Condition category
Musculoskeletal Diseases
Date applied
20/07/2010
Date assigned
04/10/2010
Last edited
13/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Edson Sasahara Sato

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

Federal University of Sao Paulo (Universidade Federal de São Paulo [UNIFESP]) (Brazil)

Sponsor details

c/o Edson Sasahara Sato
Rua Visconde de Inhaúma
81
Apartamento 32
Bairro: Saúde
São Paulo
04145-030
Brazil

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24286741

Publication citations

  1. 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.

Additional files

Editorial Notes