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CTRI Number  CTRI/2024/11/076163 [Registered on: 04/11/2024] Trial Registered Prospectively
Last Modified On: 01/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Prolotherapy In Patient Of Osteoarthritis Knee Pain 
Scientific Title of Study   Clinical study of two different doses of dextrose as a drug for prolotherapy treatment in patients of osteoarthritis knee pain 
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 Gajendra singh Baghel 
Designation  Junior Resident 
Affiliation  Gandhi Medical College, Bhopal 
Address  Department Of Anaesthesiology,Gandhi Medical College,Bhopal MADHYA PRADESH

Bhopal
MADHYA PRADESH
462001
India 
Phone  8461877025  
Fax    
Email  baghel.gajendra@142060gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jaideep Singh 
Designation  Assosiate Professor 
Affiliation  Gandhi Medical College, Bhopal 
Address  Department Of Anaesthesiology,Gandhi Medical College,Bhopal MADHYA PRADESH

Bhopal
MADHYA PRADESH
462001
India 
Phone  9827767022  
Fax    
Email  singhdrjaideep@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajkumar Ahirwal 
Designation  Assosiate Professor 
Affiliation  Gandhi Medical College, Bhopal 
Address  Department Of Anaesthesiology,Gandhi Medical College,Bhopal MADHYA PRADESH

Bhopal
MADHYA PRADESH
462001
India 
Phone  7987114383  
Fax    
Email  drrajkumarahirwal@ymail.com  
 
Source of Monetary or Material Support  
Department Of Anaesthesiology, Gandhi Medical College Bhopal,462001,Madhya Pradesh INDIA 
 
Primary Sponsor  
Name  Department of anaesthesiology 
Address  Gandhi medical college bhopal,(M.P) 462001 
Type of Sponsor  Government 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 Gajendra Singh Baghel  Gandhi Medical College associated Hamidia hospital  A Block, 2nd floor, Hamidia hospital, Department Of Anaesthesiology,Gandhi Medical College,Bhopal 462001 Madhya Pradesh INDIA MADHYA PRADESH
Bhopal
MADHYA PRADESH 
08461877025

baghel.gajendra@142060gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutiona lethics commitee Gandhi Medical College Bhopal  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  NIL  NIL 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Age groups 45 years - 75 years
2. Patients of both SEX
3. ASA Grade I & II
4. OA knee grade II &III 
 
ExclusionCriteria 
Details  1. Uncontrolled metabolic disease(DM2 ,Thyroid disease)
2. Patients with implants
3. Pregnancy
4. Know drug allergy
5. Cardiac diseases.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effects of two concentration of dextrose 10% and 25% for intraarticular injection in osteoaethritis knee pain.  Outcome will be assessed at after the procedure,at 1month,3month,6month 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the effectiveness of dextrose prolotherapy as long term treatment for chronic musculoskeletal knee pain  6 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   15/11/2024 
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="3"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

- Prolotherapy is one of the  regenerative medicine treatment and  is an injection based  medical therapy for chronic musculoskeletal pain.

-It has been used for approximately 100 years;however,its modern application can be trace to the 1950s when the prolotherapy injection protocols were formalised by Dr George Hackett, a general surgeon in the united states,remembered as grandfather of prolotherapy.

-prolotherapy ,which stimulates the healing of loosened ligaments and tendons,is a cost effective and safe treatment modality for chronic musculoskeletal pain.

-The prolotherapy technique we use is called as comprehensive prolotherapy or HACKETT-HEMWALL-HAUSER (H3) Prolotherapy.

-A combination of dextrose solution and lidocain is usually used. The concentration of dextrose and lidocaine used in the clinical field are very high (Dextrose-10%to25% ,lidocaine -0.5% to 1%)

-Prolotherapy is the technique of injecting sterile irritants which stimulates physiological acute inflammatory cascade following promotion and Healing of damaged& repairable tissue.

- Many passionate therapists call it a panacea for all ailments It is said to work by raising growth factor levels and increasing cellular proliferation, promoting healing in damaged ligaments. Proponents attribute all articular and periarticular pains to lax, injured or unhealthy ligaments. Prolotherapy can be used at any stage of the disease, and is also applicable to patients who are unwilling or unfit for surgery.

-Prolotherapy has been used in the U.S. for musculoskeletal pain since the 1930’s and is endorsed by numerous main stream practitioners.

-It has been reported in 2020 that over 2500,000 Americans had undergone prolotherapy and that many of the patients reporting benefits from prolotherapy were physicians themselves. Yet, many main stream medical practitioners have still not heard of or do not know much about prolotherapy.

-In Europe and asian countries, many millions of patients receive prolotherapy regularly and have been immensely benefited by the same.

 PROLOTHERAPY AGENT-1. Dextrose 10% -25%

2. Lidocaine 0.5% - 1% without preservatives

·        This analytical Hospital-based study will be carried out at  Gandhi Medical College and Associated Hospital, Bhopal. This study will be conducted on all patients of American Society of Anaesthesiologist physical status I and II aged between 45-75 years

·        Written and informed consent, before participating in the study will be taken from all patients/attendants.

·        METHOD-In this study half of patients will be given 10%dextrose and other half 25% dextrose with fix dose 1% of lodocaine .

-3Injections will be given with interval of one week then will be followed up in 1month 3month& 6month.

-         Site of injection will be intraarticular .

-         8 ml dextrose with 2 ml lodocaine,2.5 -3 ml will be given at multiple site for injured tendon/ligament of osteoarthritis  knee joint.

Assessment will be done by  relieve in pain,range in mobility of joint ,distance of walking.

 
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