| CTRI Number |
CTRI/2022/02/040669 [Registered on: 28/02/2022] Trial Registered Prospectively |
| Last Modified On: |
23/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Benefit of dextrose injection in treatment of heel pain |
|
Scientific Title of Study
|
Efficacy of dextrose prolotherapy in the treatment of plantar fasciitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Malovika Biswas |
| Designation |
Post Graduate Trainee |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Physical Medicine and Rehabilitation OPD Building Ground Floor VMMC and Safdarjung Hospital
New Delhi
DELHI
110029
India |
| Phone |
9647243131 |
| Fax |
|
| Email |
mlbiswas13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R K Wadhwa |
| Designation |
Professor and Head of Department |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Roon no 33 Ground Floor OPD Block Department of Physical Medicine and Rehabilitation VMMC and Safdarjung Hospital New Delhi
New Delhi
DELHI
110029
India |
| Phone |
01126164887 |
| Fax |
|
| Email |
rkwadhwa79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Malovika Biswas |
| Designation |
Post Graduate Trainee |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Physical Medicine and Rehabilitation OPD Building Ground Floor VMMC and Safdarjung Hospital
New Delhi
DELHI
110029
India |
| Phone |
9647243131 |
| Fax |
|
| Email |
mlbiswas13@gmail.com |
|
|
Source of Monetary or Material Support
|
| VMMC & Safdarjung Hospital |
|
|
Primary Sponsor
|
| Name |
VMMC Safdarjung Hospital |
| Address |
VMMC & Safdarjung Hospital, New Delhi - 110029 |
| 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 Malovika Biswas |
OPD of PMR |
Ground floor, OPD Block, Department of Physical Medicine and Rehabilitation, VMMC and Safdarjung Hospital
New Delhi
DELHI |
9647243131
mlbiswas13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee VMMC and Safdarjung Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M796||Pain in limb, hand, foot, fingersand toes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dextrose prolotherapy |
1.5 ml of 20% dextrose and 0.5 ml of 0.5% lidocaine resulting in 15% dextrose solution
Follow up at 0, 2 and 8 weeks |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed cases of plantar fasciitis with duration of symptoms more than 3 months |
|
| ExclusionCriteria |
| Details |
1. Recent history of trauma and calcaneal fracture
2. Prior injection treatment for heel pain within 6 months
3. Prior surgery for plantar fasciitis
4. Active infection at injection site
5. Uncontrolled diabetes mellitus
6. Bleeding disorders
7. Dementia and other psychiatric illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain using Numeric Pain Rating Scale
2. Foot function using Foot Function Index
3. Plantar fascia thickness |
At 0, 2 and 8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Plantar fascia thickness on USG |
At 0, 4 and 8 week |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/03/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/03/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is an interventional cohort study to study the efficacy of dextrose prolotherapy in plantar fasciitis patients in relation to pain, foot function index and plantar fascia thickness. The study will be conducted in out-patient department of Physical Medicine and Rehabilitation, VMMC & Safdarjung Hospital, New Delhi. Clinically diagnosed cases of plantar fasciitis will be enrolled in the study after applying inclusion criteria and taking informed consent. Baseline investigations will be done before intervention. Patients will undergo USG guided prolotherapy under all aseptic conditions. Patients will be clinically evaluated using numeric pain rating scale, foot function index and plantar fascia thickness on baseline day 0, week 2 and week 8. After getting clinical evaluation scores pre and post intervention data will be compiled in a tabular form. |