Diacutaneous Fibrolysis and Subacromial Syndrome

Study Overview
=================
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.

Official Title
-----------------
Effectiveness of Diacutaneous Fibrolysis for the Treatment of Subacromial Impingement Syndrome: a Randomised Controlled Trial

Conditions
-----------------
Subacromial Impingement Syndrome

Intervention / Treatment
-----------------
* Other: Actual Diacutaneous Fibrolysis
* Other: Placebo Diactuaneous Fibrolysis
* Other: Protocolized physiotherapeutic Treatment


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Actual Diacutaneous Fibrolysis<br>The group received tree weeks of a daily protocolized treatment and additionally six sessions (two a week) of actual Diacutaneous Fibrolysis. | Other: Actual Diacutaneous Fibrolysis<br>* 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.<br>Other: Protocolized physiotherapeutic Treatment<br>* Tree weeks of daily therapeutic exercises, analgesic electrotherapy and cryotherapy.<br>|
| Placebo Comparator: Placebo Diacutaneous Fybrolisis<br>This group received tree weeks of a daily protocolized treatment and additionally six sessions (two a week) of placebo Diacutaneous Fibrolysis. | Other: Placebo Diactuaneous Fibrolysis<br>* 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.<br>Other: Protocolized physiotherapeutic Treatment<br>* Tree weeks of daily therapeutic exercises, analgesic electrotherapy and cryotherapy.<br>|
| Other: No Diacutaneous Fibrolysis<br>This group received only tree weeks of a daily protocolized treatment. | Other: Protocolized physiotherapeutic Treatment<br>* Tree weeks of daily therapeutic exercises, analgesic electrotherapy and cryotherapy.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from Baseline in Pain intensity at 3 weeks and 3 months | Measure instrument: Visual Analogue Scale | Baseline -3 weeks - 3 months. | 

Secondary Outcome Measures

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