| CTRI Number |
CTRI/2026/01/101065 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial on understanding sleep, cognition, autonomic and physical function in patients with chronic low back pain. |
|
Scientific Title of Study
|
Studies on understanding and managing sleep, cognition,
Autonomic and Physical function in patients with non-specific
chronic low back pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Zubia Veqar |
| Designation |
Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room no: 202, Centre for Physiotherapy and Rehabilitation Sciences
Jamia Millia Islamia
Jamia Nagar
Room no: 202, Centre for Physiotherapy and Rehabilitation Sciences
Jamia Millia Islamia
Jamia Nagar
New Delhi
DELHI
110025
India |
| Phone |
995899386 |
| Fax |
|
| Email |
veqar.zubia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Zubia Veqar |
| Designation |
Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room mo: 202,Centre for Physiotherapy and Rehabilitation Sciences
Jamia Millia Islamia
Jamia Nagar
Room mo: 202,Centre for Physiotherapy and Rehabilitation Sciences
Jamia Millia Islamia
Jamia Nagar
DELHI
110025
India |
| Phone |
995899386 |
| Fax |
|
| Email |
veqar.zubia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Zubia Veqar |
| Designation |
Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room no: 202, Centre for Physiotherapy and Rehabilitation Sciences
Jamia Millia Islamia
Jamia Nagar
Room no: 202, Centre for Physiotherapy and Rehabilitation Sciences
Jamia Millia Islamia
Jamia Nagar
DELHI
110025
India |
| Phone |
995899386 |
| Fax |
|
| Email |
veqar.zubia@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jamia Millia Islamia |
| Address |
Jamia Millia Islamia, Jamia Nagar, New Delhi-110025 |
| Type of Sponsor |
Contract research organization |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Zubia Veqar |
Jamia Millia Islamia |
Centre for Physiotherapy and Rehabilitation Sciences
South
DELHI
110025
India
Centre for Physiotherapy and Rehabilitation Sciences
South
DELHI
110025
India w Delhi
New Delhi
DELHI |
995899386
veqar.zubia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, Jamia Millia Islamia |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M999||Biomechanical lesion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Control group will receive conventional treatment includes, hot pack, IFT and lumbar stabilization exercises |
| Intervention |
modern neuroscience approach |
Modern neuroscience intervention will be given along with conventonal treatment (hot pack, IFT and lumbar stabiliaztion exercises) |
| Intervention |
Modern neuroscience approach and cranial stimulation |
modern neuroscience approach along with cranial stimulation and conventional treatment (hot pack, IFT and lumbar stabilization exercises)
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Medical diagnosis of non-specific chronic low back pain (NCLBP) with pain and
2. symptoms persisting for longer than 3 months and lesser than 7 years in accordance
with standard diagnostic criteria and prior research conventions (Airaksinen et al.,
2006; Wand et al., 2011).
3. Age between 19 and 55 years (Heffner et al., 2011)
4. NPRS more than 3 and less than 7 (moderate pain intensity, which is clinically
significant yet not severely limiting)
5. Both male and female
6. Participants with working knowledge of english language in order to complete the
questionnaires.
7. Willing to participate in a structured exercise program
8. Willing to stay overnight for polysomnography |
|
| ExclusionCriteria |
| Details |
1.History of spinal surgery (Uchmanowicz et al., 2018)
2. Spinal and lower limb deformities
3. Inflammatory joint disease
4. Traumatic spine and lower limb injuries
5. Pregnant women
6. History or evidence of cardiovascular disease (history of angina, myocardial infarction,
shortness of breath, uncontrolled hypertension) (Bandeira et al., 2021)
7. Participants suffering from any diagnosed psychiatric, neurological or cognitive,
systematic, medical diseases/disorders
8. Use of centrally active medications and sleep medications (Aldabbas et al., 2021)
9. Previously diagnosed and treated sleep disorders (Uchmanowicz et al., 2018) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
PSQI
Polysomnography
P300 for cognition
Heart rate variability testing
Oswestry disability questionnaire
Electromyography
Pain pressure threshold
FABQ
TSK
PCS
Montreal Cognitive assessment
Central Sensitization Inventory
Sleep hygiene
R U Sated
Pittsburgh insomnia rated scale
|
At baseline
At 8 weeks
At 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
NIL
|
NIL |
|
|
Target Sample Size
|
Total Sample Size="39"
Sample Size from India="39"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
30/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/01/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will be carried out at human performance laboratory and sleep laboratory .the patients with chronic low back pain will be recruited from out patient department, centre for physiotherapy and Rehabilitation Sciences (CPRS), Jamia Millia Islamia. Subjects will be recruited on the basis of inclusion and exclusion criteria and informed about the study. Subject will be explained the purpose and the possible risks of the study. They will be given an informed consent explaining their rights as research subjects (According to Helsinki declaration,1964). All
the patients will be examined for demographics and baseline measures including pain,
cognition, subjective sleep parameters (sleep quality, sleep health, sleep hygiene, sleep-related
quality of life), objective sleep parameter (polysomnography), autonomic function, physical
function (muscle activation pattern and lumbar movement control) and psychosocial factors
(fear avoidance, kinesiophobia and pain catastrophising) by using respective outcome
measures. After assessing the baseline criterion measures, they shall further be randomly
divided into three groups (two intervention and one control group). Group A will receive
modern neuroscience approach (Pain neuroscience education and cognition targeted exercise
therapy) along with interferential therapy (IFT) and hot pack. Group B will receive cranial
16
electrostimulation in addition to modern neuroscience approach along with IFT and hot pack
and group C (control) will receive general trunk stabilization exercises along with IFT and hot
pack. Assessment of criterion measures will be taken in 2 subsequent days. On day one, P300
evoked potentials, EMG, interleukin-6 biomarker (saliva) and other subjective parameters will
be recorded and participants are requested to come to sleep lab in the night for
polysomnography familiarization session. On day two, heart rate variability and also subjects
will be asked to come to lab at around 9:30 pm, after having dinner, at their regular bed time
for complete polysomnography recording using EEG, EOG and EMG electrodes for the whole
night. Moreover, all the subjects will be asked to fill consensus sleep diary daily to get a clearer
picture of their sleep/ wake cycle for the complete study duration. The interventions will be
given three days per week for a period of eight weeks. After the completion of eight weeks of
intervention period, assessment of the outcome variables will be carried out again post
intervention. A follow up will be conducted after 12 weeks, assessing all the outcome measures
except polysomnography. |