| CTRI Number |
CTRI/2025/04/083932 [Registered on: 02/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Pilot study] |
| Study Design |
Other |
|
Public Title of Study
|
Compare the effect of LIPUS and LICUS on pain and disability among adults in knee osteoarthritis - A Pilot Study |
|
Scientific Title of Study
|
Comparating the efficacy of Low intensity pulsed Ultrasound with Low intensity continuous Ultrasound on pain and disability among adults with Knee osteoarthritis - A Pilot 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 |
Zikra Fatima |
| Designation |
BPT Student |
| Affiliation |
Galgotias University |
| Address |
Room no B-319, Department of Physiotherapy, Galgotias University,Plot No 2, Sector 17 A, Opposite Buddha International Circuit, Yamuna Expressway, Greater Noida
Gautam Buddha Nagar,
Uttar Pradesh
203201
India
Room no B-319, Department of Physiotherapy, Galgotias University,Plot No 2, Sector 17 A, Opposite Buddha International Circuit, Yamuna Expressway, Greater Noida
Gautam Buddha Nagar,
Uttar Pradesh
203201
India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
8439224129 |
| Fax |
|
| Email |
zikradiza9045@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shikha Malik |
| Designation |
Assistant Professor |
| Affiliation |
Galgotias University |
| Address |
Room No B-319, Department of Physiotherapy, Galgotias University, Plot No 2, Sector 17 A, Opposite Buddha International Circuit, Yamuna Expressway,
Gautam Buddha Nagar
Uttar Pradesh
203201
India
Room No B-319, Department of Physiotherapy, Galgotias University, Plot No 2, Sector 17 A, Opposite Buddha International Circuit, Yamuna Expressway,
Gautam Buddha Nagar
Uttar Pradesh
203201
India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
97797 61606 |
| Fax |
|
| Email |
shinny00720@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Zikra Fatima |
| Designation |
BPT Student |
| Affiliation |
Galgotias University |
| Address |
Room No B-319, Department of Physiotherapy, Galgotias University,Plot No 2, Sector 17 A, Opposite Buddha International Circuit, Yamuna Expressway, Greater Noida
Gautam Buddha Nagar
Uttar Pradesh
203201
India
Galgotias University, Department of Physiotherapy, Sector 17-A, Plot No. 2, Gautam Buddha Nagar, greater noida , Uttar pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
8439224129 |
| Fax |
|
| Email |
zikradiza9045@gmail.com |
|
|
Source of Monetary or Material Support
|
| Galgotias University, Greater Noida, Sector 17-A , Uttar pradesh |
|
|
Primary Sponsor
|
| Name |
Zikra Fatima |
| Address |
Room no.A 315, Department of Physiotherapy, Galgotias University, Plot No.2, Sector 17 A, Yamuna Expressway, Opposite Buddha International Circuit ,Greater Noida, Uttar Pradesh, 203201 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Zikra Fatima |
Galgotias university |
Room No B-319, Department of Physiotherapy, Galgotias University, Plot No 2, Sector 17 A, Opposite Buddha International Circuit, Yamuna Expressway, Greater Noida, Gautam Buddha Nagar
Uttar Pradesh
203201
India
Gautam Buddha Nagar
UTTAR PRADESH |
8439224129
zikradiza9045@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental research committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M15-M19||Osteoarthritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not Applicable |
Nil |
| Comparator Agent |
Not Applicable |
nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants should be between 40 and 75 years old.
2.Mild to Moderate Knee osteoarthritis confirmed by x-ray.
3. Moderate to severe pain level on VAS.
4. Must have Knee pain or stiffness for at least 3 months.
5.Ability to understand and comply with study procedures. |
|
| ExclusionCriteria |
| Details |
1. Prior Knee surgery
2. Current use of anti-inflammatory medications that could confound results.
3. Presence of skin lesions or infections at the treatment site.
4. Pregnancy or significant comorbidities. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
VAS (Visual analogue scale)
|
Base line (Day 0, before treatment)
day-3
Week-1(Day -7 )
week 2(Day -14)
Week -3(Day -21)
Week-4 (day 28 Final assessment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| WOMAC (The Western Ontario and Mc Master Universities osteoarthritis Index) |
Base line (Day 0, before treatment)
week 2 (day 14)
week 4( Final assessment day 28) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
07/04/2025 |
| 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 Applicable |
| 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
|
Compare the efficacy of LIPUS and LICUS on pain and disability among individual with Knee osteoarthritis- Pilot study. and the objective of the study is To compare the efficacy of LIPUS and LICUS which one is more effective in reducing pain in Knee osteoarthritis. The Aim of the study is to Compare the efficacy of LIPUS and LICUS on pain and disability among individual with Knee osteoarthritis.The need of studying both LICUS and LIPUS comes from several important reasons. First, many people are dealing with knee osteoarthritis and there’s dealing with knee osteoarthritis and there’s strong desire to find effective treatment that can help manage their pain and improve their daliy lives. Overall studying LICUS and LIPUS is essential for improving treatment options for Knee osteoarthritis. |