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CTRI Number  CTRI/2024/11/077498 [Registered on: 29/11/2024] Trial Registered Prospectively
Last Modified On: 28/11/2024
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   Study on the Development, Validation, and Impact of an Educational Booklet on Pain, Function, and Quality of Life in People with Chronic Musculoskeletal Pain  
Scientific Title of Study   Development validation and evaluation of the effectiveness of pain neuroscience education PNE booklet on pain function and quality of life in patients with chronic musculoskeletal pain A mixed method 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  Neha Abhaykumar Modi 
Designation  Ph.D. Scholar 
Affiliation  SPB Physiotherapy college, Surat 
Address  45, Celestia villas, Besides raj world shopping center, Palanpur canal road, Surat
Romm no. 4 , Musculoskeletal Physiotherapy Department, SPB Physiotherapy college, ugatbhesan road, surat
Surat
GUJARAT
395009
India 
Phone  9898936121  
Fax    
Email  mdneha1990@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anjan Desai 
Designation  I/C Principal 
Affiliation  SPB Physiotherapy college 
Address  SPB Physiotherapy college, ugat bhesan road, morabhagal, suart
I/C Principal, Professor at SPB Physiotherapy college, Neurology physiotherapy Department, SPB Physiotherapy college, ugat bhesan road, surat
Surat
GUJARAT
395005
India 
Phone  9428906995  
Fax    
Email  anjandesai@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anjan Desai 
Designation  I/C Principal 
Affiliation  SPB Physiotherapy college 
Address  SPB Physiotherapy college, ugat bhesan road, morabhagal, suart
room no 1, Neurology physiotherapy department, SPB Physiotherapy college, ugat bheasan road, morabhagal, Surat
Surat
GUJARAT
395005
India 
Phone  9428906995  
Fax    
Email  anjandesai@gmail.com  
 
Source of Monetary or Material Support  
SPB Physiotherapy college, ugat bhesan road, morabhagal, rander 395005. different physiotherapy OPDs, pain clinics in surat 
 
Primary Sponsor  
Name  Neha Abhaykumar Modi 
Address  45, Celestia Villas, Besides Raj world shopping center, Palanpur canal road, Surat 395009 
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 
Dr Neha Modi  SPB Physiotherapy college, Surat  SPB Physiotherapy college OPD, Physiotherapy department, room no 4 and 6, Ugat-Bhesan road, Morabhagal, Surat 395009
Surat
GUJARAT 		 9898936121

mdneha1990@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) South gujarat medical education and research center SPB Physiotherapy college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pain Neuroscience education booklet  PNE booklet will be given to the experimental group along with traditional physiotherapy treatment effectiveness will be seen during 2 years 
Comparator Agent  Pain Neuroscience education booklet  Traditional physiotherapy treatment will be given 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  subjects having chronic musculoskeletal pain for atleast 3 months or more. pain intensity more then 3. subjects who can read english or gujarati 
 
ExclusionCriteria 
Details  subjects who have undergone any surgical intervention in the past 3 months. diseases of central nervous system. primary diagnosis of neuropathic pain. any infection. subjects refusing to give informed consent. illiterate subjects. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
numeric pain rating scale. modified nordic questionnaire. pain disability index. WHOQOL-BREF. tampa scale of kinesiophobia. pain catastrophizing scale.  2 times 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="174"
Sample Size from India="174" 
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)   12/12/2024 
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="2"
Months="0"
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   Introduction: Chronic musculoskeletal (MS) pain, is the leading cause of disability globally. The World Health Organization (WHO) estimates that 20–33% of the world’s population suffers from chronic musculoskeletal pain, affecting approximately 1.75 billion people worldwide. More or less irreversible state of hyperexcitability within the central nervous system, known as nonneuropathic central sensitization pain (CS), is present in patients with chronic pain. Changes in the pain neuromatrix, modulating pain processes by behavioral, emotional, social, and cognitive factors are related to CS. Emotions, thoughts, attention and stress can influence the pain facilitating pathways causing cognitive emotional sensitization leading to activation of the pain neuromatrix, increased pain, affective distress, pain-related disability, and poorer treatment outcomes. In this light, treating chronic pain presents a considerable challenge for health care professionals, who should incorporate biopsychosocial (BPS) approach that address biological, psychological and social factors into their treatment plan. PNE provides the patient with a thorough understanding of the neurobiological and neurophysiological processes involved in their pain experience. PNE uses metaphors and stories; that helps to provide patients with an opportunity to improve their understanding of pain and reconceptualize their ideas about it, thereby changing the negative beliefs they have about pain and their incorrect perceptions of it. 
Need: Research has shown the ambiguous nature of delivering PNE in chronic MS pain. This requires the need of developing PNE program for chronic MS pain that could be helpful for physiotherapists in their day-to-day clinical practise.
Aim: To use the current best evidence for Pain Neuroscience Education for chronic MS pain to develop and validate a neuroscience educational booklet for chronic MS pain.
Significance: It’s noteworthy that a significant proportion of individuals dealing with chronic MS pain are unfamiliar with appropriate course of care to follow. Pain Neuroscience Education (PNE) can be viewed as an additional clinical resource that aids clinicians in managing the complexities of treating chronic MS pain. If patients perceive pain and stress as outcomes of a sensitive nervous system rather than tissue damage or pathological physiology, they may find themselves more willing to pursue active therapies they typically avoid. Such an approach could contribute to holistic wellness and comprehensive rehabilitation in cases of chronic MS pain. The creation and utilization of booklets align with studies on patient education, emphasizing their significance as valuable tools for enhancing information retention compared to relying solely on verbal communication. Booklets are not only cost-effective and straightforward but also widely favoured as a method of conveying healthcare information to patients. Hence, it can be used to positively impact compliance, alleviate anxiety, depression and empower patients. 
Objectives: To develop and study effectiveness of PNE booklet on pain, function and quality of life in patients with chronic MS pain.
Method: 
o   Type of the study:  A mixed method study
o   Study         participants:    Individuals suffering from chronic musculoskeletal pain
o   A booklet will be developed by obtaining experts’ evaluation and suggestions. (Modified Delphi approach)
o   Written consent from the participants shall be obtained.
o   Prepared PNE booklet will be given to participants for evaluation.
o   Individuals having chronic musculoskeletal pain will be randomly allotted in to two groups. Control group will receive traditional physiotherapy treatment for chronic musculoskeletal pain whereas experimental group will receive PNE booklet along with traditional physiotherapy treatment. Various outcome measures will be utilized to study the effectiveness of PNE booklet on pain, function and quality of life.
Data analysis: Descriptive and exploratory data analysis will be performed on the total data set collected which may include parametric and non-parametric tests, chi-square test, correlation coefficient and multivariate/linear regression analysis. 95% CI will be considered for statistical analysis. Statistical analysis will be done by using SPSS version 20.0.

 
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