| CTRI Number |
CTRI/2020/06/025584 [Registered on: 03/06/2020] Trial Registered Prospectively |
| Last Modified On: |
14/02/2024 |
| 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
|
Advanced Electrotherapy In Diabetes Mellitus Type 2 |
|
Scientific Title of Study
|
Effects of Pulsed Electromagnetic Field Therapy in Individuals with Diabetes Mellitus Type 2 : A Randomised Controlled Trial |
| Trial Acronym |
P.E.M.F. in DM 2 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nigel Gonsalves |
| Designation |
Ph. D Scholar |
| Affiliation |
Dr. D.Y. Patil Vidyapeeth, Pune - 18 |
| Address |
Dr. D.Y. Patil College of Physiotherapy,
Dr. D. Y. Patil Vidyapeeth, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9404082673 |
| Fax |
|
| Email |
gonsalves.nigel@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tushar Palekar |
| Designation |
Principal and Professor |
| Affiliation |
Dr. D.Y. Patil Vidyapeeth, Pune - 18 |
| Address |
Dr. D.Y. Patil College of Physiotherapy,
Dr. D. Y. Patil Vidyapeeth, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9822606869 |
| Fax |
|
| Email |
principal.physio@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Tushar Palekar |
| Designation |
Principal and Professor |
| Affiliation |
Dr. D.Y. Patil Vidyapeeth, Pune - 18 |
| Address |
Dr. D.Y. Patil College of Physiotherapy,
Dr. D. Y. Patil Vidyapeeth, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9822606869 |
| Fax |
|
| Email |
principal.physio@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Nigel Gonsalves
Dr. D. Y. Patil College of Physiotherapy,
Dr. D. Y. Patil Vidyapeeth, Pimpri, Pune - 18 |
|
|
Primary Sponsor
|
| Name |
Nigel Gonsalves |
| Address |
Dr. D. Y. Patil College of Physiotherapy,
Dr. D. Y. Patil Vidyapeeth, Pimpri, Pune - 411018 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Nigel Gonsalves |
Dr. D. Y. Patil College of Physiotherapy |
Dr. D.Y. Patil College of Physiotherapy,
Dr. D. Y. Patil Vidyapeeth, Pimpri
Pune
MAHARASHTRA |
9404082673
gonsalves.nigel@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE Dr. D. Y. Patil VIDYAPEETH, PUNE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Exercise Therapy alone |
Exercise therapy daily for 12 weeks which will also include aerobic exercise |
| Intervention |
Pulsed Electromagnetic Field Therapy and Exercise Therapy |
Pulsed Electromagnetic Field Therapy for 12 weeks along with exercise therapy- Group 1
P.E.M.F. therapy for 30 minutes daily for 12 weeks followed by a session of exercise therapy including aerobic exercise |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Individuals diagnosed with Diabetes Mellitus Type 2 for more than 6 months (Fasting Plasma Glucose > 126 mg/dL <280 mg/dL; HbA1c> 6.5% <15.6%)
Individuals on Normal Blood Glucose concentration lowering medications |
|
| ExclusionCriteria |
| Details |
1. Individuals having a difficulty in attaining sitting position for 30 minutes.
2. Suffering from acute fractures in the spinal region.
3. Individuals with musculoskeletal disorders like strains, sprains, fractures causing an impairment to perform physical activity.
4. Suffering from cardio - vascular disorders.
5. Suffering from neurological disorders.
6. Individuals with diabetes mellitus type 2 suffering from foot ulcers.
7. Individuals undergoing any other form of exercise training.
8. Individuals who are hypoglycemic.
9. Individuals who are handicapped.
10. Pregnant females.
11. Individuals who are suffering from cancer.
12. Individuals who are having sensory impairment.
13. Individuals suffering from kidney dysfunction or disorders.
14. Individuals with pacemaker.
15. Individuals with implants of gel or silicon and / or transplant organs. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Fasting blood glucose
2. HbA1c |
At baseline, 4 weeks, 8 weeks, 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Nitric oxide concentration |
1. Baseline
2. 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "114"
Final Enrollment numbers achieved (India)="114" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/06/2020 |
| Date of Study Completion (India) |
12/09/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomised controlled trial to study the effect of pulsed electromagnetic field therapy on blood glucose levels in individuals with diabetes mellitus type 2. Pulsed Electromagnetic Field Therapy will be administered for 12 weeks along with exercise therapy in one group and compared with the other group receiving only exercise therapy alone. The Fasting Blood Glucose levels, HbA1c will be assessed at pre- treatment, After 24 sessions, after 48 sessions and at post - treatment. .Nitric oxide concentration estimation would be done at pre - treatment and post - treatment. If required the outcome measures would be assessed earlier if patients feel uneasy due to a drop in blood sugar levels. Before beginning with a trial a pilot study would be undertaken to choose the best parameters of P.E.M.F. therapy. Also, based on pilot study any changes or modifications required will be made in the study. |