Short- to Medium-term Outcome of Minimally Invasive Carpal Tunnel Release

ConditionCarpal Tunnel
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland

About this trial

The aim of the study is to determine whether minimally invasive, ultrasound-guided thread carpal tunnel release leads to faster functional recovery compared to standard open and endoscopic techniques in patients with carpal tunnel syndrome.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient aged 18 years or older

Electroneurographically proven carpal tunnel syndrome

Informed Consent for trial participation

Disqualifiers

Revision surgery

Inability to give informed consent, whether it be due to an insurmountable language barrier or another reason

Trial design

Design model

Parallel

Treatments tested in this trial

  • TCTR (thread carpal tunnel release)

    Procedure/Surgery

    Percutaneous sonography guided release of carpal tunnel release

  • Standard-of-care

    Procedure/Surgery

    Open or endoscopic carpal tunnel release based on patients' and physicians' preferences

Treatment groups

61 Participants
are divided into 2 treatment groups
Group A: TCTR (thread carpal tunnel release)Experimental treatment 1 intervention
Group B: Standard of care techniqueActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The objective functional assessment of the BCTQ score at 2 weeks

Functional assessment of the BCTQ. The BCTQ is a patient reported outcome measure (PROM) questionnaire that examines subjective symptom severity and objective overall functional status. The Functional Status Scale evaluates the ability of the patient to use their hand in daily life using 8 questions, which are scored from 1-5 with 1 as no difficulty and 5 as difficult. Therefore, the higher the score, the more difficulty the patient has with the symptom.

Time frame
2 weeks post-operative

Secondary outcomes

1

The objective functional assessment of the BCTQ score

Functional assessment of the BCTQ. The BCTQ is a patient reported outcome measure (PROM) questionnaire that examines subjective symptom severity and objective overall functional status. The Functional Status Scale evaluates the ability of the patient to use their hand in daily life using 8 questions, which are scored from 1-5 with 1 as no difficulty and 5 as difficult. Therefore, the higher the score, the more difficulty the patient has with the symptom

Time frame
4 and 6 weeks and 6 month post-operative
2

Overall BCTQ score, which is a combination of the subjective symptom severity and the objective functional status.

The BCTQ is a patient reported outcome measure (PROM) questionnaire that examines subjective symptom severity and objective overall functional status. The Symptom Severity Scale with 11 questions is scored on a Likert scale of 1-5 and the Functional Status Scale with 8 questions is scored from 1-5 with 1 as no difficulty and 5 as difficult. Therefore, the higher the score, the more difficulty the patient has with the symptom.

Time frame
2, 4 and 6 weeks and 6 months post-operative
3

The subjective symptom severity score of the BCTQ

The BCTQ is a patient reported outcome measure (PROM) questionnaire that examines subjective symptom severity and objective overall functional status. The Symptom Severity Scale describes the symptoms concerning sensibility and pain and is evaluated using 11 questions scored on a Likert scale of 1-5 with 1 as no difficulty and 5 as difficult. Therefore, the higher the score, the more difficulty the patient has with the symptom.

Time frame
2, 4 and 6 weeks and 6 months post-operative
4

Hand-specific health

The Michigan Hand Questionnaire (MHQ)is one of the most widely utilized, hand-specific surveys that measures health status relevant to patients with acute and chronic hand disorders.Scale ranges from 0-100, while lower scores indicate better outcomes.

Time frame
2, 4 and 6 weeks and 6 months post-operative

Other outcomes

Sponsors and contacts

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