| 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
|
|
|
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
|
|
|
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.
|
|
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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.
|