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CTRI Number  CTRI/2019/03/018261 [Registered on: 26/03/2019] Trial Registered Prospectively
Last Modified On: 29/04/2022
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 Science Education in patients with Chronic Knee Pain  
Scientific Title of Study   Effects of Pain Neuroscience Education on Function in Knee Osteoarthritis with Central Sensitization: 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  Akhila Kandukuri 
Designation  Master of Physiotherapy(MPT) student 
Affiliation  SOAHS Manipal Academy of Higher Education 
Address  Upper basement, Department of Physiotherapy, Manipal Hospital #98, HAL,Old Airport Road, Bangalore KARNATAKA

Bangalore
KARNATAKA
560017
India 
Phone  8500447571  
Fax    
Email  akhi.kandukuri9196@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Karvannan H 
Designation  Associate Professor 
Affiliation  SOAHS Manipal Academy of Higher Education 
Address  Upper basement, Department of Physiotherapy, Manipal Hospital #98, HAL,Old Airport Road, Bangalore KARNATAKA

Bangalore
KARNATAKA
560017
India 
Phone  9986565966  
Fax    
Email  karvannan.h@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Prem V 
Designation  Associate Professor 
Affiliation  SOAHS Manipal Academy of Higher Education 
Address  Upper basement, Department of Physiotherapy, Manipal Hospital #98, HAL,Old Airport Road, Bangalore KARNATAKA

Bangalore
KARNATAKA
560017
India 
Phone  9886647732  
Fax    
Email  prem.v@manipal.edu  
 
Source of Monetary or Material Support  
No 98, Rustam Bagh, Old Airport road, Department of physiotjerapy, School of allied health sciences, Manipal Academy Of Higher Education, Bangalore- 560017 
 
Primary Sponsor  
Name  SOAHS Manipal Academy of Higher Education 
Address  Upper basement, Department of Physiotherapy, Manipal Hospital #98, HAL,Old Airport Road, Bangalore 
Type of Sponsor  Research institution and hospital 
 
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 
Akhila Kandukuri  Manipal Hospital  Outpatient physiotherapy department,Upper basement, #98 Rustam Bagh Layout, old airport road, Bangalore ,KARNATAKA
Bangalore
KARNATAKA 		 8500447571

akhi.kandukuri9196@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Physiotherapy Exercises   8 weeks of supervised rehabilitation with total 12 sessions will be given. Knee exercises with a total duration of 45 minutes to 60 minutes will be delivered. Knee exercise includes components such as- 1) Warm up - Cycling/treadmill for 10 minutes without increase in pain. Strengthening of knee extensors,Isometrics, open chain with progression,Terminal knee extension progressing with weight cuffs. Closed chain,Terminal knee extension in standing with resistance, Partial squats,Step ups, Strengthening of hip muscles (Abductors,extensors), Strengthening of knee flexor. Stretching mainly for Calf muscles, Hamstring and Quadriceps. Neuromuscular control exercises such as Standing weight shifts, Forward and lateral shifts with eyes open, Forward and lateral shifts with eyes closed,Tandem weight shifts and side stepping, and side stepping with obstacles. Carioca; stair climbing and descending; Balance exercise using double leg foam balance using wobble board will be given 
Intervention  Pain Neuroscience Education  8 weeks of supervised rehabilitation with a total 12 sessions will be given. Pain Neuroscience Education(PNE) along with exercises will be given with a total duration of 45 minutes to 60 minutes for each session. Pain neuroscience education is delivered by qualified physiotherapist as verbal one on one (interactive) education using powerpoint pictures, booklet and examples. Pain neuroscience education aims to explain patients about the biology and physiological processes of pain and more importantly defocus the issues associated with anatomical structures This includes attending the patients beliefs, attitudes, about their pain and disabilities in activities of daily life Pain neuroscience education involves explaining about neurophysiology, nervous system, synapses and neuronal plasticity 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Individuals diagnosed with OA using American College of Rheumatology (ACR) guidelines that described OA based on clinical examination as knee pain in addition to 3 of the following 6 criteria:
-more than 50 years of age
-less than 30 minutes of morning stiffness
-crepitus
-bony tenderness
-no enlargement, or an absence of palpable warmth
-along with radiographic classification of OA knee by Kellegren and Lawrence.
Knee pain for more than 3 months
Symptoms of hyperalgesia measured using two-point discrimination device vernier caliper
NPRS > 3 on walking.
 
 
ExclusionCriteria 
Details  Systemic inflammatory arthritis
Intra- articular corticosteriod injection within 6 months
A history of hip or knee surgeries
Individuals with associated neurological deficits
Intention to start or currently participating in lower limb exercise programs
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
6- minute walk test, two- point discrimination using vernier caliper  Baseline, at the end of 8th week  
 
Secondary Outcome  
Outcome  TimePoints 
Numerical Pain rating Scale  Baseline, at the end of 8th week 
Knee Injury and Osteoarthritis Outcome Survey (KOOS)  Baseline, at the end of 8th week 
Pain Catastrophizing Scale (PCS)  Baseline, at the end of 8th week 
Quantitative Sensory Testing - Pain Pressure Threshold  Baseline, at the end of 8th week 
Central Sensitization Inventory scale   Baseline, at the end of 8th week 
 
Target Sample Size   Total Sample Size="124"
Sample Size from India="124" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="116" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/04/2019 
Date of Study Completion (India) 25/04/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Osteoarthritis (OA) is the second most common chronic musculoskeletal problem. Chronic pain is a hallmark for OA knee pain, causes changes in the brain which are engaged with medial prefrontal limbic region resulting in both physical and psychological changes, the phenomenon of central sensitization plays a crucial role in subjects with chronic arthritic pain resulting from hypersensitivity of central nervous system. Current evidence provide strong support for pain neuroscience education which positively influences pain rating pain knowledge improving limitation of movement and fear avoidance behaviour .Majority of literature review suggest that both clinical identification and treatment of OA using pain neuroscience education in reducing pain intensity improving cognition,emotional and functional aspects is still insufficient.  

 
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