Sleep DisturbanceNCT03976232
Trans Cranial Direct Current Stimulation Along With Craniosacral Therapy on Sleep Disturbances in Patients With Chronic Low Back Pain
A study testing Trans cranial Direct Current Stimulation (tDCS), Craniosacral therapy (CST) and tDCS+ CST in people with Sleep Disturbance and Chronic Low-back Pain, run by Maharishi Markendeswar University (Deemed to be University).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Sleep Disturbance, Chronic Low-back Pain
- What is being tested?
- Trans cranial Direct Current Stimulation (tDCS), Craniosacral therapy (CST) and tDCS+ CST
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2019to 2 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- People with chronic low back pain (more than 3 months)
- Both males and females.
- 18-50 years
- Able to follow verbal commands.
Who cannot join
- Diagnosed with primary sleep disorders
- Pregnancy
- Taking any medication for a psychological disorder
- Acute or subacute LBP
- Diagnosed with any other systemic disorder.
- Spinal tumour.
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- Radicular pain and nerve root compression.
- Severe spinal stenosis, spondylolisthesis, fibromyalgia.
- Unstable angina and other cardiovascular disorders.
- Malignancy.
- History of other systemic and inflammatory disease.
Trial locations and contacts
No sites are listed yet.
Vandana Esht, Ph.D contact
About this study
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)
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.
- Conditions
- Sleep Disturbance, Chronic Low-back Pain
- Being tested
- Trans cranial Direct Current Stimulation (tDCS), Craniosacral therapy (CST), tDCS+ CST
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans cranial Direct Current Stimulation (tDCS)Device
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.
Craniosacral therapy (CST)Other
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.
tDCS+ CSTOther
This group will receive tDCS along with CST
| Study group | Role | What they receive |
|---|---|---|
| tDCS-Group | Experimental | Participants of this arm will receive tDCS and Conventional therapy for 2 weeks. Receives: Device: Trans cranial Direct Current Stimulation (tDCS) |
| CST- Group | Experimental | Participants of this arm will receive CST and Conventional therapy for 2 weeks. Receives: Other: Craniosacral therapy (CST) |
| combination of tDCS and CST | Active comparator | Participants of this arm will receive CST+ tDCS and Conventional therapy for 2 weeks. Receives: Other: tDCS+ CST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polysomnography
Polysomnographic parameters will be recorded.
Measured: changes between baseline to 2 weeks and 6 weeks
Pittsburgh sleep quality Index scale.
Qualitative assessment of sleep will be recorded by this scale
Measured: changes between baseline to 2 weeks and 6 weeks
Secondary outcomes (2)
Modified Oswestry disability index
Chronic low back pain-related disability will be recorded
Measured: changes between baseline to 2 weeks and 6 weeks
NPRS
Pain intensity will be recorded
Measured: changes between baseline to 2 weeks and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study startJun 2019 (estimated)
- Primary completion30 Jan 2021 (estimated)
- Study completion2 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Subhasish Chatterjee, Maharishi Markendeswar University (Deemed to be University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976232
- Sponsor's protocol ID
- IEC-1361
- Status last verified
- Jun 2019
- First submitted
- 27 May 2019
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03976232
- Acronym / sponsor ID
- IEC-1361
- Conditions
- Sleep Disturbance, Chronic Low-back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)University, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- 30 Jan 2021 (estimated)
- Study completion
- 2 Feb 2021 (estimated)
- First posted
- 5 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tDCS-Group | Experimental | Device: Trans cranial Direct Current Stimulation (tDCS)Participants of this arm will receive tDCS and Conventional therapy for 2 weeks. |
| CST- Group | Experimental | Other: Craniosacral therapy (CST)Participants of this arm will receive CST and Conventional therapy for 2 weeks. |
| combination of tDCS and CST | Active comparator | Other: tDCS+ CSTParticipants of this arm will receive CST+ tDCS and Conventional therapy for 2 weeks. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- People with chronic low back pain (more than 3 months)
- Both males and females.
- 18-50 years
- Able to follow verbal commands.
Key exclusion criteria (11 listed)
- Diagnosed with primary sleep disorders
- Pregnancy
- Taking any medication for a psychological disorder
- Acute or subacute LBP
- Diagnosed with any other systemic disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | tDCS-Group |
| 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. | Other | CST- Group |
| tDCS+ CSTThis group will receive tDCS along with CST | Other | combination of tDCS and CST |
Primary outcome
Polysomnography
Time frame: changes between baseline to 2 weeks and 6 weeks
Polysomnographic parameters will be recorded.
Pittsburgh sleep quality Index scale.
Time frame: changes between baseline to 2 weeks and 6 weeks
Qualitative assessment of sleep will be recorded by this scale
2 secondary outcomes
Modified Oswestry disability index
Time frame: changes between baseline to 2 weeks and 6 weeks
NPRS
Time frame: changes between baseline to 2 weeks and 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vandana Esht, Ph.D contact
Questions about this trial
What is this clinical trial studying?
A study testing Trans cranial Direct Current Stimulation (tDCS), Craniosacral therapy (CST) and tDCS+ CST in people with Sleep Disturbance and Chronic Low-back Pain, run by Maharishi Markendeswar University (Deemed to be University).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Subhasish Chatterjee, MPT (8708660994, subhasishphysio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polysomnography (time frame: changes between baseline to 2 weeks and 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.