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CTRI Number  CTRI/2022/06/043209 [Registered on: 13/06/2022] Trial Registered Prospectively
Last Modified On: 04/04/2023
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   Effects of Dynamic Neuromuscular Stabilization Exercises in Non-Specific Chronic Low Back Pain Patients 
Scientific Title of Study   Effectiveness of Dynamic Neuromuscular Stabilization Exercises in Patients of Non- Specific Chronic Low Back Pain with Movement Control Impairment  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Irshad Ahmad 
Designation  Assistant Professor, Physiotherapy 
Affiliation  Manav Rachna International Institute of Research & Studies, Faridabad, Haryana 
Address  Department of Physiotherapy, Faculty of Allied Health Sciences, Manav Rachna International Institute of Research & Studies,

Faridabad
HARYANA
121001
India 
Phone  9911878341  
Fax    
Email  irshad.fahs@mriu.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Manju Kaushik 
Designation  PhD. Scholar 
Affiliation  Manav Rachna International Institute of Research & Studies 
Address  Department of Physiotherapy, Faculty of Allied Health Sciences, Manav Rachna International Institute of Research & Studies,

Faridabad
HARYANA
121001
India 
Phone  9891182228  
Fax    
Email  manju.vats@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Manju Kaushik 
Designation  PhD. Scholar 
Affiliation  Manav Rachna International Institute of Research & Studies 
Address  Department of Physiotherapy, Faculty of Allied Health Sciences, Manav Rachna International Institute of Research & Studies,

Faridabad
HARYANA
121001
India 
Phone  9891182228  
Fax    
Email  manju.vats@rediffmail.com  
 
Source of Monetary or Material Support  
Department of Physiotherapy , Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan), Department of Empowerment of Persons with Disabilities (Under the Ministry of Social Justice and Empowerment, Government of India) 
 
Primary Sponsor  
Name  Manju Kaushik 
Address  PhD. Scholar/ Lecturer, Physiotherapy 1 Department of Physiotherapy , Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan) 4-Vishnu Digamber Marg, New Delhi-110002 
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 
Manju Kaushik  Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan)  Department of Physiotherapy, 4- Vishnu Digamber Marg
New Delhi
DELHI 		 9891182228

manju.vats@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee, Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan)  Approved 
Research Ethics Committee, Manav Rachna International Institute of Research & Studies (MRIIRS)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M999||Biomechanical lesion, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dynamic Neuromuscular Stabilization Exercises (DNS)   Patients enrolled in DNS specific exercise group will be trained for various progressive DNS approach based postural and dynamic stabilization exercises throughout the training sessions. All patients will be engaged in 30-45 minutes of DNS exercises maximally for 5 days a week, for a total of 6 weeks or altogether for 30 sessions of treatment in consecutive weeks of study duration. Exercises will mainly include diaphragmatic breathing, static and dynamic postures of Baby Rock (supine 90-90), Prone, Rolling, Side Lying, Oblique Sit, Tripod Stand and transitions between the immediate developmental postures. 
Comparator Agent  Strengthening and Flexibility Exercises (SFE)  Patients participating in SFE group will be trained for basic Strengthening and flexibility exercises with an emphasis of improving the strength of all of the trunk muscles and improving trunk and lower limb flexibility in all planes as per the designed protocol of Van Dillen et al., 2021. All exercises are prescribed and progressed based on American College of Sports Medicine guidelines. All patients will be engaged in 30-45 minutes of DNS exercises maximally for 5 days a week, for a total of 6 weeks or altogether for 30 sessions of treatment in consecutive weeks of study duration. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Numeric Pain Rating Scale (NPRS) of 2 or more
2. Positive prone instability test
3. Two or more positive test findings on Luomajoki MCI tests battery as 
well as MCI specific complaints of pain elicitation in static postures
4. Score of 20% or more on Oswestry Disability Index version 2.1a (ODI v 2.1a)
 
 
ExclusionCriteria 
Details  1. Back discomfort caused by a specific pathology, such as a disc herniation, tumour, infection, or fracture, osteoporosis, structural deformity, inflammatory illness, radicular syndrome, or cauda equina syndrome
2. Lower Back pain that is constant or severe, as determined by clinical criteria, due to nerve root irritation 

3. Any Spinal surgery or Major surgery within the past years 

4. Current Pregnancy or post partum period less than 6 months and a multiparous woman who 
has given birth more than twice

5. BMI ≥ 30 Or Presence of co-morbidity (e.g. history of angina, shortness of breath, 
uncontrolled hypertension), which may limit exercise performance.
6. Straight Leg 
Raise (SLR) less than 50° Or positive sacroiliac-joint pain provocation tests 

7. Patients with a score of ≥ 72 on the Örebro Musculoskeletal Screening Questionnaire -12 (OMSQ-12) will be excluded to avoid confounding by psychosocial factors.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
1. Lumbar Segmental Motion
2. Lumbo-Pelvic Dynamic Stability 

3. Trunk Endurance
4. Proprioception 
 		 Two measurement points -At the baseline and at the end of the six-week intervention or 30 sessions 
 
Secondary Outcome  
Outcome  TimePoints 
Pain 

 		 Two measurement points -At the baseline and at the end of the six-week intervention or 30 sessions 
Functional Disability 
  Two measurement points -At the baseline and at the end of the six-week intervention or 30 sessions 
Kinesiophobia 
(Fear of Movement)  Two measurement points -At the baseline and at the end of the six-week intervention or 30 sessions 
Quality of life 
  Two measurement points -At the baseline and at the end of the six-week intervention or 30 sessions 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/06/2022 
Date of Study Completion (India) 09/08/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [manju.vats@rediffmail.com].

  6. For how long will this data be available start date provided 31-12-2025 and end date provided 31-12-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This study will examine and compare the therapeutic outcomes of Dynamic Neuromuscular Stabilization (DNS) with Strengthening and Flexibility Exercises (SFE) in patients with Non-Specific Chronic Low Back Pain (NSCLBP) with Movement Control Impairment (MCI). 

The intended study is an assessor-blinded, experimental, randomized controlled trial with two parallel arms and two measurement points: baseline assessment and at the end of the six-week intervention or after the conclusion of 30 sessions of intervention. A total of 66 subjects having non-specific chronic low back pain will be chosen based on inclusion criteria and randomly assigned to one of the two groups (33 subjects in each group). Outcome variables will include lumbar segmental stability (sagittal plane inter-vertebral rotations and translations), lumbo-pelvic dynamic stability, trunk endurance, proprioception, pain, disability, kinesiophobia and quality of life. Both groups will receive progressive group-specific exercises. Group A will receive DNS Exercises and Group B will receive generally prescribed strengthening and flexibility exercises (SFE) for 30-45 minutes per session. Altogether, participants will have maximum 5 sessions of supervised training in a week for a total of 6 weeks (30 sessions). 

 
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