Effectiveness of Diacutaneous Fibrolysis in Painful Shoulder
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2007
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 9, 2009
CompletedFirst Posted
Study publicly available on registry
April 20, 2009
CompletedResults Posted
Study results publicly available
April 20, 2009
CompletedMarch 23, 2015
March 1, 2015
7 months
February 9, 2009
February 9, 2009
March 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (1)
Change in Pain in the Hand Behind Back Position After Intervention Minus Baseline
Baseline and the same day (just after intervention)
Study Arms (2)
Intervention Group
EXPERIMENTALThe intervention group was treated with a single session of DF following the procedure as described by the authors.
Control Group
PLACEBO COMPARATORThe control group was treated with a single placebo session of DF.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- over 18 years of age
- being referred for treatment of painful shoulder (except for adhesive capsulitis)
- not having been previously treated with DF
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Catalan Institute of Health - Servei de Rhb Sant Ildefons
Cornellà de Llobregat, Barcelona, 08940, Spain
Related Publications (1)
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.
PMID: 21078700BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Martín Eusebio Barra López
- Organization
- Catalan Institut of Health - Servei de Rhb Sant Ildefons
Study Officials
- PRINCIPAL INVESTIGATOR
Martín-Eusebio Barra-López, PT
Catalan Institute of Health
- PRINCIPAL INVESTIGATOR
Carlos López-de-Celis, DO, PT
Catalan Institute of Health
- PRINCIPAL INVESTIGATOR
Gabriela Fernández-Jentsch, PT
Servicio Gallego de Salud
- PRINCIPAL INVESTIGATOR
Ernesto Murillo-Barrios, PT
Servicio Gallego de Salud
- PRINCIPAL INVESTIGATOR
Edurne Villar-Mateo, PT
Catalan Institute of Health
- PRINCIPAL INVESTIGATOR
Laura Raya-de-Cardenas, PT
Catalan Institute of Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2009
First Posted
April 20, 2009
Study Start
June 1, 2007
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
March 23, 2015
Results First Posted
April 20, 2009
Record last verified: 2015-03