| CTRI Number |
CTRI/2025/03/083544 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| 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 to study the effect of pain education on sleep quality, mental processing and posture in patients with chronic low back pain. |
|
Scientific Title of Study
|
Effect of pain science education on sleep quality, cognition and posture in patients with non-specific chronic low back pain. A pilot investigation. |
| Trial Acronym |
NILL |
|
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 |
Centre for Physiotherapy and Rehabilitation Sciences
South
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 |
Centre for Physiotherapy and Rehabilitation Sciences
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 |
Centre for Physiotherapy and Rehabilitation Sciences
DELHI
110025
India |
| Phone |
995899386 |
| Fax |
|
| Email |
veqar.zubia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamia Millia Islamia, Jamia Magar. Okhla, New Delhi-110025 |
|
|
Primary Sponsor
|
| Name |
Jamia Millia Islamia |
| Address |
Jamia Millia Islamia, Okhla, 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 clinic (OPD), Jamia Millia Islamia
South
DELHI |
9958993486
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 |
Lumbar stabilization exercises and hot pack |
Group 2 will receive lumbar stabilization exercises three sessions per week, 30-60 minutes in each session and each exercise will be performed with 10 times repetitions. The exercises will progressed gradually from easy to difficult. Total duration is 6 weeks. |
| Intervention |
Pain neuroscience education and Lumbar stabilization exercises |
Pain neuroscience education will be given once a week for 6 weeks and Lumbar stabilization exercises will be done for six weeks, three sessions per week, 30-60 minutes in each session and each exercise will be performed with 10 times repetitions. The exercises progressed gradually from easy to difficult. Total duration is 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Medical diagnosis of non-specific chronic Low
back pain (NCLBP) with pain and symptoms
persisting for longer than 3 months
2. NPRS more than 3
3. Ambulation without a walking aid.
4. Subjects volunteering to participate in the
study
5. Participants having a basic understanding of
the English language
|
|
| ExclusionCriteria |
| Details |
1. Unwilling or unable to complete the extensive
physical examination.
2. Pregnant women
3. Any Lumbar surgery
4. Spinal deformities
5. Lower limb deformities
6. Severe hip degenerative disorders
7. Inflammatory joint disease
8. Traumatic low back and lower limb injuries
9. Osteoporosis
10. Spine and lower extremity fracture or dislocation
11. Any neurological or motor deficit
12. Known case of any serious medical pathology
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
PSQI
Gait On posture analysis
P300-Event related potential
Oswestry disability questionnaire |
At baseline
At 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
MOCA for cognition assessment
Tampa scale of kinesiophobia
Centra sensitization Inventory
Fear avoidance scale
|
0 day
45 day |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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 out patient department, centre for physiotherapy and Rehabilitation Sciences (CPRS), Jamia Millia Islamia. Subjects with Chronic low back pain
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).
Following the screening, demographics including age, height, weight, and BMI as
well as clinical characteristics such as Numeric pain rating scale, Oswestry
disability questionnaire, Mc gill pain quessionnaire, central sensitization
Inventory, PSQI for sleep quality, the cognitive assessment will be done by
using Montreal Cognitive Assessment (MoCA) (subjective) and Event related
potential P300 (objective) will be assessed. Posture analysis will be done by
using Gait On posture analysis device. After assessing the baseline criterion
measures, the participants will be further randomly allocated to one of the
three interventions groups: (I) Conventional treatment (Lumbar
stabilization exercises, hot pack and IFT) (II) Pain science education group
(conventional treatment with pain science education). The intervention will be given for 6 weeks
period. The outcome variables will be assessed at baseline and after a period
of 6 weeks. |