'Trigger finger': comparative analysis of treatment methods by steroid injection, percutaneous release and open surgery

ISRCTN	ISRCTN19255926
DOI	https://doi.org/10.1186/ISRCTN19255926
Protocol serial number	N/A
Sponsor	Federal University of Sao Paulo (Universidade Federal de São Paulo [UNIFESP]) (Brazil)
Funder	Federal University of Sao Paulo (Universidade Federal de São Paulo [UNIFESP]) (Brazil)

Submission date: 20/07/2010
Registration date: 04/10/2010
Last edited: 13/08/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Edson Sasahara Sato
Scientific

Rua Visconde De Inhaúma 81
Apartamento 32
Bairro: Saúde
São Paulo
04145-030
Brazil

Study information

Primary study design	Interventional
Study design	Single-centre interventional randomised active-controlled parallel-group clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	The Ethics in Research Committee of the Federal University of São Paulo, Hospital São Paulo, 23/05/2003, ref: 0349/03
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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.
Completion date	03/03/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	137
Key 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
Key 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
Date of first enrolment	01/11/2002
Date of final enrolment	03/03/2007

Locations

Countries of recruitment

Brazil

Study participating centre

Rua Visconde De Inhaúma 81

São Paulo
04145-030
Brazil

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes