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CompletedNCT02092805Updated Mar 20, 2014

rTMS as a Treatment of Visceral Pain Secondary to Malignancy

An interventional study of 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) and Sham rTMS (same parameters but with coil elevated and angled away from the head) every day for 10 consecutive days (5 days/week). in Malignancy, sponsored by Assiut University. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-03-20.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Malignancy

Keywords

  • VAS
  • VDS
  • HAM-D
  • Visceral pain
  • Malignancy
  • rTMS
  • Motor cortex
  • Analgesia
  • Dynorphin
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 34 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Sham comparator
    Sham rTMS

    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.

    Procedure: Sham rTMS (same parameters but with coil elevated and angled away from the head) every day for 10 consecutive days (5 days/week).

  • Active comparator
    Real 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).

    Procedure: 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)

Interventions

  • ProcedureReal 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)
  • ProcedureSham rTMS (same parameters but with coil elevated and angled away from the head) every day for 10 consecutive days (5 days/week).
06

What researchers measure

Primary outcomes

  1. Visceral pain improvement

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

    Time frame: one month

Secondary outcomes

  1. Reduction of depression manifestation

    Measurement of depression by using (HAM-D) scale.

    Time frame: one month

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02092805
Lead sponsor
Assiut University
Responsible party
Eman M. Khedr (Clinical rofessor, Assiut University) — Principal investigator
First posted
Mar 20, 2014
Start date
Jan 2010
Primary completion
Jan 2012
Completion
Jan 2012
Last update
Mar 20, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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