Diacutaneous Fibrolysis and Subacromial Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Subacromial Impingement Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Actual Diacutaneous Fibrolysis

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

Group Type EXPERIMENTAL

Actual Diacutaneous Fibrolysis

Intervention Type OTHER

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.

Protocolized physiotherapeutic Treatment

Intervention Type OTHER

Tree weeks of daily therapeutic exercises, analgesic electrotherapy and cryotherapy.

Placebo Diacutaneous Fybrolisis

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

Group Type PLACEBO_COMPARATOR

Placebo Diactuaneous Fibrolysis

Intervention Type OTHER

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.

Protocolized physiotherapeutic Treatment

Intervention Type OTHER

Tree weeks of daily therapeutic exercises, analgesic electrotherapy and cryotherapy.

No Diacutaneous Fibrolysis

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

Group Type OTHER

Protocolized physiotherapeutic Treatment

Intervention Type OTHER

Tree weeks of daily therapeutic exercises, analgesic electrotherapy and cryotherapy.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Protocolized physiotherapeutic Treatment

Tree weeks of daily therapeutic exercises, analgesic electrotherapy and cryotherapy.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No