Effectiveness of Diacutaneous Fibrolysis in Painful Shoulder

This study has been completed.
Sponsor:
Information provided by:
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT00884065
First received: February 9, 2009
Last updated: August 24, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Shoulder Pain
Other: Diacutaneous Fibrolysis
Other: Diacutaneous Fibrolysis (placebo)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Diacutaneous Fibrolysis on Pain and Mobility in Patients Suffering From Painful Shoulder. A Randomized Pilot Study.

Further study details as provided by Jordi Gol i Gurina Foundation:

Primary Outcome Measures:
  • Change in Active Flexion Movement After Intervention Minus Baseline [ Time Frame: Baseline and the same day (just after intervention) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and the same day (just after intervention) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and the same day (just after intervention) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and the same day (just after intervention) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and the same day (just after intervention) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and the same day (just after intervention) ] [ Designated as safety issue: No ]
    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.


Enrollment: 50
Study Start Date: June 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Group
The intervention group was treated with a single session of DF following the procedure as described by the authors.
Other: Diacutaneous Fibrolysis
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.
Other Name: Manual therapy
Placebo Comparator: Control Group
The control group was treated with a single placebo session of DF.
Other: Diacutaneous Fibrolysis (placebo)
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.
Other Name: Manual therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00884065

Locations
Spain
Catalan Institute of Health - Servei de Rhb Sant Ildefons
Cornella de Llobregat, Barcelona, Spain, 08940
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Investigators
Principal Investigator: Martín-Eusebio Barra-López, PT Catalan Institute of Health
Principal Investigator: Carlos López-de-Celis, DO, PT Catalan Institute of Health
Principal Investigator: Gabriela Fernández-Jentsch, PT Galician Health Service
Principal Investigator: Ernesto Murillo-Barrios, PT Galician Health Service
Principal Investigator: Edurne Villar-Mateo, PT Catalan Institute of Health
Principal Investigator: Laura Raya-de-Cardenas, PT Catalan Institute of Health
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00884065     History of Changes
Other Study ID Numbers: Idiap08/187
Study First Received: February 9, 2009
Results First Received: February 9, 2009
Last Updated: August 24, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Jordi Gol i Gurina Foundation:
Physiotherapy
Manual therapy
Painful Shoulder
Diacutaneous Fibrolysis

Additional relevant MeSH terms:
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014