After 3 months | 3.43 score on a scale | Standard Deviation 1.12 |
| TRF on DRG | To Measure Change in Analgesic Usage | Before intervention | 4.57 score on a scale | Standard Deviation 1.12 |
| TRF on DRG | To Measure Change in Analgesic Usage | After 3 months | 2.70 score on a scale | Standard Deviation 1.26 |
| Control Group | To Measure Change in Analgesic Usage | Before intervention | 3.87 score on a scale | Standard Deviation 0.87 |
| Control Group | To Measure Change in Analgesic Usage | After 3 months | 3.52 score on a scale | Standard Deviation 0.95 |