CTRI Number |
CTRI/2021/05/033445 [Registered on: 07/05/2021] Trial Registered Prospectively |
Last Modified On: |
06/05/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
Analysis of Musculoskeletal Dysfunction and perception in subjects with Chronic Non-Specific Neck Pain
|
Scientific Title of Study
|
To analyse the Musculoskeletal Dysfunction ,Physical Performance and Patient’s perception towards Pain and Disability in subjects with Chronic Non-Specific 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 |
Dipti Geete |
Designation |
Assistant Professor |
Affiliation |
Physiotherapy School and Center Seth G S Medical College And K E M Hospital |
Address |
OPD NO 402, Room NO 5,Physiotherapy School and Center Seth G S Medical College and K.E. M . Hospital, Parel Mumbai 400012 OPD NO 402, Room NO 5,Physiotherapy School and Center Seth G S Medical College and K.E. M . Hospital, Parel Mumbai 400012 Mumbai MAHARASHTRA 400012 India |
Phone |
|
Fax |
|
Email |
diptigeete123@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dipti Geete |
Designation |
Assistant Professor |
Affiliation |
Physiotherapy School and Center Seth G S Medical College And K E M Hospital |
Address |
OPD NO 402, Room NO 5,Physiotherapy School and Center Seth G S Medical College and K.E. M . Hospital, Parel Mumbai 400012 OPD NO 402, Room NO 5,Physiotherapy School and Center Seth G S Medical College and K.E. M . Hospital, Parel Mumbai 400012 Mumbai MAHARASHTRA 400012 India |
Phone |
|
Fax |
|
Email |
diptigeete123@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dipti Geete |
Designation |
Assistant Professor |
Affiliation |
Physiotherapy School and Center Seth G S Medical College And K E M Hospital |
Address |
OPD NO 402, Room NO 5,Physiotherapy School and Center Seth G S Medical College and K.E. M . Hospital, Parel Mumbai 400012 OPD NO 402, Room NO 5,Physiotherapy School and Center Seth G S Medical College and K.E. M . Hospital, Parel Mumbai 400012 Mumbai MAHARASHTRA 400012 India |
Phone |
|
Fax |
|
Email |
diptigeete123@gmail.com |
|
Source of Monetary or Material Support
|
OPD NO 402, Room NO 5,Physiotherapy School and Center Seth G S Medical College and K.E. M . Hospital, Parel Mumbai 400012 |
|
Primary Sponsor
|
Name |
Dipti Geete |
Address |
PT School and Center GS Medical College and K E M Hospital |
Type of Sponsor |
Other [Self] |
|
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 |
Mrs Bhavana Mhatre |
PT School And Center, GSMC and KEM Hospital |
OPD NO 402, Room NO 5,Physiotherapy School and Center Seth G S Medical College and K.E. M . Hospital, Parel Mumbai 400012 Mumbai MAHARASHTRA |
02224143435
us_contact@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
Institutional Ethics Committee , Seth Gs Medical College |
Approved |
Institutional Ethics Committee , Seth Gs Medical College |
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
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Both |
Details |
Chronic non-specific neck pain |
|
ExclusionCriteria |
Details |
1) History of cervical trauma /injury
2) Cervical Radiculopathy, Myelopathy, Instability
3) History of cervical spine surgery
4) Signs of Central Nervous System Affection
5) Systemic Conditions like uncontrolled diabetes mellitus, fibromyalgia,
6) Pregnancy, Fibromyalgia.
7) Infections or Inflammatory Pathologies involving the cervical Spine
8) History of psychiatric disorders or usage of antipsychotic drugs.
9) History of Acute Neck Pain |
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Other |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
- Posture, Joint Position sense, balance, Cervical Endurance Test
- Neck Disability Index, Patient Specific Functional scale, Pain self Efficacy Scale. |
At the baseline |
|
Secondary Outcome
|
Outcome |
TimePoints |
NIL |
NIL |
|
Target Sample Size
|
Total Sample Size="87" Sample Size from India="87"
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)
|
17/05/2021 |
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
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Summary of Protocol Nonspecific Neck pain is one of the most prevalent musculoskeletal conditions resulting in physical impairments and functional limitations. It is assumed to be a multifactorial disease. There may be dysfunction of body structure along with psychological and environmental factors that might influence the physical performance of an individual. The overall prevalence of neck pain in the general population ranges between 0.4% and 86.8% (mean: 23.1%); and 1 year prevalence ranges from 4.8% to 79.5% (mean: 25.8%). Prevalence is generally higher in women, higher in high-income countries compared with low- and middle-income countries, and higher in urban areas compared with rural areas. Our study will be conducted by recruiting people with non-specific neck pain. Study group, which consists of 87 subjects between 18-45 years of age with non-specific neck pain. The subjects will be asses for musculoskeletal dysfunction which includes posture, balance, muscle endurance test, and proprioception. The subject’s perception towards pain and disability will be assessed by pain on NRS and through the self-reported questionnaires, for example, Neck disability index, Patient-Specific functional scale, and self– efficacy scale. Along with the above-mentioned evaluation, the subjects will be asses on the basis of the physical performance also. The study aims to find a relationship between musculoskeletal dysfunction of the cervical spine and the patient’s perception toward pain and disability and its effect on physical performance. |