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Effectiveness of Diacutaneous Fibrolysis in Painful Shoulder

Primary Purpose

Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Diacutaneous Fibrolysis
Diacutaneous Fibrolysis (placebo)
Sponsored by
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring Physiotherapy, Manual therapy, Painful Shoulder, Diacutaneous Fibrolysis

Eligibility Criteria

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

Inclusion Criteria:

  • over 18 years of age
  • being referred for treatment of painful shoulder (except for adhesive capsulitis)
  • not having been previously treated with DF

Exclusion Criteria:

  • Damaged skin and/or cutaneous lesions in the shoulder area
  • History of shoulder surgery
  • Vascular abnormalities
  • Platelet antiaggregant therapy
  • Acute inflammatory condition of the shoulder (<1 week)
  • Patients with a pending litigation or court claim

Sites / Locations

  • Catalan Institute of Health - Servei de Rhb Sant Ildefons

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention Group

Control Group

Arm Description

The intervention group was treated with a single session of DF following the procedure as described by the authors.

The control group was treated with a single placebo session of DF.

Outcomes

Primary Outcome Measures

Change in Active Flexion Movement After Intervention Minus Baseline
A universal double armed goniometer was used to measure change in active flexión movement in the sagital plane with the elbow fully extended and the forearm in indifferent pronosupination (thumb forward)
Change in Active Abduction Movement After Intervention Minus Baseline
A universal double armed goniometer was used to measure change in active abduction movement in the scapular plane with the elbow in extension and the forearm in supination
Change in Active extensión Movement After Intervention Minus Baseline
A universal double armed goniometer was used to measure change in active extensión movement in the sagital plane with the elbow fully extended and the forearm in indifferent pronosupination (thumb forward)
Change in Active External Rotation After Intervention Minus Baseline
A universal double armed goniometer was used to measure change in active external rotation measured in the neutral position of the shoulder (arm pinned to the trunk), elbow flexed to 90º and the forearm in indifferent pronosupination (thumb forward)
Change in Active Internal Rotation After Intervention Minus Baseline
Change in active internal rotation was measured with the hand behind back test. The position achieved by the tip of the thumb was marked and with a flexible metric tape (always the same) the distance in centimetres between this mark and the inferior tip of the spinous process of C7 was measured; the shorter the distance, the better the mobility

Secondary Outcome Measures

Change in Pain in the Hand Behind Back Position After Intervention Minus Baseline
An unmarked Visual Analogue Scale from 0 (no pain) to 100 (worst pain) millimeters was used. At baseline, participants registered the pain perceived in the position used to measure the internal rotation. After intervention, they registered the pain with the hand placed in the same position taking as a reference the mark in the first evaluation.

Full Information

First Posted
February 9, 2009
Last Updated
March 3, 2015
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
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1. Study Identification

Unique Protocol Identification Number
NCT00884065
Brief Title
Effectiveness of Diacutaneous Fibrolysis in Painful Shoulder
Official Title
Effectiveness of Diacutaneous Fibrolysis on Pain and Mobility in Patients Suffering From Painful Shoulder. A Randomized Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

4. Oversight

5. Study Description

Brief Summary
While Diacutaneous fibrolysis (DF) has achieved promising results empirically, its effectiveness has not been tested in clinical trials. The investigators hypothesized that the use of DF in patients suffering from painful shoulder would increase the active mobility and reduce the pain during movement. To test the hypothesis a double blind (patient and investigator) randomized clinical trial was carried out in two public Primary Health Care Centres. Fifty patients were randomly allocated to two groups: the intervention group, who received a real DF session, and the control group, who received a placebo DF session.
Detailed Description
Background and objectives: Diacutaneous fibrolysis (DF) is a manual technique to treat the mechanical pain of the musculoskeletal system. While this technique has achieved promising results empirically, its effectiveness has not been tested in clinical trials. We aimed at evaluating the effectiveness of a single session of DF on pain and mobility in patients suffering from painful shoulder. Subjects and methods: This clinical trial took place in two public Primary Health Care Centres. Fifty patients were randomly allocated to two groups: the intervention group, who received a real DF session, and the control group, who received a placebo DF session. The degree of active mobility (flexion, abduction, extension, external and internal rotation), the pain in the hand behind back position and the participant's perception of the technique in terms of comfort and results obtained were measured.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
Physiotherapy, Manual therapy, Painful Shoulder, Diacutaneous Fibrolysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The intervention group was treated with a single session of DF following the procedure as described by the authors.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
The control group was treated with a single placebo session of DF.
Intervention Type
Other
Intervention Name(s)
Diacutaneous Fibrolysis
Other Intervention Name(s)
Manual therapy
Intervention Description
The implementation of the technique consists of three consecutive stages: The first stage involves manual palpation, which is carried out by the hand that is not holding the hook, with the objective to find the area to be treated; the second, or instrumental palpation stage, is carried out by introducing the spatula of the hook together with the index finger of the palpatory hand to locate with precision the adherent connective fibers or fibrous corpuscles; the third, or fibrolysis stage, is the actual treatment. Here, a brief supplementary traction is carried out with the hook.
Intervention Type
Other
Intervention Name(s)
Diacutaneous Fibrolysis (placebo)
Other Intervention Name(s)
Manual therapy
Intervention Description
The placebo was designed for this study and the stages of manual and instrumental palpation occur strictly at a superficial level. In the third stage, instead of fibrolysis a pinch of skin is hold with the thumb of the palpatory hand and the tip of the spatula, so that the patient feels the hook distinctly but without any action taking place on the deep tissular planes.
Primary Outcome Measure Information:
Title
Change in Active Flexion Movement After Intervention Minus Baseline
Description
A universal double armed goniometer was used to measure change in active flexión movement in the sagital plane with the elbow fully extended and the forearm in indifferent pronosupination (thumb forward)
Time Frame
Baseline and the same day (just after intervention)
Title
Change in Active Abduction Movement After Intervention Minus Baseline
Description
A universal double armed goniometer was used to measure change in active abduction movement in the scapular plane with the elbow in extension and the forearm in supination
Time Frame
Baseline and the same day (just after intervention)
Title
Change in Active extensión Movement After Intervention Minus Baseline
Description
A universal double armed goniometer was used to measure change in active extensión movement in the sagital plane with the elbow fully extended and the forearm in indifferent pronosupination (thumb forward)
Time Frame
Baseline and the same day (just after intervention)
Title
Change in Active External Rotation After Intervention Minus Baseline
Description
A universal double armed goniometer was used to measure change in active external rotation measured in the neutral position of the shoulder (arm pinned to the trunk), elbow flexed to 90º and the forearm in indifferent pronosupination (thumb forward)
Time Frame
Baseline and the same day (just after intervention)
Title
Change in Active Internal Rotation After Intervention Minus Baseline
Description
Change in active internal rotation was measured with the hand behind back test. The position achieved by the tip of the thumb was marked and with a flexible metric tape (always the same) the distance in centimetres between this mark and the inferior tip of the spinous process of C7 was measured; the shorter the distance, the better the mobility
Time Frame
Baseline and the same day (just after intervention)
Secondary Outcome Measure Information:
Title
Change in Pain in the Hand Behind Back Position After Intervention Minus Baseline
Description
An unmarked Visual Analogue Scale from 0 (no pain) to 100 (worst pain) millimeters was used. At baseline, participants registered the pain perceived in the position used to measure the internal rotation. After intervention, they registered the pain with the hand placed in the same position taking as a reference the mark in the first evaluation.
Time Frame
Baseline and the same day (just after intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: over 18 years of age being referred for treatment of painful shoulder (except for adhesive capsulitis) not having been previously treated with DF Exclusion Criteria: Damaged skin and/or cutaneous lesions in the shoulder area History of shoulder surgery Vascular abnormalities Platelet antiaggregant therapy Acute inflammatory condition of the shoulder (<1 week) Patients with a pending litigation or court claim
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martín-Eusebio Barra-López, PT
Organizational Affiliation
Catalan Institute of Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlos López-de-Celis, DO, PT
Organizational Affiliation
Catalan Institute of Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gabriela Fernández-Jentsch, PT
Organizational Affiliation
Servicio Gallego de Salud
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ernesto Murillo-Barrios, PT
Organizational Affiliation
Servicio Gallego de Salud
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edurne Villar-Mateo, PT
Organizational Affiliation
Catalan Institute of Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura Raya-de-Cardenas, PT
Organizational Affiliation
Catalan Institute of Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catalan Institute of Health - Servei de Rhb Sant Ildefons
City
Cornella de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08940
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
21078700
Citation
Barra ME, Lopez C, Fernandez G, Murillo E, Villar E, Raya L. The immediate effects of diacutaneous fibrolysis on pain and mobility in patients suffering from painful shoulder: a randomized placebo-controlled pilot study. Clin Rehabil. 2011 Apr;25(4):339-48. doi: 10.1177/0269215510385480. Epub 2010 Nov 15.
Results Reference
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Effectiveness of Diacutaneous Fibrolysis in Painful Shoulder

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