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.

Study Overview

• Status: Completed
• Conditions: Subacromial Impingement Syndrome
• Intervention / Treatment: Other: Actual Diacutaneous Fibrolysis; Other: Protocolized physiotherapeutic Treatment; Other: Placebo Diactuaneous Fibrolysis

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Cornellà de Llobregat, Barcelona, Spain, 08940
      • ICS Servei de Rehabilitació Sant Ildefons

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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: Protocolized physiotherapeutic Treatment; Tree weeks of daily therapeutic exercises, analgesic electrotherapy and cryotherapy.
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.	Other: Protocolized physiotherapeutic Treatment; Tree weeks of daily therapeutic exercises, analgesic electrotherapy and cryotherapy.; 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: No Diacutaneous Fibrolysis; This group received only tree weeks of a daily protocolized treatment.	Other: Protocolized physiotherapeutic Treatment; Tree weeks of daily therapeutic exercises, analgesic electrotherapy and cryotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from Baseline in Pain intensity at 3 weeks and 3 months	Measure instrument: Visual Analogue Scale	Baseline -3 weeks - 3 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline - 3 weeks - 3 months
Changes from Baseline in Functional status at 3 weeks and 3 months	Measure instrument: Constant-Murley score	Baseline - 3 weeks - 3 months

Collaborators and Investigators

• Sponsor: Jordi Gol i Gurina Foundation
• Investigators: 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

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: August 24, 2011
• First Submitted That Met QC Criteria: August 26, 2011
• First Posted (Estimate): August 29, 2011

Study Record Updates

• Last Update Posted (Estimate): April 5, 2013
• Last Update Submitted That Met QC Criteria: April 3, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Syndrome; Shoulder Impingement Syndrome
• Other Study ID Numbers: CEIC-P07/22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No