| CTRI Number |
CTRI/2025/01/079695 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between Sleep and Pain |
|
Scientific Title of Study
|
A cross-sectional study to explore the association between sleep disturbances and musculoskeletal 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 |
SOWMYA R |
| Designation |
Under Graduate |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research[Deemed to be university] |
| Address |
Faculty of Physiotherapy, Room No 4.3, Floor 4, Sri Ramachandra
Institute of Higher Education and Research[Deemed to be
university],Porur,Chennai-600116,Tamil Nadu, India.
Chennai
TAMIL NADU
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
6383618413 |
| Fax |
|
| Email |
sowmya20021130@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Soundararajan |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research[Deemed to be university] |
| Address |
Faculty of Physiotherapy, Room No 2.3, Floor 2, Sri Ramachandra
Institute of Higher Education and Research[Deemed to be
university],Porur,Chennai-600116,Tamil Nadu, India
Chennai
TAMIL NADU
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9551163416 |
| Fax |
|
| Email |
soundararajan.k@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Soundararajan |
| Designation |
Undergraduate |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research[Deemed to be university] |
| Address |
Faculty of Physiotherapy, Room No 4.3, Floor 4, Sri Ramachandra
Institute of Higher Education and Research[Deemed to be
university],Porur,Chennai-600116,Tamil Nadu, India.
Chennai
TAMIL NADU
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
6383618413 |
| Fax |
|
| Email |
soundararajan.k@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research[Deemed to be university] |
| Address |
Faculty of Physiotherapy,Sri Ramachandra Institute of Higher
Education and Research[Deemed to be
university],Porur,Chennai-600116,Tamil Nadu,India |
| Type of Sponsor |
Private medical college |
|
|
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 Deva Rajan |
Sri Ramachandra Hospital |
Faculty of
Physiotherapy, Room
No 2.3, Floor 2, Sri
Ramachandra Institute
of Higher Education
and Research[Deemed
to be university],Porur,
Chennai-600116,Tamil
Nadu, India.
Chennai
TAMIL NADU
Kancheepuram
TAMIL NADU |
8778601824
vishnudevaraj2003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH INSTITUTIONAL ETHICS COMMITTEE OF STUDENT PROJECTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects identified with musculoskeletal pain.
Age 18 years including both men and women.
|
|
| ExclusionCriteria |
| Details |
Individuals with comorbid sleep disorders unrelated to musculoskeletal conditions. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pittsburgh sleep quality index |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="520"
Sample Size from India="520"
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)
|
10/02/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
o The association between sleep disturbances and musculoskeletal pain is bidirectional. Poor sleep quality can worsen in existing pain conditions and increase sensitivity to pain. Observingly, chronic pain can reduce sleep patterns, leading to insomnia, difficulty falling asleep, or frequent awakenings throughout the night. This relationship is often assign to shared neural pathways involved in pain perception and sleep regulation in impact of pain on physical activity and well-being, Further , conditions such as sleep apnea and restless leg syndrome can contribute to both sleep disturbances and musculoskeletal pain. o Sleep problems are commonly associated with various musculoskeletal (MSK) conditions. Patients suffering from musculoskeletal pain often report poor-quality sleep. The relationship between pain and sleep is complicated. Sleep disturbances are adequately in patients with MSK disorders. Evidence suggests a bidirectional association between sleep-related problems (SRP) and musculoskeletal pain (MP). Insomnia, poor sleep quality, and nonrestorative sleep are frequently reported by individuals with MSK pain.
|