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Trigger FingerNCT01987115

Comparison of Fascial Manipulation With Traditional Physiotherapy for the Treatment of Trigger Fingers

A study testing Fascial manipulation and Traditional physiotherapy in people with Trigger Finger, run by Sorin Daniel Iordache at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Trigger finger is a relatively common disorder affecting the hand. There is limited evidence on the efficiency of traditional physiotherapy in treating this condition. Fascial manipulation is a gaining momentum manual therapy method. 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?
Fascial manipulation and Traditional physiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteIsrael
Study dates
Nov 2013to 1 Oct 2016
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

  • Diagnosed with trigger finger by primary investigator
  • Adult
  • Good command of Hebrew

Who cannot join

  • Locked finger
  • Younger than 18
  • Secondary triggers (Post-traumatic, tumor, rheumatic disease, pregnancy, etc.)
  • Low pain tolerance (hyperalgesia/allodynia etc.)
  • Trigger thumbs
  • Multiple trigger fingers
Show all 10Show fewer
  • Recurrent trigger finger
  • Patient received additional treatments
  • Patients with compensation claims
  • Patients who cannot commit to attend the planned therapeutic sessions

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • Migdal Hamea Clinic Clalit Health Services

    Tel Aviv

Other trials in Israel

About this study

Official title: Comparison of Fascial Manipulation With Traditional Physiotherapy for the Treatment of Trigger Fingers.

Trigger finger is a relatively common disorder affecting the hand. There is limited evidence on the efficiency of traditional physiotherapy in treating this condition. Fascial manipulation is a gaining momentum manual therapy method. To our knowledge the efficiency of fascial manipulation techniques in the treatment of trigger finger was not reported. The purpose of this study is to investigate the efficiency of the technique and to compare it with the traditional physiotherapy treatment.

Read the detailed description

All adult patients diagnosed with a trigger finger by the primary investigator will be eligible for the study. Criteria for diagnosing the condition are a history of catching of the involved finger accompanied by pain over the A1 pulley on the volar aspect of the hand. Exclusion criteria include patients with a locked finger (SST Grade IV on the Quinell classification as modified by Green (18)), age younger than 18, traumatic trigger fingers (post-surgery or fracture in the distal forearm or hand), patient with low pain tolerance (hyperalgesia/allodynia etc.), trigger thumbs, multiple (more than 1) and recurrent trigger fingers or patients who received additional treatments for this finger in the past year, motor vehicle or work accidents or patients with additional compensation claims, patients with conditions that may cause secondary catching including tumors involving the finger or the joint, inflammatory conditions especially rheumatoid arthritis, and patients with osteoarthritis involving the specific metacarpo-phalangeal joint. Patients who cannot commit to attend the planned therapeutic sessions will also be excluded from the study.

All the subjects will be informed of the study and consented will be obtained. The patients will be randomized in two groups based on drawing a closed envelope from a box containing an equal number of notes for the respective therapeutic protocols. Each patient will undergo 8 sessions of therapy over a period of 6 weeks.

Group A protocol includes U.S. treatment delivered to the A1 pulley area (3 MHz, over 1cm², for 5 minutes), MP and PIP joint mobilization (for 5 minutes), eccentric stretching, and self exercises at home (self-stretch and self-massage).

Group B protocol will receive fascial manipulation including deep kneading of muscular fascia at 3 centers of coordination (C.C) at: 1. C.C above the pronator teres muscle. (M.F unit of INTRA-CUBITUS), 2. C.C above proximal part of pronator quadratus muscle, between the palmaris longus and the flexor carpi radialis tendons (M.F unit of INTRA-CARPUS), 3. C.C in the mid-palmar region between metacarpus 3-4 (M.F unit of INTRA-DIGIT).

Demographic data including the age and gender, and previous medical history will be recorded. The duration of the symptoms and the fingers involved will be noted. The patients will undergo a brief assessment including the determination of the SST according to the modified Quinell classification, and the determination of the number of triggering events occurring in 10 active flexion/extension cycles. The grip power (average of 3 times) and pinch will be measured using dynamometers. An x-ray of the involved hand will be obtained to rule out concomitant conditions in the hand. The patients will be asked to fill a Quick Dash questionnaire and a VAS chart.

A similar assessment will be repeated at 6 weeks by an independent assessor, who will be blinded to the protocol which was used.

Six months from the end of the treatment a mail survey will be conducted in patients in whom the treatment succeeded. The survey will include information about recurrence of the condition (No recurrence, occasional pain or catching, or full recurrence) a VAS scale and the Quick DASH questionnaire.

We consider a difference of 1.5 points in VAS between the two treatment groups at 6 weeks to be clinically significant. Assuming a 20% decrease in VAS with traditional physiotherapy, considering an α value of 0.05 and a β value of 0.2 to obtain 80% statistical power, and allowing for a 35% lost to follow-up, we plan to recruit 70 patients for this study, 35 patients in each treatment group.

The data will be recorded and the statistical analysis will be performed using the Microsoft Excel Spreadsheet.

Conditions
Trigger Finger
Being tested
Fascial manipulation, Traditional physiotherapy
Keywords
Trigger Finger, Physiotherapy, Fascial Manipulation
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.

  • Fascial manipulationProcedure or surgery

    Group will receive fascial manipulation at 3 centers of coordination (C.C) at: 1. C.C above the pronator teres muscle. (M.F unit of INTRA-CUBITUS), 2. C.C above proximal part of pronator quadratus muscle, between the palmaris longus and the flexor carpi radialis tendons (M.F unit of INTRA-CARPUS), 3. C.C in the mid-palmar region between metacarpus 3-4 (M.F unit of INTRA-DIGIT).4. C.C. over the muscle belly of Ext. Digit and Ext. Pollicis Longus (M.F unit of EXTRA-CARPUS).

  • Traditional physiotherapyProcedure or surgery

    Group will receive U.S. treatment delivered to the A1 pulley area (3 Megahertz, over 1cm², for 5 minutes), Metacarpophalangeal and Proximal interphalangeal joint mobilization (for 5 minutes), eccentric stretching, and self exercises at home (self-stretch and self-massage).

Study groups in NCT01987115
Study groupRoleWhat they receive
Fascial ManipulationExperimentalGroup will receive fascial manipulation at 3 centers of coordination (C.C) at: 1. C.C above the pronator teres muscle. (M.F unit of INTRA-CUBITUS), 2. C.C above proximal part of pronator quadratus muscle, between the palmaris longus and the flexor carpi radialis tendons (M.F unit of INTRA-CARPUS), 3. C.C in the mid-palmar region between metacarpus 3-4 (M.F unit of INTRA-DIGIT).4. C.C. over the muscle belly of Ext. Digit and Ext. Pollicis Longus (M.F unit of EXTRA-CARPUS).
Receives: Procedure: Fascial manipulation
Traditional physiotherapyActive comparatorGroup will receive U.S. treatment delivered to the A1 pulley area (3 Megahertz, over 1cm², for 5 minutes), Metacarpophalangeal and Proximal interphalangeal joint mobilization (for 5 minutes), eccentric stretching, and self exercises at home (self-stretch and self-massage).
Receives: Procedure: Traditional physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analog Scale for pain

    Decrease in pain as measured by a visual analog scale at 6 weeks

    Measured: 6 weeks

Secondary outcomes (1)
  1. The Disabilities of the Arm, Shoulder and Hand score

    Decrease in the The Disabilities of the Arm, Shoulder and Hand at 6 weeks

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2013 (estimated)
  2. Study startNov 2013
  3. Primary completion1 Oct 2016
  4. Study completion1 Oct 2016

Resources

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
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01987115
Sponsor's protocol ID
FMTF-1
Status last verified
Feb 2021
First submitted
12 Nov 2013
Last updated
12 Feb 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Fascial manipulation and Traditional physiotherapy in people with Trigger Finger, run by Sorin Daniel Iordache at 1 site in Israel.

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 3 inclusion and 10 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: finished, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale for pain (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 12 Feb 2021.

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