Subacromial Impingement Syndrome Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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