Diacutaneous Fibrolysis and Subacromial Syndrome

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status: Completed

Conditions: Subacromial Impingement Syndrome

Treatments: Other: Actual Diacutaneous Fibrolysis; Other: Protocolized physiotherapeutic Treatment; Other: Placebo Diactuaneous Fibrolysis

Study type: Interventional

Funder types: Other

Identifiers

NCT01424579

CEIC-P07/22

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups, including a placebo group

Actual Diacutaneous Fibrolysis

Experimental group

Description:

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

Treatment:

Other: Actual Diacutaneous Fibrolysis

Other: Protocolized physiotherapeutic Treatment

Placebo Diacutaneous Fybrolisis

Placebo Comparator group

Description:

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

Treatment:

Other: Protocolized physiotherapeutic Treatment

Other: Placebo Diactuaneous Fibrolysis

No Diacutaneous Fibrolysis

Other group

Description:

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

Treatment:

Other: Protocolized physiotherapeutic Treatment