Effectiveness of Diacutaneous Fibrolysis in Painful Shoulder

Not Applicable

Completed

Conditions: Shoulder Pain

Interventions: Other: Diacutaneous Fibrolysis (placebo)
Other: Diacutaneous Fibrolysis

Registration Number: NCT00884065

Lead Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Diacutaneous Fibrolysis (placebo)	The control group was treated with a single placebo session of DF.
Intervention Group	Diacutaneous Fibrolysis	The intervention group was treated with a single session of DF following the procedure as described by the authors.

Primary Outcome Measures

Name	Time	Method
Change in Active Flexion Movement After Intervention Minus Baseline	Baseline and the same day (just after intervention)	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)
Change in Active Abduction Movement After Intervention Minus Baseline	Baseline and the same day (just after intervention)	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
Change in Active extensión Movement After Intervention Minus Baseline	Baseline and the same day (just after intervention)	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)
Change in Active External Rotation After Intervention Minus Baseline	Baseline and the same day (just after intervention)	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)
Change in Active Internal Rotation After Intervention Minus Baseline	Baseline and the same day (just after intervention)	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

Secondary Outcome Measures

Name	Time	Method
Change in Pain in the Hand Behind Back Position After Intervention Minus Baseline	Baseline and the same day (just after intervention)	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.