| CTRI Number |
CTRI/2024/10/075348 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Features of Taut Bands and Walking Ability in Knee Arthritis patients coming to Tertiary Care Hospital in Gangtok |
|
Scientific Title of Study
|
Characteristics of Myofascial Trigger Points and Functional Status in Unilateral Knee Osteoarthritis Reporting to Tertiary Care Hospital in Gangtok: A Cross Sectional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanstutee Mishra |
| Designation |
Post Graduation Student |
| Affiliation |
Sikkim Manipal University |
| Address |
Sikkim Manipal College of Physiotherapy, Sikkim Manipal University, 5th mile Upper Tadong, Gangtok, Sikkim
Sikkim Manipal College of Physiotherapy, Sikkim Manipal University, 5th mile Upper Tadong, Gangtok, Sikkim
East
SIKKIM
737102
India |
| Phone |
9380189718 |
| Fax |
|
| Email |
sanstutee2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nikita Joshi Sonowal |
| Designation |
Professor |
| Affiliation |
Sikkim Manipal University |
| Address |
Sikkim Manipal College of Physiotherapy, Sikkim Manipal University, 5th mile Upper Tadong, Gangtok, Sikkim
Sikkim Manipal College of Physiotherapy, Sikkim Manipal University, 5th mile Upper Tadong, Gangtok, Sikkim
East
SIKKIM
737102
India |
| Phone |
9932470754 |
| Fax |
|
| Email |
nikita.j@smims.smu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sanstutee Mishra |
| Designation |
Post Graduation Student |
| Affiliation |
Sikkim Manipal University |
| Address |
Sikkim Manipal College of Physiotherapy, Sikkim Manipal University, 5th mile Upper Tadong, Gangtok, Sikkim
Sikkim Manipal College of Physiotherapy, Sikkim Manipal University, 5th mile Upper Tadong, Gangtok, Sikkim
East
SIKKIM
737102
India |
| Phone |
9380189718 |
| Fax |
|
| Email |
sanstutee2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy
Central Referral Hospital
5th Mile Tadong
East Sikkim
737102 |
|
|
Primary Sponsor
|
| Name |
Sanstutee Mishra |
| Address |
Central Referral Hospital
5th Mile Tadong
East Sikkim |
| 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 |
| DrSanstutee MishraPT |
Central Referral Hospital |
Department of Physiotherapy OPD
East
SIKKIM |
9380189718
sanstutee2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMIMS INSTITUTE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Unilateral Osteoarthritis knee symptoms fulfilling Kellgren and Lawrence system of classification grade 0-3 (mild-moderate) |
|
| ExclusionCriteria |
| Details |
Lumbar radiculopathy associated myofascial pain
Diagnosed case of Bilateral Knee Osteoarthritis
Grade 4(severe) OA knee
Unable to walk without walking aids
Surgical or medical autoimmune conditions that severely limits functional status
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Functional Knee Range of Motion |
at the start of assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Timed up and go test |
Time taken should be less than 30 seconds |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2024 |
| Date of Study Completion (India) |
28/03/2025 |
| Date of First Enrollment (Global) |
01/11/2024 |
| Date of Study Completion (Global) |
28/03/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Malaysian Journal of Medical Sciences |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to find out the characteristics of myofascial trigger point in patients with unilateral knee osteoarthritis of grade 0-3 that is mild-moderate who are able to walk independently without use of any assistive devices.First Western Ontario and Mc Master Osteoarthritis Index(WOMAC) questionnaire will be given to the patient in which the patient has to grade his/her pain,stiffness and difficulty in doing activities of daily living.It is graded from 0 that is nil to 4 that is severe.The total score will be calculated from 68. The affected and unaffected functional knee range of motion will be checked to see how much difference is their in the joint range of motion. Then the characteristics of myofascial trigger points that is whether there is a taut band, palpable nodule, hypersensitive point or referred pain will be checked in the surrounding knee joint and calf muscles of both affected and unaffected side. Pressure Algometer will be used to record the pain pressure threshold of trigger points palpated in the muscles. Lastly the functional status, balance of the patient will be checked by Timed Up and Go test(TUG) in which patient willl be asked to get up from chair and walk 3 m from the chair. Timer will be started from the point the patient gets up from chair and timer will be stopped once the patient returns back to sit on chair again.Demographic Data will be collected,assessed, compiled and analyzed. |