An interventional study of Diacutaneous Fibrolysis and Diacutaneous Fibrolysis (placebo) in Shoulder Pain, sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-23.
Sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Not applicable, Interventional, and Treatment
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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This study's enrollment of 50 is below the median of 60 across 561 interventional studies indexed under Shoulder Pain.
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Exclusion Criteria:
The intervention group was treated with a single session of DF following the procedure as described by the authors.
Other: Diacutaneous Fibrolysis
The control group was treated with a single placebo session of DF.
Other: Diacutaneous Fibrolysis (placebo)
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.
Also known as: Manual therapy
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.
Also known as: Manual therapy
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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Baseline and the same day (just after intervention)
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.
Time frame: Baseline and the same day (just after intervention)
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.
| Milestone | Intervention Group (Diacutaneous Fibrolysis) | Control Group (Placebo) |
|---|---|---|
| Started | 25 | 25 |
| Completed | 25 | 25 |
| Not completed | 0 | 0 |
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.
| Millimeters | Intervention Group (Diacutaneous Fibrolysis) | Control Group (Placebo) |
|---|---|---|
| Change in Pain in the Hand Behind Back Position After Intervention Minus Baseline | -9.20 ± 15.16 | -7.48 ± 13.68 |
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)
| Sexagesimal Degrees | Intervention Group (Diacutaneous Fibrolysis) | Control Group (Placebo) |
|---|---|---|
| Change in Active Flexion Movement After Intervention Minus Baseline | 9.48 ± 10.86 | -1.92 ± 9.03 |
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
| Sexagesimal degrees | Intervention Group (Diacutaneous Fibrolysis) | Control Group (Placebo) |
|---|---|---|
| Change in Active Abduction Movement After Intervention Minus Baseline | 7.88 ± 9.61 | 0.64 ± 8.69 |
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)
| Sexagesimal degrees | Intervention Group (Diacutaneous Fibrolysis) | Control Group (Placebo) |
|---|---|---|
| Change in Active extensión Movement After Intervention Minus Baseline | 2.08 ± 5.66 | 0.16 ± 6.44 |
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)
| Sexagesimal degrees | Intervention Group (Diacutaneous Fibrolysis) | Control Group (Placebo) |
|---|---|---|
| Change in Active External Rotation After Intervention Minus Baseline | 0.76 ± 9.55 | 0.16 ± 5.24 |
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
| Centimeters | Intervention Group (Diacutaneous Fibrolysis) | Control Group (Placebo) |
|---|---|---|
| Change in Active Internal Rotation After Intervention Minus Baseline | 4.50 ± 6.79 | 1.42 ± 3.12 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group (Diacutaneous Fibrolysis) | — | 0/25 (0%) | 0/25 (0%) |
| Control Group (Placebo) | — | 0/25 (0%) | 0/25 (0%) |
| Age, Categorical(Participants) | Intervention Group (Diacutaneous Fibrolysis) | Control Group (Placebo) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0.0 |
| Between 18 and 65 years | 17 | 15 | 32.0 |
| >=65 years | 8 | 10 | 18.0 |
| Age, Continuous(years) | Intervention Group (Diacutaneous Fibrolysis) | Control Group (Placebo) | Total |
|---|---|---|---|
| Mean | 56.76 ± 10.33 | 60.8 ± 10.12 | 58.78 ± 10.33 |
| Sex: Female, Male(Participants) | Intervention Group (Diacutaneous Fibrolysis) | Control Group (Placebo) | Total |
|---|---|---|---|
| Female | 16 | 13 | 29.0 |
| Male | 9 | 12 | 21.0 |
| Region of Enrollment(participants) | Intervention Group (Diacutaneous Fibrolysis) | Control Group (Placebo) | Total |
|---|---|---|---|
| Spain | 25 | 25 | 50.0 |
| Months of pain(Months) | Intervention Group (Diacutaneous Fibrolysis) | Control Group (Placebo) | Total |
|---|---|---|---|
| Mean | 14.48 ± 16.21 | 17.88 ± 27.56 | 16.18 ± 22.44 |
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Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina