| CTRI Number |
CTRI/2025/07/090207 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Sleep Disruption and Its Role in Neck Pain due to Cervical Dysfunction: An Experimental Study |
|
Scientific Title of Study
|
The Impact of Sleep Disruption on Cervical Dysfunction-Related Neck 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 |
Nisha Yadav |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
Department of Physiotherapy, Galgotias University, Plot No. 2, Sector 17A, Yamuna Expressway, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9311522870 |
| Fax |
|
| Email |
Nishyadav847@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nisha Yadav |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
Department of Physiotherapy, Galgotias University, Plot No. 2, Sector 17A, Yamuna Expressway, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh 203201
UTTAR PRADESH
203201
India |
| Phone |
9311522870 |
| Fax |
|
| Email |
Nishyadav847@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti Yadav |
| Designation |
Associate Professor |
| Affiliation |
Galgotias Univeristy |
| Address |
Department of Physiotherapy, Galgotias University, Plot No. 2, Sector 17A, Yamuna Expressway, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
8057366428 |
| Fax |
|
| Email |
jyoti.yadav@galgotiasuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Galgotias University, Plot No. 2, Sector 17A, Yamuna Expressway, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh 203201 |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Department of Physiotherapy, Galgotias University |
| Type of Sponsor |
Research institution |
|
|
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 Jyoti Yadav |
Galgotias University |
Department of Physiotherapy, B 315, Gautam Buddha Nagar, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH |
8057366428
jyoti.yadav@galgotiasuniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M953||Acquired deformity of neck, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Sleep Disruption and Neck pain |
The 20 participants in the study were divided into two groups, with 10 individuals in each group. Group A participants received cognitive-behavioral therapy for insomnia (CBT-I) for 4 weeks. Group B participants underwent a structured exercise program focused on neck pain rehabilitation for 4 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with sleep disorders, such as insomnia or obstructive sleep apnea, through polysomnography or validated questionnaires. |
|
| ExclusionCriteria |
| Details |
History of cervical spine surgery, Presence of malignancies, Acute neck injuries, Neurological disorders affecting sleep or pain perception, Structural deformities of the cervical spine, Severe psychiatric disorders
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Both groups were assessed before and after the intervention using the Visual Analogue Scale (VAS for pain assessment, the Oswestry Disability Index (ODI) for functional disability, and the Pittsburgh Sleep Quality Index (PSQI) for sleep quality. |
one time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 4 |
|
Date of First Enrollment (India)
|
15/07/2025 |
| 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="1"
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
|
Neck pain dysfunction (NPD) is a widespread musculoskeletal disorder that impacts a significant portion of the population, with studies indicating a prevalence of 30% to 50% among adults at some point in their lives. Characterized by discomfort, stiffness, and reduced mobility in the cervical region, NPD can lead to substantial physical limitations and emotional distress. The primary aim of this research is to explore the relationship between sleep-related disorders and neck pain dysfunction (NPD). The study involved 20 individuals experiencing neck pain dysfunction (NPD) and sleep-related disorders, recruited from outpatient clinics specializing in pain management and sleep medicine. The 20 participants in the study were divided into two groups, with 10 individuals in each group. Group A participants received cognitive-behavioral therapy for insomnia (CBT-I) for 4 weeks. Group B participants underwent a structured exercise program focused on neck pain rehabilitation for 4 weeks. Both groups were assessed before and after the intervention using the Visual Analogue Scale (VAS for pain assessment, the Oswestry Disability Index (ODI) for functional disability, and the Pittsburgh Sleep Quality Index (PSQI) for sleep quality. |