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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 31, 2020
    Last Updated
    September 12, 2020
    Sponsor
    Assiut University
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    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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