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出境医 / 临床实验 / Trans Cranial Direct Current Stimulation Along With Craniosacral Therapy on Sleep Disturbances in Patients With Chronic Low Back Pain

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

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.

Condition or disease Intervention/treatment Phase
Sleep Disturbance Chronic Low-back Pain Device: Trans cranial Direct Current Stimulation (tDCS) Other: Craniosacral therapy (CST) Other: tDCS+ CST Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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)
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : January 30, 2021
Estimated Study Completion Date : February 2, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: tDCS-Group
Participants of this arm will receive tDCS and Conventional therapy for 2 weeks.
 Device: Trans cranial Direct Current Stimulation (tDCS)
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.
Experimental: CST- Group
Participants of this arm will receive CST and Conventional therapy for 2 weeks.
 Other: Craniosacral therapy (CST)
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.
Active Comparator: combination of tDCS and CST
Participants of this arm will receive CST+ tDCS and Conventional therapy for 2 weeks.
 Other: tDCS+ CST
This group will receive tDCS along with CST
Outcome Measures
Primary Outcome Measures :
  1. Polysomnography [ Time Frame: changes between baseline to 2 weeks and 6 weeks ]
    Polysomnographic parameters will be recorded.

  2. Pittsburgh sleep quality Index scale. [ Time Frame: changes between baseline to 2 weeks and 6 weeks ]
    Qualitative assessment of sleep will be recorded by this scale


Secondary Outcome Measures :
  1. Modified Oswestry disability index [ Time Frame: changes between baseline to 2 weeks and 6 weeks ]
    Chronic low back pain-related disability will be recorded

  2. NPRS [ Time Frame: changes between baseline to 2 weeks and 6 weeks ]
    Pain intensity will be recorded


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Subhasish Chatterjee, MPT 8708660994 subhasishphysio@gmail.com
Contact: Vandana Esht, Ph.D 8059930235

Sponsors and Collaborators
Maharishi Markendeswar University (Deemed to be University)
Tracking Information
First Submitted Date  ICMJE May 27, 2019
First Posted Date  ICMJE June 5, 2019
Last Update Posted Date June 5, 2019
Estimated Study Start Date  ICMJE June 2019
Estimated Primary Completion Date January 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
  • Polysomnography [ Time Frame: changes between baseline to 2 weeks and 6 weeks ]
    Polysomnographic parameters will be recorded.
  • Pittsburgh sleep quality Index scale. [ Time Frame: changes between baseline to 2 weeks and 6 weeks ]
    Qualitative assessment of sleep will be recorded by this scale
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
  • Modified Oswestry disability index [ Time Frame: changes between baseline to 2 weeks and 6 weeks ]
    Chronic low back pain-related disability will be recorded
  • NPRS [ Time Frame: changes between baseline to 2 weeks and 6 weeks ]
    Pain intensity will be recorded
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trans Cranial Direct Current Stimulation Along With Craniosacral Therapy on Sleep Disturbances in Patients With Chronic Low Back Pain
Official Title  ICMJE Efficacy of Trans Cranial Direct Current Stimulation (tDCS) Along With Craniosacral Therapy (CST) on Sleep Disturbances in Patients With Chronic Low Back Pain (CLBP)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Sleep Disturbance
  • Chronic Low-back Pain
Intervention  ICMJE
  • Device: Trans cranial Direct Current Stimulation (tDCS)
    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.
  • Other: Craniosacral therapy (CST)
    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.
  • Other: tDCS+ CST
    This group will receive tDCS along with CST
Study Arms  ICMJE
  • Experimental: tDCS-Group
    Participants of this arm will receive tDCS and Conventional therapy for 2 weeks.
    Intervention: Device: Trans cranial Direct Current Stimulation (tDCS)
  • Experimental: CST- Group
    Participants of this arm will receive CST and Conventional therapy for 2 weeks.
    Intervention: Other: Craniosacral therapy (CST)
  • Active Comparator: combination of tDCS and CST
    Participants of this arm will receive CST+ tDCS and Conventional therapy for 2 weeks.
    Intervention: Other: tDCS+ CST
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 4, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2, 2021
Estimated Primary Completion Date January 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03976232
Other Study ID Numbers  ICMJE IEC-1361
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Subhasish Chatterjee, Maharishi Markendeswar University (Deemed to be University)
Study Sponsor  ICMJE Maharishi Markendeswar University (Deemed to be University)
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Maharishi Markendeswar University (Deemed to be University)
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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