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CTRI Number  CTRI/2022/11/047209 [Registered on: 11/11/2022] Trial Registered Prospectively
Last Modified On: 10/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Alternate therapy in treatment of osteoarthritis knee 
Scientific Title of Study   A study on the effect of hypertonic dextrose injection in Osteoarthritis knee-A Cohort study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR MADAN MOHAN NAGAR 
Designation  PROFESSOR 
Affiliation  Rohilkhand Medical college and Hospital 
Address  ROOM NO:1012 4, Pilibhit Bypass Rd, Pawan Vihar, Bareilly, Uttar Pradesh 243006
ROOM NO:1012 4, Pilibhit Bypass Rd, Pawan Vihar, Bareilly, Uttar Pradesh 243006
Bareilly
UTTAR PRADESH
243006
India 
Phone  9837147854  
Fax    
Email  AHANAGAR@YAHOO.CO.IN  
 
Details of Contact Person
Scientific Query
 
Name  DR MADAN MOHAN NAGAR 
Designation  PROFESSOR 
Affiliation  Rohilkhand Medical College and Hospital  
Address  ROOM NO:1012 4, Pilibhit Bypass Rd, Pawan Vihar, Bareilly, Uttar Pradesh 243006
4, Pilibhit Bypass Rd, Pawan Vihar, Bareilly, Uttar Pradesh 243006
Bareilly
UTTAR PRADESH
243006
India 
Phone  9837147854  
Fax    
Email  AHANAGAR@YAHOO.CO.IN  
 
Details of Contact Person
Public Query
 
Name  Sarthak Dahiya 
Designation  Resident  
Affiliation  Rohilkhand Medical College and Hospital 
Address  Room no-32, PG boys hostel, Rohilkhand Medical College and Hospital
4, Pilibhit Bypass Rd, Pawan Vihar, Bareilly, Uttar Pradesh 243006
Bareilly
UTTAR PRADESH
243006
India 
Phone  9811583841  
Fax    
Email  sarthak.dahiya14@gmail.com  
 
Source of Monetary or Material Support  
Rohilkhand Medical college 4, Pilibhit Bypass Rd, Pawan Vihar, Bareilly, Uttar Pradesh 243006 
 
Primary Sponsor  
Name  ROHILKHAND MEDICAL COLLEGE AND HOSPITAL 
Address  4, Pilibhit Bypass Rd, Pawan Vihar, Bareilly, Uttar Pradesh 243006 
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 Madan Mohan Nagar   Rohilkhand medical college  Room Number 1012 RMCH 4, Pilibhit Bypass Rd, Pawan Vihar, Bareilly, Uttar Pradesh 243006
Bareilly
UTTAR PRADESH 
9837147854

AHANAGAR@YAHOO.CO.IN 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee,rmch  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hypertonic dextrose therapy  25% hypertonic dextrose injection  
Comparator Agent  none  none 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients aged 18 years or more
Patients willing to take the injection
Patients with diagnosis of knee osteoarthritis based on clinical criteria
Patients with radiographic evidence of knee osteoarthiritis  
 
ExclusionCriteria 
Details  patients with BMI>40
pregnancy
Uncontrolled diabetes
History of total knee replacement
Any knee injection in the past 3 months
Inflammatory or post infectious knee arthritis
Daily use of opioid medication
Comorbidity severe enough to prevent participation in the study
Patients with local skin condition at injection site  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the effect of Hypertonic dexxtrose injection in patients with Osteoarthritis knee  week 5, 9, 12 ,24 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the functional outcome of hypertonic dextrose injection in knee osteoarthritis on the basis of:
1. Composite score of Western Ontario McMaster University Osteoarthritis Index (WOMAC)
2. VAS score
 
Week 5, 9, 12 ,24 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   14/11/2022 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Rabago D, Patterson JJ, Mundt M, Kijowski R, Grettie J, Segal NA, Zgierska A. Dextrose prolotherapy for knee osteoarthritis: a randomized controlled trial. The Annals of Family Medicine. 2013 May 1;11(3):229-37.  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Knee Osteoarthritis is a chronic, progressive and disabling joint disease1. Knee OA is important due to high prevalence of pain and disability that they cause in older adults. It is estimated that over 80% of people over 55years of age have osteoarthritis of at least one joint. Pain origin is from both intra articular as well as extra articular structures2,3 resulting in decreased function of the joint. Conservative management by any single therapy has shown no clear benefit. Standard of care involves multiple disciplines.4

Currently available treatment modalities focus majorly on symptom relief and improvement of joint function rather than modifying the disease progression. There is ongoing research on various disease modifying treatments that regulate cartilage breakdown and formation, modulation of inflammation and subchondral bone remodeling. In recent years, a variety of treatment modalities have been researched upon but these interventions incur considerable costs and have questionable efficacy.5

Modern use of prolotherapy dates back to the 1950s, with increased focus by physicians in 1990s. Hypertonic dextrose therapy is an injection therapy used for chronic musculoskeletal injury, including knee osteoarthritis.6,7 The underlying principle is the injection of small volumes of an irritant solution at multiple tender ligament and tendon insertion sites and in adjacent intra articular joint spaces over several strategically spaced treatment sessions. The irritant solution leads to initiation of a local inflammatory cascade, leading to proliferation of tissue and remodeling of bone and cartilage. Even though exact mechanism of action is unknown but potential mechanisms have been put forth suggesting regeneration and repair of tissue by inciting inflammation by use of irritant solutions. Other proposed mechanisms are increase in PDGF (platelet derived growth factors) and direct acting on pain modulation

Osteoarthritis knee presents a great burden and disability in the elderly population without any standard treatment recommendations with only joint replacement as the definitive management in end stage disease and symptomatic treatment in early stages with no definitive cure. Joint replacement as a definitive treatment presents its own challenges in being expensive, surgical complications, patients with co-morbidities unfit for surgery. Prolotherapy is an emergent non-surgical, effective, affordable therapy suitable for the patients in different stage of disease and those unfit to undergo surgery.

The need for this study arises due to scanty research and underpowered studies in the use of hypertonic dextrose therapy in the treatment of osteoarthritis knee.     

 
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