Bone Neoplasm,Malignant Vertebral Column Thoracic SecondaryNCT03204942

Dorsal Root Ganglion Thermal Radiofrequency Versus Pulsed Radiofrequency for Metastatic Pain in Thoracic Vertebral Body

A study testing PRF on DRG, TRF on DRG and Corticosteroid injection in people with Bone Neoplasm,Malignant Vertebral Column Thoracic Secondary, run by National Cancer Institute, Egypt at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bone Neoplasm,Malignant Vertebral Column Thoracic Secondary
What is being tested?: PRF on DRG, TRF on DRG and Corticosteroid injection
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 69 participants
Where: 1 siteEgypt
Study dates: 14 Feb 2017to 30 Jul 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

A greater than 6-month history of segmental pain of thoracic vertebral body metastasis origin.
Unsatisfactory pain control with oral pharmacotherapy including strong opioid with VAS >5 .
Absence of a chronic or progressive motor deficit.
Absence of significant sensory deficit.
No indication for percutaneous or open surgical intervention.
Magnetic resonance imaging and Computed Tomogrophy evidence of thoracic involvement.

Show all 10Show fewer

ASA status of II to III .
Age > 18 .
Body mass index (BMI) :less than forty and more than twenty .
Informed consent

Who cannot join

Known sensitivity or contraindication to injected materials: local anesthetics.
History of psychological disorders.
Evidence of significant neurological deficit.
Inability to lie prone.
Local contraindication to procedure e.g. local sepsis at the site of intervention, coagulopathy.
Patient refusal.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Sherry Nabil Elia Fanous
Cairo, 11627

Other trials in Egypt

About this study

Official title: Comparison Between Dorsal Root Ganglion Thermal Radiofrequency Versus Pulsed Radiofrequency for the Management of Intractable Metastatic Pain in Thoracic Vertebral Body

Read the 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.

Conditions: Bone Neoplasm,Malignant Vertebral Column Thoracic Secondary
Being tested: PRF on DRG, TRF on DRG, Corticosteroid injection
Keywords: Bone metastasis,Thoracic secondary, Cancer Pain,
Medical subject headings: Bone Neoplasms, Cancer Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PRF on DRGDevice
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.
TRF on DRGDevice
Similar to the group of " PRF on DRG", but the types of the waves will be different as previously described
Corticosteroid injectionDrug
Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described

Study groups in NCT03204942
Study group	Role	What they receive
PRF on DRG	Active comparator	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). Receives: Device: PRF on DRG
TRF on DRG	Active comparator	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) . Receives: Device: TRF on DRG
Control group	Active comparator	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). Receives: Drug: Corticosteroid injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Assessment done at 3 months after the procedure.
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.
Measured: Assessment done at 3 months after the procedure.
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
Measured: Assessment of pain done at 3 months after the procedure.
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
Measured: Assessment of pain done at 3 months after the procedure.

Secondary outcomes (3)

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.
Measured: Assessment done at 3 months after the procedure
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.
Measured: Assessment was done before intervention and at at 3 months after the procedure.
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 )
Measured: a week after procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Feb 201730 Jul 2018

First posted2 Jul 2017
Study start14 Feb 2017
Primary completion30 Jul 2018
Study completion30 Jul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Bone Neoplasm,Malignant Vertebral Column Thoracic SecondaryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03204942
Sponsor's protocol ID: CdGrPfMiPnB
Status last verified: Jun 2020
First submitted: 11 Jun 2017
Last updated: 7 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided: All the data that will be found relevant to the primary and secondary outcome

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison Between Dorsal Root Ganglion Thermal Radiofrequency Versus Pulsed Radiofrequency for the Management of Intractable Metastatic Pain in Thoracic Vertebral Body
ClinicalTrials.gov ID: NCT03204942
Acronym / sponsor ID: CdGrPfMiPnB
Conditions: Bone Neoplasm,Malignant Vertebral Column Thoracic Secondary
Keywords: Bone metastasis,Thoracic secondary, Cancer Pain,
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: National Cancer Institute, EgyptUniversity, hospital or other
Study start: 14 Feb 2017 (actual)
Primary completion: 30 Jul 2018 (actual)
Study completion: 30 Jul 2018 (actual)
First posted: 2 Jul 2017 (actual)
Results: Posted 7 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
PRF on DRG	Active comparator	Device: PRF on DRGPatients 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).
TRF on DRG	Active comparator	Device: TRF on DRGPatients 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) .
Control group	Active comparator	Drug: Corticosteroid injectionThe 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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

A greater than 6-month history of segmental pain of thoracic vertebral body metastasis origin.
Unsatisfactory pain control with oral pharmacotherapy including strong opioid with VAS >5 .
Absence of a chronic or progressive motor deficit.
Absence of significant sensory deficit.
No indication for percutaneous or open surgical intervention.

Key exclusion criteria (6 listed)

Known sensitivity or contraindication to injected materials: local anesthetics.
History of psychological disorders.
Evidence of significant neurological deficit.
Inability to lie prone.
Local contraindication to procedure e.g. local sepsis at the site of intervention, coagulopathy.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PRF on DRGRF 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.	Device	PRF on DRG
TRF on DRGSimilar to the group of " PRF on DRG", but the types of the waves will be different as previously described	Device	TRF on DRG
Corticosteroid injectionSimilar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described	Drug	Control group

Primary outcome

The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30
Time frame: 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
Time frame: 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
Time frame: 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),
Time frame: 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

3 secondary outcomes

Number of Participants With Any Complications
Time frame: Assessment done at 3 months after the procedure
To Measure Change in Analgesic Usage
Time frame: Assessment was done before intervention and at at 3 months after the procedure.
Patients' Satisfaction, Descriptive Scale
Time frame: a week after procedure

Results and safety

Results posted to the registry on 7 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PRF on DRG	23	23
TRF on DRG	23	23
Control Group	23	23

Primary outcome: The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30

Time frame: Assessment done at 3 months after the procedure.. Mean (Standard Deviation). Unit: score on a scale

Measure	PRF on DRG n = 23	TRF on DRG n = 23	Control Group n = 23
Global health status/QoL	41.30 (9.56)	51.08 (9.51)	38.76 (12.47)
Physical functioning	42.48 (20.77)	46.53 (19.10)	54.96 (15.92)
Role functioning	59.16 (25.99)	62.06 (21.89)	65.67 (23.57)
Emotional functioning	33.42 (24.53)	29.43 (22.83)	50.09 (22.93)
Cognitive functioning	26.54 (25.44)	30.16 (20.29)	38.84 (18.62)
Social functioning	65.67 (22.47)	62.05 (24.60)	67.85 (25.28)
Fatigue	52.67 (16.51)	49.27 (14.94)	62.33 (13.72)
Nausea and vomiting	24.64 (23.49)	28.26 (16.22)	37.68 (23.69)

Population analysed: At 3 months post intervention, there are changes in all groups in the Global health of the QLQ-C30 questionnaire.

Primary outcome: EORTC QLQ-BM22

Time frame: Assessment done at 3 months after the procedure.. Mean (Standard Deviation). Unit: score on a scale

Measure	PRF on DRG n = 23	TRF on DRG n = 23	Control Group n = 23
Painful Sites	50.43 (16.80)	35.07 (12.10)	44.36 (16.65)
Pain Characteristics	41.54 (15.09)	30.41 (13.90)	34.75 (10.75)
Functional Interference	54.43 (22.62)	52.08 (16.33)	59.88 (14.64)
Psychosocial Aspects	51.90 (26.31)	56.49 (20.42)	51.41 (24.03)

Population analysed: The QLQ-BM22 at 3 months post intervention there were changes in terms of Painful sites and Pain characteristics.

Primary outcome: Visual Analog Scale (VAS), to Evaluate Pain

Time frame: Assessment of pain done at 3 months after the procedure.. Mean (Standard Deviation). Unit: units on a scale

Measure	PRF on DRG n = 23	TRF on DRG n = 23	Control Group n = 23
Value	68.57 (9.06)	48.78 (9.55)	66.17 (6.67)

Population analysed: Patients receiving PRF treatment changes in VAS% at 3 months.

Primary outcome: Oswestry Low Back Pain Disability Questionnaire (ODI),

Time frame: Assessment of pain done at 3 months after the procedure.. Mean (Standard Deviation). Unit: score on a scale

Measure	PRF on DRG n = 23	TRF on DRG n = 23	Control Group n = 23
Value	62.52 (12.89)	52.87 (11.86)	61.61 (8.45)

Population analysed: TRF group showed changes in pain and ODI% at 3 months.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected over the study course ( 3 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PRF on DRG	0 of 23 (0%)	0 of 23 (0%)	0 of 23
TRF on DRG	0 of 23 (0%)	7 of 23 (30.4%)	0 of 23
Control Group	0 of 23 (0%)	1 of 23 (4.3%)	0 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided. All the data that will be found relevant to the primary and secondary outcome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sherry Na Fanous, M.Sc. principal investigator

National Cancer Institute, Egypt

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The European Organisation for Research and Treatment of Cancer (EORTC) Questionnaire to Measure Change in the Intensity of Pain QLQ-C30 (time frame: Assessment done at 3 months after the procedure.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03204942.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.