| CTRI Number |
CTRI/2022/10/046322 [Registered on: 10/10/2022] Trial Registered Prospectively |
| Last Modified On: |
31/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Pain on movement while performing weight-bearing and non-weight-bearing activities in patients with knee osteoarthritis |
|
Scientific Title of Study
|
To explore movement evoked pain in weight-bearing and non-weight-bearing activities in patients with chronic knee osteoarthritis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Isha Nitinkumar Agrawal |
| Designation |
Postgraduate Student |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal- 576104, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9113012403 |
| Fax |
|
| Email |
agrawal.nitinkumar@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Ganesh Balthillaya M |
| Designation |
Assistant Professor (Selection grade) |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal- 576104, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9448263631 |
| Fax |
|
| Email |
ganesh.bm@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Anupama Prabhu |
| Designation |
Assistant Professor (Selection grade) |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal- 576104, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9986451010 |
| Fax |
|
| Email |
anupama.prabhu@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions |
|
|
Primary Sponsor
|
| Name |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal-576104, Karnataka, India |
| Type of Sponsor |
Research institution and hospital |
|
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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 |
| Isha Agrawal |
Kasturba Hospital |
Department of Physiotherapy, Manipal- 576104, Karnataka, India
Udupi
KARNATAKA |
9113012403
agrawal.nitinkumar@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M17||Osteoarthritis of knee, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Chronic knee osteoarthritis (more than 3 months)
2. Conservatively managed or pre-operative knee osteoarthritis cases
3. Pain severity of more than 3 out of 10 on the Numeric Pain Rating Scale (NPRS)
4. Radiologically (Kellgren Lawrence grade of more than 0) or clinically (ACR criteria) diagnosed knee osteoarthritis
5. Can read and understand English and/or Kannada
6. Cognitively sound |
|
| ExclusionCriteria |
| Details |
1. Known case of neurological disorder (e.g., peripheral neuropathy, stroke, GBS, multiple sclerosis, spinal cord lesion, cognitive impairment)
2. Known case of systemic disorder (e.g., rheumatoid arthritis, SLE, fibromyalgia)
3. Skin lesion at assessment site
4. Pain for more than 3 months in areas other than the knee (e.g., chronic low back pain) |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Numeric Pain Rating Scale (NPRS) score in weight-bearing activities
2) Numeric Pain Rating Scale (NPRS) score in non-weight-bearing activities
3) Percentage change in pain severity in weight-bearing activities
4) Percentage change in pain severity in non-weight-bearing activities |
One time assessment at the time of recruitment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Wind-up ratio
2. Pain pressure threshold
3. Knee Injury and Osteoarthritis Outcome Score (KOOS)
4. Michigan Body Map (MBM) |
One time assessment at the time of recruitment |
|
|
Target Sample Size
|
Total Sample Size="41"
Sample Size from India="41"
Final Enrollment numbers achieved (Total)= "41"
Final Enrollment numbers achieved (India)="41" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/10/2022 |
| Date of Study Completion (India) |
30/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
After CTRI approval has been obtained, the participants will be screened based on the inclusion and exclusion criteria. They will be included in the study after giving their informed consent. Demographic details and knee osteoarthritis characteristics will be recorded, after which Knee Injury and Osteoarthritis Outcome Score (KOOS) and Michigan Body Map (MBM) will be administered. The participants will be asked to perform weight-bearing and non-weight-bearing activities, during which the movement evoked pain and its sensitivity will be recorded using the 11-point Numeric Rating Scale (NPRS). Quantitative sensory tests (QST)- temporal summation and pain pressure threshold will be assessed and the results will be recorded. Data will be analyzed statistically and the results will be reported.
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