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Diacutaneous Fibrolysis and Subacromial Syndrome

Primary Purpose

Subacromial Impingement Syndrome

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Actual Diacutaneous Fibrolysis
Placebo Diactuaneous Fibrolysis
Protocolized physiotherapeutic Treatment
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 Subacromial Impingement Syndrome

Eligibility Criteria

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

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

Sites / Locations

  • ICS Servei de Rehabilitació Sant Ildefons

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Other

Arm Label

Actual Diacutaneous Fibrolysis

Placebo Diacutaneous Fybrolisis

No Diacutaneous Fibrolysis

Arm Description

The group received tree weeks of a daily protocolized treatment and additionally six sessions (two a week) of actual Diacutaneous Fibrolysis.

This group received tree weeks of a daily protocolized treatment and additionally six sessions (two a week) of placebo Diacutaneous Fibrolysis.

This group received only tree weeks of a daily protocolized treatment.

Outcomes

Primary Outcome Measures

Changes from Baseline in Pain intensity at 3 weeks and 3 months
Measure instrument: Visual Analogue Scale

Secondary Outcome Measures

Changes from Baseline in Active Range of Motion at 3 weeks and 3 months
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
Measure instrument: Constant-Murley score

Full Information

First Posted
August 24, 2011
Last Updated
April 3, 2013
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
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1. Study Identification

Unique Protocol Identification Number
NCT01424579
Brief Title
Diacutaneous Fibrolysis and Subacromial Syndrome
Official Title
Effectiveness of Diacutaneous Fibrolysis for the Treatment of Subacromial Impingement Syndrome: a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
December 2011 (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

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement Syndrome

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Actual Diacutaneous Fibrolysis
Arm Type
Experimental
Arm Description
The group received tree weeks of a daily protocolized treatment and additionally six sessions (two a week) of actual Diacutaneous Fibrolysis.
Arm Title
Placebo Diacutaneous Fybrolisis
Arm Type
Placebo Comparator
Arm Description
This group received tree weeks of a daily protocolized treatment and additionally six sessions (two a week) of placebo Diacutaneous Fibrolysis.
Arm Title
No Diacutaneous Fibrolysis
Arm Type
Other
Arm Description
This group received only tree weeks of a daily protocolized treatment.
Intervention Type
Other
Intervention Name(s)
Actual Diacutaneous Fibrolysis
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo Diactuaneous Fibrolysis
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Protocolized physiotherapeutic Treatment
Intervention Description
Tree weeks of daily therapeutic exercises, analgesic electrotherapy and cryotherapy.
Primary Outcome Measure Information:
Title
Changes from Baseline in Pain intensity at 3 weeks and 3 months
Description
Measure instrument: Visual Analogue Scale
Time Frame
Baseline -3 weeks - 3 months.
Secondary Outcome Measure Information:
Title
Changes from Baseline in Active Range of Motion at 3 weeks and 3 months
Description
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.
Time Frame
Baseline - 3 weeks - 3 months
Title
Changes from Baseline in Functional status at 3 weeks and 3 months
Description
Measure instrument: Constant-Murley score
Time Frame
Baseline - 3 weeks - 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martín Barra-López, PT
Organizational Affiliation
Institut Català de la Salut
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlos López-de-Celis, DO, PT
Organizational Affiliation
Institut Català de la Salut
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gabriela Fernández-Jentsch, PT
Organizational Affiliation
Servicio Gallego de Salud
Official's Role
Study Chair
Facility Information:
Facility Name
ICS Servei de Rehabilitació Sant Ildefons
City
Cornellà de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08940
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/23523255
Description
Related Info

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Diacutaneous Fibrolysis and Subacromial Syndrome

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