Effectiveness of Diacutaneous Fibrolysis in Painful Shoulder

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Shoulder Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intervention Group

The intervention group was treated with a single session of DF following the procedure as described by the authors.

Group Type EXPERIMENTAL

Diacutaneous Fibrolysis

Intervention Type 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.

Control Group

The control group was treated with a single placebo session of DF.

Group Type PLACEBO_COMPARATOR

Diacutaneous Fibrolysis (placebo)

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Other Intervention Names

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Manual therapy Manual therapy

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No