CTRI

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CTRI Number

CTRI/2025/11/097686 [Registered on: 19/11/2025] Trial Registered Prospectively

Last Modified On:

19/11/2025

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

A Study Comparing two Exercise Programs with TENS for Reducing Low back pain

Scientific Title of Study

Effects of Core Stability Exercise with TENS versus General Strengthening Exercise with TENS on Pain in Individuals Non Specific Low Back Pain: A Randomized Controlled Trial

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Abhilasha
Designation	MPT
Affiliation
Address	School of health Sciences Department of Physiotherapy SHS 128 CSJMU KANPUR NAGAR UTTAR PRADESH 208024 INDIA Kanpur Nagar UTTAR PRADESH 208024 India
Phone	9336233071
Fax
Email	vabhilasha541@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Chandra Shekhar kumar
Designation	Assistant Professor
Affiliation
Address	School of health Sciences Department of Physiotherapy SHS 128 CSJMU KANPUR NAGAR UTTAR PRADESH 208024 INDIA Kanpur Nagar UTTAR PRADESH 208024 India
Phone	9919630553
Fax
Email	chandrasekhar@csjmu.ac.in

Details of Contact Person
Public Query

Name	Dr Chandra Shekhar kumar
Designation	Assistant Professor
Affiliation
Address	School of health Sciences Department of Physiotherapy SHS 128 CSJMU KANPUR NAGAR UTTAR PRADESH 208024 INDIA UTTAR PRADESH 208024 India
Phone	9919630553
Fax
Email	chandrasekhar@csjmu.ac.in

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	Abhilasha
Address	School of health Sciences Department of Physiotherapy SHS 128 CSJMU KANPUR NAGAR UTTAR PRADESH 208024 INDIA School of health Sciences Department of Physiotherapy SHS 128 CSJMU KANPUR NAGAR UTTAR PRADESH 208024 INDIA
Type of Sponsor	Other [MYSELF]

Details of Secondary Sponsor

Name	Address
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 Chandra Shekhar kumar	Physiotherapy OPD 128 S Department of Physiotherapy CSJMU kanpur	School of health Sciences Department of Physiotherapy SHS 128 CSJMU KANPUR NAGAR UTTAR PRADESH 208024 INDIA Kanpur Nagar UTTAR PRADESH	09919630553 chandrasekhar@csjmu.ac.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Human Ethical Committee Chhatrapati Shahu Ji Maharaj University, Kanpur, India,	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: M958\|\|Other specified acquired deformities of musculoskeletal system,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Group A	TENS 80HZ PULSE WIDTH 100-200 FOR 20 MINUTES Abdominal drawing in 10 reps and 2 set for 4 week Bird dog 10 reps and 2 set for 4 week Plank10 reps and 2 set for 4 week Bridging with core activation 10 reps and 2 set for 4 week
Comparator Agent	Group B	TENS 80 HZ for 20 minutes SLR10 reps and 2 set for 4 week Prone extension10 reps and 2 set for 4 week Pelvic bridging without core activation10 reps and 2 set for 4 week

Inclusion Criteria

Age From	18.00 Year(s)
Age To	40.00 Year(s)
Gender	Both
Details	Patient will be aged between 18-40 years. Patient will have subacute low backpain duration 6-12weeks. Pain intensity will be 3-7 on NPRS Open to participation and able to provide written informed consent. Both males and females

ExclusionCriteria

Details

History or diagnosis of specific causes of low back pain (e.g., disc herniation, spinal stenosis, fracture, infection, tumor).
History of previous spinal surgery or major trauma.
Any contraindication to TENS (e.g., pacemaker, epilepsy, open wounds at the electrode site).

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

An Open list of random numbers

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
G power	G power with the effect size of pain will be evaluated

Secondary Outcome

Outcome	TimePoints
Pain by NPRS	the baseline data will be evaluated by 4 weeks of intervention

Target Sample Size

Total Sample Size="50"
Sample Size from India="50"
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

Date of First Enrollment (India)

02/12/2025

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="6"
Days="10"

Recruitment Status of Trial (Global)

Not Yet Recruiting

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

Brief Summary

Nonspecific low back pain is very common among young adults and often affects daily activities, work, and quality of life. Many treatment methods are used, including exercises and electrotherapy. This study aims to find out which type of exercise works better when combined with Transcutaneous Electrical Nerve Stimulation (TENS) for reducing pain.

Participants with nonspecific low back pain will be randomly divided into two groups. One group will receive core stability exercises along with TENS, while the other group will receive general strengthening exercises along with TENS. Both groups will receive their respective treatment sessions for a fixed duration.

Pain and functional disability will be measured at the beginning and at the end of the treatment period using standard assessment tools. The study will compare the improvements in both groups to determine which treatment method is more effective. The findings may help physiotherapists choose better exercise programs for managing nonspecific low back pain.