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Clinical Trials/NCT01424579
NCT01424579
Completed
Not Applicable

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

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina1 site in 1 country120 target enrollmentFebruary 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Subacromial Impingement Syndrome
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Enrollment
120
Locations
1
Primary Endpoint
Changes from Baseline in Pain intensity at 3 weeks and 3 months
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 2008
End Date
December 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • Changes from Baseline in Functional status at 3 weeks and 3 months(Baseline - 3 weeks - 3 months)
  • Changes from Baseline in Active Range of Motion at 3 weeks and 3 months(Baseline - 3 weeks - 3 months)

Study Sites (1)

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