About this trial

The goal of this clinical trial is to learn if surgery helps with wrist ganglions in adults. The main question it aims to answer is:

* Does surgery result in better patient-reported outcomes and satisfaction over a 6-months follow-up period?

Researchers will compare surgery to conservative treatment (self-administered exercises and use of the hand as tolerated) to see if surgery provides superior outcomes.

Participants will:

* Be randomly assigned to receive either surgery or conservative treatment * Complete questionnaires about wrist pain, function, quality of life, satisfaction, and recovery at 3, 6, and 12 months

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

wrist pain located in the ganglion area

diagnosis of ganglion of the wrist, based on clinical examination or imaging findings

age over 18 years

ability to fill out the Finnish or English version of the questionnaires

Disqualifiers

pregnant or breast feeding

other known wrist pathology that likely explains the pain

previous surgical treatments of the wrist

wrist ganglion presumed to be related to a work injury

Trial design

Design model

Parallel

Treatments tested in this trial

Open resection
Procedure/Surgery
A transverse or longitudinal incision is done depending on surgeon's preference. The ganglion and its pedicle are traced up to its origin. The pedicle is resected tangentially, usually, from the SL ligament for dorsal ganglions and depending on the site for volar ganglion. Wrist capsule is not closed.
Arthroscopic resection
Procedure/Surgery
Portals are selected by surgeon's preference. The pedicle of the ganglion is located and resected with a shaver. It is not necessary to remove all the ganglion walls. The portal incisions do not need to be sutured.
Conservative treatment
Other intervention
Participant will be informed about the natural course of wrist ganglions. The conservative treatment may include needle aspiration of the ganglion, but it is not performed routinely. Participants are informed that wrist loading in extension may exacerbate the pain, and that the pain is not a sign of further injury to wrist joint. They can avoid heavy use it if they have too much pain, but they are advised to use hand as tolerated. Participants may use NSAIDs and acetaminophen for pain management as needed; however, the protocol does not specify a required course or dosage. A simple self-implemented exercise therapy instructions are given to every participant.

Treatment groups

220 Participants

are divided into 2 treatment groups

Group A: SurgeryExperimental treatment 2 interventions

Group B: Conservative treatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Patient-Rated Wrist/Hand Evaluation (PRWHE) pain score

The PRWHE is a 15-item questionnaire that is designed to measure wrist pain and disability in activities of daily living. Symptoms are described as average over the past week. The PRWHE consists of two subscales: pain and function. The PRWHE pain includes five items with combined score from 0 (no pain) to 50 (worst ever).

Time frame

6 months follow-ups

Secondary outcomes

1

PRWHE pain score

The PRWHE is a 15-item questionnaire that is designed to measure wrist pain and disability in activities of daily living. Symptoms are described as average over the past week. The PRWHE consists of two subscales: pain and function. The PRWHE pain includes five items with combined score from 0 (no pain) to 50 (worst ever).

Time frame

3 and 12 months follow-ups

2

PRWHE function score

The PRWHE is a 15-item questionnaire that is designed to measure wrist pain and disability in activities of daily living. Symptoms are described as average over the past week. The PRWHE consists of two subscales: pain and function. Score of the PRWHE function ranges from 0 (no difficulty) to 50 (unable to do).

Time frame

3, 6, and 12 months follow-ups

3

PRWHE total score

The PRWHE is a 15-item questionnaire that is designed to measure wrist pain and disability in activities of daily living. Symptoms are described as average over the past week. The PRWHE consists of two subscales: pain and function. The PRWHE total ranges from 0 (best) to 100 (worst).

Time frame

3, 6, and 12 months follow-ups

4

Global improvement

Self-reported global improvement will be gathered as 7-step Likert scale as a response to question: "Compared with the beginning of the study, my wrist feels much worse - somewhat worse - little worse - no change - little better - somewhat better - much better."

Time frame

3, 6, and 12 months follow-ups

Ganglion Resection Effectiveness Trial

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts