| CTRI Number |
CTRI/2025/09/094664 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Sleep Disability Questionnaire in Individuals with Chronic Low Back Pain: Development, Validation and Reliability |
|
Scientific Title of Study
|
Development, Validation and Reliability Testing of Sleep Disability Questionnaire in Individuals with 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 |
Mousumi Saha |
| Designation |
PhD Scholar |
| Affiliation |
MMIPR |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation Maharishi Markandeshwar Deemed to be University Mullana
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation Maharishi Markandeshwar Deemed to be University Mullana
Ambala
HARYANA
133207
India |
| Phone |
9366787310 |
| Fax |
|
| Email |
msaha0029@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manu Goyal |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation Maharishi Markandeshwar Deemed to be University Mullana
Ambala
HARYANA
133207
India |
| Phone |
8307715320 |
| Fax |
|
| Email |
manu.goyal@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Mousumi Saha |
| Designation |
PhD Schollar |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation Maharishi Markandeshwar Deemed to be University Mullana
Ambala
HARYANA
133207
India |
| Phone |
9366787310 |
| Fax |
|
| Email |
msaha0029@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation. Mullana, Ambala, Haryana, 133207 |
|
|
Primary Sponsor
|
| Name |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation. Mullana, Ambala, Haryana, 133207 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Mousumi Saha |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
Room no 5 Physiotherapy Department Maharishi Markandeshwar Deemed to be University Mullana
Ambala
HARYANA |
9366787310
msaha0029@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC MMIMSR |
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 |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals with chronic mechanical low back pain.
2. BMI as per Asian classification
3. Individuals reported to have fair to severe sleep disturbances on numeric sleep disturbance scale after developing back pain.
4. Both Male and female.
5. Age between 20-50 years
6. Pain more than 5 on VAS
|
|
| ExclusionCriteria |
| Details |
1. Acute low back pain (less than 3 months)
2. History of spinal surgery in last 6 month.
3. History of taking treatment for insomnia in last 6 months.
4. suffering from other comorbid illness.
5. Suffering from metabolic disorders.
6. Suffering from psychosomatic ill ness.
7. History of sleep apnea related problem.
8. History of Restless leg syndrome.
9. History of peripheral vascular disease.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sleep Disability Questionnaire |
baseline and after 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="51"
Sample Size from India="51"
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
|
N/A |
|
Date of First Enrollment (India)
|
13/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Background Chronic low back pain (CLBP) is one of the most common musculoskeletal illnesses, affecting up to 80% of people at some point in their lives and making them unable to work. About 70% of people with CLBP say they have trouble sleeping, which is a big deal. Chronic pain and sleep problems are linked in complicated ways, but the instruments we use to assess them don’t always take into consideration the unique problems that people with CLBP encounter. Methods The investigation will happen in two separate stages: Phase 1 In this first step, we will create and test the Sleep Disability Questionnaire (SDQ). This method will include finding the right domains and things by talking to experts, interviewing patients, and doing extensive evaluations of the literature. We will use the Delphi approach to make sure the material is valid, and then we will do pilot testing to see how useful and effective the questionnaire is. We will use exploratory factor analysis to look at construct validity. Phase 2 The second step will be all about checking the SDQ’s reliability and other psychometric qualities, such as internal consistency and reliability between and within raters. We will choose 51 CLBP patients who have serious sleep problems based on criteria we have already set. Results The study will use kappa statistics and indices like the Item-Level Content Validity Index (I-CVI) and the Scale-Level Content Validity Index (S-CVI) to check the content validity. We will also use normalcy tests like the Kolmogorov-Smirnov and Shapiro-Wilk tests. We will use regression analysis, Cronbach’s alpha, Pearson or Spearman correlations, Bland-Altman plots, and the intraclass correlation coefficient (ICC) to check for reliability. Conclusion the goal of our project is to make a new, dependable Sleep Disability Questionnaire that is specifically designed for people with CLBP and test it fully. We think that the SDQ will give researchers and doctors a better way to look at and treat sleep problems in this group of people. This will lead to better patient outcomes and a better quality of life over time. |