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

• Sponsor: Maharishi Markendeswar University (Deemed to be University) (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03976232
• Collaborator: (none)
• Enrollment: 60
• Arms: 3
• Anticipated Duration (Months): 20.1

Study Details

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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)
• Anticipated Study Start Date: Jun 1, 2019
• Anticipated Primary Completion Date: Jan 30, 2021
• Anticipated Study Completion Date: Feb 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 [changes between baseline to 2 weeks and 6 weeks]

   Polysomnographic parameters will be recorded.

2. Pittsburgh sleep quality Index scale. [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 [changes between baseline to 2 weeks and 6 weeks]

   Chronic low back pain-related disability will be recorded

2. NPRS [changes between baseline to 2 weeks and 6 weeks]

   Pain intensity will be recorded

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• Maharishi Markendeswar University (Deemed to be University)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Subhasish Chatterjee, Subhasish Chatterjee, Maharishi Markendeswar University (Deemed to be University)
• ClinicalTrials.gov Identifier: NCT03976232
• Other Study ID Numbers: IEC-1361
• First Posted: Jun 5, 2019
• Last Update Posted: Jun 5, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dyssomnias; Parasomnias; Back Pain; Low Back Pain

Study Results

No Results Posted as of Jun 5, 2019