| CTRI Number |
CTRI/2026/02/102777 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
31/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Benefits of a structured exercise program and pain education in knee osteoarthritis patients |
|
Scientific Title of Study
|
Effects of Structured Exercise and Pain Neuroscience Education on Pain Qualifiers in Knee Osteoarthritis |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tejjuas G |
| Designation |
Postgraduate student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Room No:2.2,second floor, Sri Ramachandra Faculty of physiotherapy, Sri Ramachandra Institute of higher education and Research, Porur, Chennai, Tamil Nadu
Chennai TAMIL NADU 600116 India |
| Phone |
7010127258 |
| Fax |
|
| Email |
tejjuasgandhinathan31@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
AngelineR |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Faculty of physiotherapy, Sri Ramachandra Institute of higher education and Research, Porur, Chennai, Tamil Nadu
Chennai TAMIL NADU 600116 India |
| Phone |
9943529400 |
| Fax |
|
| Email |
angelinejobin75@sriramachandra.edu.in |
|
Details of Contact Person Public Query
|
| Name |
AngelineR |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Faculty of physiotherapy, Sri Ramachandra Institute of higher education and Research, Porur, Chennai, Tamil Nadu
Chennai TAMIL NADU 600116 India |
| Phone |
9943529400 |
| Fax |
|
| Email |
angelinejobin75@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research, New block Physiotherapy OPD , Ground floor, No:1 sri ramachandra nagar , Porur , Chennai,Tamil Nadu, 600116 |
|
|
Primary Sponsor
|
| Name |
Tejjuas G |
| Address |
No:1 Sri Ramachandra Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research , Porur, Chennai,Tamil Nadu 600116 |
| Type of Sponsor |
Other [self funded] |
|
|
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 Angeline |
sri ramachandra institute of higher education and research |
new G block physiotherapy OPD ground floor sri ramachandra hospital sri ramachandra institute of higher education and research porur chennai 600116 Chennai TAMIL NADU |
9943529400
angelinejobin75@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Commitee For Students project |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M859||Disorder of bone density and structure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Structured exercise alone |
Supervisied structured exercise without pain neuroscience education |
| Intervention |
Structured exercise with Pain neuroscience education |
supervised structure exercise combined with pain neuroscience education 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Age 45 to 75 years.
Experienced knee pain for at least 3 months
Average knee pain greater than 3/10 on Numeric Pain Rating Scale (NPRS) over the past week
Pain Catastrophizing Scale (PCS) more than 20
|
|
| ExclusionCriteria |
| Details |
Knee surgery in past 6 months or planned in next 3 months
Systemic inflammatory arthritis, oncologic pain, or other red-flag conditions
Neurological diseases affecting lower limb sensation
Intra-articular injection in past 3 months
pregnant women
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
SF MPQ sensory subscale
Pain DETECT |
baseline and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
numerical pain rating scale
Central sensitization inventory
pain catastrophizing scale
Knee injury & osteoarthritis outcome score |
baseline week 0 & end of the intervention week 4 |
|
|
Target Sample Size
|
Total Sample Size="76" Sample Size from India="76"
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)
|
15/02/2026 |
| 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="0" Months="1" 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
|
Knee osteoarthritis is a common condition that causes long-term knee pain, stiffness, and difficulty in daily activities. Many people with knee osteoarthritis experience different types of pain sensations such as aching, burning, or sharp pain, which can affect their quality of life. Exercise therapy is commonly recommended for managing knee osteoarthritis pain; however, pain education may further improve pain experience by helping individuals better understand and manage their pain.This study aims to compare the effects of a structured exercise program alone and a structured exercise program combined with pain education on pain characteristics in individuals with knee osteoarthritis. Participants will be randomly allocated into two groups. Both groups will receive supervised structured exercises three times per week for four weeks. In addition, one group will receive weekly pain education sessions along with exercise, while the other group will receive exercise alone.Pain characteristics, pain intensity, physical function, and pain-related psychological factors will be assessed before and after the four-week intervention period. The findings of this study may help improve non-surgical management strategies for knee osteoarthritis by identifying whether adding pain education to exercise provides additional benefits in reducing knee pain and improving function. |