- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06651034
Efficacy of Intralesional Platelet Rich Plasma in Patients of De Quervain's Tenosynovitis
October 18, 2024 updated by: Muhammad Aamir Latif
De Quervain's tenosynovitis (DQT) was originally identified by Swiss surgeon Fritz de Quervain in 1895.
It is a condition involving the entrapment of tendons within the first dorsal compartment of the wrist.
In DQT, the sheaths surrounding the abductor pollicis longus (APL) and extensor pollicis brevis tendons thicken as they pass through a fibro-osseous tunnel near the radial styloid of the distal wrist.
This thickening leads to pain, which worsens with thumb movements and radial or ulnar deviation of the wrist.
Traditional treatment methods, such as corticosteroid injections and physical therapy, often provide only temporary relief and may not address the underlying inflammation effectively.
Intralesional platelet rich plasma (PRP) therapy has emerged as a promising alternative, utilizing the patient's own growth factors and cytokines to promote healing and reduce inflammation.
By investigating the efficacy of intralesional PRP in patients with DQT, this research aims to provide evidence for a minimally invasive treatment option that could enhance recovery times, reduce pain, and improve functional outcomes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
67
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lahore, Pakistan
- Department of Orthopedic surgery, KEMU/ Affiliated hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Either gender,
- Aged between 18 and 60 years
- Presenting with de quervain's tenosynovitis
Exclusion Criteria:
- Previous surgery or intervention forde quervain's tenosynovitis
- Local skin infection or osteomyelitis
- Pregnant or lactating mothers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PRP
Intralesional Platelet rich plasma
|
Under aseptic measures, a phlebotomist obtained the blood in vacutainers.
Vacutainers was centrifuged and middle zone containing platelet rich plasma was aspirated in a 5 ml disposable syringe.
The patient received intralesional injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VAS Pain Score
Time Frame: 3-week
|
The patients were evaluated three weeks after treatment for efficacy.
Efficacy was labeled as VAS pain score < 3 after 3 weeks of intralesional PRP injection.
|
3-week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Muhammad Zarak Awais, MBBS, Department of Orthopedic Surgery, Mayo Hospital, Lahore, Pakistan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2021
Primary Completion (Actual)
October 30, 2022
Study Completion (Actual)
October 30, 2022
Study Registration Dates
First Submitted
October 18, 2024
First Submitted That Met QC Criteria
October 18, 2024
First Posted (Actual)
October 21, 2024
Study Record Updates
Last Update Posted (Actual)
October 21, 2024
Last Update Submitted That Met QC Criteria
October 18, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mayo-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.