Diacutaneous Fibrolysis and Subacromial Syndrome

NCT01424579 | Completed

• 1 other identifier: CEIC-P07/22
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Subacromial Impingement Syndrome

Outcome Measures

Primary Outcomes (1)

• Changes from Baseline in Pain intensity at 3 weeks and 3 months

  Measure instrument: Visual Analogue Scale

  Baseline -3 weeks - 3 months.

Secondary Outcomes (2)

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

  Baseline - 3 weeks - 3 months

• Changes from Baseline in Functional status at 3 weeks and 3 months

  Baseline - 3 weeks - 3 months

Study Arms (3)

Actual Diacutaneous Fibrolysis

EXPERIMENTAL

The group received tree weeks of a daily protocolized treatment and additionally six sessions (two a week) of actual Diacutaneous Fibrolysis.

Other: Actual Diacutaneous Fibrolysis; Other: Protocolized physiotherapeutic Treatment

Placebo Diacutaneous Fybrolisis

PLACEBO COMPARATOR

This group received tree weeks of a daily protocolized treatment and additionally six sessions (two a week) of placebo Diacutaneous Fibrolysis.

Other: Placebo Diactuaneous Fibrolysis; Other: Protocolized physiotherapeutic Treatment

No Diacutaneous Fibrolysis

OTHER

This group received only tree weeks of a daily protocolized treatment.

Other: Protocolized physiotherapeutic Treatment

Interventions

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.

Actual Diacutaneous Fibrolysis

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.

Placebo Diacutaneous Fybrolisis

Protocolized physiotherapeutic Treatment OTHER

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

Actual Diacutaneous Fibrolysis; No Diacutaneous Fibrolysis; Placebo Diacutaneous Fybrolisis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead

Study Sites (1)

ICS Servei de Rehabilitació Sant Ildefons

Cornellà de Llobregat, Barcelona, 08940, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Study Officials

• Martín Barra-López, PT

  Institut Català de la Salut

  PRINCIPAL INVESTIGATOR

• Carlos López-de-Celis, DO, PT

  Institut Català de la Salut

  STUDY CHAIR

• Gabriela Fernández-Jentsch, PT

  Servicio Gallego de Salud

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2011
• First Posted: August 29, 2011
• Study Start: February 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 5, 2013

Record last verified: 2013-04

Locations

ES (1)