## Protocol Section
### Identification Module
**NCT ID:** NCT01424579

**Brief Title:** Diacutaneous Fibrolysis and Subacromial Syndrome

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

#### Organization Study ID Info
**ID:** CEIC-P07/22
#### Organization
**Class:** OTHER
**Full Name:** Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
### Status Module
#### Completion Date
**Date:** 2011-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-04-05

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-04-03

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2011-08

**Type:** ACTUAL

#### Start Date
**Date:** 2008-02

**Status Verified Date:** 2013-04

#### Study First Post Date
**Date:** 2011-08-29
**Type:** ESTIMATED
**Study First Submit Date:** 2011-08-24
**Study First Submit QC Date:** 2011-08-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Subacromial Impingement Syndrome

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 120

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: Actual Diacutaneous Fibrolysis

- Other: Protocolized physiotherapeutic Treatment

**Label:** Actual Diacutaneous Fibrolysis

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Other: Placebo Diactuaneous Fibrolysis

- Other: Protocolized physiotherapeutic Treatment

**Label:** Placebo Diacutaneous Fybrolisis

**Type:** PLACEBO_COMPARATOR

#### Arm Group 3

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

**Intervention Names:**

- Other: Protocolized physiotherapeutic Treatment

**Label:** No Diacutaneous Fibrolysis

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Actual Diacutaneous Fibrolysis

**Description:** 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.

**Name:** Actual Diacutaneous Fibrolysis

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Placebo Diacutaneous Fybrolisis

**Description:** 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.

**Name:** Placebo Diactuaneous Fibrolysis

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Actual Diacutaneous Fibrolysis

- No Diacutaneous Fibrolysis

- Placebo Diacutaneous Fybrolisis

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

**Name:** Protocolized physiotherapeutic Treatment

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Measure instrument: Visual Analogue Scale

**Measure:** Changes from Baseline in Pain intensity at 3 weeks and 3 months

**Time Frame:** Baseline -3 weeks - 3 months.

#### Secondary Outcomes

**Description:** 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.

**Measure:** Changes from Baseline in Active Range of Motion at 3 weeks and 3 months

**Time Frame:** Baseline - 3 weeks - 3 months

**Description:** Measure instrument: Constant-Murley score

**Measure:** Changes from Baseline in Functional status at 3 weeks and 3 months

**Time Frame:** Baseline - 3 weeks - 3 months

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Cornellà de Llobregat

**Country:** Spain

**Facility:** ICS Servei de Rehabilitació Sant Ildefons

**State:** Barcelona

**Zip:** 08940

#### Overall Officials

**Official 1:**

**Affiliation:** Institut Català de la Salut

**Name:** Martín Barra-López, PT

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Institut Català de la Salut

**Name:** Carlos López-de-Celis, DO, PT

**Role:** STUDY_CHAIR

**Official 3:**

**Affiliation:** Servicio Gallego de Salud

**Name:** Gabriela Fernández-Jentsch, PT

**Role:** STUDY_CHAIR

### References Module

#### See Also Links

**Label:** Related Info

**URL:** http://www.ncbi.nlm.nih.gov/pubmed/23523255

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004194

- Term: Disease

- ID: D000010335

- Term: Pathologic Processes

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000070599

- Term: Shoulder Injuries

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: HIGH

- As Found: Syndrome

- ID: M21476

- Name: Shoulder Impingement Syndrome

- Relevance: HIGH

- As Found: Subacromial Impingement Syndrome

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M602

- Name: Shoulder Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000019534

- Term: Shoulder Impingement Syndrome

- ID: D000013577

- Term: Syndrome

### Intervention Browse Module - Browse Branches

- Abbrev: Analg

- Name: Analgesics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
