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Clinical Trials/NCT02092805
NCT02092805
Completed
N/A

Repetitive Transcranial Magnetic Stimulation in Visceral Pain Secondary to Malignancy

Assiut University0 sites34 target enrollmentJanuary 2010
ConditionsMalignancy

Overview

Phase
N/A
Intervention
Not specified
Conditions
Malignancy
Sponsor
Assiut University
Enrollment
34
Primary Endpoint
Visceral pain improvement
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
January 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eman M. Khedr

Clinical rofessor

Assiut University

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.

Outcomes

Primary Outcomes

Visceral pain improvement

Time Frame: one month

Reduction of visceral pain in patients with malignancy measured by VAS, VDS.

Secondary Outcomes

  • Reduction of depression manifestation(one month)

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