Advanced Electrotherapy In Diabetes Mellitus Type 2

Completed

Conditions: Type 2 diabetes mellitus without complications,

Registration Number: CTRI/2020/06/025584

Lead Sponsor: Nigel Gonsalves

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 100

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Fasting blood glucose	At baseline, 4 weeks, 8 weeks, 12 weeks
2. HbA1c	At baseline, 4 weeks, 8 weeks, 12 weeks

Secondary Outcome Measures

Name	Time	Method
1. Nitric oxide concentration	1. Baseline

Trial Locations

Locations (1): Dr. D. Y. Patil College of Physiotherapy
🇮🇳
Pune, MAHARASHTRA, India
Dr. D. Y. Patil College of Physiotherapy
🇮🇳Pune, MAHARASHTRA, India
Nigel Gonsalves
Principal investigator
9404082673
gonsalves.nigel@yahoo.com