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Diacutaneous Fibrolysis and Subacromial Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT01424579
First received: August 24, 2011
Last updated: April 3, 2013
Last verified: April 2013

August 24, 2011
April 3, 2013
February 2008
August 2011   (final data collection date for primary outcome measure)
Changes from Baseline in Pain intensity at 3 weeks and 3 months [ Time Frame: Baseline -3 weeks - 3 months. ] [ Designated as safety issue: No ]
Measure instrument: Visual Analogue Scale
Same as current
Complete list of historical versions of study NCT01424579 on ClinicalTrials.gov Archive Site
  • Changes from Baseline in Active Range of Motion at 3 weeks and 3 months [ Time Frame: Baseline - 3 weeks - 3 months ] [ Designated as safety issue: No ]

    Flexion, extension, abduction and external rotation movement were measured with a universal double-armed goniometer, and results are expressed in degrees.

    For Internal rotation the distance between the position achieved by the tip of the thumb in the hand-behind-back test and the inferior tip of the spinous process of C7 was measured with a flexible metric tape and results are expressed in centimeters.

  • Changes from Baseline in Functional status at 3 weeks and 3 months [ Time Frame: Baseline - 3 weeks - 3 months ] [ Designated as safety issue: No ]
    Measure instrument: Constant-Murley score
Same as current
Not Provided
Not Provided
 
Diacutaneous Fibrolysis and Subacromial Syndrome
Effectiveness of Diacutaneous Fibrolysis for the Treatment of Subacromial Impingement Syndrome: a Randomised Controlled Trial

Subacromial Impingement Syndrome (SIS) is the most common cause of shoulder pain with high lifetime prevalence (one in three) in general population. In occupational population is the most common upper extremity disorder. Symptoms include pain, a variable degree of mobility limitation and a more or less pronounced functional impairment. Conservative treatment is usually the first therapeutic option and some physiotherapeutic techniques have proved its efficacy but nevertheless treatment remains challenging.

According to the investigators clinical experience, Diacutaneous Fibrolysis has a beneficial effect on patients suffering from SIS, but no one published clinical trial has evaluated this manual technique previously. The investigators hypothesis is that adding Diacutaneous Fibrolysis to a protocolized physiotherapeutic treatment can provide better outcomes. The investigators objective was to assess the effect of Diacutaneous Fibrolysis on pain, mobility and functional status in patients suffering from SIS.

A double-blind (patient and evaluator) randomized clinical trial was carried out in two public centres of Primary Health Care of the Spanish National Health System. The study protocol was approved by the Clinical Research Ethics Committee from the Jordi Gol Institute of Research in Primary Health Care and all the patients provided written consent.

A hundred and twenty patients with clinical diagnosis of SIS were included and randomly allocated to one of three groups. All groups received the same daily protocolized treatment based on therapeutic exercises, analgesic electrotherapy and cryotherapy during three weeks. Additionally, intervention group received six sessions (two a week) of actual Diacutaneous Fibrolysis; placebo group received six sessions (two a week) of placebo Diacutaneous Fibrolysis, while control group received only the protocolized treatment.

Pain intensity (VAS), active range of motion (flexion, abduction, extension, external and internal rotation) and functional status (Constant-Murley score) were measured in baseline, after the three weeks of treatment and three months after the end of treatment.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Subacromial Impingement Syndrome
  • Other: Actual Diacutaneous Fibrolysis
    Diacutaneous Fibrolysis is a non-invasive physiotherapeutic technique applied by means of a set of metallic hooks ending in a spatula with bevelled edges that allow a deeper and more precise application, which could not be achieved manually. Appropriate hook is applied following the intermuscular septum between the muscles with an anatomical or functional relationship with the painful structure, in a centripetal direction towards the pain location, in order to release adherences between musculoskeletal structures.
  • Other: Placebo Diactuaneous Fibrolysis
    Placebo Diacutaneous Fibrolysis was applied at a superficial level and, instead of fibrolysis, a pinch of skin was held with the thumb of the palpatory hand and the tip of the spatula, without any action taking place on the deep tissular levels.
  • Other: Protocolized physiotherapeutic Treatment
    Tree weeks of daily therapeutic exercises, analgesic electrotherapy and cryotherapy.
  • Experimental: Actual Diacutaneous Fibrolysis
    The group received tree weeks of a daily protocolized treatment and additionally six sessions (two a week) of actual Diacutaneous Fibrolysis.
    Interventions:
    • Other: Actual Diacutaneous Fibrolysis
    • Other: Protocolized physiotherapeutic Treatment
  • Placebo Comparator: Placebo Diacutaneous Fybrolisis
    This group received tree weeks of a daily protocolized treatment and additionally six sessions (two a week) of placebo Diacutaneous Fibrolysis.
    Interventions:
    • Other: Placebo Diactuaneous Fibrolysis
    • Other: Protocolized physiotherapeutic Treatment
  • No Diacutaneous Fibrolysis
    This group received only tree weeks of a daily protocolized treatment.
    Intervention: Other: Protocolized physiotherapeutic Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
December 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Over 18 years
  • Diagnosed of Subacromial Impingement Syndrome
  • Signed a written consent form.

Exclusion criteria:

  • Damaged skin and/or cutaneous lesions in the shoulder area,
  • A concomitant treatment with platelet antiaggregant agents
  • Acute inflammatory conditions in the shoulder
  • Previous shoulder surgery
  • A pending litigation or court claim
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01424579
CEIC-P07/22
No
Jordi Gol i Gurina Foundation
Jordi Gol i Gurina Foundation
Not Provided
Principal Investigator: Martín Barra-López, PT Institut Català de la Salut
Study Chair: Carlos López-de-Celis, DO, PT Institut Català de la Salut
Study Chair: Gabriela Fernández-Jentsch, PT Servicio Gallego de Salud
Jordi Gol i Gurina Foundation
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP