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

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Trans Cranial Direct Current Stimulation (tDCS) Along With Craniosacral Therapy (CST) on Sleep Disturbances in Patients With Chronic Low Back Pain (CLBP)

Conditions
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Sleep Disturbance, Chronic Low-back Pain

Intervention / Treatment
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* Device: Trans cranial Direct Current Stimulation (tDCS)
* Other: Craniosacral therapy (CST)
* Other: tDCS+ CST


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tDCS-Group<br>Participants of this arm will receive tDCS and Conventional therapy for 2 weeks. | Device: Trans cranial Direct Current Stimulation (tDCS)<br>* 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.<br>|
| Experimental: CST- Group<br>Participants of this arm will receive CST and Conventional therapy for 2 weeks. | Other: Craniosacral therapy (CST)<br>* 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.<br>|
| Active Comparator: combination of tDCS and CST<br>Participants of this arm will receive CST+ tDCS and Conventional therapy for 2 weeks. | Other: tDCS+ CST<br>* This group will receive tDCS along with CST<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Oswestry disability index | Chronic low back pain-related disability will be recorded | changes between baseline to 2 weeks and 6 weeks | 
| NPRS | Pain intensity will be recorded | changes between baseline to 2 weeks and 6 weeks |