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Ganglion CystPhase 1/2NCT06790615

Comparison of Thread Technique Versus Aspiration Plus Steroid Injection for Wrist Ganglion Recurrence

A Phase 1/2 study testing methyl prednisolone acetate and Silk suture in people with Ganglion Cyst, run by Benazir Bhutto Hospital, Rawalpindi at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Ganglion Cyst
What is being tested?
methyl prednisolone acetate and Silk suture
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 sitePakistan
Study dates
1 Jun 2020to 31 Dec 2020
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • PAF Hospital, Islamabad

    Islamabad, Federal

Other trials in Pakistan

About this study

Official title: To Compare Thread Technique Versus Aspiration Plus Steroid Injection of Wrist Ganglion in Terms of Frequency of Recurrence

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:

Read more

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.

Read the detailed description

INTRODUCTION Ganglia is the commonest cause of referral for upper extremity soft tissue tumors. More than 50% of referrals belong to this category. Ganglion originated from joint capsule or tendon sheaths. The most common site is wrist followed by the vicinity of interphalangeal joints. The dorsal ganglia mostly originate from scapho-lunate interosseous ligament while volar may arise from radio-scaphoid joint or scapho-trapezial joint. The most common presentation is painless lump at abovementioned areas. The pain may arise when the ganglia exert pressure effects during movements. The diagnosis is clinical in most cases and additional laboratory, or radiological investigations are often not helpful.

The treatment of ganglia is mainly sought out due to pain or cosmetic reasons. Management is tailored accordingly ranging from simple reassurance to surgical excision with in between options of aspiration with and without steroid injection, hyaluronidase injection and thread or seton insertion. The surgical excision may be orthoscopic as well. The aspiration and steroid injection may be cost effective but is associated with skin pigmentation, atrophic changes, and increased chances of recurrence. Surgical excision is associated with operative cost, infections and possible chances of nerve, tendon, or joint damage. The thread technique has been seen in some early research but to some extent has been ignored irrespective of the fact that it is cost effective and has comparable outcomes. The recurrence is common with all the current procedures.

Investigators conducted this study to determine the frequency of recurrence of wrist ganglia between threading technique and aspiration plus steroid injection. Both these procedures are being practiced as outpatient procedures in our setup. There is paucity in local and international literature regarding this specific subject. The result of our study would provide us with better insight into this subject and will leave us with a better choice to treat wrist ganglia..

METHODS AND MATERIALS This randomized controlled trial was conducted at HIT hospital Taxila from January 2020 to June 2020 for period of one year with clinical diagnosis of wrist ganglion. This study was conducted in accordance with ethical standards and principles. Institutional Review Board (IRB) or Ethics Committee approval was obtained prior to the commencement of the research (Reference number: ERC/19/15(b). Informed consent was acquired from all participants involved in the study. The research was conducted with respect for participant privacy, confidentiality, and autonomy. The sample size of 60 patients (30 in each group) was calculated by taking recurrence rates of 4% and 43% for threading technique and aspiration plus steroid injection respectively from a study.9 The level of significance was 5% and power of test was 90%. Randomization of patients was done into two equal groups by computer generated numbers. In group A, the aspiration of ganglion was done by 18G needle attached to a 10 ml syringe. After full aspiration, methylprednisolone (40 mg/ml) was injected into the cavity. In group B, the silk suture size 1 was passed horizontally through the ganglion and tied over sterile gauze. The evacuation of mucinous contents was done manually, and patients were instructed to do manual massage three times daily for 7 days. The thread was removed after 2 weeks or when only serosanguinous discharge was observed at the entry points of thread. Both procedures were done with full aseptic measures and under local anesthesia of 1% lignocaine. The patients were followed in OPD after 2 weeks, 6 weeks, 3 months, and 6 months. The recurrence was noted down on specially designed proforma for study.

The data was analyzed by Statistical Package for Social Science (SPSS) version 25 registered for Microsoft windows. The quantitative variables like age and duration of disease were expressed by mean and standard deviation. The qualitative variables like gender and recurrence at follow up visits were expressed as frequency and proportions. Both groups A and B were compared among each other in terms of recurrence at 2 week, 6 weeks, 3 months, and 6 months by Chi Square test. P value of <0.05 was considered statistically significant.

Conditions
Ganglion Cyst
Being tested
methyl prednisolone acetate, Silk suture
Keywords
Cyst, ganglion, Thread technique, Wrist swelling
Medical subject headings
Ganglion Cysts, Cysts

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • methyl prednisolone acetateDrug

    methyl prednisolone acetate was injected after the aspiration

  • Silk sutureOther

    The silk suture was used for threading technique

Study groups in NCT06790615
Study groupRoleWhat they receive
Thread techniqueExperimentalThe thread technique was used for the wrist ganglion
Receives: Other: Silk suture
Steriod injectionActive comparatorSteriod injection was given into the cyst after aspiration
Receives: Drug: methyl prednisolone acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence

    Number of patients with recurrence of ganglion cyst

    Measured: 2 weeks

  2. Recurrence

    Number of patients with recurrence of ganglion cyst

    Measured: 6 weeks

  3. Recurrence

    Number of patients with recurrence of ganglion cyst

    Measured: 3 months

  4. Recurrence

    Number of patients with recurrence of ganglion cyst

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2025
  2. Study start1 Jun 2020
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06790615
Sponsor's protocol ID
ERC/19/15(b)
Status last verified
Jan 2025
First submitted
14 Jan 2025
Last updated
24 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing methyl prednisolone acetate and Silk suture in people with Ganglion Cyst, run by Benazir Bhutto Hospital, Rawalpindi at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence (time frame: 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.

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