search
Back to results

Effect of tDCS on Chronic Abdominal Visceral Pain in HCC Patients

Primary Purpose

Abdominal Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
transcranial direct current stimulation tDCS
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Pain focused on measuring tDCS, cancer liver, chronic abdominal pain, VAS, VDS, HAM-D, BPI, analgesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients of above 18 years old, with malignant visceral pain due to primary liver cancer or on top of cirrhosis, resistant to medical treatment for at least 2 months or associated with significant adverse effect from medication will be involved in this study

Exclusion Criteria:

  • Investigators will exclude patients with intracranial metallic devices or with pacemakers or any other device. Investigators also exclude those with extensive myocardial ischemia and those known to have epilepsy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Real tDCS

    Sham tDCS

    Arm Description

    In the active stimulation condition a constant current of active transcranial direct current stimulation (tDCS) of 2mA intensity was applied for 30 minutes,over primary motor cortex M1. The treatment was repeated every day for 10 consecutive days.

    Sham tDCS was applied using the same parameters but only for 30 seconds then the machine is deactivated.

    Outcomes

    Primary Outcome Measures

    visual analog scale (VAS)
    measurement of reduction of chronic abdominal pain in cancer liver patients.
    verbal descriptor scale (VDS)
    measurement of reduction of chronic abdominal pain in cancer liver patients.

    Secondary Outcome Measures

    Hamilton rating scale for depression (HAM-D)
    Measurement of reduction of depression

    Full Information

    First Posted
    March 26, 2016
    Last Updated
    October 6, 2016
    Sponsor
    Assiut University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02928237
    Brief Title
    Effect of tDCS on Chronic Abdominal Visceral Pain in HCC Patients
    Official Title
    Effect of the Transcranial Direct Current Stimulation (tDCS) of the Motor Cortex on Chronic Abdominal Pain in Patients With Hepatocellular Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2015 (undefined)
    Primary Completion Date
    April 2016 (Actual)
    Study Completion Date
    August 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To evaluate the effect of transcranial direct current stimulation (tDCS) applied to the motor cortex to reduce chronic abdominal visceral pain in a group of participants with hepatocellular carcinoma
    Detailed Description
    This study will be carried out in Assiut University Hospital pain clinic and in participation of department of neuropsychiatry in Assiut University Hospital. After obtaining approval of hospital ethical committee, informed written consent will be taken from all patients with malignant visceral pain to be involved in this study. In these study investigators test the hypothesis that Does transcranial direct current stimulation induce analgesia in chronic abdominal visceral pain due to liver cancer ? Preparation: The patient will seat in a comfortable chair and will be asked to relax as much as possible. tDCS was delivered using a battery driven DC stimulator (neuroConn Gmbh,98693 llmenau, Germany). Current was delivered by electrodes encased in sponge pads soaked with 1% saline solution. The machine was kept behind the participant and out of their view at all times. For both the active and sham conditions, the anode was placed over the motor cortex of the patient and the cathode was placed over the contralateral supraorbital region. Electrodes were secured using soft elastic straps. In the active stimulation condition a constant current of 2mA intensity was applied for 30 minutes with a 5-second ramp phase at the beginning. In the sham stimulation condition the machine was activated for 30 seconds using identical parameters but was then switched off without the patient's knowledge. This sham control is commonly employed because over the initial 30 seconds of stimulation, an initial sensation of tingling under the electrode fades away. Patients are less likely to distinguish active from sham conditions if the initial period of tingling is present in both. 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, and 1 month after end of sessions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Abdominal Pain
    Keywords
    tDCS, cancer liver, chronic abdominal pain, VAS, VDS, HAM-D, BPI, analgesia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Real tDCS
    Arm Type
    Active Comparator
    Arm Description
    In the active stimulation condition a constant current of active transcranial direct current stimulation (tDCS) of 2mA intensity was applied for 30 minutes,over primary motor cortex M1. The treatment was repeated every day for 10 consecutive days.
    Arm Title
    Sham tDCS
    Arm Type
    Placebo Comparator
    Arm Description
    Sham tDCS was applied using the same parameters but only for 30 seconds then the machine is deactivated.
    Intervention Type
    Device
    Intervention Name(s)
    transcranial direct current stimulation tDCS
    Intervention Description
    A battery driven DC stimulator (neuroConn Gmbh,98693 llmenau, Germany)
    Primary Outcome Measure Information:
    Title
    visual analog scale (VAS)
    Description
    measurement of reduction of chronic abdominal pain in cancer liver patients.
    Time Frame
    one month
    Title
    verbal descriptor scale (VDS)
    Description
    measurement of reduction of chronic abdominal pain in cancer liver patients.
    Time Frame
    one month
    Secondary Outcome Measure Information:
    Title
    Hamilton rating scale for depression (HAM-D)
    Description
    Measurement of reduction of depression
    Time Frame
    one month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patients of above 18 years old, with malignant visceral pain due to primary liver cancer or on top of cirrhosis, resistant to medical treatment for at least 2 months or associated with significant adverse effect from medication will be involved in this study Exclusion Criteria: Investigators will exclude patients with intracranial metallic devices or with pacemakers or any other device. Investigators also exclude those with extensive myocardial ischemia and those known to have epilepsy.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    28605527
    Citation
    Ibrahim NM, Abdelhameed KM, Kamal SMM, Khedr EMH, Kotb HIM. Effect of Transcranial Direct Current Stimulation of the Motor Cortex on Visceral Pain in Patients with Hepatocellular Carcinoma. Pain Med. 2018 Mar 1;19(3):550-560. doi: 10.1093/pm/pnx087.
    Results Reference
    derived

    Learn more about this trial

    Effect of tDCS on Chronic Abdominal Visceral Pain in HCC Patients

    We'll reach out to this number within 24 hrs