| CTRI Number |
CTRI/2022/08/045060 [Registered on: 30/08/2022] Trial Registered Prospectively |
| Last Modified On: |
25/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of nano particle through ultrasound administration in adults with musculoskeletal inflammation |
|
Scientific Title of Study
|
Therapeutic effects of ultrasound-mediated phonophoresis using gold nanoparticles in musculoskeletal inflammation among male adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Darshni Thakkar |
| Designation |
Assistant Professor |
| Affiliation |
Krupanidhi College of Physiotherapy |
| Address |
Krupanidhi College of Physiotherapy
12/1, Chikka Bellandur, Sarjapur Road, Varthur Hobli, Carmelaram, Bengaluru, Karnataka 560035
203 A block, Adithi Arcade, LBS nagar, Bangalore, Karnataka, 560017
Bangalore
KARNATAKA
560035
India |
| Phone |
8939501005 |
| Fax |
|
| Email |
rahuali@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Darshni Thakkar |
| Designation |
Assistant Professor |
| Affiliation |
Krupanidhi College of Physiotherapy |
| Address |
Krupanidhi College of Physiotherapy
12/1, Chikka Bellandur, Sarjapur Road, Varthur Hobli, Carmelaram, Bengaluru, Karnataka 560035
203 A block, Adithi Arcade, LBS nagar, Bangalore 560017
Bangalore
KARNATAKA
560035
India |
| Phone |
8939501005 |
| Fax |
|
| Email |
rahuali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Darshni Thakkar |
| Designation |
Assistant Professor |
| Affiliation |
Krupanidhi College of Physiotherapy |
| Address |
Krupanidhi College of Physiotherapy
12/1, Chikka Bellandur, Sarjapur Road, Varthur Hobli, Carmelaram, Bengaluru, Karnataka 560035
203 A block, Adithi Arcade, LBS nagar, Bangalore 560017
Bangalore
KARNATAKA
560035
India |
| Phone |
8939501005 |
| Fax |
|
| Email |
rahuali@gmail.com |
|
|
Source of Monetary or Material Support
|
| Krupanidhi college of physiotherapy |
|
|
Primary Sponsor
|
| Name |
krupanidhi college of physiotherapy |
| Address |
12/1, Chikka Bellandur, Sarjapur Road, Varthur Hobli, Carmelaram, Bengaluru, Karnataka 560035 |
| Type of Sponsor |
Other [Educational Institution] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| RGUHS |
Jayanagr, Karnataka, Bangalore 560041 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Darshni Thakkar |
Krupanidhi College of Physiotherapy |
12/1, Chikka Bellandur, Sarjapur Road, Varthur Hobli, Carmelaram, Bengaluru, Karnataka 560035
Department: Physiotherapy
Division: Health Sciences
Room number: 1
Bangalore
KARNATAKA |
8939501005
rahuali@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mallige Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
DOMS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
AuNp |
Anti inflammatory effect of AuNp is done on healthy humans with outcome measure of IL6 |
| Intervention |
Phonophoresis with AuNp |
Anti inflammatory effect of AuNp is done on healthy humans with outcome measure of IL6 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Male |
| Details |
1. Age: 18-25 years
2. Gender: Males
|
|
| ExclusionCriteria |
| Details |
1. Athletes
2. Any other medical or inflammatory conditions
3. Allergic to analgesic or nano particles
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Inflammatory markers-IL6
Algometer |
To measure at 6, 12, 24 and 36 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| VAS |
To measure at 6, 12, 24 and 36 hours |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/12/2022 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
9. Zortea, D., Silveira, P. C., Souza, P. S., Fidelis, G. S., Paganini, C. S., Pozzi, B. G., ... & Pinho, R. A. (2015). Effects of phonophoresis and gold nanoparticles in experimental model of muscle overuse: role of oxidative stress. Ultrasound in Medicine & Biology, 41(1), 151-162. doi.org/10.1016/j.ultrasmedbio.2014.08.020 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background: Phonophoresis can be described as a non-invasive technique that uses piezoelectric potential of ultrasound to increase the percutaneous absorption of a drug, usually an anti-inflammatory or anesthetic agents, for the management of pain and inflammation in musculoskeletal/sports-related injuries. Gold nanoparticles (AuNPs) are widely used in medical field and has been employed for diagnostics, and have seen increasing use in the area of therapeutics. Aim of the study: To evaluate the therapeutic effects of US- mediated phonophoresis using AuNps in musculoskeletal inflammation among male adults. Methodology: Study design is Experimental and total of 40 subjects are included using random sampling method. 40 subjects are divided into 4 groups: Group A (Phonophoresis with Analgesics) = 10, Group B (Phonophoresis with AuNp) =10, Group C=10(Control group- UST) and Group D =10(Application of AuNp). Procedure: All the four groups will receive exercise induced DOMS in calf area and then pretest measures will be taken for subjects using inflammatory markers (Detection of IL-6), Algometry and VAS. Intervention will be given using Phonophoresis after 6, 12, 24 and 26 hours after inducing DOMS. The posttest measures will be taken after every intervention. Statistical Analysis will be done using Descriptive statistics, Paired t test between the groups and Correlation between the outcome measures. |