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rTMS as a Treatment of Neuropathic Pain Secondary to Malignancy

Primary Purpose

Malignancy

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

20 Hz, 10 s, 10 trains with inter-train interval 30 s 2000 pulses , intensity 80% over hand area 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 ten consecutive days (5 days/week).

About this trial

This is an interventional treatment trial for Malignancy focused on measuring Malignancy, VAS, LANSS, VDS, Neuropathic pain, rTMS, motor cortex, analgesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All Sexes

Inclusion Criteria:

All patients within age group 18-65 years with malignant lateralized neuropathic pain resistant to medical treatment for at least 2 months or associated with significant adverse effects from medication were involved in this study.

Exclusion Criteria:

Patients with intracranial metallic devices Patients with pacemakers or any other device. Patients with recent myocardial ischemia, unstable angina Patients known to have history of epilepsy.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Real rTMS

Sham rTMS

Arm Description

The active group received Real rTMS over the hand area of motor cortex (20 Hz, 10 second, 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).

Sham-rTMS was applied using the same parameters but with the coil elevated and angled away from the head to reproduce the same of subjective sensation of rTMS

Outcomes

Primary Outcome Measures

Neuropathic pain improvement

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

Secondary Outcome Measures

Reduction of depression manifestation

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

Full Information

NCT ID

NCT02078479

First Posted

March 1, 2014

Last Updated

March 1, 2014

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT02078479

Brief Title

rTMS as a Treatment of Neuropathic Pain Secondary to Malignancy

Official Title

Repetitive Transcranial Magnetic Stimulation in Neuropathic Pain Secondary to Malignancy.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study isto assess the efficacy of daily 10 sessions of rTMS over primary motor cortex in patients suffering from malignant neuropathic pain. Thirty four patients were divided randomly into 2 groups equally using closed envelops to undergo real (20 Hz, 10 second, 10 trains with inter-train interval 30 second with total pulses 2000, intensity 80% of motor threshold over hand area of motor cortex) or sham rTMS (same parameters but with coil elevated and angled away from the head)every day for ten consecutive days (5 days/week). Patients were evaluated using a verbal descriptor scale (VDS), visual analog scale (VAS), Leeds assessment of neuropathic symptoms and signs (LANSS) and Hamilton rating scale for depression (HAM-D) at baseline, after 1st, 5th, 10thtreatment session, and then 15 days and 1 month after the end of treatment. ic pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignancy

Keywords

Malignancy, VAS, LANSS, VDS, Neuropathic pain, rTMS, motor cortex, analgesia

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

Real rTMS

Arm Type

Active Comparator

Arm Description

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 the same of subjective sensation of rTMS

Intervention Type

Procedure

Intervention Name(s)

20 Hz, 10 s, 10 trains with inter-train interval 30 s 2000 pulses , intensity 80% over hand area 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 ten consecutive days (5 days/week).

Primary Outcome Measure Information:

Title

Neuropathic pain improvement

Description

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

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 lateralized neuropathic pain resistant to medical treatment for at least 2 months or associated with significant adverse effects from medication were involved in this study. Exclusion Criteria: Patients with intracranial metallic devices Patients with pacemakers or any other device. Patients with recent myocardial ischemia, unstable angina Patients known to have history of epilepsy.

12. IPD Sharing Statement

Learn more about this trial

rTMS as a Treatment of Neuropathic Pain Secondary to Malignancy

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