| CTRI Number |
CTRI/2023/11/059861 [Registered on: 15/11/2023] Trial Registered Prospectively |
| Last Modified On: |
09/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing the relationship between pain with knee cartilage thickness and disability in knee pain patients |
|
Scientific Title of Study
|
Association of neuropathic pain with femoral cartilage thickness and disability in patients of osteoarthritis knee : 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 |
Shadan javad p |
| Designation |
Junior resident |
| Affiliation |
Aiims jodhpur |
| Address |
Ground floor
Department of PMR
All India Institute Of Medical Sciences(AIIMS) Basni Industrial Area Phase-2 Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8547123240 |
| Fax |
|
| Email |
s.javadslr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi gaur |
| Designation |
Additional Professor and HOD department of PMRent of |
| Affiliation |
Aiims jodhpur |
| Address |
Ground floor
Department of PMR
All India Institute Of Medical Sciences(AIIMS) Basni Industrial Area Phase-2 Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8299711753 |
| Fax |
|
| Email |
ravisms80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RAVI GAUR |
| Designation |
Additional Professor and HOD department of PMR |
| Affiliation |
AIIMS JODHPUR |
| Address |
Ground Floor, Department of PMR,AIIMS JODHPUR, Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8299711753 |
| Fax |
|
| Email |
ravisms80@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aiims Jodhpur
Marudhar Industrial Area, 2nd Phase, Basni, Basni, Jodhpur, Rajasthan Pin:342005 |
|
|
Primary Sponsor
|
| Name |
Shadan Javad P |
| Address |
Ground floor
Department of PMR
All India Institute Of Medical Sciences(AIIMS) Basni Industrial Area Phase-2 Jodhpur-342005 Rajasthan |
| 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 |
| Dr Ravi gaur |
All India Institute Of Medical Sciences |
Groung floor
department of PMR
All India Institute Of Medical Sciences, Basni Industrial Area Phase-2 Jodhpur-342005 Rajasthan
Jodhpur
RAJASTHAN |
829971153
ravisms80@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Aiims jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Chronic history of knee joint pain (going back at least three months)
Knee osteoarthritis diagnosed with ACR criteria
Knee osteoarthritis with radiographic evidence, grades 2 to 3. |
|
| ExclusionCriteria |
| Details |
Previous trauma history
Knee-related surgeries in the past or any radiological interventions of nerves on the
affected limb.
Inflammatory rheumatic disease
Central or peripheral neuropathy
Radiculopathy with established history.
Severe cardiac, pulmonary, or cancerous diseases or diabetes mellitus |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. neuropathic pain and femoral cartilage thickness have direct relationship
2.neuropathic pain causes disability for the patients |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.neuropathic pain causes disability for the patients |
18 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/11/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/11/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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
|
Population: Chronic knee pain patients who are diagnosed with Osteoarthritis knee
Intervention: No intervention
Comparison: Comparison of femoral cartilage thickness and disability in patients with and
without neuropathic component of pain in Osteoarthritis.
Outcome: Correlation between femoral cartilage thickness and neuropathic pain in
Osteoarthritis.
Type of study: Cross sectional study
Aim: To determine if neuropathic pain is associated with femoral cartilage thickness and
impairment in OA knee patient.
Objectives of the study are to evaluate and determine the relationship between neuropathic
pain component and femoral cartilage thickness in OA knee patients using the painDETECT
questionnaire. Also to evaluate the neuropathic pain component in OA knee patients using the
painDETECT questionnaire and to evaluate and identify correlations between the neuropathic
pain component and pain using VAS, quality of life using the Short Form-36 questionnaire,
and functional status using the WOMAC questionnaire in patients with OA knees.
Inclusion criteria: Patients with Age more than 40 years, Chronic history of knee joint pain
(going back at least three months), Knee osteoarthritis diagnosed with ACR criteria and Knee osteoarthritis with radiographic evidence, grades 2 to 3 (according to the Kellgren-Lawrence
radiographic grading system). |