Clinical trial NCT00884065: Effectiveness of Diacutaneous Fibrolysis in Painful Shoulder
Official title: Effectiveness of Diacutaneous Fibrolysis on Pain and Mobility in Patients Suffering From Painful Shoulder. A Randomized Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Keywords: Physiotherapy
Manual therapy
Painful Shoulder
Diacutaneous Fibrolysis
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
First posted: 2009-04-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Active Flexion Movement After Intervention Minus Baseline
timeFrame: Baseline and the same day (just after intervention)
measure: Change in Active Abduction Movement After Intervention Minus Baseline
timeFrame: Baseline and the same day (just after intervention)
measure: Change in Active extensión Movement After Intervention Minus Baseline
timeFrame: Baseline and the same day (just after intervention)
measure: Change in Active External Rotation After Intervention Minus Baseline
timeFrame: Baseline and the same day (just after intervention)
measure: Change in Active Internal Rotation After Intervention Minus Baseline
timeFrame: Baseline and the same day (just after intervention)
Secondary outcomes:
measure: Change in Pain in the Hand Behind Back Position After Intervention Minus Baseline
timeFrame: Baseline and the same day (just after intervention)
Other outcomes:
Locations:
city: Cornella de Llobregat
country: Spain
facility: Catalan Institute of Health - Servei de Rhb Sant Ildefons
state: Barcelona
Study officials:
affiliation: Catalan Institute of Health
name: Martín-Eusebio Barra-López, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Catalan Institute of Health
name: Carlos López-de-Celis, DO, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio Gallego de Salud
name: Gabriela Fernández-Jentsch, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio Gallego de Salud
name: Ernesto Murillo-Barrios, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Catalan Institute of Health
name: Edurne Villar-Mateo, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Catalan Institute of Health
name: Laura Raya-de-Cardenas, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barra ME, Lopez C, Fernandez 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.