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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | The intervention group was treated with a single session of DF following the procedure as described by the authors. |
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| Control Group | Placebo Comparator | The control group was treated with a single placebo session of DF. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diacutaneous Fibrolysis | Other | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catalan Institute of Health - Servei de Rhb Sant Ildefons | Cornellà de Llobregat | Barcelona | 08940 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21078700 | Background | 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. |
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The study participants were recruited from two public services of primary health care of the Spanish National Health Service, one in Cornellà de Llobregat (Barcelona), the other in Ponteareas (Pontevedra), from June 2007 to January 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group (Diacutaneous Fibrolysis) | The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure. |
| FG001 | Control Group (Placebo) | The control group was treated with a single placebo session of Diacutaneous Fibrolysis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group (Diacutaneous Fibrolysis) | The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure. |
| BG001 | Control Group (Placebo) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Millimeters | Baseline and the same day (just after intervention) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group (Diacutaneous Fibrolysis) | The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Martín Eusebio Barra López | Catalan Institut of Health - Servei de Rhb Sant Ildefons | martinbarra@gmail.com |
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| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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|
|
| Diacutaneous Fibrolysis (placebo) | Other | 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. |
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|
| Baseline and the same day (just after intervention) |
| Baseline and the same day (just after intervention) |
The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Months of pain | Mean | Standard Deviation | Months |
|
The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
|
|
|
| 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) | Posted | Mean | Standard Deviation | Sexagesimal Degrees | Baseline and the same day (just after intervention) |
|
|
|
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| 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 | Posted | Mean | Standard Deviation | Sexagesimal degrees | Baseline and the same day (just after intervention) |
|
|
|
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| 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) | Posted | Mean | Standard Deviation | Sexagesimal degrees | Baseline and the same day (just after intervention) |
|
|
|
|
| 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) | Posted | Mean | Standard Deviation | Sexagesimal degrees | Baseline and the same day (just after intervention) |
|
|
|
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| 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 | Posted | Mean | Standard Deviation | Centimeters | Baseline and the same day (just after intervention) |
|
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|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Control Group (Placebo) | The control group was treated with a single placebo session of Diacutaneous Fibrolysis. | 0 | 25 | 0 | 25 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |