| CTRI Number |
CTRI/2025/12/098322 [Registered on: 02/12/2025] Trial Registered Prospectively |
| Last Modified On: |
02/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to see how Tai Chi helps reduce knee pain and improve daily movement in people with knee osteoarthritis |
|
Scientific Title of Study
|
EFFICACY OF TAI CHI ON PAIN AND PHYSICAL FUNCTION IN INDIVIDUALS WITH 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 |
Dr Sanjib Kumar Das |
| Designation |
Associate Professor |
| Affiliation |
Amity University, Noida |
| Address |
Amity University, Sector 125,
Noida, Uttar Pradesh 201313
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
8879485847 |
| Fax |
|
| Email |
skdas@amity.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjib Kumar Das |
| Designation |
Associate Professor |
| Affiliation |
Amity University, Noida |
| Address |
Amity University, Sector 125,
Noida, Uttar Pradesh 201313
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
8879485847 |
| Fax |
|
| Email |
skdas@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjib Kumar Das |
| Designation |
Associate Professor |
| Affiliation |
Amity University, Noida |
| Address |
Amity University, Sector 125,
Noida, Uttar Pradesh 201313
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
8879485847 |
| Fax |
|
| Email |
skdas@amity.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Amity University Noida Amity Institute of Physiotherapy |
| Address |
Amity University, Sector 125,
Noida, Uttar Pradesh 201313 |
| Type of Sponsor |
Private medical college |
|
|
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 Sanjib Kumar Das |
Amity Institute of Physiotherapy |
Department of Physiotherapy,
Amity Institute of Physiotherapy,
Block - F,
Amity University, Sector 125,
Noida, Uttar Pradesh 201313
Gautam Buddha Nagar
UTTAR PRADESH |
8879485847
skdas@amity.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional NTCC Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
24 - Form Tai Chi Program |
Participants in the 24-Form Tai Chi group will receive supervised Tai Chi sessions lasting 60 minutes, consisting of 10 minutes of warm up, 45 minutes of Tai Chi practice, and 5 minutes of cool down. Sessions will be conducted 2 days per week for 12 weeks. |
| Intervention |
8 - form Tai Chi Program |
Participants in the 8-Form Tai Chi group will receive supervised Tai Chi sessions lasting 60 minutes, consisting of 10 minutes of warm up, 45 minutes of Tai Chi practice, and 5 minutes of cool down. Sessions will be conducted 2 days per week for 12 weeks. |
| Comparator Agent |
Conventional Physiotherapy Protocol |
The control group will receive only the standardized Conventional Physiotherapy protocol. The protocol includes hot fomentation for 10 minutes, open and closed kinetic chain exercises (10 repetitions × 1 set), calf and hamstring stretches (3 repetitions with 30-second hold), and ultrasound therapy (continuous mode, 1.5 W/cm², 7 minutes). Sessions will be conducted 2 days per week for 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age range: 45–60 years
Clinical diagnosis of primary osteoarthritis of the knee
Radiographic evidence Mild to moderate osteoarthritis (Kellgren–Lawrence Grade I–III) confirmed by X-ray
Able to understand and follow exercise instructions
Provides written informed consent to participate
At least Grade 3/5 muscle strength in key lower limb muscles (quadriceps and hamstrings) based on the Oxford Scale for Manual Muscle Testing |
|
| ExclusionCriteria |
| Details |
Knee pain caused by other conditions (example rheumatoid arthritis, inflammatory arthritis, post-traumatic arthritis)
History of total knee replacement on the affected knee, or planned knee surgery during the study period Intra-articular steroid injection in the knee within the past 3 months Significant knee instability or severe deformity
Neurological or musculoskeletal disorder affecting lower limb function
Participation in any formal exercise program for the knee in the last 6 months
Any unstable medical condition where exercise is not advised Inability to follow instructions due to cognitive impairment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
KOOS Score ( Pain, Function, Quality of Life )
NPRS (Numeric Pain Rating Scale) |
Baseline, 4 weeks, 8 weeks, 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Timed Up & Go
TUG TEST |
Baseline, 4 weeks, 8 weeks, 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="183"
Sample Size from India="183"
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)
|
15/12/2025 |
| 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="3"
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
|
This study aims to evaluate the efficacy of Tai Chi on pain and physical function in individuals with primary knee osteoarthritis. A randomized controlled trial design will be used. Participants aged 45 to 60 years with clinically diagnosed mild to moderate primary knee osteoarthritis will be randomly allocated into three groups: an 8 form Tai Chi group, a 24 form Tai Chi group, and a control group receiving conventional physiotherapy only. The intervention will be conducted for 12 weeks with supervised sessions twice a week. Primary outcomes will include pain and knee specific function measured using KOOS and NPRS. Secondary outcomes will include functional mobility and dynamic balance assessed using the Timed Up and Go Test. The study aims to determine whether Tai Chi can provide additional benefits when combined with conventional physiotherapy. |