Clinical trial NCT01424579: 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
Overall status: COMPLETED
Phase: NA
Conditions: Subacromial Impingement Syndrome
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
First posted: 2011-08-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changes from Baseline in Pain intensity at 3 weeks and 3 months
timeFrame: Baseline -3 weeks - 3 months.
Secondary outcomes:
measure: Changes from Baseline in Active Range of Motion at 3 weeks and 3 months
timeFrame: Baseline - 3 weeks - 3 months
measure: Changes from Baseline in Functional status at 3 weeks and 3 months
timeFrame: Baseline - 3 weeks - 3 months
Other outcomes:
Locations:
city: Cornellà de Llobregat
country: Spain
facility: ICS Servei de Rehabilitació Sant Ildefons
state: Barcelona
Study officials:
affiliation: Institut Català de la Salut
name: Martín Barra-López, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Català de la Salut
name: Carlos López-de-Celis, DO, PT
role: STUDY_CHAIR
affiliation: Servicio Gallego de Salud
name: Gabriela Fernández-Jentsch, PT
role: STUDY_CHAIR
References: