Diacutaneous Fibrolysis and Subacromial Syndrome

Not Applicable

Completed

• Conditions: Subacromial Impingement Syndrome

• Registration Number: NCT01424579
• Lead Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2011-08
• Study First Submitted: 2011-08-24
• Study First Submitted QC: 2011-08-26
• Study First Posted: 2011-08-29
• Study Completion: 2011-12
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-03
• Last Update Posted: 2013-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes from Baseline in Functional status at 3 weeks and 3 months	Baseline - 3 weeks - 3 months	Measure instrument: Constant-Murley score
Changes from Baseline in Active Range of Motion at 3 weeks and 3 months	Baseline - 3 weeks - 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.

Trial Locations

Locations (1)

ICS Servei de Rehabilitació Sant Ildefons; 🇪🇸 Cornellà de Llobregat, Barcelona, Spain