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Study of the effect of local Infiltration in comparison with intramuscular Infiltration in the treatment of Trigger finger

"Local versus systemic infiltration for the treatment of trigger finger: randomized clinical trial - PHASE 3 study"

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-8mgdwm
Enrollment
Unknown
Registered
2020-04-16
Start date
2017-04-12
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trigger finger

Interventions

All patients included in this study will be treated at the hand surgery outpatient centers, previously mentioned. After confirmation of the diagnosis of trigger finger with grade II and III, by Green'
Drug

Sponsors

Hospital Alvorada Moema
Lead Sponsor
Hospital Alvorada Moema
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients over 18 years of age, with trigger finger grade II and grade III of the Green Classification will be submitted to clinical evaluation, in which we will consider three criteria for diagnosis: Clinical history: pain at A1 pulley level, history of bounce and / or active or passive block, exacerbation of symptoms in the morning; Physical examination: presence of pain in pulley A1, with or without shoulder or block; USG: presence of tenosynovitis, with or without tendon nodule. The presence of two of the three criteria will be sufficient for diagnosis and inclusion. There will be no intervention by researchers with regard to the inclusion of patients, with the aim of controlling potential inclusion bias. After reading, explaining the study proposal and accepting to participate, all research subjects will sign a Free and Informed Consent Form (ICF)

Exclusion criteria

Exclusion criteria: Anterior surgical treatment of trigger finger; Hypersensitivity to the corticosteroid; Refusal of the consent term

Design outcomes

Primary

MeasureTime frame
Remission of pain and post-intervention finger “triggering"– Clinical evaluation to verify remission of pain and finger blocking, referred by the patient at the time of initial care.

Secondary

MeasureTime frame
Pain Evaluation by Visual Analog Scale (VAS): The visual analogue pain scale is formed by two bars, joined by a line with 100 millimeters, which mark the beginning and the end. The starting bar is "0" and indicates no pain. The final bar is "10" and indicates maximum pain. The patient will be asked to register their pain with a line on this line that joins the two bars. The measurement of pain will be performed by measuring the distance between the initial bar and the trace performed by the patient and considered as a continuous variable, from 0 to 100 millimeters.; Satisfaction scale: The visual analogue satisfaction scale consists of two bars, joined by a line with 100 millimeters, which mark the beginning and the end. The starting bar is "0%" and indicates total dissatisfaction with the treatment. The final bar is "100%" and indicates maximum satisfaction with the treatment. The patient will be asked to register his / her satisfaction with a line in this line that joins the two bars.;QuickDASH questionnaire: QuickDASH is a shorter version of the DASH questionnaire. Arm, Shoulder and Hand Dysfunction (DASH) It quantifies dysfunction of the upper limbs and detects changes in the function of the upper limb and the patient's responses to treatments. DASH was introduced by the American Academy of Orthopedic Surgeons in 2001 with the aim of measuring the deficiency caused by various disorders of the upper limbs, demonstrating validity and reliability. There are 30 questions self-applicable, specific for upper extremity function and symptoms during the week prior to application. QuickDASH, was developed from DASH and also demonstrated equivalent validity, reliability and sensitivity. Detects changes in upper limb function and patient responses to treatment. It has eleven items addressing the symptoms and daily skills in people with some or more disorders in the upper limb, provides the same quality of information in a summarized form, facilitating the score for the cl

Countries

Brazil

Contacts

Public ContactÉrica;João Troiano;Belloti

hospital alvorada moema;Hospital Alvorada Moema

ericaditroia@hotmail.com;jcbelloti@gmail.com11956598928;+55-011-954073111

Outcome results

None listed

Source: REBEC (via WHO ICTRP)