Analgesic Efficacy of Sacral Neuromodulation for Pelvic Cancer Pain: A Preliminary Report
Primary Purpose
Chronic Pain
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
sacral neuromodulation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- Age, 18-70
- Pain localized to the pelvic and perineal region
- The pain is due to pelvic cancer or chronic pelvic pain after pelvic surgery for cancer
- The intensity of pain assessed by VAS (visual analogue pain scale) > 7
- Importantly, the included participants should gain > 50% reduction of their pain in response to sacral roots block, S2,3 and 4 with bupivacaine 0.5%, 2 ml for each root
Exclusion Criteria:
- Coagulopathy
- Infection at site of maneuver
- Abnormal Psychological behavior that interfere with integrity of obtained data
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
sacral neuromodulation
medical therapy
Arm Description
Sacral neuromodulation group, will be treated with Stimulation of the sacral nerve roots by placement of a lead and generator, typically using an implanted InterStim® device that provides constant electrical stimulation to the S 2, 3 and 4 nerve roots, for 2-week trial stimulation
this group will be treated with sustained release morphine tablets for pain control
Outcomes
Primary Outcome Measures
The change of intensity of pain
The intensity of pain measured by VAS pain score (visual analogue pain scale) where 0= no pain and 10=the maximum tolerated pain
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04549818
Brief Title
Analgesic Efficacy of Sacral Neuromodulation for Pelvic Cancer Pain: A Preliminary Report
Official Title
Does Sacral Neuromodulation Relieve Chronic Pelvic Cancer Pain, Compared With Medical Treatment?
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 10, 2020 (Anticipated)
Primary Completion Date
September 10, 2021 (Anticipated)
Study Completion Date
December 10, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
in this trial, we will test the analgesic efficacy of sacral neuromodulation for patients with pelvic cancer, complaining of chronic pelvic pain in comparison to medical treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
sacral neuromodulation
Arm Type
Experimental
Arm Description
Sacral neuromodulation group, will be treated with Stimulation of the sacral nerve roots by placement of a lead and generator, typically using an implanted InterStim® device that provides constant electrical stimulation to the S 2, 3 and 4 nerve roots, for 2-week trial stimulation
Arm Title
medical therapy
Arm Type
No Intervention
Arm Description
this group will be treated with sustained release morphine tablets for pain control
Intervention Type
Device
Intervention Name(s)
sacral neuromodulation
Intervention Description
Sacral neuromodulation group, N=22 will be treated with Stimulation of the sacral nerve roots by placement of a lead and generator, typically using an implanted InterStim® device that provides constant electrical stimulation to the S 2, 3 and 4 nerve roots, for 2-week trial stimulation
Primary Outcome Measure Information:
Title
The change of intensity of pain
Description
The intensity of pain measured by VAS pain score (visual analogue pain scale) where 0= no pain and 10=the maximum tolerated pain
Time Frame
The outcome will be measured at day 15 postoperatively.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age, 18-70
Pain localized to the pelvic and perineal region
The pain is due to pelvic cancer or chronic pelvic pain after pelvic surgery for cancer
The intensity of pain assessed by VAS (visual analogue pain scale) > 7
Importantly, the included participants should gain > 50% reduction of their pain in response to sacral roots block, S2,3 and 4 with bupivacaine 0.5%, 2 ml for each root
Exclusion Criteria:
Coagulopathy
Infection at site of maneuver
Abnormal Psychological behavior that interfere with integrity of obtained data
12. IPD Sharing Statement
Learn more about this trial
Analgesic Efficacy of Sacral Neuromodulation for Pelvic Cancer Pain: A Preliminary Report
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