| CTRI Number |
CTRI/2024/07/070857 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
15/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Checking Forward Bent Position Of Neck In People With Fibromyalgia |
|
Scientific Title of Study
|
Assessment Of Forward Head Posture In Patients With Fibromyalgia Syndrome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vathsalya Sanil |
| Designation |
1st Year MPT Student |
| Affiliation |
Father Muller College Of Physiotherapy |
| Address |
Father Muller Medical College Father Muller Road Kankanady Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8762732051 |
| Fax |
|
| Email |
sanivathsalya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Leah Mohandas |
| Designation |
Professor |
| Affiliation |
Father Muller College Of Physiotherapy |
| Address |
Father Muller Medical College Father Muller Road Kankanady Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9739863768 |
| Fax |
|
| Email |
leahdas86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vathsalya Sanil |
| Designation |
1st Year MPT Student |
| Affiliation |
Father Muller College Of Physiotherapy |
| Address |
Father Muller Medical College Father Muller Road Kankanady Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8762732051 |
| Fax |
|
| Email |
sanivathsalya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Father Muller College Of Physiotherapy
Father Muller College Father Muller Road Kankanady Mangalore
karnataka India Pin Code 575002 |
|
|
Primary Sponsor
|
| Name |
Vathsalya Sanil |
| Address |
Father Muller College Father Muller Road Kankanady Mangalore
karnataka India Pin Code 575002 |
| 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 |
| VATHSALYA SANIL |
Father Muller College Of Physiotherapy |
Department Of Physiotherapy Basement 3rd room Kankanady Mangalore-575002
Dakshina Kannada
KARNATAKA |
8762732051
sanivathsalya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| FATHER MULLER INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed fibromyalgia syndrome
Wide spread bodily pain
Poorly localized chronic pain |
|
| ExclusionCriteria |
| Details |
Patients with head and neck trauma or tumor
Patients with systematic condition(rheumatoid arthritis)
Patients with sever dental disease
Patients with psychiatric disorder
Patients with history of fracture or surgery past six months
Patients with neurological disorder
Patients with sever osteoarthritis
Patients with progressive central and peripheral nervous disorder
Patients with mental disability
Pregnancy
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Kinovea Software to assess forward head posture |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fibromyalgia Impact Questionnaire |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
30/07/2024 |
| 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
|
Fibromyalgia syndrome is a condition where people experience widespread muscle pain. Fatigue,
stiffness, in the morning, trouble sleeping, memory and mood issues, chronic headaches, jaw pain and
digestive problem like irritable bowel syndrome. It’s quite common, affecting around 2% to 8% of the
population. One common issue in fibromyalgia is problem with the jaw joint, called temporomandibular joint
disorder (TMJD), which can lead to pain in the face and neck, Research has shown that many people with
fibromyalgia also have TMJ problem, often linked to poor posture, particularly a head position that leans
forward. Neck pain is another big problem for people with fibromyalgia, often leads forward head posture.
Taking side photo is the usual way to check if someone’s head is leaning forward, and it’s a quick and cheap
method. Since, fibromyalgia can be affected by many things, its best to treat it using different approaches. the
current study aimed to check forward head posture in fibromyalgia syndrome in order to correct posture.
|