| CTRI Number |
CTRI/2024/08/072476 [Registered on: 13/08/2024] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Radiological assessment on the effect of circular rigid taping with traction in knee osteoarthritis : A Randomized controlled trial |
|
Scientific Title of Study
|
Effect of circular taping with traction versus conventional physiotherapy on radiological changes in knee Osteoarthritis: A Randomized Controlled Trial |
| Trial Acronym |
NIIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nishella Sardinha |
| Designation |
Post Graduate student |
| Affiliation |
KAHER Institue of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, Department of Orthopedic manual therapy , OPD No 39, room no: 13, Nehru Nagar , Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9518543096 |
| Fax |
|
| Email |
sardinhanishella@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSantosh Metgud |
| Designation |
Professor |
| Affiliation |
KAHER institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, Department of Orthopedic manual therapy , OPD No 39, room no: 13, Nehru Nagar , Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9880088400 |
| Fax |
|
| Email |
santoshmetgud@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DrSantosh Metgud |
| Designation |
Professor |
| Affiliation |
KAHER institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, Department of Orthopedic manual therapy , OPD No 39, room no: 13, Nehru Nagar , Belagavi
KARNATAKA
590010
India |
| Phone |
9880088400 |
| Fax |
|
| Email |
santoshmetgud@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
| KLES DR. PRABHAKAR KORE HOSPITAL AND MEDICAL RESEARCH CENTER |
|
|
Primary Sponsor
|
| Name |
KLES DR. PRABHAKAR KORE HOSPITAL AND MEDICAL RESEARCH CENTER |
| Address |
KAHER Institute of Physiotherapy, Department of Orthopedic manual therapy , OPD No 39, room no: 13, Nehru Nagar , Belagavi |
| 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 Santosh Metgud |
KLEs DR.PRABHAKAR KORE HOSPITAL AND MEDICAL RESEARCH CENTER |
KAHER Institute of Physiotherapy, Department of Orthopedic manual therapy , OPD No 39, room no: 13, Nehru Nagar , Belagavi
Belgaum
KARNATAKA |
9880088400
santoshmetgud@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH |
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 |
| Comparator Agent |
Conventional Physiotherapy |
1. Hip and knee flexion
2. Short arc quadriceps
3. Straight leg raise
4. Long arc quadriceps
5. Inter Ferential Therapy - 20 mins |
| Intervention |
Medial rotation with circular rigid taping + traction to the knee joint + conventional physiotherapy
The intervention will be done 3 times a week for 2 weeks.
|
Medial rotation with circular rigid taping + traction to the knee joint + conventional physiotherapy will be given for 2 weeks, 3 days per week |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants Diagnosed With Grade 2 And Grade 3 Osteoarthritis According To Kellegren AND Lawrence Classification
2.Participants Have To Meet The Clinical Criteria Of Diagnosis Of Knee Osteoarthritis According To The Criteria Of American College Of Rheumatology |
|
| ExclusionCriteria |
| Details |
1.Participants Diagnosed With Rheumatoid Arthritis, Osteoporosis
2.Previous Surgeries Of The Lower Limb
3.Acute Trauma And Fracture In And Around The Knee Joint
4.Anterior Knee Pain
5.Patellofemoral Pain Syndrome
6.Lower Limb Deformities
7.Open Wound, Skin Diseases |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Radiological X-Ray Of The Knee In Anterior-Posterior View And Lateral View
2. The Western Ontario And Mcmaster University Osteoarthritis Index - Modified Pune Version
3. Numeric Pain Rating Scale
4. Digital Goniometer
|
The Baseline Assessment Will Be Taken On Day One and Post Intervention Assessment Will Be Taken After Two Weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/09/2024 |
| Date of Study Completion (India) |
21/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
21/03/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Effect of circular taping with traction versus conventional physiotherapy on radiological changes in knee Osteoarthritis: A Randomized Controlled Trial Aim of the study: To determine and compare the effect of circular taping with traction versus conventional physiotherapy in terms of radiological changes in knee Osteoarthritis. Null hypothesis: There will be no difference in the effect of circular taping, traction and conventional physiotherapy in terms of radiological changes, pain, Range of motion in OA knee. Alternate hypothesis: There will be difference in the effect of circular taping, traction and conventional physiotherapy in terms of radiological changes, pain, Range of motion in OA knee. Inclusion Criteria: 1. Participants between the age of 45 years to 70 years of both gender, 2. Participants have to meet the clinical criteria of diagnosis of OA of the knee according to the criteria after American College of Rheumatology, 3. Participants diagnosed with grade 2 and grade 3 on the Xray according to the kellgren and lawrence classification Exclusion Criteria: 1. Participants diagnosed with Rheumatoid arthritis, Osteoporosis, 2. Participants with Anterior knee pain, Patellofemoral pain syndrome, 3. Previous surgeries of the lower limb, 4. Participants with fracture in and around the knee, 5. Lower limb deformities, 6. Open wounds or skin diseases A written consent form will be obtained from the participants. Demographic data will be obtained from the participants, outcome measures will be measured before the intervention and after completion of the intervention. A total of 30 participants will be recruited. Participants will be divided into two groups, Group A (n=15), Group B(n=15). Group A will receive Conventional physiotherapy which includes, Electrotherapeutic modality, hip and knee flexion, short arc quadriceps, straight leg raise, long arc quadriceps. All exercises will be performed for 5 repetitions for 1 set. Group B will receive conventional physiotherapy, electrotherapeutic modality, Intermittent mechanical traction at the knee with 30 seconds of hold followed by 10 seconds of rest for 6 mins and medial rotational glide in non-weight bearing with circular rigid taping. |