Diacutaneous Fibrolysis and Subacromial Syndrome
- Conditions
- Subacromial Impingement Syndrome
- Interventions
- Other: Protocolized physiotherapeutic TreatmentOther: Actual Diacutaneous FibrolysisOther: Placebo Diactuaneous Fibrolysis
- Registration Number
- NCT01424579
- Lead Sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description No Diacutaneous Fibrolysis Protocolized physiotherapeutic Treatment This group received only tree weeks of a daily protocolized treatment. Actual Diacutaneous Fibrolysis Protocolized physiotherapeutic Treatment The group received tree weeks of a daily protocolized treatment and additionally six sessions (two a week) of actual Diacutaneous Fibrolysis. Actual Diacutaneous Fibrolysis Actual Diacutaneous Fibrolysis The group received tree weeks of a daily protocolized treatment and additionally six sessions (two a week) of actual Diacutaneous Fibrolysis. Placebo Diacutaneous Fybrolisis Placebo Diactuaneous Fibrolysis This group received tree weeks of a daily protocolized treatment and additionally six sessions (two a week) of placebo Diacutaneous Fibrolysis. Placebo Diacutaneous Fybrolisis Protocolized physiotherapeutic Treatment This group received tree weeks of a daily protocolized treatment and additionally six sessions (two a week) of placebo Diacutaneous Fibrolysis.
- Primary Outcome Measures
Name Time Method Changes from Baseline in Pain intensity at 3 weeks and 3 months Baseline -3 weeks - 3 months. Measure instrument: Visual Analogue Scale
- Secondary Outcome Measures
Name Time Method Changes from Baseline in Functional status at 3 weeks and 3 months Baseline - 3 weeks - 3 months Measure instrument: Constant-Murley score
Changes from Baseline in Active Range of Motion at 3 weeks and 3 months 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.
Trial Locations
- Locations (1)
ICS Servei de Rehabilitació Sant Ildefons
🇪🇸Cornellà de Llobregat, Barcelona, Spain