rTMS as a Treatment of Neuropathic Pain Secondary to Malignancy

Not Applicable

Completed

• Conditions: Malignancy
• Interventions: Procedure: 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).; Procedure: sham rTMS (same parameters but with coil elevated and angled away from the head)every day for ten consecutive days (5 days/week).

• Registration Number: NCT02078479
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-02
• Study First Submitted: 2014-03-01
• Study First Submitted QC: 2014-03-01
• Last Update Submitted: 2014-03-01
• Study First Posted: 2014-03-05
• Last Update Posted: 2014-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Real rTMS	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).	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	sham rTMS (same parameters but with coil elevated and angled away from the head)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

Primary Outcome Measures

Name	Time	Method
Neuropathic pain improvement	one month	Reduction of neuropathic pain in patients with malignancy measured by VDS, VAS, LANSS.

Secondary Outcome Measures

Name	Time	Method
Reduction of depression manifestation	one month	Measurement of depression by using (HAM-D) scale.