| CTRI Number |
CTRI/2025/03/082244 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| 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
|
Comparing Effect of Integrated Neuromuscular Inhibition Technique Versus Local Vibration in treatment of Knee Osteoarthritis. |
|
Scientific Title of Study
|
Comparing the effectiveness of Integrated Neuromuscular Inhibition Technique Versus Local Vibration on Iliotibial Band Tightness as an adjunct in treatment of 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 |
RUCHIRA PRAKASH PATIL |
| Designation |
MPT STUDENT |
| Affiliation |
Sunandan Divatia School of Science |
| Address |
Department of Physiotherapy Ground floor, Nanavati Max Super Speciality Hospital Swami Vivekananda Rd, next to Suresh Colony LIC Colony Vile Parle West Sunandan Divatia School of Science Bhaktivedanta Rd vile parle west Mumbai Mumbai MAHARASHTRA 400056 India |
| Phone |
8767291859 |
| Fax |
|
| Email |
ruchiraphysio2000@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Arnaaz Doctor |
| Designation |
Assistant Professor |
| Affiliation |
Sunandan Divatia School of Science |
| Address |
Sunandan Divatia School of Science, Department of Physiotherapy, 7th floor, Mithibai College Building, Bhaktivedanta Road, Vile Parle west
Mumbai MAHARASHTRA 400056 India |
| Phone |
9930033014 |
| Fax |
|
| Email |
Arnaaz.Doctor@nmims.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Arnaaz Doctor |
| Designation |
Assistant Professor |
| Affiliation |
Sunandan Divatia School of Science |
| Address |
Sunandan Divatia School of Science, Department of Physiotherapy, 7th floor, Mithibai College Building, Bhaktivedanta Road, Vile Parle west
Mumbai MAHARASHTRA 400056 India |
| Phone |
9930033014 |
| Fax |
|
| Email |
Arnaaz.Doctor@nmims.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Ground floor, Nanavati Max Super Speciality Hospital Swami Vivekananda Rd, next to Suresh Colony LIC Colony Vile Parle West, Mumbai, MAHARASHTRA -400056, India |
|
|
Primary Sponsor
|
| Name |
none |
| Address |
NA |
| Type of Sponsor |
Other [nil] |
|
|
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 |
| Ruchira Patil |
Department of physiotherapy and Sports Medicine |
Ground floor, Nanavati Max Super Speciality Hospital Swami Vivekananda Rd, next to Suresh Colony LIC Colony Vile Parle West -400056, India Mumbai MAHARASHTRA |
8767291859 - ruchiraphysio2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Commitee, Dr Balabhai Nanavati Hospital |
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 |
Integrated Neuromuscular Inhibition Technique (INIT) |
The INIT techniques includes:
• Ischemic compression (20 SEC)
• Positional Release Technique (PRT)(20 SEC X 3 TIMES)
• Muscle Energy Technique (Isometric Contraction held for 10 SEC X 3 TIMES), given along with convention exercises
Dosage: 5 sessions/ week for 2 weeks |
| Comparator Agent |
Local vibration therapy |
Local Vibration (Using Electric Fascial Gun for 2 mins),
given along with conventional exercises
Dosage: 5 session / week for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients having Osteoarthritis of knee (Grade 1 & 2 according to Kellgren-Lawrence Osteoarthritis Grading scale)
2) patients having Iliotibial Band tightness
|
|
| ExclusionCriteria |
| Details |
1) Any musculoskeletal disorder or injury in past 6 months
2) Any major joint surgery
3) Any neuromuscular or cognitive disorder
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) VISUAL ANALOGUE SCALE (VAS)
2) TIMED UP AND GO TEST(TUG)
3) WOMAC (WESTERN ONTARIO MCMASTER UNIVERSITIED OSTEOARTHRITIS INDEX)
|
PRE AND POST INTERVENTION AFTER 2 WEEKS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1)OBERS TEST |
PRE AND POST INTERVENTION AFTER 2 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="46" Sample Size from India="46"
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)
|
19/03/2025 |
| 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="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
|
Background
and purpose of study:
Osteoarthritis (OA) is a degenerative joint condition
causing cartilage loss, joint narrowing, and varus deformity, leading to
iliotibial band (ITB) tightness, pain, and restricted mobility. Conventional
treatments like stretching and strengthening offer relief, while emerging
methods like vibration therapy and Integrated Neuromuscular Inhibition
Technique (INIT) show promise. Vibration therapy reduces muscle tightness,
whereas INIT combines ischemic compression, positional release, and isometric
stretching. This study will compare the effectiveness of vibration therapy versus
INIT on ITB tightness in knee OA using Ober’s Test, VAS, TUG,
and WOMAC outcome measures.. The effectiveness of local
vibration and integrated neuromuscular inhibition technique, is not
well-established due to limited research. Hence, we intend to study and compare
the effectiveness of these two techniques on ITB tightness in knee
osteoarthritis
INTERVENTION:
GROUP A: Conventional exercise + Local Vibration
GROUP B: CONVENTIONAL exercises + INIT
CONVENTIONAL
EXERCISES:
WEEK 1:
1)
Cryotherapy - 10 mins
2) Ankle
toe movements & rotations - 10 reps
3)
Statics (Quadriceps, Hamstrings, Glutes) - 5 sec hold x 10 reps
4)
Vastus Medialis Oblique Strengthening - 5 sec hold x 10 reps
5) Hip
Knee Flexion - 10 reps
6)
Straight leg Abduction & Raises - 10 reps
7) Hip
Clamps- 5 sec hold x 10 reps
8)
Dynamic Quadriceps exercise –5 sec hold x 10 reps
9)
Hamstrings stretching & TA – 30 sec each x 2reps
Week 2
10) Aerobic Straight leg raises-20 reps
11) Aerobic Straight leg abduction- 20 reps
12) Pelvic Bridging - 5 sec hold x 10 reps
13) Prone Hip Extension – 10 reps
14) Heel and toe raises - 10 reps
15) One Leg Standing - 30 sec each leg
16) Mat walking ( forward, backward, sideways)
17) Stepping - 10 reps each leg
18) Cycling exercise 10 reps |