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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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03976232
Enrollment
60
Registered
2019-06-05
Start date
2019-06-30
Completion date
2021-02-02
Last updated
2019-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low-back Pain, Sleep Disturbance

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.

Interventions

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.

OTHERCraniosacral 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.

OTHERtDCS+ CST

This group will receive tDCS along with CST

Sponsors

Maharishi Markendeswar University (Deemed to be University)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Polysomnographychanges between baseline to 2 weeks and 6 weeksPolysomnographic parameters will be recorded.
Pittsburgh sleep quality Index scale.changes between baseline to 2 weeks and 6 weeksQualitative assessment of sleep will be recorded by this scale

Secondary

MeasureTime frameDescription
Modified Oswestry disability indexchanges between baseline to 2 weeks and 6 weeksChronic low back pain-related disability will be recorded
NPRSchanges between baseline to 2 weeks and 6 weeksPain intensity will be recorded

Contacts

Primary ContactSubhasish Chatterjee, MPT
subhasishphysio@gmail.com8708660994
Backup ContactVandana Esht, Ph.D
8059930235

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026