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CTRI Number  CTRI/2025/10/096322 [Registered on: 22/10/2025] Trial Registered Prospectively
Last Modified On: 21/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study Comparing Yoga Therapy with Standard Care for Managing Long-Term Low Back Pain 
Scientific Title of Study   Comparison of Integrated Approach of Yoga Therapy (IAYT) versus Usual Care in Management of Chronic Low Back Pain Using Quantitative Sensory Testing 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NIKHIL MANUKONDA 
Designation  Junior Resident 
Affiliation  tion Post Graduate Institute of Medical Research 
Address  Department of Anaesthesia, Nehru Hospital, Level 4, Postgraduate Institute of Medical Education and Research, Chandigarh Sector 12, Chandigarh Chandigarh CHANDIGARH 160012 India

Chandigarh
CHANDIGARH
160012
India 
Phone  7696798339  
Fax    
Email  mnikhil14@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nitika Goel 
Designation  Assistant Professor 
Affiliation  tion Post Graduate Institute of Medical Research 
Address  Department of Anaesthesia, Nehru Hospital, Level 4, Postgraduate Institute of Medical Education and Research, Chandigarh Sector 12, Chandigarh Chandigarh CHANDIGARH 160012 India

Chandigarh
CHANDIGARH
160012
India 
Phone  88266 22159  
Fax    
Email  nitikagoel7@gmail.com  
 
Details of Contact Person
Public Query  
Name  NIKHIL MANUKONDA 
Designation  Junior Resident 
Affiliation  tion Post Graduate Institute of Medical Research 
Address  Department of Anaesthesia, Nehru Hospital, Level 4, Postgraduate Institute of Medical Education and Research, Chandigarh Sector 12, Chandigarh Chandigarh CHANDIGARH 160012 India

Chandigarh
CHANDIGARH
160012
India 
Phone  7696798339  
Fax    
Email  mnikhil14@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Yoga and Naturopathy (CCRYN) is: 61-65, Institutional Area, Janakpuri, New Delhi-110058, India 
 
Primary Sponsor  
Name  Central Council For Research In Yoga And Naturopathy 
Address  Central Council for Research in Yoga and Naturopathy 61-65, Institutional Area, Janakpuri, New Delhi - 110058 ,India 
Type of Sponsor  Government funding agency 
 
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 
Nikhil Manukonda  Postgraduate Institute of Medical Education and Research Chandigarh  Pain clinic , Room No 5023, New Old Building ,Department of Anaesthesia
Chandigarh
CHANDIGARH 		 7696798339

mnikhil14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, intramural  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M468||Other specified inflammatory spondylopathies,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Integrated Approach of Yoga Therapy (IAYT) for low back pain   A structured series of 60-minute IAYT sessions will be conducted over two weeks, with six classes per week, totalling 12 sessions. 
Comparator Agent  Standard institutional protocol therapy  • Education about the disease process and the importance of self-care • Ergonomic and posture advice • Guidance on remaining physically active • Lifestyle modification recommendations • A back care booklet38 developed and validated at the participating site Medications will be prescribed as deemed necessary by the treating physician. Patients will adhere to the usual care protocol for the same duration as the yoga group, under the supervision of a pain physician and physiotherapist. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  History of non-specific low back pain (LBP) with symptoms persisting for more than three months
Failure to respond to conservative management
Numerical Rating Scale (NRS) score of greater than or equal to 5 at the time of enrolment
Age grater than 18 years
Ambulatory and naïve to yoga 
 
ExclusionCriteria 
Details  LBP caused by nerve root compression, disc prolapse, spinal stenosis, tumor, spinal infection, ankylosing spondylitis, spondylolisthesis, kyphosis, structural scoliosis, or widespread neurological disorders
Pre-surgical candidates
Compromised cardiopulmonary system
Pregnancy
Body mass index (BMI) greater than 35
Individuals experiencing major depression or substance abuse
Participants who are unable to communicate in either Hindi or English
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate changes in the Verbal Numeric Rating Scale (NRS) and Quantitative Sensory Testing (QST) parameters Pressure Pain Threshold (PPT) and Conditioned Pain Modulation (CPM) in patients with CLBP  at baseline, 4 weeks, 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1) To study the changes in the results of the Modified Oswestry Low Back Pain Disability Index (MODI) & EuroQOL (EQ-5D) in patients with CLBP at baseline  at baseline, 4 weeks, 12 weeks 
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
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)   01/11/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

This prospective, Randomized ,parallel group clinical trial will compare the effectiveness of the Intergrated Approach of Yoga Therapy (IAYT) versus usual care in patients with chronic non- specific low back pain. A total of 82 adult participants with low back pain for more than three months and a pain score of (NRS) more than 5 will be randomized in a 1:1 ratio to either receive IAYT or usual care. The IAYT group will undergo 60 minute yoga sessions over 2 weeks including physical, postures, breathing exercises, and meditation, followed by Home practice. The usual care group will receive standard advice on ergonomics, posture, physical activity, and a back care booklet. Participants will be assessed at baseline, four weeks and at 12 weeks for pain intensity (NRS) , disability (modified oswestry, disability index), quality of life (EQ – 5D), and quantitative sensory testing parameters (pressure, pain threshold, and conditioned pain modulation). The primary aim is to estimate the difference in pain, intensity, and sensory testing parameters between groups and to demonstrate the effectiveness of yoga as an adjunct in managing chronic low back pain. The study will be conducted at the pain clinic, department of anaesthesia and intensive care, PGIMER, Chandigarh from January 2025 to June 2026.

 
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