Interactable Malignant Perineal PainPhase 2NCT03084575
Thermal Radiofrequency Versus Neurolytic Saddle Rhizotomyfor Severe Pereneal Cancer Pain
A Phase 2 study testing Thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy, hyperbaric chemical saddle Rhizotomy (6 % pherol in glycerin) and Thermal RF lesioning is done using Bailys RF generator in people with Interactable Malignant Perineal Pain, run by Cairo University.
Trial summary
The control of perineal malignant pain is difficult and challenging for pain physicians. Different modalities have been tried to treat this complex pain syndrome including pharmacotherapy and interventional therapy. Neuroaxial phenol rhizolysis is simple and cheap option. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interactable Malignant Perineal Pain
- What is being tested?
- Thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy, hyperbaric chemical saddle Rhizotomy (6 % pherol in glycerin) and Thermal RF lesioning is done using Bailys RF generator
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Jun 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Cancer patients with moderate to severe perineal pain (VAS > 40mm over 100 mm scale).
- Intractable pain not responding to adequate tolerated opioid therapy + adjuvant therapy after reasonable period of time for at least 4 weeks (Rad and Kallmes, 2011).
- Limited life expectancy < 12 months (Slatakin etal 2003).
- Patients are continent to urine and stool (no stomas).
Who cannot join
- Uncorrected coagulopathy.
- Local or systemic sepsis.
- Known allergy to the used medications.
- Distorted local anatomy e.g. by advanced local neoplastic growth rendering the procedure technically difficult or hazardous.
- Sign of increased intracranial tension (Mintzer and Devarajan, 2012).
About this study
Official title: The Role of Selective Thermal Radiofrequency Saddle Rhizotomy In Managing Interactable Malignant Perineal Pain: A Comparative Study
The control of perineal malignant pain is difficult and challenging for pain physicians. Different modalities have been tried to treat this complex pain syndrome including pharmacotherapy and interventional therapy.
Neuroaxial phenol rhizolysis is simple and cheap option. However; for patients with pelvic or rectal neoplasms and intact bowel and bladder sphincteric functions, there are neurosurgical recomendations of selective sacral nerve roots rhizotomy blockade "as an alternative to chemical saddle rhizotomy".
Read the detailed description
40 selected patients were randomly allocated into 2 groups "20 patients each"
Group 1 "RF group": in which patients underwent thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy.
Group 2 "phenol group": in which patients underwent hyperbaric chemical saddle rhizotomy using 6% phenol in glycerin.
- Conditions
- Interactable Malignant Perineal Pain
- Being tested
- Thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy, hyperbaric chemical saddle Rhizotomy (6 % pherol in glycerin), Thermal RF lesioning is done using Bailys RF generator
- Keywords
- neuroaxial rhizolysis -selective rhizolysis-thermal radiofrequency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomyProcedure or surgery
Thermal RF lesioning is done using Bailys RF generator. TRF parameters are 80 C, 120 seconds the TRF lesion is repeated after 180 rotation of the needle tip again after sensory and motor pre-stimulation.
hyperbaric chemical saddle Rhizotomy (6 % pherol in glycerin)Drug
Also called 6 % pherol in glycerin
L5-S1 intrathecal injection of 0.5-1 ml of 6 % pherol in glycerin. The patient is seated in the sitting position with 30-45o leaning backwards to make the posterior sensory roots lowermost.
Thermal RF lesioning is done using Bailys RF generatorDevice
| Study group | Role | What they receive |
|---|---|---|
| Thermal Radiofrequency group | Active comparator | Group 1 "RF group": in which patients will receive thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy. Receives: Procedure: Thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy; Device: Thermal RF lesioning is done using Bailys RF generator |
| phenol group | Active comparator | Group 2 "phenol group": in which patients will recieve hyperbaric chemical saddle rhizotomy using 6% phenol in glycerin. Receives: Drug: hyperbaric chemical saddle Rhizotomy (6 % pherol in glycerin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VAS
VAS: A 100mm scale, horizontal line with 2 stop ends; the left end means no pain \& the right end means the worst impaginable pain. It is a valid and practical scale for assessing chronic pain and for pain researches.
Measured: baseline, one month, 3months
Functional improvement
Functional improvement. It is a self-reported analysis for the primary outcome after performing pain interventions. It is divided into four categorie (0-25%) ≈ no or minimal functional improvement, (> 25% to 50%) ≈ mild improvement, (>50% to 75%) ≈ moderate improvement, and (>75% to 100%) ≈ marked improvement
Measured: baseline, one month, 3 months
Change in dose of daily drug consuption
drug (opioid, pregabalin \& amitryptiline) consumption (mg/day) .
Measured: base line, one month, 3 months
Secondary outcomes (2)
ODI
(Oswestry Disability Index): Self-reported questionnaire with 10 sections each with five items designed to assess limitations of various asctivities of daily living.
Measured: baseline, one month, 3 months
PGIC
Patient satisfaction (PGIC): Patient Global Impression of Changes
Measured: baseline, one month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study startFeb 2016
- Primary completionMay 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interactable Malignant Perineal PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomization was done using a computer-generated random numbers with proper concealment in opaque sealed envelopes .
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Dina Nabil Abbas, Cairo University
- Investigators
- Dina N Abbas, MD, Principal investigator, National Cancer Institute,Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084575
- Sponsor's protocol ID
- IRB No.201516026.2
- Status last verified
- Mar 2017
- First submitted
- 9 Mar 2017
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Selective Thermal Radiofrequency Saddle Rhizotomy In Managing Interactable Malignant Perineal Pain: A Comparative Study
- ClinicalTrials.gov ID
- NCT03084575
- Acronym / sponsor ID
- IRB No.201516026.2
- Conditions
- Interactable Malignant Perineal Pain
- Keywords
- neuroaxial rhizolysis -selective rhizolysis-thermal radiofrequency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2016 (actual)
- Primary completion
- May 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 21 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The control of perineal malignant pain is difficult and challenging for pain physicians. Different modalities have been tried to treat this complex pain syndrome including pharmacotherapy and interventional therapy.
Neuroaxial phenol rhizolysis is simple and cheap option. However; for patients with pelvic or rectal neoplasms and intact bowel and bladder sphincteric functions, there are neurosurgical recomendations of selective sacral nerve roots rhizotomy blockade "as an alternative to chemical saddle rhizotomy".
Detailed description
40 selected patients were randomly allocated into 2 groups "20 patients each"
Group 1 "RF group": in which patients underwent thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy.
Group 2 "phenol group": in which patients underwent hyperbaric chemical saddle rhizotomy using 6% phenol in glycerin.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomization was done using a computer-generated random numbers with proper concealment in opaque sealed envelopes .
| Arm | Type | Receives |
|---|---|---|
| Thermal Radiofrequency group | Active comparator | Procedure: Thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy, Device: Thermal RF lesioning is done using Bailys RF generatorGroup 1 "RF group": in which patients will receive thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy. |
| phenol group | Active comparator | Drug: hyperbaric chemical saddle Rhizotomy (6 % pherol in glycerin)Group 2 "phenol group": in which patients will recieve hyperbaric chemical saddle rhizotomy using 6% phenol in glycerin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cancer patients with moderate to severe perineal pain (VAS > 40mm over 100 mm scale).
- Intractable pain not responding to adequate tolerated opioid therapy + adjuvant therapy after reasonable period of time for at least 4 weeks (Rad and Kallmes, 2011).
- Limited life expectancy < 12 months (Slatakin etal 2003).
- Patients are continent to urine and stool (no stomas).
Key exclusion criteria (5 listed)
- Uncorrected coagulopathy.
- Local or systemic sepsis.
- Known allergy to the used medications.
- Distorted local anatomy e.g. by advanced local neoplastic growth rendering the procedure technically difficult or hazardous.
- Sign of increased intracranial tension (Mintzer and Devarajan, 2012).
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 |
|---|---|---|
| Thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomyThermal RF lesioning is done using Bailys RF generator. TRF parameters are 80 C, 120 seconds the TRF lesion is repeated after 180 rotation of the needle tip again after sensory and motor pre-stimulation. | Procedure or surgery | Thermal Radiofrequency group |
| hyperbaric chemical saddle Rhizotomy (6 % pherol in glycerin)Also: 6 % pherol in glycerinL5-S1 intrathecal injection of 0.5-1 ml of 6 % pherol in glycerin. The patient is seated in the sitting position with 30-45o leaning backwards to make the posterior sensory roots lowermost. | Drug | phenol group |
| Thermal RF lesioning is done using Bailys RF generator | Device | Thermal Radiofrequency group |
Primary outcome
Change in VAS
Time frame: baseline, one month, 3months
VAS: A 100mm scale, horizontal line with 2 stop ends; the left end means no pain \& the right end means the worst impaginable pain. It is a valid and practical scale for assessing chronic pain and for pain researches.
Functional improvement
Time frame: baseline, one month, 3 months
Functional improvement. It is a self-reported analysis for the primary outcome after performing pain interventions. It is divided into four categorie (0-25%) ≈ no or minimal functional improvement, (> 25% to 50%) ≈ mild improvement, (>50% to 75%) ≈ moderate improvement, and (>75% to 100%) ≈ marked improvement
Change in dose of daily drug consuption
Time frame: base line, one month, 3 months
drug (opioid, pregabalin \& amitryptiline) consumption (mg/day) .
2 secondary outcomes
ODI
Time frame: baseline, one month, 3 months
PGIC
Time frame: baseline, one month and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- Individual participant dataSharing planned: Undecided
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.
Dina N Abbas, MD principal investigator
National Cancer Institute,Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy, hyperbaric chemical saddle Rhizotomy (6 % pherol in glycerin) and Thermal RF lesioning is done using Bailys RF generator in people with Interactable Malignant Perineal Pain, run by Cairo University.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Change in VAS (time frame: baseline, one month, 3months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2017.