NCT06651034

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 21, 2024

Completed
Last Updated

October 21, 2024

Status Verified

October 1, 2024

Enrollment Period

1.2 years

First QC Date

October 18, 2024

Last Update Submit

October 18, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • VAS Pain Score

    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

Study Arms (1)

PRP

EXPERIMENTAL

Intralesional Platelet rich plasma

Other: Platelet Rich Plasma

Interventions

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

PRP

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Either gender,
  • Aged between 18 and 60 years
  • Presenting with de quervain's tenosynovitis

You may not qualify if:

  • Previous surgery or intervention forde quervain's tenosynovitis
  • Local skin infection or osteomyelitis
  • Pregnant or lactating mothers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopedic surgery, KEMU/ Affiliated hospital

Lahore, Pakistan

Location

MeSH Terms

Conditions

De Quervain Disease

Condition Hierarchy (Ancestors)

Tendon EntrapmentTendinopathyMuscular DiseasesMusculoskeletal Diseases

Study Officials

  • Muhammad Zarak Awais, MBBS

    Department of Orthopedic Surgery, Mayo Hospital, Lahore, Pakistan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Quasi-experimental study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Consultant

Study Record Dates

First Submitted

October 18, 2024

First Posted

October 21, 2024

Study Start

September 1, 2021

Primary Completion

October 30, 2022

Study Completion

October 30, 2022

Last Updated

October 21, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations