Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A comparative analysis of treatment methods, steroid injection, percutaneous release and open surgery for patients with stenosing tenosynovitis: a randomised controlled clinical trial
Acronym
Study hypothesis
The 'trigger finger' is a case of stenosing tenosynovitis which occurs as a result of blocking the active extension of the fingers as a result of disproportion between the diameter of the flexor tendons and pulley system. This phenomenon occurs when the tendon has its landslide blocked the pass through the tunnel on the A1 pulley osteofibroses not getting more touring and naturally return to starting position. Its etiology is unknown. Causal factors which are cited include, the presence of cyst intratendineous, synovial proliferation and fibrosis of the flexor sheath, although no consensus as to its true cause.
Aims:
1. To compare the recovery rates of the 'trigger finger' by methods of corticosteroids injection, percutaneous release and conventional open surgery
2. Observe the rate of recurrence of the 'trigger finger' after the procedures
3. To analyse the complications associated with the methods used
Ethics approval
The Ethics in Research Committee of the Federal University of São Paulo, Hospital São Paulo, 23/05/2003, ref: 0349/03
Study design
Single-centre interventional randomised active-controlled parallel-group clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Stenosing tenosynovitis (trigger finger)
Intervention
150 'trigger fingers' were randomised using sealed envelopes to one of three treatments:
1. Corticosteroids injection (n = 49): 2 ml methylprednisolone acetate 40 mg/ml injection at the site corresponding to A1 pulley, trying to inject the solution inside the tunnel osteofibroses
2. Percutaneous release (n=45): release of the A1 pulley, 40x12 with a needle through longitudinal movements, on the axis of the flexor tendon, introduced at the site corresponding to the A1 pulley
3. Conventional open surgery (n=56): skin incision 2 cm transverse to the axis of the finger, the palmar skin fold, followed by subcutaneous dissection and longitudinal opening of the A1 pulley
Results:
First injection showed a success rate of 57%. Patients whose trigger remained or relapsed underwent a second injection, increasing success rate to 86%. As for percutaneous release of trigger finger, trigger remission was obtained in all cases.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Trigger finger cure: Defined as the end the blockade of the finger and the free tour of its movement, maintaining remission of the 'trigger' for 6 months.
2. Recurrence of the trigger: Defined as the return of the finger blocking during the six month follow-up study
3. Failures:
3.1. Corticosteroid injection: Defined as trigger fingers that relapsed or continued blockade, after the second infiltration
3.2. Open and percutaneous release: Defined as trigger fingers that relapsed or maintained the blockade after treatment
Secondary outcome measures
1. Pain:
1.1. Local pain: Defined as pain reported at the site of the procedure in the thumb, index, middle, ring and little finger in the outpatient follow up visit (7 days, 14 days, 1 month, 2 months, 4 months and 6 months).
1.2. Joint pain: Defined as joint pain reported in the interphalangeal joint of the thumb and proximal interphalangeal of index, middle, ring and little finger at the outpatient follow up visit (7 days, 14 days, 1 month, 2 months, 4 months and 6 months).
2. Active motion of the fingers (Total Active Motion [TAM]): TAM is recommended by the Committee of tendon injuries of the International Federation of Societies for Surgery of the Hand (Kleinert, Verdan, 1983) to evaluate the active motion of fingers. To calculate the value of TAM, we add the degree of flexion of the three joints of the fingers in active flexion, subtracting the loss of extension, measured with the active finger extension. The measurements were performed with the goniometer on the dorsal region of the fingers. Measurements were taken before treatment and at 1, 2, 4 and 6 months post-treatment.
Overall trial start date
01/11/2002
Overall trial end date
03/03/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients of both sexes
2. More than 15 years with symptoms of blockage of the movement ('trigger finger') in any finger
3. No previous treatment for any type of therapy and classified as type II to IV in the classification proposed by Quinnell (1980)
4. Greater than 15 years of age, no upper age limit
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150 trigger fingers in 137 patients
Participant exclusion criteria
1. Patients who refused to accept the consent approved by the Ethics in Research
2. Type I 'Trigger fingers'
3. Condition considered secondary to congenital partial tendon injury
Recruitment start date
01/11/2002
Recruitment end date
03/03/2007
Locations
Countries of recruitment
Brazil
Trial participating centre
Rua Visconde De Inhaúma 81
São Paulo
04145-030
Brazil
Funders
Funder type
University/education
Funder name
Federal University of Sao Paulo (Universidade Federal de São Paulo [UNIFESP]) (Brazil)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24286741
Publication citations
-
Results
Sato ES, dos Santos JB, Belloti JC, Albertoni WM, Faloppa F, Percutaneous release of trigger fingers., Hand Clin, 2014, 30, 1, 39-45, doi: 10.1016/j.hcl.2013.08.017.