NCT06790615

Brief Summary

This study is a randomized controlled trial comparing two treatment methods for wrist ganglion cysts to evaluate which method has a lower recurrence rate. Ganglion cysts are non-cancerous lumps commonly found on the wrist, arising from joint capsules or tendon sheaths. They are often painless but may cause discomfort or cosmetic concerns. The primary objective of this study was to compare the recurrence rates of wrist ganglia treated with two methods: Thread technique: Inserting a silk thread through the cyst to allow drainage. Aspiration plus steroid injection: Removing the cyst fluid with a needle followed by injecting a corticosteroid to reduce inflammation. Study Design The trial was conducted at HIT Hospital, Taxila, from June to December 2020. It included 60 participants aged 18-50 years, divided equally into two groups. Group A underwent the thread technique, and Group B received aspiration and steroid injections. Patients were followed up at intervals of 2 weeks, 6 weeks, 3 months, and 6 months to monitor for cyst recurrence. Methods Thread Technique: A silk suture was passed through the cyst, allowing its contents to drain. Patients were instructed to massage the area daily for one week. The thread was removed once drainage ceased. Aspiration and Steroid Injection: Fluid was removed using a needle, and 40 mg of methylprednisolone acetate was injected into the cyst cavity. Both procedures were performed under local anesthesia in an outpatient setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2020

Shorter than P25 for phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 24, 2025

Completed
Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

7 months

First QC Date

January 14, 2025

Last Update Submit

January 22, 2025

Conditions

Keywords

CystganglionThread techniqueWrist swelling

Outcome Measures

Primary Outcomes (4)

  • Recurrence

    Number of patients with recurrence of ganglion cyst

    2 weeks

  • Recurrence

    Number of patients with recurrence of ganglion cyst

    6 weeks

  • Recurrence

    Number of patients with recurrence of ganglion cyst

    3 months

  • Recurrence

    Number of patients with recurrence of ganglion cyst

    6 months

Study Arms (2)

Thread technique

EXPERIMENTAL

The thread technique was used for the wrist ganglion

Other: Silk suture

Steriod injection

ACTIVE COMPARATOR

Steriod injection was given into the cyst after aspiration

Drug: methyl prednisolone acetate

Interventions

methyl prednisolone acetate was injected after the aspiration

Steriod injection

The silk suture was used for threading technique

Thread technique

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with a clinical and radiological diagnosis of wrist ganglion.
  • Both genders.
  • Age range of 18 to 50 years.

You may not qualify if:

  • Patients with a history of previous invasive treatments.
  • Patients with compound ganglion.
  • Patients with diabetes mellitus.
  • Patients with bleeding diathesis. Patients with immunosuppression. Patients with rheumatoid arthritis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PAF Hospital, Islamabad

Islamabad, Federal, Pakistan

Location

MeSH Terms

Conditions

Ganglion CystsCysts

Condition Hierarchy (Ancestors)

NeoplasmsMucinosesConnective Tissue DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Abdul Basit, MBBS, FCPS

    POF Hospital, Wah Cantt.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Surgeon

Study Record Dates

First Submitted

January 14, 2025

First Posted

January 24, 2025

Study Start

June 1, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

January 24, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations