| 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
|
|
|
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
|
|
|
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. |