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CTRI Number  CTRI/2025/08/092357 [Registered on: 04/08/2025] Trial Registered Prospectively
Last Modified On: 19/07/2025
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   Study to see if Core and Movement exercises can help reduce Back Pain and improve daily function in adults with long-term Low Back Pain. 
Scientific Title of Study   Effectiveness Of Integrated Kinetic Control Training And Deep Core Muscle Activation On Pain, Function, And Movement Control In Individuals With Chronic Low Back Pain: A Randomized Experimental Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr S J GHOKKUL  
Designation  Under graduate  
Affiliation  Sri Ramachandra Institute of Higher Education and Research[Deemed to be university] 
Address  Faculty of Physiotherapy, Room No 4.3, Floor 4, Sri Ramachandra Institute of Higher Education and Research[Deemed to be university],Porur,Chennai-600116,Tamil Nadu, India.

Chennai
TAMIL NADU
600116
India 
Phone  9092324444  
Fax    
Email  t0121020@sriher.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr K Soundararajan 
Designation  Assistant Professor 
Affiliation  Sri Ramachandra Institute of Higher Education and Research[Deemed to be university] 
Address  Faculty of Physiotherapy, Room No 2.3, Floor 2, Sri Ramachandra Institute of Higher Education and Research[Deemed to be university],Porur,Chennai-600116,Tamil Nadu, India.

Chennai
TAMIL NADU
600116
India 
Phone  9551163416  
Fax    
Email  soundararajan.k@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr K Soundararajan 
Designation  Assistant Professor 
Affiliation  Sri Ramachandra Institute of Higher Education and Research[Deemed to be university] 
Address  Faculty of Physiotherapy, Room No 2.3, Floor 2, Sri Ramachandra Institute of Higher Education and Research[Deemed to be university],Porur,Chennai-600116,Tamil Nadu, India.


TAMIL NADU
600116
India 
Phone  9551163416  
Fax    
Email  soundararajan.k@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research[Deemed to be university], Porur, Chennai-600116, Tamil Nadu, India. 
 
Primary Sponsor  
Name  Sri Ramachandra Institute of Higher Education and ResearchDeemed to be university 
Address  Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research[Deemed to be university], Porur, Chennai-600116, Tamil Nadu, India. 
Type of Sponsor  Private medical college 
 
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 K Soundararajan  Sri Ramachandra Hospital  New Block Physiotherapy OPD, ground Floor , Room No 1, Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research[Deemed to be university], Porur, Chennai-600116, Tamil Nadu,India
Chennai
TAMIL NADU 
9551163416

soundararajan.k@sriramachandra.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Students Project, Faculty of Physiotherapy,Sri Ramachandra Institute of Higher Education and Research[Deemed to be university],Porur, Chennai-600116,Tamil Nadu,India  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 
Comparator Agent  Low back pain Exercises   Participants in this group received routine physiotherapy based on guidelines to improve pain relief, functional capacity, and movement control compared to the baseline. Frequency: 3 times/week Duration:25-30 Minutes 
Intervention  Luomajoki’s exercises and Pressure BioFeed Back  The interventional group will receive validated treatment protocols based on Luomajoki’s exercises for kinetic control training. This will include deep core muscle activation utilizing a standardized machine, the Pressure BioFeedback. Frequency: 3 times/week Duration:25-30 Minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Individuals clinically diagnosed with non-specific chronic low back pain persisting for more than 12 weeks.
Age between 18 to 60 years, both men and women.
Pain intensity of 3 to 8 on the Numeric Pain Rating Scale (NPRS) at baseline.
Participants who are ambulatory without assistive devices.
Willingness to participate in a 6-week supervised physiotherapy program and provide informed consent.
 
 
ExclusionCriteria 
Details  Healthy people.
People with walking aids.
Subjects who had spinal fractures or surgery.
People who are unable to understand instructions due to cognitive impairment.
Individuals who have a medical impairment that affects their ability to walk.
Pain Score of more than 9 in NRS.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Roland-Morris Disability Questionnaire.
2. Patient-Specific Functional Scale.
 
at baseline, 2 weeks, 4 weeks, 6 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Numeric Pain Rating Scale.   at baseline, 2 weeks, 4 weeks, 6 weeks. 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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   N/A 
Date of First Enrollment (India)   14/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  14/08/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
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  
BACKGROUND:
Low back pain (LBP) is a prevalent condition encountered by individuals at various points in their lives, typically presenting as a transient issue that resolves within a few days or weeks. In contrast, chronic low back pain (CLBP) constitutes a significant global contributor to disability, frequently arising from compromised movement control and muscular dysfunction. Research indicates that exercise-based interventions aimed at enhancing motor control, particularly those that engage deep core stabilizers, may effectively alleviate symptoms associated with this condition. Kinetic Control Training (KCT) is designed to address movement impairments, while Deep Core Muscle Activation (DCMA) focuses on improving spinal stability through targeted muscle engagement. Nevertheless, the potential synergistic effects of integrating these methodologies warrant further investigation.

AIM: 
The study aims to evaluate the effectiveness of a combined intervention of KCT and DCMA in reducing pain, improving functional ability, and enhancing movement control among individuals with CLBP

OBJECTIVE:
Primary objective:
To evaluate the effectiveness of a combined intervention of Kinetic Control Training and Deep Core Muscle Activation in reducing pain, improving functional ability

Secondary objectives:
To compare the combined KCT and DCMA intervention with standard care in terms of:
Pain intensity reduction (measured by Numeric Pain Rating Scale),
Functional disability improvement (measured by Roland-Morris Disability Questionnaire),
Movement control impairment reduction (measured by Luomajoki’s test battery),
Patient-specific functional improvements (measured by Patient-Specific Functional Scale)

NEED FOR THE STUDY:
Despite available treatments, chronic low back pain (CLBP) persists as a major health burden. Kinetic Control Therapy (KCT) and Dynamic Core Muscle Activation (DCMA) target movement dysfunction and core stability, respectively, but their combined effects remain unknown. This study examines whether integrating KCT and DCMA improves pain, function, and movement control better than single interventions, potentially offering a more effective CLBP management strategy.


PROCEDURE:
     Institutional Ethical Committee, SRIHER, will be obtained, and the Study will be registered in the Clinical Trial Registry of India. The participants will be screened for eligibility criteria. Once the participant fulfils the inclusion criteria, informed consent will be obtained and all baseline outcome measures will be recorded. The study will measure pain severity in participants using a Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Next, Participants will be assigned to one of two groups (Group A: Experimental group, Group B: Standard Exercise care)   using block randomization. The allocation sequence will be placed in opaque, sealed envelopes. The therapist treating the participants would open the sealed envelope and administer the treatment according to the group allocation during treatment time. The Interventional group will receive a combined KCT  by Luomajoki’s validated movement control test battery and DCMA protocol by using Pressure BioFeedback. The intervention will be delivered over 6 weeks (3 sessions/week), supervised by trained physiotherapists. The Control group will receive standardised exercise therapy care. Between group comparison will be performed.


 
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