Back to resultsrTMS as a Treatment of Visceral Pain Secondary to Malignancy
Primary Purpose
Malignancy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Real rTMS(20 Hz, 10 trains, inter train interval 30 sc with total pulses 2000, intensity 80% of motor threshold) daily for 10 consecutive days (5 days/week)
Sham rTMS (same parameters but with coil elevated and angled away from the head) every day for 10 consecutive days (5 days/week).
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About this trial
This is an interventional treatment trial for Malignancy focused on measuring VAS, VDS, HAM-D, Visceral pain, Malignancy, rTMS, Motor cortex, Analgesia, Dynorphin
Eligibility Criteria
Inclusion Criteria:
- All patients within age group 18-65 years with malignant visceral pain resistant to medical treatment for at least 2 months or associated with significant adverse effect from medication was involved in this study.
Exclusion Criteria:
- We excluded patients with intracranial metallic devices or with pacemakers or any other device. We also excluded those with extensive myocardial ischemia, unstable angina and those known to have epilepsy.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Sham rTMS
Real rTMS
Arm Description
Sham-rTMS was applied using the same parameters but with the coil elevated and angled away from the head to reproduce some of subjective sensation of rTMS.
The active group recieved real-rTMS over the motor cortical area corresponding to the hand of painful side. Each train consist of 2000 pulses at 20 Hz and 80% RMT (total duration 10s). The treatment was repeated every day for 5 consecutive days in week for two weeks (the total number of sessions had be given was 10 sessions).
Outcomes
Primary Outcome Measures
Visceral pain improvement
Reduction of visceral pain in patients with malignancy measured by VAS, VDS.
Secondary Outcome Measures
Reduction of depression manifestation
Measurement of depression by using (HAM-D) scale.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02092805
Brief Title
rTMS as a Treatment of Visceral Pain Secondary to Malignancy
Official Title
Repetitive Transcranial Magnetic Stimulation in Visceral Pain Secondary to Malignancy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the efficacy of rTMS over primary motor cortex in patients suffering from malignant visceral pain. Thirty four patients were included in the study. They are divided randomly into 2 groups using closed envelop as real rTMS group and sham group. Real rTMS over the hand area of motor cortex (20 Hz, 10 trains with inter train interval 30 second with total pulses 2000, intensity 80% of motor threshold) every day for ten consecutive days (5 days/week) and the coil elevated and angled away from the head as sham stimulation. Patients were evaluated by verbal descriptor scale (VDS), visual analog scale (VAS), and Hamilton rating scale for depression (HAM-D) at the baseline, after 1st, 5th, 10th session, 15 day and 1 month after end of sessions. Serum human dynorphin (Dyn) level was measured at baseline, 5th and 10th session.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignancy
Keywords
VAS, VDS, HAM-D, Visceral pain, Malignancy, rTMS, Motor cortex, Analgesia, Dynorphin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sham rTMS
Arm Type
Sham Comparator
Arm Description
Sham-rTMS was applied using the same parameters but with the coil elevated and angled away from the head to reproduce some of subjective sensation of rTMS.
Arm Title
Real rTMS
Arm Type
Active Comparator
Arm Description
The active group recieved real-rTMS over the motor cortical area corresponding to the hand of painful side. Each train consist of 2000 pulses at 20 Hz and 80% RMT (total duration 10s). The treatment was repeated every day for 5 consecutive days in week for two weeks (the total number of sessions had be given was 10 sessions).
Intervention Type
Procedure
Intervention Name(s)
Real rTMS(20 Hz, 10 trains, inter train interval 30 sc with total pulses 2000, intensity 80% of motor threshold) daily for 10 consecutive days (5 days/week)
Intervention Type
Procedure
Intervention Name(s)
Sham rTMS (same parameters but with coil elevated and angled away from the head) every day for 10 consecutive days (5 days/week).
Primary Outcome Measure Information:
Title
Visceral pain improvement
Description
Reduction of visceral pain in patients with malignancy measured by VAS, VDS.
Time Frame
one month
Secondary Outcome Measure Information:
Title
Reduction of depression manifestation
Description
Measurement of depression by using (HAM-D) scale.
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Eligibility Criteria
Inclusion Criteria:
All patients within age group 18-65 years with malignant visceral pain resistant to medical treatment for at least 2 months or associated with significant adverse effect from medication was involved in this study.
Exclusion Criteria:
We excluded patients with intracranial metallic devices or with pacemakers or any other device. We also excluded those with extensive myocardial ischemia, unstable angina and those known to have epilepsy.
12. IPD Sharing Statement
Learn more about this trial
rTMS as a Treatment of Visceral Pain Secondary to Malignancy
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