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

Not Applicable

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

• Registration Number: NCT03976232
• Lead Sponsor: Maharishi Markendeswar University (Deemed to be University)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-27
• Status Verified: 2019-06
• Study Start: 2019-06
• Study First Submitted QC: 2019-06-04
• Last Update Submitted: 2019-06-04
• Study First Posted: 2019-06-05
• Last Update Posted: 2019-06-05
• Primary Completion: 2021-01-30
• Study Completion: 2021-02-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
CST- Group	Craniosacral therapy (CST)	Participants of this arm will receive CST and Conventional therapy for 2 weeks.
combination of tDCS and CST	tDCS+ CST	Participants of this arm will receive CST+ tDCS and Conventional therapy for 2 weeks.
tDCS-Group	Trans cranial Direct Current Stimulation (tDCS)	Participants of this arm will receive tDCS and Conventional therapy for 2 weeks.

Primary Outcome Measures

Name	Time	Method
Pittsburgh sleep quality Index scale.	changes between baseline to 2 weeks and 6 weeks	Qualitative assessment of sleep will be recorded by this scale
Polysomnography	changes between baseline to 2 weeks and 6 weeks	Polysomnographic parameters will be recorded.

Secondary Outcome Measures

Name	Time	Method
Modified Oswestry disability index	changes between baseline to 2 weeks and 6 weeks	Chronic low back pain-related disability will be recorded
NPRS	changes between baseline to 2 weeks and 6 weeks	Pain intensity will be recorded