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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01987115
Recruitment Status : Unknown
Verified August 2013 by Clalit Health Services.
Recruitment status was:  Recruiting
First Posted : November 19, 2013
Last Update Posted : February 5, 2015
Sponsor:
Information provided by (Responsible Party):
Clalit Health Services

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.

Condition or disease Intervention/treatment Phase
Trigger Finger Procedure: Fascial manipulation Procedure: Traditional physiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Fascial Manipulation With Traditional Physiotherapy for the Treatment of Trigger Fingers.
Study Start Date : November 2013
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : October 2015

Arm Intervention/treatment
Experimental: Fascial Manipulation
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).
Procedure: Fascial manipulation
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).

Active Comparator: Traditional physiotherapy
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).
Procedure: Traditional physiotherapy
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 Measures :
  1. Visual Analog Scale for pain [ Time Frame: 6 weeks ]
    Decrease in pain as measured by a visual analog scale at 6 weeks


Secondary Outcome Measures :
  1. The Disabilities of the Arm, Shoulder and Hand score [ Time Frame: 6 weeks ]
    Decrease in the The Disabilities of the Arm, Shoulder and Hand at 6 weeks



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01987115


Contacts
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Contact: Arnon Ravid, B.Pt ++97235206400 ArnonRa@clalit.org.il
Contact: Sorin D Iordache, MD ++97239376160 sorindl@clalit.org.il

Locations
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Israel
Migdal Hamea Clinic Clalit Health Services Recruiting
Tel Aviv, Israel
Contact: Arnon Ravid, B.PT    ++97235206400    ArnonRa@clalit.org.il   
Contact: Ori Firsteter, B.PT    ++97235206400    TAOriFir@clalit.org.il   
Principal Investigator: Sorin D Iordache, MD         
Sub-Investigator: Arnon Ravid, B.PT         
Sub-Investigator: Ori Firsteter, B.PT         
Sub-Investigator: Yaakov Pizem, B.PT         
Sponsors and Collaborators
Clalit Health Services
Investigators
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Principal Investigator: Sorin D Iordache, MD Clalit Health Services
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Responsible Party: Clalit Health Services
ClinicalTrials.gov Identifier: NCT01987115    
Other Study ID Numbers: FMTF-1
First Posted: November 19, 2013    Key Record Dates
Last Update Posted: February 5, 2015
Last Verified: August 2013
Keywords provided by Clalit Health Services:
Trigger Finger
Physiotherapy
Fascial Manipulation
Additional relevant MeSH terms:
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Trigger Finger Disorder
Tendon Entrapment
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases