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Completed

NCT Number: NCT01424579

Diacutaneous Fibrolysis and Subacromial Syndrome

Subacromial Impingement Syndrome (SIS) is the most common cause of shoulder pain with high lifetime prevalence (one in three) in general population. In occupational population is the most common upper extremity disorder. Symptoms include pain, a variable degree of mobility limitation and a more or less pronounced functional impairment. Conservative treatment is usually the first therapeutic option and some physiotherapeutic techniques have proved its efficacy but nevertheless treatment remains challenging.

According to the investigators clinical experience, Diacutaneous Fibrolysis has a beneficial effect on patients suffering from SIS, but no one published clinical trial has evaluated this manual technique previously. The investigators hypothesis is that adding Diacutaneous Fibrolysis to a protocolized physiotherapeutic treatment can provide better outcomes. The investigators objective was to assess the effect of Diacutaneous Fibrolysis on pain, mobility and functional status in patients suffering from SIS.

A double-blind (patient and evaluator) randomized clinical trial was carried out in two public centres of Primary Health Care of the Spanish National Health System. The study protocol was approved by the Clinical Research Ethics Committee from the Jordi Gol Institute of Research in Primary Health Care and all the patients provided written consent.

A hundred and twenty patients with clinical diagnosis of SIS were included and randomly allocated to one of three groups. All groups received the same daily protocolized treatment based on therapeutic exercises, analgesic electrotherapy and cryotherapy during three weeks. Additionally, intervention group received six sessions (two a week) of actual Diacutaneous Fibrolysis; placebo group received six sessions (two a week) of placebo Diacutaneous Fibrolysis, while control group received only the protocolized treatment.

Pain intensity (VAS), active range of motion (flexion, abduction, extension, external and internal rotation) and functional status (Constant-Murley score) were measured in baseline, after the three weeks of treatment and three months after the end of treatment.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ICS Servei de Rehabilitació Sant Ildefons

Cornellà de Llobregat, Barcelona, 08940, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Over 18 years
  • Diagnosed of Subacromial Impingement Syndrome
  • Signed a written consent form.

Exclusion criteria

  • Damaged skin and/or cutaneous lesions in the shoulder area,
  • A concomitant treatment with platelet antiaggregant agents
  • Acute inflammatory conditions in the shoulder
  • Previous shoulder surgery
  • A pending litigation or court claim

Treatment and study plan

Actual Diacutaneous Fibrolysis

Other

Diacutaneous Fibrolysis is a non-invasive physiotherapeutic technique applied by means of a set of metallic hooks ending in a spatula with bevelled edges that allow a deeper and more precise application, which could not be achieved manually. Appropriate hook is applied following the intermuscular septum between the muscles with an anatomical or functional relationship with the painful structure, in a centripetal direction towards the pain location, in order to release adherences between musculoskeletal structures.

Placebo Diactuaneous Fibrolysis

Other

Placebo Diacutaneous Fibrolysis was applied at a superficial level and, instead of fibrolysis, a pinch of skin was held with the thumb of the palpatory hand and the tip of the spatula, without any action taking place on the deep tissular levels.

Protocolized physiotherapeutic Treatment

Other

Tree weeks of daily therapeutic exercises, analgesic electrotherapy and cryotherapy.

Primary outcomes

  1. Changes from Baseline in Pain intensity at 3 weeks and 3 months

    Time frame: Baseline -3 weeks - 3 months.

    Measure instrument: Visual Analogue Scale

Secondary outcomes

  1. Changes from Baseline in Active Range of Motion at 3 weeks and 3 months

    Time frame: Baseline - 3 weeks - 3 months

    Flexion, extension, abduction and external rotation movement were measured with a universal double-armed goniometer, and results are expressed in degrees.

    For Internal rotation the distance between the position achieved by the tip of the thumb in the hand-behind-back test and the inferior tip of the spinous process of C7 was measured with a flexible metric tape and results are expressed in centimeters.

  2. Changes from Baseline in Functional status at 3 weeks and 3 months

    Time frame: Baseline - 3 weeks - 3 months

    Measure instrument: Constant-Murley score

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 for the Treatment of Subacromial Impingement Syndrome: a Randomised Controlled Trial

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Aug 29, 2011
Registry last updated
Apr 5, 2013

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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