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

Primary Purpose

Trigger Finger

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Fascial manipulation
Traditional physiotherapy
Sponsored by
Sorin Daniel Iordache
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigger Finger focused on measuring Trigger Finger, Physiotherapy, Fascial Manipulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • Recurrent trigger finger
  • Patient received additional treatments
  • Patients with compensation claims
  • Patients who cannot commit to attend the planned therapeutic sessions

Sites / Locations

  • Migdal Hamea Clinic Clalit Health Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fascial Manipulation

Traditional physiotherapy

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Visual Analog Scale for pain
Decrease in pain as measured by a visual analog scale at 6 weeks

Secondary Outcome Measures

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

Full Information

First Posted
November 12, 2013
Last Updated
February 10, 2021
Sponsor
Sorin Daniel Iordache
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1. Study Identification

Unique Protocol Identification Number
NCT01987115
Brief Title
Comparison of Fascial Manipulation With Traditional Physiotherapy for the Treatment of Trigger Fingers
Official Title
Comparison of Fascial Manipulation With Traditional Physiotherapy for the Treatment of Trigger Fingers.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
October 1, 2016 (Actual)
Study Completion Date
October 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sorin Daniel Iordache

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Finger
Keywords
Trigger Finger, Physiotherapy, Fascial Manipulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fascial Manipulation
Arm Type
Experimental
Arm Description
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).
Arm Title
Traditional physiotherapy
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Fascial manipulation
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Traditional physiotherapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Visual Analog Scale for pain
Description
Decrease in pain as measured by a visual analog scale at 6 weeks
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
The Disabilities of the Arm, Shoulder and Hand score
Description
Decrease in the The Disabilities of the Arm, Shoulder and Hand at 6 weeks
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with trigger finger by primary investigator Adult Good command of Hebrew Exclusion Criteria: 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 Recurrent trigger finger Patient received additional treatments Patients with compensation claims Patients who cannot commit to attend the planned therapeutic sessions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sorin D Iordache, MD
Organizational Affiliation
Clalit Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Migdal Hamea Clinic Clalit Health Services
City
Tel Aviv
Country
Israel

12. IPD Sharing Statement

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

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