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NCT Number: NCT00884065

Effectiveness of Diacutaneous Fibrolysis in Painful Shoulder

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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Key information

Conditions

Shoulder Pain Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catalan Institute of Health - Servei de Rhb Sant Ildefons

Cornellà de Llobregat, Barcelona, 08940, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Manual therapy

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.

Other names: Manual therapy

Primary outcomes

  1. Change in Active Flexion Movement After Intervention Minus Baseline

    Time frame: Baseline and the same day (just after intervention)

    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)

  2. Change in Active Abduction Movement After Intervention Minus Baseline

    Time frame: Baseline and the same day (just after intervention)

    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

  3. Change in Active extensión Movement After Intervention Minus Baseline

    Time frame: Baseline and the same day (just after intervention)

    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)

  4. Change in Active External Rotation After Intervention Minus Baseline

    Time frame: Baseline and the same day (just after intervention)

    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)

  5. Change in Active Internal Rotation After Intervention Minus Baseline

    Time frame: Baseline and the same day (just after intervention)

    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

Secondary outcomes

  1. Change in Pain in the Hand Behind Back Position After Intervention Minus Baseline

    Time frame: Baseline and the same day (just after intervention)

    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.

Sponsors and collaborators

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Other

Registry information

Official study title

Effectiveness of Diacutaneous Fibrolysis on Pain and Mobility in Patients Suffering From Painful Shoulder. A Randomized Pilot Study.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 20, 2009
Registry last updated
Mar 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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