Effectiveness of Diacutaneous Fibrolysis in Painful Shoulder

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00884065
• Other study ID #: Idiap08/187
• Status: Completed
• Phase: N/A
• First received: February 9, 2009
• Last updated: March 3, 2015
• Start date: June 2007
• Est. completion date: January 2008

Study information

• Verified date: March 2015
• Source: Jordi Gol i Gurina Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Other:
• Diacutaneous Fibrolysis
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.
• Diacutaneous Fibrolysis (placebo)
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.

Locations

Country	Name	City	State
Spain	Catalan Institute of Health - Servei de Rhb Sant Ildefons	Cornella de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Barra ME, López C, Fernández G, Murillo E, Villar E, Raya L. The immediate effects of diacutaneous fibrolysis on pain and mobility in patients suffering from painful shoulder: a randomized placebo-controlled pilot study. Clin Rehabil. 2011 Apr;25(4):339-48. doi: 10.1177/0269215510385480. Epub 2010 Nov 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Primary	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)	No
Secondary	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)	No