| CTRI Number |
CTRI/2024/12/078382 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
19/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to assess the role of platelet rich fibrin in chronic pain management of musculoskeletal injuries. |
|
Scientific Title of Study
|
A comparative study to evaluate the clinical efficacy of autologous platelets rich fibrin on chronic pain management of musculoskeletal injuries. |
| 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 Rajmala Jaiswal |
| Designation |
Senior Professor |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science. |
| Address |
Room no:04, Department of Anesthesiology and Critical Care, Second floor Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science, Rohtak,124001
Rohtak
HARYANA
124001
India |
| Phone |
8950615744 |
| Fax |
|
| Email |
para3007@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monika |
| Designation |
PG student |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science. |
| Address |
Room no: 5, 2nd floor, Department of anaesthesiology and Critical Care, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science Rohtak 124001.
Rohtak
HARYANA
124001
India |
| Phone |
8930895596 |
| Fax |
|
| Email |
monikapunia810@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monika |
| Designation |
PG student |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science. |
| Address |
Room no: 02, Second floor, Department of Anaesthesiology and Critical Care, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science Rohtak 124001.
Rohtak
HARYANA
124001
India |
| Phone |
8930895596 |
| Fax |
|
| Email |
monikapunia810@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science, Rohtak, Haryana, India-124001. |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Monika |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science. |
Department of Anesthesiology and Critical Care, Second floor, Rohtak, Haryana.
Rohtak
HARYANA |
8930895596
monikapunia810@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bio Medical Research Ethics Committee, Pt.B.D.Sharma PGIMS/UHS, Rohtak. |
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 |
Platelet rich fibrin |
Platelet rich fibrin is a second generation platelet Concentrate which Contains platelets,leukocytes,fibronectin,vitronectin and thrombospondin-1.Platelet rich fibrin acts as a binding site for both platelets and growth factors. Through increasing the local concentration of growth factors at specific tissue, PRF promotes tissue regeneration. Use of PRF as a beneficial adjuvant for a range of chronic muscle,tendon,bone or other soft tissue injuries. Ease of preparation,low cost,minimal risk for the patient and possible outpatient use make PRf an optimal scaffold for tissue healing process.2ml of PRF is injected for once with follow up of duration for 2 months. |
| Comparator Agent |
Tramadol 50mg |
Tramadol is a centrally opioid atypical analgesics structurally related to morphine. It acts as a mu opoid receptor agonist and serotonin re uptake inhibitor. It mainly use for chronic pain and less likely to generate addiction and less sedative effect. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of age group equal or more than 18 years of either sex with ASA grade 1 and 2.
2.Patient suffering from chronic pain due to musculoskeletal injuries for atleast 3 months . 3.Patient having VAS score more than 5 without satisfactory pain relief from standard treatment. 4.Patient who have not received any local injectables like corticosteroids presenting to the pain clinic OPD. |
|
| ExclusionCriteria |
| Details |
1. History of previous local anaesthetic
infiltration.
2. Malignancy.
3. Active local infection/skin infection
4. Patients on anticoagulant, antiplatelet drugs,
bleeding disorders
5. Patient on immunosuppressants/steroids
6. Fever
7. Diabetic mellitus
8. Unwillingness to participate
9. Patients on treatment for psychiatric illness
10. Pregnant and lactating women will be excluded
from the study. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess clinical recovery by VAS score in assessment of local pain before and after PRF injection. |
To assess clinical recovery by VAS score in assessment of local pain at intervals of baseline,2 weeks, 4 weeks, 8 weeks and 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Requirement of rescue analgesia (Tramadol) |
3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/12/2024 |
| 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="1"
Months="0"
Days="0" |
|
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
|
We intend to undertake the study to evaluate and compare the clinical efficacy of platelet rich fibrin (PRF) in pain management of musculoskeletal injuries. The primary objective of study is to assess the clinical recovery by VAS score in assessment of local pain before and after PRF injection. The total of 40 patients of age group equal or more than 18 years of either sex with ASA grade 1 and 2 suffering from chronic pain due to musculoskeletal injuries for atleast 3 months and patients will be followed further beyond study period. |