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CTRI Number  CTRI/2018/07/014791 [Registered on: 10/07/2018] Trial Registered Prospectively
Last Modified On: 17/12/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   THE EFFECT OF PAIN EDUCATION AND EXERCISES IN PATIENT SUFFERING WITH SHOULDER PAIN. 
Scientific Title of Study   THE EFFECTS OF PAIN NEUROSCIENCE EDUCATION & EXERCISE IN SHOULDER PAIN PATIENTS- A RANDOMIZED CONTROLLED TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SURESH MAITY 
Designation  Post graduate  
Affiliation  SDM COLLEGE OF PHYSIOTHERAPY 
Address  SDM college of medical science and hospital manjushree nagar, sattur

Dharwad
KARNATAKA
580009
India 
Phone  09091858701  
Fax  08362461651  
Email  sureshmphysio@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shweta Kulkarni 
Designation  Associate professor 
Affiliation  SDM COLLEGE OF PHYSIOTHERAPY 
Address  SDM college of medical science and hospital sattur

Dharwad
KARNATAKA
580009
India 
Phone  09091858701  
Fax  08362461651  
Email  dr.shweta07@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shweta Kulkarni 
Designation  Associate professor 
Affiliation  SDM COLLEGE OF PHYSIOTHERAPY 
Address  SDM college of medical science and hospital sattur

Dharwad
KARNATAKA
580009
India 
Phone  09091858701  
Fax  08362461651  
Email  dr.shweta07@gmail.com  
 
Source of Monetary or Material Support  
Suresh Maity SDM college of physiotherapy sattur dharwad 
 
Primary Sponsor  
Name  Suresh Maity 
Address  SDM college of medical science and hospital, manjushree nagar, sattur 
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 
Suresh Maity  SDM college of medical science and hospital   Orthopedic physiotherapy outpatient department no.5
Dharwad
KARNATAKA 
9091858701
08362461651
sureshmphysio@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee permission  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, Shoulder pain ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group Exercise   All the exercise will tailor made as per patients complaint 
Intervention  Group Pain Neuroscience Education  Pain Education, Tactile Discrimination, Graded Motor Imagery, Laterality Training, Explicit Motor Imagery, Mirror therapy 
Intervention  Group Pain Neuroscience Education along with Exercise   Exercises will be tailor made, Pain Education, Tactile Discrimination, Graded Motor Imagery, Laterality Training, Explicit Motor Imagery, Mirror therapy 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed as shoulder pain with duration more than 3 months by orthopedician.
2. Men / women aged between 30 to 70 years.
3. Unilateral shoulder pain.
4. Pain after shoulder surgery (more than 3 months).
5. Patient who agreed to sign the consent form. 
 
ExclusionCriteria 
Details  1. Pain less than 3 months.
2. Shoulder pain considered to be originating from another region like cervical, thoracic spine.
3. Neurological conditions and multiple system disorder.
4. Subject with vision, auditory & speech problems.
5. Mental/psychological health issues.
6. Inability to provide informed consent and/or complete the written questionnaire.
7. Subjects not willing to participate. 
 
Method of Generating Random Sequence    
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Visual analog scale
SPADI 
2 time assessment
 
 
Secondary Outcome  
Outcome  TimePoints 
Tampa scale of kinesiophobia
SF-36 16
 
2 time assessment 
 
Target Sample Size   Total Sample Size="99"
Sample Size from India="99" 
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)   17/07/2018 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Shoulder pain is a very common musculoskeletal disorder. The lifetime prevalence of shoulder pain in India is as high as 67%.The prevalence & incidence of shoulder pain varies largely across age & population. It has been reported that it occurs most commonly in middle age adults, women are prone to develop shoulder pain according to the literature. However, some prevalence studies did not find any significant difference in shoulder pain among men and women. The most common source of shoulder pain is the rotator cuff, accounting for over two-thirds of cases and age, gender, diabetes & alcoholism are considered as various risk factors for shoulder pain. Common conditions that can result in chronic shoulder pain include rotator cuff disorders, adhesive capsulitis, shoulder instability, shoulder arthritis. According to a study, prevalence of rotator cuff impingement is 31%, also in 15.7% patients no specific diagnosis could be made. The factors that start an episode of shoulder pain are not necessarily the same as those that contribute to persistent and chronic pain.

Pain is a complex experience that includes multiple dimensions but a recent definition of pain by Moseley (2003) defines pain as “a multiple system output that is activated by an individual’s specific neural signature.” A cognitive based education known as pain neuroscience education is used to treat both the aspects of pain by helping patients gain an increased understanding of the biological processes underpinning their pain state and by focusing on neurophysiology, neurobiology and processing of pain. Studies that have used pain neuroscience education in the treatment of chronic musculoskeletal pain & low back pain have been shown to decrease the fear, pain catastrophization, limitation in the movement. 

Many treatment options are available to treat chronic shoulder pain, but these treatment approaches only focus on the physical aspect of pain rather than psychological aspect, as well as there are limited studies done to see the effectiveness of Pain Neuroscience Education on chronic shoulder pain whereas, further studies have been done to see the effectiveness of mirror therapy in patients with shoulder pain, which is also a part of pain neuroscience education. 

 
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