Trigger FingerNCT02972879
Effectiveness of Non-surgical Interventions for the Trigger Finger: a Randomized Clinical Trial
A study testing Therapeutic modalities: Orthotic (Group 1), Therapeutic modalities: LLLT (Group 2) and Therapeutic modalities: Paraffin (Group 3) in people with Trigger Finger, run by Beatriz Sernajoto Cristiani Pedro.
Trial summary
The aim of this study is to assess the effectiveness of therapeutic modalities (paraffin, ultrasound and orthotics) versus corticosteroid injection for trigger finger. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigger Finger
- What is being tested?
- Therapeutic modalities: Orthotic (Group 1), Therapeutic modalities: LLLT (Group 2) and Therapeutic modalities: Paraffin (Group 3)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2018to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 2-3 grade of trigger finger (Quinnell´s classification)
- Signing the Terms of Consent.
Who cannot join
- Presence of finger trigger in children
- Presence of traumatic finger trigger
- Secondary causes (patients with tumor of the tendon sheath,
- synovitis tuberculosis, etc ...)
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to assess the effectiveness of therapeutic modalities (paraffin, ultrasound and orthotics) versus corticosteroid injection for trigger finger.
Read the detailed description
There are several forms of nonsurgical treatment for trigger finger, the most used are:
- Oral nonsteroidal and steroidal antiinflammatory's drugs use to resolve the inflammatory process
- Corticosteroids local injection: that proposes to control the inflammation, these injections have shown good effectiveness for trigger finger treatment.
- Orthotic: with the aim of to immobilize the affected joint until the resolution of the inflammatory process.
- Electrotherapeutic modalities:
- Paraffin that increases cellular metabolism and promotes peripheral vasodilatation, favoring the transduction tissue fluid, lymph flow, hyperemia and consequent absorption of exsudato.
- LASER -Lower Level Laser Therapy (LLLT): the absorption of light through the skin's photoreceptors stimulates mitochondrial chain reactions, promoting adenosine triphosphate (ATP) synthesis, acting on gene expression, which raises the level of growth factors and Tissue repair
Although the non-surgical treatment is often used there is no evidence in the literature of which is the most effective conservative treatment for trigger finger. Thus, it is necessary use appropriate methodology to define the benefits and harms of each treatment modality and assess the effectiveness of these nonsurgical treatments, and may define which one has a higher resolution and lower rates of trigger finger recurrences in short, medium and long term.
- Conditions
- Trigger Finger
- Being tested
- Therapeutic modalities: Orthotic (Group 1), Therapeutic modalities: LLLT (Group 2), Therapeutic modalities: Paraffin (Group 3), Corticosteroid injection (Group 4)
- Keywords
- trigger finger, Therapeutic Modalities, Corticosteroid Injection, non-surgical treatment, physical therapy
- Medical subject headings
- Trigger Finger Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic modalities: Orthotic (Group 1)Procedure or surgery
Also called Metal orthotic
participants will be instructed to remove the orthosis only two hours in the morning, two hours in the afternoon and two hours at night to avoid joint stiffness
Therapeutic modalities: LLLT (Group 2)Procedure or surgery
Also called Ibramed's LASERPULSED 904nm
The LLLT parameters are:
- LASER 904nm
- P: 1.5W/cm²
- 30mV/cm²
- Area 2 cm²
- 1 Joule por ponto ( in the A1 pulley)
Therapeutic modalities: Paraffin (Group 3)Procedure or surgery
Also called Bath Paraffin Carci´s
Paraffin will be heated and maintained at 50 ° C. Participants will immerse their affected hand 10 times in heated paraffin, then they will roll up their affected hand in a towel that they will bring, after 20 minutes timed by a trained professional, the subjects will remove the towel and "paraffin glove":
Corticosteroid injection (Group 4)Procedure or surgery
Also called Bethametasone
The injection solution is composed of 1 ml of betamethasone and 1 ml of 2% lidocaine.This group may repeat the procedure in two weeks if they report that there was no improvement of the triggering or pain.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Modalities | Active comparator | * Group 1: Metal orthotic, keeping 0º of the extension of the proximal interphalangeal joint, during all day, for 5 weeks, stopping the use only for bathing
* Group 2: 10 LLLT sessions applications on the A1 pulley and lump formed on the flexor tendon of the the affected finger; Two sessions per week, five weeks of treatment.
* Group 3: Paraffin bath 2 times a week for 20 minutes (total of 10 sessions). Receives: Procedure: Therapeutic modalities: Orthotic (Group 1); Procedure: Therapeutic modalities: LLLT (Group 2); Procedure: Therapeutic modalities: Paraffin (Group 3) |
| Corticosteroid injection | Active comparator | Group 4: Corticosteroid injection in the A1 pulley, 1 application. Receives: Procedure: Corticosteroid injection (Group 4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Resolution/cure of the trigger finger until the six months of the treatment
The patient must extend and flex the affected
finger 10 times to verify the presence or absence of the trigger finger and determine
the degree of commitment.
Measured: 1, 5, 12 weeks and 6 month
Secondary outcomes (5)
Changes in Visual Analogue Scale (VAS)
Measured: 1, 5, 12 weeks and 6 month
Changes in Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)
Measured: 1, 5, 12 weeks and 6 month
Changes in SF-12 (quality of life)
Measured: 1, 5, 12 weeks and 6 month
Changes in the numbers of the Complications
Measured: 1, 5, 12 weeks and 6 month
Changes in the numbers of the Relapses
Measured: 1, 5, 12 weeks and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study start1 Mar 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Trigger FingerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beatriz Sernajoto Cristiani Pedro
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of São Paulo
- Responsible party
- Sponsor-investigator, Beatriz Sernajoto Cristiani Pedro, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972879
- Sponsor's protocol ID
- BSCPedro
- Status last verified
- Jul 2017
- First submitted
- 7 Nov 2016
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Binder A, Hodge G, Greenwood AM, Hazleman BL, Page Thomas DP. Is therapeutic ultrasound effective in treating soft tissue lesions? Br Med J (Clin Res Ed). 1985 Feb 16;290(6467):512-4. doi: 10.1136/bmj.290.6467.512.
PubMed 3918652Colbourn J, Heath N, Manary S, Pacifico D. Effectiveness of splinting for the treatment of trigger finger. J Hand Ther. 2008 Oct-Dec;21(4):336-43. doi: 10.1197/j.jht.2008.05.001. Epub 2008 Aug 22.
PubMed 19006759Chen PT, Lin CJ, Jou IM, Chieh HF, Su FC, Kuo LC. One digit interruption: the altered force patterns during functionally cylindrical grasping tasks in patients with trigger digits. PLoS One. 2013 Dec 31;8(12):e83632. doi: 10.1371/journal.pone.0083632. eCollection 2013.
PubMed 24391799Tarbhai K, Hannah S, von Schroeder HP. Trigger finger treatment: a comparison of 2 splint designs. J Hand Surg Am. 2012 Feb;37(2):243-9, 249.e1. doi: 10.1016/j.jhsa.2011.10.038. Epub 2011 Dec 20.
PubMed 22189188Langer D, Luria S, Maeir A, Erez A. Occupation-based assessments and treatments of trigger finger: a survey of occupational therapists from Israel and the United States. Occup Ther Int. 2014 Dec;21(4):143-55. doi: 10.1002/oti.1372. Epub 2014 May 12.
PubMed 24821018Howitt S, Wong J, Zabukovec S. The conservative treatment of Trigger thumb using Graston Techniques and Active Release Techniques. J Can Chiropr Assoc. 2006 Dec;50(4):249-54.
PubMed 17549185Peters-Veluthamaningal C, van der Windt DA, Winters JC, Meyboom-de Jong B. Corticosteroid injection for trigger finger in adults. Cochrane Database Syst Rev. 2009 Jan 21;2009(1):CD005617. doi: 10.1002/14651858.CD005617.pub2.
PubMed 19160256Huisstede BM, Hoogvliet P, Coert JH, Friden J; European HANDGUIDE Group. Multidisciplinary consensus guideline for managing trigger finger: results from the European HANDGUIDE Study. Phys Ther. 2014 Oct;94(10):1421-33. doi: 10.2522/ptj.20130135. Epub 2014 May 8.
PubMed 24810861Renno AC, Toma RL, Feitosa SM, Fernandes K, Bossini PS, de Oliveira P, Parizotto N, Ribeiro DA. Comparative effects of low-intensity pulsed ultrasound and low-level laser therapy on injured skeletal muscle. Photomed Laser Surg. 2011 Jan;29(1):5-10. doi: 10.1089/pho.2009.2715. Epub 2010 Dec 18.
PubMed 21166589Salim N, Abdullah S, Sapuan J, Haflah NH. Outcome of corticosteroid injection versus physiotherapy in the treatment of mild trigger fingers. J Hand Surg Eur Vol. 2012 Jan;37(1):27-34. doi: 10.1177/1753193411415343. Epub 2011 Aug 4.
PubMed 21816888Quinnell RC. Conservative management of trigger finger. Practitioner. 1980 Feb;224(1340):187-90. No abstract available.
PubMed 7367373Valdes K. A retrospective review to determine the long-term efficacy of orthotic devices for trigger finger. J Hand Ther. 2012 Jan-Mar;25(1):89-95; quiz 96. doi: 10.1016/j.jht.2011.09.005.
PubMed 22265444Dingemanse R, Randsdorp M, Koes BW, Huisstede BM. Evidence for the effectiveness of electrophysical modalities for treatment of medial and lateral epicondylitis: a systematic review. Br J Sports Med. 2014 Jun;48(12):957-65. doi: 10.1136/bjsports-2012-091513. Epub 2013 Jan 18.
PubMed 23335238Dilek B, Gozum M, Sahin E, Baydar M, Ergor G, El O, Bircan C, Gulbahar S. Efficacy of paraffin bath therapy in hand osteoarthritis: a single-blinded randomized controlled trial. Arch Phys Med Rehabil. 2013 Apr;94(4):642-9. doi: 10.1016/j.apmr.2012.11.024. Epub 2012 Nov 24.
PubMed 23187044Sibtain F, Khan A, Shakil-Ur-Rehman S. Efficacy of Paraffin Wax Bath with and without Joint Mobilization Techniques in Rehabilitation of post-Traumatic stiff hand. Pak J Med Sci. 2013 Apr;29(2):647-50.
PubMed 24353596
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Non-surgical Interventions for the Trigger Finger: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02972879
- Acronym / sponsor ID
- BSCPedro
- Conditions
- Trigger Finger
- Keywords
- trigger finger, Therapeutic Modalities, Corticosteroid Injection, non-surgical treatment, physical therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Beatriz Sernajoto Cristiani PedroUniversity, hospital or other
- Collaborators
- Federal University of São Paulo
- Study start
- 1 Mar 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 25 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess the effectiveness of therapeutic modalities (paraffin, ultrasound and orthotics) versus corticosteroid injection for trigger finger.
Detailed description
There are several forms of nonsurgical treatment for trigger finger, the most used are:
- Oral nonsteroidal and steroidal antiinflammatory's drugs use to resolve the inflammatory process
- Corticosteroids local injection: that proposes to control the inflammation, these injections have shown good effectiveness for trigger finger treatment.
- Orthotic: with the aim of to immobilize the affected joint until the resolution of the inflammatory process.
- Electrotherapeutic modalities:
- Paraffin that increases cellular metabolism and promotes peripheral vasodilatation, favoring the transduction tissue fluid, lymph flow, hyperemia and consequent absorption of exsudato.
- LASER -Lower Level Laser Therapy (LLLT): the absorption of light through the skin's photoreceptors stimulates mitochondrial chain reactions, promoting adenosine triphosphate (ATP) synthesis, acting on gene expression, which raises the level of growth factors and Tissue repair
Although the non-surgical treatment is often used there is no evidence in the literature of which is the most effective conservative treatment for trigger finger. Thus, it is necessary use appropriate methodology to define the benefits and harms of each treatment modality and assess the effectiveness of these nonsurgical treatments, and may define which one has a higher resolution and lower rates of trigger finger recurrences in short, medium and long term.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Modalities | Active comparator | Procedure: Therapeutic modalities: Orthotic (Group 1), Procedure: Therapeutic modalities: LLLT (Group 2), Procedure: Therapeutic modalities: Paraffin (Group 3)* Group 1: Metal orthotic, keeping 0º of the extension of the proximal interphalangeal joint, during all day, for 5 weeks, stopping the use only for bathing * Group 2: 10 LLLT sessions applications on the A1 pulley and lump formed on the flexor tendon of the the affected finger; Two sessions per week, five weeks of treatment. * Group 3: Paraffin bath 2 times a week for 20 minutes (total of 10 sessions). |
| Corticosteroid injection | Active comparator | Procedure: Corticosteroid injection (Group 4)Group 4: Corticosteroid injection in the A1 pulley, 1 application. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 2-3 grade of trigger finger (Quinnell´s classification)
- Signing the Terms of Consent.
Key exclusion criteria (4 listed)
- Presence of finger trigger in children
- Presence of traumatic finger trigger
- Secondary causes (patients with tumor of the tendon sheath,
- synovitis tuberculosis, etc ...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic modalities: Orthotic (Group 1)Also: Metal orthoticparticipants will be instructed to remove the orthosis only two hours in the morning, two hours in the afternoon and two hours at night to avoid joint stiffness | Procedure or surgery | Therapeutic Modalities |
| Therapeutic modalities: LLLT (Group 2)Also: Ibramed's LASERPULSED 904nmThe LLLT parameters are: * LASER 904nm * P: 1.5W/cm² * 30mV/cm² * Area 2 cm² * 1 Joule por ponto ( in the A1 pulley) | Procedure or surgery | Therapeutic Modalities |
| Therapeutic modalities: Paraffin (Group 3)Also: Bath Paraffin Carci´sParaffin will be heated and maintained at 50 ° C. Participants will immerse their affected hand 10 times in heated paraffin, then they will roll up their affected hand in a towel that they will bring, after 20 minutes timed by a trained professional, the subjects will remove the towel and "paraffin glove": | Procedure or surgery | Therapeutic Modalities |
| Corticosteroid injection (Group 4)Also: BethametasoneThe injection solution is composed of 1 ml of betamethasone and 1 ml of 2% lidocaine.This group may repeat the procedure in two weeks if they report that there was no improvement of the triggering or pain. | Procedure or surgery | Corticosteroid injection |
Primary outcome
Changes in the Resolution/cure of the trigger finger until the six months of the treatment
Time frame: 1, 5, 12 weeks and 6 month
The patient must extend and flex the affected finger 10 times to verify the presence or absence of the trigger finger and determine the degree of commitment.
5 secondary outcomes
Changes in Visual Analogue Scale (VAS)
Time frame: 1, 5, 12 weeks and 6 month
Changes in Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)
Time frame: 1, 5, 12 weeks and 6 month
Changes in SF-12 (quality of life)
Time frame: 1, 5, 12 weeks and 6 month
Changes in the numbers of the Complications
Time frame: 1, 5, 12 weeks and 6 month
Changes in the numbers of the Relapses
Time frame: 1, 5, 12 weeks and 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2017.
- Background: PubMed 3918652Binder A, Hodge G, Greenwood AM, Hazleman BL, Page Thomas DP. Is therapeutic ultrasound effective in treating soft tissue lesions? Br Med J (Clin Res Ed). 1985 Feb 16;290(6467):512-4. doi: 10.1136/bmj.290.6467.512.
- Background: PubMed 19006759Colbourn J, Heath N, Manary S, Pacifico D. Effectiveness of splinting for the treatment of trigger finger. J Hand Ther. 2008 Oct-Dec;21(4):336-43. doi: 10.1197/j.jht.2008.05.001. Epub 2008 Aug 22.
- Background: PubMed 24391799Chen PT, Lin CJ, Jou IM, Chieh HF, Su FC, Kuo LC. One digit interruption: the altered force patterns during functionally cylindrical grasping tasks in patients with trigger digits. PLoS One. 2013 Dec 31;8(12):e83632. doi: 10.1371/journal.pone.0083632. eCollection 2013.
- Background: PubMed 22189188Tarbhai K, Hannah S, von Schroeder HP. Trigger finger treatment: a comparison of 2 splint designs. J Hand Surg Am. 2012 Feb;37(2):243-9, 249.e1. doi: 10.1016/j.jhsa.2011.10.038. Epub 2011 Dec 20.
- Background: PubMed 24821018Langer D, Luria S, Maeir A, Erez A. Occupation-based assessments and treatments of trigger finger: a survey of occupational therapists from Israel and the United States. Occup Ther Int. 2014 Dec;21(4):143-55. doi: 10.1002/oti.1372. Epub 2014 May 12.
- Background: PubMed 17549185Howitt S, Wong J, Zabukovec S. The conservative treatment of Trigger thumb using Graston Techniques and Active Release Techniques. J Can Chiropr Assoc. 2006 Dec;50(4):249-54.
- Background: PubMed 19160256Peters-Veluthamaningal C, van der Windt DA, Winters JC, Meyboom-de Jong B. Corticosteroid injection for trigger finger in adults. Cochrane Database Syst Rev. 2009 Jan 21;2009(1):CD005617. doi: 10.1002/14651858.CD005617.pub2.
- Background: PubMed 24810861Huisstede BM, Hoogvliet P, Coert JH, Friden J; European HANDGUIDE Group. Multidisciplinary consensus guideline for managing trigger finger: results from the European HANDGUIDE Study. Phys Ther. 2014 Oct;94(10):1421-33. doi: 10.2522/ptj.20130135. Epub 2014 May 8.
- Background: PubMed 21166589Renno AC, Toma RL, Feitosa SM, Fernandes K, Bossini PS, de Oliveira P, Parizotto N, Ribeiro DA. Comparative effects of low-intensity pulsed ultrasound and low-level laser therapy on injured skeletal muscle. Photomed Laser Surg. 2011 Jan;29(1):5-10. doi: 10.1089/pho.2009.2715. Epub 2010 Dec 18.
- Background: PubMed 21816888Salim N, Abdullah S, Sapuan J, Haflah NH. Outcome of corticosteroid injection versus physiotherapy in the treatment of mild trigger fingers. J Hand Surg Eur Vol. 2012 Jan;37(1):27-34. doi: 10.1177/1753193411415343. Epub 2011 Aug 4.
- Background: PubMed 7367373Quinnell RC. Conservative management of trigger finger. Practitioner. 1980 Feb;224(1340):187-90. No abstract available.
- Background: PubMed 22265444Valdes K. A retrospective review to determine the long-term efficacy of orthotic devices for trigger finger. J Hand Ther. 2012 Jan-Mar;25(1):89-95; quiz 96. doi: 10.1016/j.jht.2011.09.005.
- World Association of Laser Therapy. Recommended antiinflammatory dosage for low level laser therapy. 2005. (accessed june 20, 2017).Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic modalities: Orthotic (Group 1), Therapeutic modalities: LLLT (Group 2) and Therapeutic modalities: Paraffin (Group 3) in people with Trigger Finger, run by Beatriz Sernajoto Cristiani Pedro.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beatriz S C Pedro (05511998035668, bscristiani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Resolution/cure of the trigger finger until the six months of the treatment (time frame: 1, 5, 12 weeks and 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02972879, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2017.