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)

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Low-back Pain; Sleep Disturbance
• Intervention / Treatment: Device: Trans cranial Direct Current Stimulation (tDCS); Other: Craniosacral therapy (CST); Other: tDCS+ CST

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Maharishi Markendeswar University (Deemed to be University)

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2019
• Primary Completion (Anticipated): January 30, 2021
• Study Completion (Anticipated): February 2, 2021

Study Registration Dates

• First Submitted: May 27, 2019
• First Submitted That Met QC Criteria: June 4, 2019
• First Posted (Actual): June 5, 2019

Study Record Updates

• Last Update Posted (Actual): June 5, 2019
• Last Update Submitted That Met QC Criteria: June 4, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Dyssomnias; Parasomnias
• Other Study ID Numbers: IEC-1361

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No