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CTRI Number  CTRI/2024/02/063067 [Registered on: 23/02/2024] Trial Registered Prospectively
Last Modified On: 05/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Benefits of TECAR therapy given with good corrective back exercises in people with low back pain 
Scientific Title of Study   Efficacy of capacitive and resistive transfer of energy (TECAR) therapy with therapeutic exercises in individuals with chronic mechanical low back pain 
Trial Acronym  TECAR 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Thanjingla Anth Thangal 
Designation  Student 
Affiliation  Amity institute of health allied sciences, Amity University 
Address  Room no.107A, F-1 block Amity institute of health allied sciences, Amity university, Sector 125 Noida, Gautam Buddh Nagar, Uttar Pradesh 201301

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  9611218758  
Fax    
Email  thanjingthangal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pankaj Kumar Malik 
Designation  Assistant professor 
Affiliation  Amity institute of health allied sciences, Amity university 
Address  Room no.107A, F-1 Block Amity institute of health allied sciencces, Amity university, F-1 103, Sector 125 Noida, Gautum Buddh Nagar, Uttar Pradesh 201301

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  9899274238  
Fax    
Email  pkmalik@amity.edu  
 
Details of Contact Person
Public Query  
Name  Dr Pankaj Kumar Malik 
Designation  Assistant professor 
Affiliation  Amity institute of health allied sciences, Amity university 
Address  Room no.107A, F-1 Block, Amity institute of health allied sciencces, Amity university, Sector 125 Noida, Gautum Buddh Nagar, Uttar Pradesh 201301


UTTAR PRADESH
201301
India 
Phone  9899274238  
Fax    
Email  pkmalik@amity.edu  
 
Source of Monetary or Material Support  
Amity institute of health allied sciences Amity University 
 
Primary Sponsor  
Name  Thanjingla Anth Thangal 
Address  Room no.107A, F-1 block Amity institute of health allied sciences, Amity university, Sector 125 Noida, Gautam Buddh Nagar, Uttar Pradesh 201301 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Poonam Dahiya  Quantum physical therapy and wellness centre  A1 111 basement safdarjung enclave new delhi 110029
South West
DELHI 		 9810918929

healthcarequantum@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Amity University Noida NTCC committee  Approved 
Quantum physical therapy and wellness centre   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M545||Low back pain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  TECAR combined with therapeutic back exercises  Group A will be given TECAR therapy where capacitive mode will be given for 5 minutes and resistive mode will be given for 15 minutes for alternate days along with therapeutic back exercises which incudes bridging, clamshells,tummy tuck in, core stabilization with physio ballfor 30 minutes 1 set each for 10 repetitions and 10 seconds hold. 
Comparator Agent  Therapeutic back exercises  Group B will perform only back exercises which incudes bridging, clamshells,tummy tuck in, core stabilization with physio ball. Exercise to be precribed from week 0 to 4. Exercise will be done for 30 minutes 1 set each for 10 repetitions and 10second hold.  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Numeric pain scale between 5 to 8, Roland Morris disability questionnaire score between 50 to 80 percentage, Modified Schober test positive, mechanical low back pain arising from spine, intervertebral disc and surrounding soft tissues. 
 
ExclusionCriteria 
Details  Subjects with implants, known cases of cancer and abnormal cartilage growth, pregnant individuals, history of previous spine surgery and neuropathic pain, neurological conditions such as epilepsy, Parkinsons, history of psychiatric disorders 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain, Lumbar range of motion, disability  week 1, week 2, week 3, week 4 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life  week 1, week 2, week 3, week 4 
 
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 2/ Phase 3 
Date of First Enrollment (India)   01/03/2024 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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   This study is carried to out to find the effectiveness of capacitive and resistive electric transfer (TECAR) therapy combined with back exercise on individauals with chronic mechanical low back pain.Capacitive and resistive electric transfer (TECAR) therapy is a physical treatment modality used to treat pain in several musculoskeletal disorders. It is classified as a type of diathermy. It use very high-frequency electromagnetic waves to increase heat in deep tissues of the body. Among the various methods of diathermy, TECAR therapy is considered the most convenient and safe as it has few limitations concerning the treatment area and does not cause excessive heat generation between the skin and the electrode.It helps in regulating the ionic activity inside and outside the cell. The energy causes a stream of ions with excessively rapid electrical oscillations will lead to permeabilization of the plasma membrane. It can open large number of ion channels, effectively help ions through the membrane channel for transmembrane movement, so that the positive and negative ion exchange of cells to normal, so as to achieve cell repair. It has two modes, capacitive mode and resistive modeIt offers various frequencies 300 KHZ to 1 MHZ. The higher the frequency, the more concentric and more superficial. The lower the frequency is, the more diffuse and deeper.448 KHz approx is known to be the most appropriate frequency to regulate the activities of the ions. The capacitive mode works with an isolated electrode that concentrates most of the electric changes close to the electrode. In this way, it works on superficial and water-based tissues such as muscles, blood and lymphatic vessels. On the contrary, the resistive modality works with a non-isolated electrode: electric charges can penetrate the superficial tissues and reach deeper structures such as tendons, ligaments, bones and cartilages. Mechanical back pain refers to any sort of back pain caused by inserting abnormal stress and strain on muscles of the backbone. Mechanical back pain arises from dangerous habits, like poor posture, poorly designed seating, and incorrect bending and lifting motions. Back endurance exercises has evidence in enhancing muscle reactivation and reconditioning. There is emerging evidence to suggest that endurance training of the low-back extensors and core stability exercises in patients with LBP can be effective in reducing pain, disability, and work loss, and improving fatigue threshold and physical performance.

Total 40 subjects will be taken for the study where the subjects will be divided into 2 groups of 20 subjects each. Numeric pain rating scale (NPRS), Roland-Morris Disability Questionnaire (RMDQ), Modified Schober’s Test will be used to select the subjects for chronic mechanical low back pain. Group A will be given TECAR along with therapeutic back exercises and group B will be given only therapeutic back exercises. On group A, TECAR therapy with both capacitive and resistive modes to be given. Capacitive mode with dynamic  electrode will be given for 5 minutes and resistive static electrode will be given for 15 minutes for alternate days for 4 weeks. Exercises to be done for 30 minutes 1 set each for 10 repetitions and 10 seconds hold. Exercises includes bridging , clamshells , tummy tuck in, core stabilization with physio ball.After  4 weeks of treatment program, the patients will be reassessed on the basis of pain rating of NPRS and disability rating on the Rolland Morris Disability Questionnaire.


 

 
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