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.
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.
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 group | Role | What they receive |
|---|---|---|
| Fascial Manipulation | Experimental | 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). Receives: Procedure: Fascial manipulation |
| Traditional physiotherapy | Active comparator | 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). Receives: Procedure: Traditional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale for pain
Decrease in pain as measured by a visual analog scale at 6 weeks
Measured: 6 weeks
Secondary outcomes (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.
- First posted19 Nov 2013 (estimated)
- Study startNov 2013
- Primary completion1 Oct 2016
- Study completion1 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorin Daniel Iordache
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sorin Daniel Iordache, Clalit Health Services
- Investigators
- Sorin D Iordache, MD, Principal investigator, Clalit Health Services
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Fascial Manipulation With Traditional Physiotherapy for the Treatment of Trigger Fingers.
- ClinicalTrials.gov ID
- NCT01987115
- Acronym / sponsor ID
- FMTF-1
- Conditions
- Trigger Finger
- Keywords
- Trigger Finger, Physiotherapy, Fascial Manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Sorin Daniel IordacheUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- 1 Oct 2016 (actual)
- Study completion
- 1 Oct 2016 (actual)
- First posted
- 19 Nov 2013 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fascial Manipulation | Experimental | Procedure: Fascial manipulationGroup 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 physiotherapy | Active comparator | Procedure: Traditional physiotherapyGroup 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with trigger finger by primary investigator
- Adult
- Good command of Hebrew
Key exclusion criteria (10 listed)
- Locked finger
- Younger than 18
- Secondary triggers (Post-traumatic, tumor, rheumatic disease, pregnancy, etc.)
- Low pain tolerance (hyperalgesia/allodynia etc.)
- Trigger thumbs
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 |
|---|---|---|
| Fascial manipulationGroup 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). | Procedure or surgery | Fascial Manipulation |
| Traditional physiotherapyGroup 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). | Procedure or surgery | Traditional physiotherapy |
Primary outcome
Visual Analog Scale for pain
Time frame: 6 weeks
Decrease in pain as measured by a visual analog scale at 6 weeks
1 secondary outcome
The Disabilities of the Arm, Shoulder and Hand score
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
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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.
Sorin D Iordache, MD principal investigator
Clalit Health Services
1 site in 1 country: see every site and its status.
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.