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Trans Cranial Direct Current Stimulation Along With Craniosacral Therapy on Sleep Disturbances in Patients With Chronic Low Back Pain

Primary Purpose

Sleep Disturbance, Chronic Low-back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Trans cranial Direct Current Stimulation (tDCS)
Craniosacral therapy (CST)
tDCS+ CST
Sponsored by
Maharishi Markendeswar University (Deemed to be University)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disturbance

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. People with chronic low back pain (more than 3 months)
  2. Both males and females.
  3. 18-50 years
  4. Able to follow verbal commands.

Exclusion Criteria:

  1. Diagnosed with primary sleep disorders
  2. Pregnancy
  3. Taking any medication for a psychological disorder
  4. Acute or subacute LBP
  5. Diagnosed with any other systemic disorder.
  6. Spinal tumour.
  7. Radicular pain and nerve root compression.
  8. Severe spinal stenosis, spondylolisthesis, fibromyalgia.
  9. Unstable angina and other cardiovascular disorders.
  10. Malignancy.
  11. History of other systemic and inflammatory disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    tDCS-Group

    CST- Group

    combination of tDCS and CST

    Arm Description

    Participants of this arm will receive tDCS and Conventional therapy for 2 weeks.

    Participants of this arm will receive CST and Conventional therapy for 2 weeks.

    Participants of this arm will receive CST+ tDCS and Conventional therapy for 2 weeks.

    Outcomes

    Primary Outcome Measures

    Polysomnography
    Polysomnographic parameters will be recorded.
    Pittsburgh sleep quality Index scale.
    Qualitative assessment of sleep will be recorded by this scale

    Secondary Outcome Measures

    Modified Oswestry disability index
    Chronic low back pain-related disability will be recorded
    NPRS
    Pain intensity will be recorded

    Full Information

    First Posted
    May 27, 2019
    Last Updated
    June 4, 2019
    Sponsor
    Maharishi Markendeswar University (Deemed to be University)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03976232
    Brief Title
    Trans Cranial Direct Current Stimulation Along With Craniosacral Therapy on Sleep Disturbances in Patients With Chronic Low Back Pain
    Official Title
    Efficacy of Trans Cranial Direct Current Stimulation (tDCS) Along With Craniosacral Therapy (CST) on Sleep Disturbances in Patients With Chronic Low Back Pain (CLBP)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2019 (Anticipated)
    Primary Completion Date
    January 30, 2021 (Anticipated)
    Study Completion Date
    February 2, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Maharishi Markendeswar University (Deemed to be University)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Sleep problems in patients with CLBP are a very common complication and is the most neglected part of the management. Though previous literature suggested that sleep problems need to be managed in patients with CLBP, no physical therapy or manual therapy techniques has been checked for their efficacy to manage the same. Therefore, there is a need to check the efficacy of various physical therapy and manual therapy techniques so that sleep problems associated with CLBP can be managed effectively by physical means. The main purpose of the study is to check the efficacy of tDCS and CST to improve sleep, pain and quality of life in patients with CLBP.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sleep Disturbance, Chronic Low-back Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    tDCS-Group
    Arm Type
    Experimental
    Arm Description
    Participants of this arm will receive tDCS and Conventional therapy for 2 weeks.
    Arm Title
    CST- Group
    Arm Type
    Experimental
    Arm Description
    Participants of this arm will receive CST and Conventional therapy for 2 weeks.
    Arm Title
    combination of tDCS and CST
    Arm Type
    Active Comparator
    Arm Description
    Participants of this arm will receive CST+ tDCS and Conventional therapy for 2 weeks.
    Intervention Type
    Device
    Intervention Name(s)
    Trans cranial Direct Current Stimulation (tDCS)
    Intervention Description
    Active tDCS will be applied for 20 minutes with 2 mA intensity. Anode will be placed at left dorsolateral prefrontal cortex and cathode will be placed at the right cerebellar cortex.
    Intervention Type
    Other
    Intervention Name(s)
    Craniosacral therapy (CST)
    Intervention Description
    Craniosacral therapy will be given to all the participants which includes release of all major diaphragm, frontal lift, parietal lift, occipital lift, CV4 and dural tube rocking.
    Intervention Type
    Other
    Intervention Name(s)
    tDCS+ CST
    Intervention Description
    This group will receive tDCS along with CST
    Primary Outcome Measure Information:
    Title
    Polysomnography
    Description
    Polysomnographic parameters will be recorded.
    Time Frame
    changes between baseline to 2 weeks and 6 weeks
    Title
    Pittsburgh sleep quality Index scale.
    Description
    Qualitative assessment of sleep will be recorded by this scale
    Time Frame
    changes between baseline to 2 weeks and 6 weeks
    Secondary Outcome Measure Information:
    Title
    Modified Oswestry disability index
    Description
    Chronic low back pain-related disability will be recorded
    Time Frame
    changes between baseline to 2 weeks and 6 weeks
    Title
    NPRS
    Description
    Pain intensity will be recorded
    Time Frame
    changes between baseline to 2 weeks and 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: People with chronic low back pain (more than 3 months) Both males and females. 18-50 years Able to follow verbal commands. Exclusion Criteria: Diagnosed with primary sleep disorders Pregnancy Taking any medication for a psychological disorder Acute or subacute LBP Diagnosed with any other systemic disorder. Spinal tumour. Radicular pain and nerve root compression. Severe spinal stenosis, spondylolisthesis, fibromyalgia. Unstable angina and other cardiovascular disorders. Malignancy. History of other systemic and inflammatory disease.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Subhasish Chatterjee, MPT
    Phone
    8708660994
    Email
    subhasishphysio@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Vandana Esht, Ph.D
    Phone
    8059930235

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Trans Cranial Direct Current Stimulation Along With Craniosacral Therapy on Sleep Disturbances in Patients With Chronic Low Back Pain

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