Trans Cranial Direct Current Stimulation Along With Craniosacral Therapy on Sleep Disturbances in Patients With Chronic Low Back Pain
Efficacy of Trans Cranial Direct Current Stimulation (tDCS) Along With Craniosacral Therapy (CST) on Sleep Disturbances in Patients With Chronic Low Back Pain (CLBP)
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2019
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedFirst Posted
Study publicly available on registry
June 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2021
CompletedJune 5, 2019
June 1, 2019
1.7 years
May 27, 2019
June 4, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Polysomnography
Polysomnographic parameters will be recorded.
changes between baseline to 2 weeks and 6 weeks
Pittsburgh sleep quality Index scale.
Qualitative assessment of sleep will be recorded by this scale
changes between baseline to 2 weeks and 6 weeks
Secondary Outcomes (2)
Modified Oswestry disability index
changes between baseline to 2 weeks and 6 weeks
NPRS
changes between baseline to 2 weeks and 6 weeks
Study Arms (3)
tDCS-Group
EXPERIMENTALParticipants of this arm will receive tDCS and Conventional therapy for 2 weeks.
CST- Group
EXPERIMENTALParticipants of this arm will receive CST and Conventional therapy for 2 weeks.
combination of tDCS and CST
ACTIVE COMPARATORParticipants of this arm will receive CST+ tDCS and Conventional therapy for 2 weeks.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- People with chronic low back pain (more than 3 months)
- Both males and females.
- years
- Able to follow verbal commands.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Subhasish Chatterjee
Study Record Dates
First Submitted
May 27, 2019
First Posted
June 5, 2019
Study Start
June 1, 2019
Primary Completion
January 30, 2021
Study Completion
February 2, 2021
Last Updated
June 5, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share