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

Sleep Disturbance Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03976232
• Other study ID #: IEC-1361
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2019
• Est. completion date: February 2, 2021

Study information

• Verified date: June 2019
• Source: Maharishi Markendeswar University
• Contact: Subhasish Chatterjee, MPT
• Phone: 8708660994
• Email: subhasishphysio[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 2, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Dyssomnias
• Low Back Pain
• Parasomnias
• Sleep Disturbance
• Sleep Wake Disorders

Intervention

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.
• tDCS+ CST
This group will receive tDCS along with CST

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maharishi Markendeswar University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polysomnography	Polysomnographic parameters will be recorded.	changes between baseline to 2 weeks and 6 weeks
Primary	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	Modified Oswestry disability index	Chronic low back pain-related disability will be recorded	changes between baseline to 2 weeks and 6 weeks
Secondary	NPRS	Pain intensity will be recorded	changes between baseline to 2 weeks and 6 weeks