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CTRI Number  CTRI/2024/05/066984 [Registered on: 08/05/2024] Trial Registered Prospectively
Last Modified On: 24/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Pain Neuroscience Education with Physiotherapy versus Physiotherapy alone in treating Pain and Disability in patients with Cervical Spondylosis 
Scientific Title of Study   Added Effect of Pain Neuroscience Education Combined with Conventional Physiotherapy Treatment versus Conventional Physiotherapy Treatment Alone on Pain and Disability in Patients with Cervical Spondylosis : Assessor-blinded, Quasi 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  Dr Aditi Ramesh Pathak 
Designation  PG student 
Affiliation  MAEERs College of Physiotherapy, Talegaon Dabhade 
Address  MAEERs College of Physiotherapy, OPD building, 2nd floor, near Talegaon Railway Station, Talegaon Dabhade

Pune
MAHARASHTRA
410507
India 
Phone  8329482599  
Fax    
Email  aditip39@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Snehal Ghodey  
Designation  Principal 
Affiliation  MAEERs College of Physiotherapy, Talegaon Dabhade 
Address  MAEERs College of Physiotherapy, A-207, Musculoskeletal Physiotherapy Department, OPD building, 2nd floor, near Talegaon Railway Station, Talegaon Dabhade

Pune
MAHARASHTRA
410507
India 
Phone  9422326959  
Fax    
Email  gsnehavi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Snehal Ghodey  
Designation  Principal 
Affiliation  MAEERs College of Physiotherapy, Talegaon Dabhade 
Address  MAEERs College of Physiotherapy, OPD building, 2nd floor, near Talegaon Railway Station, Talegaon Dabhade


MAHARASHTRA
410507
India 
Phone  9422326959  
Fax    
Email  gshehavi@gmail.com  
 
Source of Monetary or Material Support  
A-207, Musculoskeletal Physiotherapy department, OPD building, 2nd floor, Near Talegaon Dabhade Railway station, Talegaon Dabhade, 410507 
 
Primary Sponsor  
Name  MAEERs College of Physiotherapy, Talegaon Dabhade 
Address  MAEERs College of Physiotherapy, OPD building, 2nd floor, Near Talegaon Railway Station, Talegaon Dabhade 
Type of Sponsor  Private medical college 
 
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 
Dr Snehal Ghodey  MAEERs College of Physiotherapy, Talegaon Dabhade  2nd floor, OPD building, A-207, Musculoskeletal Physiotherapy Department, Near Talegaon Dabhade Railway Station, Talegaon Dabhade, 410507
Pune
MAHARASHTRA 		 9422326959

gsnehavi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAEERs College Of Physiotherapy, Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M472||Other spondylosis with radiculopathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Physiotherapy Treatment  Conventional Physiotherapy Treatment will include Application of Hot Pack, delivery of exercises and application of Interferential Therapy (IFT). 
Intervention  Pain Neuroscience Education along with Conventional Physiotherapy Treatment  In Pain Neuroscience Education, patients will be first explained about their condition, followed by delivery of Motivational and meta-cognitive strategies, and will then be explained about the Evolutionary biology. This will be followed by delivery of various metaphors and patients will then be provided with a Questionnaire. Conventional Physiotherapy Treatment will include Application of Hot Pack, delivery of exercises and application of Interferential Therapy (IFT). Pain Neuroscience Education will be delivered one a week for total 4 weeks and Conventional Physiotherapy Treatment will be given thrice a week for 4 weeks. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with age group 40-60 years
Patients diagnosed with chronic cases of Cervical Spondylosis presenting with pain (radiating and/ or non-radiating) and Disability as their chief complaint
Patients with chief complaints of Cervical Spondylosis diagnosed by any Orthopedician
Patients with a fear factor score above 33, when assessed with FABQ will be selected in the study 
 
ExclusionCriteria 
Details  Patients with other Cervical Spine Problems e.g. Inter-vertebral Disc Hernia on Cervical Spine, Spinal Stenosis of the Cervical Region
Patients with a History of Cervical Spine over the past year.
A history of inflammatory diseases involving neck joints.
Myelopathies.
A history of Fractures or Dislocations of the Cervical Vertebrae.
Patients with any known Psychiatric Disorders will also be excluded. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain using Numerical Pain Rating Scale  Baseline and 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Disability using Neck Disability Index  Baseline and 4 weeks 
 
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   N/A 
Date of First Enrollment (India)   25/05/2024 
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="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  
The World Health Organization (WHO) states that Cervical Spondylosis (CS) is currently regarded as epidemic since neck pain is the second most frequent musculoskeletal illness, right behind low back pain. The cervical spine is especially susceptible to pain, and in two thirds of patients, neck pain develops into a chronic condition that makes it difficult to function and causes considerable agony. 10 to 24% of people are thought to have chronic neck pain.
The effectiveness of PNE as a treatment for chronic pain has been evaluated in a number of research. The first trial, which compared four weeks of PNE and physical therapy (PT) with care provided by regular medical practitioners, was published in 2002. According to the study’s findings, PNE and PT together dramatically decreased pain and impairment both immediately and one year later.
Methodology: Patients selected according to the inclusion criteria will be divided into 2 groups. Group A will include delivery of Pain Neuroscience Education along with Conventional Physiotherapy Treatment (Hot Pack, Neck Isometrics, and Scapular Strengthening) and Group B will be given Conventional Physiotherapy Treatment alone. Data will be collected and analyzed.

 
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