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

Maharishi Markendeswar University (Deemed to be University)

Status: Unknown

Conditions: Chronic Low-back Pain; Sleep Disturbance

Treatments: Device: Trans cranial Direct Current Stimulation (tDCS); Other: Craniosacral therapy (CST); Other: tDCS+ CST

Study type: Interventional

Funder types: Other

Identifiers

NCT03976232

IEC-1361

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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60 participants in 3 patient groups

tDCS-Group

Experimental group

Description:

Participants of this arm will receive tDCS and Conventional therapy for 2 weeks.

Treatment:

Device: Trans cranial Direct Current Stimulation (tDCS)

CST- Group

Experimental group

Description:

Participants of this arm will receive CST and Conventional therapy for 2 weeks.

Treatment:

Other: Craniosacral therapy (CST)

combination of tDCS and CST

Active Comparator group

Description:

Participants of this arm will receive CST+ tDCS and Conventional therapy for 2 weeks.

Treatment:

Other: tDCS+ CST