| 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
|
|
|
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
|
|
|
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. | |