| CTRI Number |
CTRI/2024/09/073362 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Comparing two different kinds of treatments: one uses a small electrical device and the other uses a laser. Both treatments are used along with exercise |
|
Scientific Title of Study
|
Effectiveness of TENS VERSUS LASER intervention with the enrolment of exercise and foot care in grade 2 diabetic foot |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arshdeep Kaur |
| Designation |
MPT ( orthopeadic) student |
| Affiliation |
Lovely Professional University |
| Address |
Lovely school of allied medical sciences,Department of physiotherapy,Block no.3 ,Room no.105 ,Lovely professional University,Phagwara,Punjab-India
Lovely school of allied medical sciences,Department of physiotherapy,Block no.3 ,Room no.105 ,Lovely professional University,Phagwara,Punjab-India
Jalandhar
PUNJAB
144411
India |
| Phone |
9815124037 |
| Fax |
|
| Email |
arshx55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reema Rasotra |
| Designation |
Assistant Professor |
| Affiliation |
Lovely Professional University |
| Address |
Lovely school of allied medical sciences,Department of physiotherapy,Block no.3 ,Room no.105 ,Lovely professional University,Phagwara,Punjab-India
Lovely school of allied medical sciences,Department of physiotherapy,Block no.3 ,Room no.105 ,Lovely professional University,Phagwara,Punjab-India
Jalandhar
PUNJAB
144411
India |
| Phone |
9888706015 |
| Fax |
|
| Email |
rasotra1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arshdeep Kaur |
| Designation |
MPT ( orthopeadic) student |
| Affiliation |
Lovely Professional University |
| Address |
Lovely school of allied medical sciences,Department of physiotherapy,Block no.3 ,Room no.105 ,Lovely professional University,Phagwara,Punjab-India
Lovely School of Allied Medical Sciences, Department of physiotherapy, Block no.3 ,Room no.105 ,Lovely professional University,Phagwara,Punjab,India
Jalandhar
PUNJAB
144411
India |
| Phone |
9815124037 |
| Fax |
|
| Email |
arshx55@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lovely school of allied medical sciences,Department of physiotherapy,Block no.3 ,Room no.105 ,Lovely professional University,Phagwara,Punjab-India pincode 144411
|
|
|
Primary Sponsor
|
| Name |
Arshdeep Kaur |
| Address |
Lovely school of allied medical sciences,Department of physiotherapy,Block no.3 ,Room no.105 ,Lovely professional University,Phagwara,Punjab-India
|
| Type of Sponsor |
Other [Lovely professional University] |
|
|
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 |
| Dr Reema Rasotra |
Lovely school of allied medical sciences,Department of physiotherapy,Block no.3 ,Room no.105 |
Lovely school of allied medical sciences,Department of physiotherapy,Block no.3 ,Room no.105 ,Lovely professional University,Phagwara,Punjab-India
Jalandhar
PUNJAB |
9888706015
rasotra1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE , LOVELY PROFESSIONAL UNIVERSITY (IEC-LPU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Diabetic foot |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Laser |
Laser therapy, specifically Low-Level Laser Therapy (LLLT), is a non-invasive treatment modality used in physiotherapy to promote tissue healing, reduce pain, and decrease inflammation.
Position of the patient patient will be in supine lying . knee will be flexed by placing pillow under the knee.
Position of the therapist the therapist will stand beside the patient After cleaning the ulcer using sodium chloride solution.
Patient was placed in comfortable position offered protection goggles for the phototherapy.
Procedure was done 4 times a week
The low level laser was used in this study with
Wavelength of 632.8nm
Peak potency of 30mw
Time 80sec (4 J/cm 2)
The application was punctual without contact(distance of 1mm), with the pen being held perpendicular the wound ,in equidistant point around it .
Ulcer will be measured using square centimeter cm2
Record were made in the first appointment and last one, after 15 days .
Then ankle exercise are given which include circulatory exercise ,ankle ROM , Ankle strengthen .
|
| Intervention |
TENS with exercises |
The subject for TENS will be allotted on the baises of randomization .
Position of the patient : patient will be in supine lying . knee will be flexed by placing pillow under the knee .
Position of the therapist : the therapist will stand beside the patient After cleaning the ulcer using sodium chloride solution.
TENS intervention are given for 15 minutes.
Electrodes of TENS tools placed in path which the nerve pain around the wound with the frequency of 100 hz .
The pain is recorded using NPRS scale .
The size of ulcer will be measured using measuring tape.
Record of pain and size of ulcer were made in the first appointment and last one ,after two weeks .
Then ankle exercises are given which include circulatory exercise ankle ROM Ankle strengthen .
Intervention details - pre assesment will be taken before the start of the intervention which will be 4 days in a week for one month.During the intervention again assesment will be taken after two weeks . After the complition of study again assessment will be taken .
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Grade 2 diabetic foot
Age 40-80 YEARS
Patient with grade 3-/5 3/5 MMT
Patient having normal ROM of ankle
|
|
| ExclusionCriteria |
| Details |
Grade 1/5, 2/5, 4/5 MMT daibetic foot
Patient recommended amputation of foot
Impaired sensations
Patient with gas / gangrenous foot
Patient having open wound
Recent ankle or foot fracture
Carcinoma of foot
Osteomylitis of foot
Recent skin allergies or infections
Auto immune disease
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| NPRS numeric pain rating scale |
The NPRS typically ranges from 0 to 10. A score of 0 indicates no pain while a score of 10 represents the worst possible pain. To use the scale the patient is asked to rate their current pain level by choosing a number between 0 and 10. pre assesment will be taken before the start of the intervention which will be 4 days in a week for one month.During the intervention again assesment will be taken after two weeks . After the complition of study again assessment will be taken .
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Range of motion |
Range of motion refers to the distance & direction a joint can move between the flexed position & the extended position. pre assesment will be taken before the start of the intervention which will be 4 days in a week for one month.During the intervention again assesment will be taken after two weeks . After the complition of study again assessment will be taken .
|
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
15/09/2024 |
| 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="0"
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
|
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Brief Summary
|
The data collection has yet to be started , we will be starting data collection from September 2024, after that data analysis will be there using statistical analyse then using that data we will further go for publication in UGC and scopus. |