| CTRI Number |
CTRI/2022/12/048526 [Registered on: 27/12/2022] Trial Registered Prospectively |
| Last Modified On: |
17/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Analysis of Correlation of the Neck Muscles Endurance and Pain with Neck Disability in Neck Pain Patients |
|
Scientific Title of Study
|
Analysis of Correlation between the Neck Muscle Endurance and Pain with Neck Disability in Patients with Chronic Neck Pain |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swati Paranjape |
| Designation |
Assistant Professor |
| Affiliation |
Seth G S Medical College, KEM Hospital |
| Address |
Department of Physiotherapy, Seth G S Medical College, KEM Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
022-24107000 |
| Fax |
|
| Email |
swati.paranjape@kem.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh Gore PT |
| Designation |
Post Graduate Student |
| Affiliation |
Seth G S Medical College, KEM Hospital |
| Address |
Department of Physiotherapy, Seth G S Medical College, KEM Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
022-24107000 |
| Fax |
|
| Email |
ganeshgore1997@gmai.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ganesh Gore PT |
| Designation |
Post Graduate Student |
| Affiliation |
Seth G S Medical College, KEM Hospital |
| Address |
Department of Physiotherapy, Seth G S Medical College, KEM Hospital, Parel, Mumbai
MAHARASHTRA
400012
India |
| Phone |
022-24107000 |
| Fax |
|
| Email |
ganeshgore1997@gmai.com |
|
|
Source of Monetary or Material Support
|
| Seth G S Medical College, KEM Hospital |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Ganesh Gore PT |
Seth G S Medical College, KEM Hospital |
Department of Physiotherapy OPD 402, Ground Floor, Orthopedic Centre, Opp Tata Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA |
022-24107000
ganeshgore1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IEC II |
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, (2) ICD-10 Condition: M999||Biomechanical lesion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients with chronic neck pain lasting more than 3 months
2)Pain experienced in the area between occiput and third thoracic vertebra and between the medial borders of scapula
3)Both males and females
4)Adults over 18 years
5)Visual analog scale rating for pain 4 and above
6)Willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1)Patients with disorders of the cervical spine such as Disc prolapse, Spinal Canal stenosis, Radiculopathy
2)Patients suffering from neurological conditions like stroke, upper or lower motor neuron lesions, spinal cord injuries, Parkinson’s disease, multiple sclerosis, amyotrophic lateral sclerosis, muscular dystrophy, ataxia, epilepsy and seizures
3)Major medical or surgical history
4)A history of trauma
5)History of spinal surgery
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)The endurance of the neck flexor and neck extensor muscles using neck flexor muscle endurance test and neck extensor muscle endurance test
2)Intensity of neck pain using Visual Analogue Scale(VAS)
3) Neck disability using the Copenhagen Neck Functional Disability Scale
|
Baseline (First visit) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="47"
Sample Size from India="47"
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)
|
06/01/2023 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Neck pain is common condition and can affect the 50% population at some time of their lives. There found to be reduced efficiency, strength and endurance of neck muscles in neck pain patients. However there is conflicting evidence about correlation between pain , endurance and disability. There are various factors which influence the disability and function. Limited studies were found in Indian population. Hence the present research is designed to study the correlation between pain, endurance with disability in chronic neck pain patients. |