## Protocol Section
### Identification Module
**NCT ID:** NCT02972879

**Brief Title:** Effectiveness of Non-surgical Interventions for the Trigger Finger: a Randomized Clinical Trial

**Official Title:** Effectiveness of Non-surgical Interventions for the Trigger Finger: a Randomized Clinical Trial

#### Organization Study ID Info
**ID:** BSCPedro
#### Organization
**Class:** OTHER
**Full Name:** Federal University of São Paulo
### Status Module
#### Completion Date
**Date:** 2020-07

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2017-07-06

**Type:** ACTUAL

**Last Update Submit Date:** 2017-07-05

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2019-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2018-03-01

**Type:** ESTIMATED

**Status Verified Date:** 2017-07

#### Study First Post Date
**Date:** 2016-11-25
**Type:** ESTIMATED
**Study First Submit Date:** 2016-11-07
**Study First Submit QC Date:** 2016-11-21
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Federal University of São Paulo

#### Lead Sponsor

**Class:** OTHER

**Name:** Beatriz Sernajoto Cristiani Pedro

#### Responsible Party

**Investigator Affiliation:** Federal University of São Paulo

**Investigator Full Name:** Beatriz Sernajoto Cristiani Pedro

**Investigator Title:** BSCPedro

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Trigger Finger

**Keywords:**

- trigger finger

- Therapeutic Modalities

- Corticosteroid Injection

- non-surgical treatment

- physical therapy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 132

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** * 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).

**Intervention Names:**

- Procedure: Therapeutic modalities: Orthotic (Group 1)

- Procedure: Therapeutic modalities: LLLT (Group 2)

- Procedure: Therapeutic modalities: Paraffin (Group 3)

**Label:** Therapeutic Modalities

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Group 4: Corticosteroid injection in the A1 pulley, 1 application.

**Intervention Names:**

- Procedure: Corticosteroid injection (Group 4)

**Label:** Corticosteroid injection

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Therapeutic Modalities

**Description:** 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

**Name:** Therapeutic modalities: Orthotic (Group 1)

**Other Names:**

- Metal orthotic

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Therapeutic Modalities

**Description:** The LLLT parameters are:

* LASER 904nm
* P: 1.5W/cm²
* 30mV/cm²
* Area 2 cm²
* 1 Joule por ponto ( in the A1 pulley)

**Name:** Therapeutic modalities: LLLT (Group 2)

**Other Names:**

- Ibramed's LASERPULSED 904nm

**Type:** PROCEDURE

#### Intervention 3

**Arm Group Labels:**

- Therapeutic Modalities

**Description:** 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":

**Name:** Therapeutic modalities: Paraffin (Group 3)

**Other Names:**

- Bath Paraffin Carci´s

**Type:** PROCEDURE

#### Intervention 4

**Arm Group Labels:**

- Corticosteroid injection

**Description:** 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.

**Name:** Corticosteroid injection (Group 4)

**Other Names:**

- Bethametasone

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**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

#### Secondary Outcomes

**Measure:** Changes in Visual Analogue Scale (VAS)

**Time Frame:** 1, 5, 12 weeks and 6 month

**Measure:** Changes in Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)

**Time Frame:** 1, 5, 12 weeks and 6 month

**Measure:** Changes in SF-12 (quality of life)

**Time Frame:** 1, 5, 12 weeks and 6 month

**Measure:** Changes in the numbers of the Complications

**Time Frame:** 1, 5, 12 weeks and 6 month

**Measure:** Changes in the numbers of the Relapses

**Time Frame:** 1, 5, 12 weeks and 6 month

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 2-3 grade of trigger finger (Quinnell´s classification)
* Signing the Terms of Consent.

Exclusion Criteria:

* Presence of finger trigger in children
* Presence of traumatic finger trigger
* Secondary causes (patients with tumor of the tendon sheath,

synovitis tuberculosis, etc ...)

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** bscristiani@gmail.com

**Name:** Beatriz S C Pedro

**Phone:** 05511998035668

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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.

**PMID:** 3918652

**Citation:** Colbourn 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.

**PMID:** 19006759

**Citation:** Chen 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.

**PMID:** 24391799

**Citation:** Tarbhai 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.

**PMID:** 22189188

**Citation:** Langer 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.

**PMID:** 24821018

**Citation:** Howitt 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.

**PMID:** 17549185

**Citation:** Peters-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;(1):CD005617. doi: 10.1002/14651858.CD005617.pub2.

**PMID:** 19160256

**Citation:** Huisstede 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.

**PMID:** 24810861

**Citation:** Renno 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.

**PMID:** 21166589

**Citation:** Salim 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.

**PMID:** 21816888

**Citation:** Quinnell RC. Conservative management of trigger finger. Practitioner. 1980 Feb;224(1340):187-90. No abstract available.

**PMID:** 7367373

**Citation:** Valdes 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.

**PMID:** 22265444

**Citation:** Dingemanse 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.

**PMID:** 23335238

**Citation:** Dilek 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.

**PMID:** 23187044

**Citation:** Sibtain 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.

**PMID:** 24353596

**Citation:** Beaton DE, Wright JG, Katz JN; Upper Extremity Collaborative Group. Development of the QuickDASH: comparison of three item-reduction approaches. J Bone Joint Surg Am. 2005 May;87(5):1038-46. doi: 10.2106/JBJS.D.02060.

**PMID:** 15866967

**Citation:** Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.

**PMID:** 8628042

#### See Also Links

**Label:** World Association of Laser Therapy. Recommended antiinflammatory dosage for low level laser therapy. 2005. (accessed june 20, 2017).

**URL:** http://www.walt.nu/dosage-recommendations.html

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000053682

- Term: Tendon Entrapment

- ID: D000052256

- Term: Tendinopathy

- ID: D000009135

- Term: Muscular Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M27045

- Name: Trigger Finger Disorder

- Relevance: HIGH

- As Found: Trigger Finger

- ID: M27421

- Name: Tendon Entrapment

- Relevance: LOW

- As Found: Unknown

- ID: M27013

- Name: Tendinopathy

- Relevance: LOW

- As Found: Unknown

- ID: M12092

- Name: Muscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000052582

- Term: Trigger Finger Disorder

### Intervention Browse Module - Browse Branches

- Abbrev: AnArAg

- Name: Anti-Arrhythmia Agents

- Abbrev: ChanBlk

- Name: Channel Blockers

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: Resp

- Name: Respiratory System Agents

### Intervention Browse Module - Browse Leaves

- ID: M11014

- Name: Lidocaine

- Relevance: LOW

- As Found: Unknown

- ID: M16759

- Name: Tin Fluorides

- Relevance: LOW

- As Found: Unknown

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M4909

- Name: Betamethasone

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
