Effectiveness of Diacutaneous Fibrolysis in Painful Shoulder

Study Overview
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Brief Summary
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While Diacutaneous fibrolysis (DF) has achieved promising results empirically, its effectiveness has not been tested in clinical trials. The investigators hypothesized that the use of DF in patients suffering from painful shoulder would increase the active mobility and reduce the pain during movement. To test the hypothesis a double blind (patient and investigator) randomized clinical trial was carried out in two public Primary Health Care Centres. Fifty patients were randomly allocated to two groups: the intervention group, who received a real DF session, and the control group, who received a placebo DF session.

Detailed Description
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Background and objectives: Diacutaneous fibrolysis (DF) is a manual technique to treat the mechanical pain of the musculoskeletal system. While this technique has achieved promising results empirically, its effectiveness has not been tested in clinical trials. We aimed at evaluating the effectiveness of a single session of DF on pain and mobility in patients suffering from painful shoulder. Subjects and methods: This clinical trial took place in two public Primary Health Care Centres. Fifty patients were randomly allocated to two groups: the intervention group, who received a real DF session, and the control group, who received a placebo DF session. The degree of active mobility (flexion, abduction, extension, external and internal rotation), the pain in the hand behind back position and the participant's perception of the technique in terms of comfort and results obtained were measured.

Official Title
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Effectiveness of Diacutaneous Fibrolysis on Pain and Mobility in Patients Suffering From Painful Shoulder. A Randomized Pilot Study.

Conditions
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Shoulder Pain

Intervention / Treatment
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* Other: Diacutaneous Fibrolysis
* Other: Diacutaneous Fibrolysis (placebo)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over 18 years of age being referred for treatment of painful shoulder (except for adhesive capsulitis) not having been previously treated with DF Exclusion Criteria: Damaged skin and/or cutaneous lesions in the shoulder area History of shoulder surgery Vascular abnormalities Platelet antiaggregant therapy Acute inflammatory condition of the shoulder (<1 week) Patients with a pending litigation or court claim

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>The intervention group was treated with a single session of DF following the procedure as described by the authors. | Other: Diacutaneous Fibrolysis<br>* The implementation of the technique consists of three consecutive stages: The first stage involves manual palpation, which is carried out by the hand that is not holding the hook, with the objective to find the area to be treated; the second, or instrumental palpation stage, is carried out by introducing the spatula of the hook together with the index finger of the palpatory hand to locate with precision the adherent connective fibers or fibrous corpuscles; the third, or fibrolysis stage, is the actual treatment. Here, a brief supplementary traction is carried out with the hook.<br>* Other names: Manual therapy;|
| Placebo Comparator: Control Group<br>The control group was treated with a single placebo session of DF. | Other: Diacutaneous Fibrolysis (placebo)<br>* The placebo was designed for this study and the stages of manual and instrumental palpation occur strictly at a superficial level. In the third stage, instead of fibrolysis a pinch of skin is hold with the thumb of the palpatory hand and the tip of the spatula, so that the patient feels the hook distinctly but without any action taking place on the deep tissular planes.<br>* Other names: Manual therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Active Flexion Movement After Intervention Minus Baseline | A universal double armed goniometer was used to measure change in active flexión movement in the sagital plane with the elbow fully extended and the forearm in indifferent pronosupination (thumb forward) | Baseline and the same day (just after intervention) | 
| Change in Active Abduction Movement After Intervention Minus Baseline | A universal double armed goniometer was used to measure change in active abduction movement in the scapular plane with the elbow in extension and the forearm in supination | Baseline and the same day (just after intervention) | 
| Change in Active extensión Movement After Intervention Minus Baseline | A universal double armed goniometer was used to measure change in active extensión movement in the sagital plane with the elbow fully extended and the forearm in indifferent pronosupination (thumb forward) | Baseline and the same day (just after intervention) | 
| Change in Active External Rotation After Intervention Minus Baseline | A universal double armed goniometer was used to measure change in active external rotation measured in the neutral position of the shoulder (arm pinned to the trunk), elbow flexed to 90º and the forearm in indifferent pronosupination (thumb forward) | Baseline and the same day (just after intervention) | 
| Change in Active Internal Rotation After Intervention Minus Baseline | Change in active internal rotation was measured with the hand behind back test. The position achieved by the tip of the thumb was marked and with a flexible metric tape (always the same) the distance in centimetres between this mark and the inferior tip of the spinous process of C7 was measured; the shorter the distance, the better the mobility | Baseline and the same day (just after intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain in the Hand Behind Back Position After Intervention Minus Baseline | An unmarked Visual Analogue Scale from 0 (no pain) to 100 (worst pain) millimeters was used. At baseline, participants registered the pain perceived in the position used to measure the internal rotation. After intervention, they registered the pain with the hand placed in the same position taking as a reference the mark in the first evaluation. | Baseline and the same day (just after intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physiotherapy, Manual therapy, Painful Shoulder, Diacutaneous Fibrolysis