## Protocol Section
### Identification Module
**NCT ID:** NCT02833779

**Brief Title:** Trial to Compare the Effectiveness of Group Versus Individual Therapy on Alternate Days in Patients With Subacromial Impingement Syndrome

#### Organization Study ID Info
**ID:** SSD
#### Organization
**Class:** OTHER_GOV
**Full Name:** Basque Health Service
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-07-15

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-07-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-10

**Type:** ACTUAL

#### Start Date
**Date:** 2010-04

**Status Verified Date:** 2016-07

#### Study First Post Date
**Date:** 2016-07-14
**Type:** ESTIMATED
**Study First Submit Date:** 2016-07-05
**Study First Submit QC Date:** 2016-07-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Basque Health Service

#### Responsible Party

**Investigator Affiliation:** Basque Health Service

**Investigator Full Name:** Marcos Sanchez Garcia

**Investigator Title:** Registered physiotherapist

**Type:** PRINCIPAL_INVESTIGATOR

### Description Module

**Brief Summary:** Pathology of the rotator cuff and subacromial bursa is considered to be the principal cause of pain and symptoms arising from the shoulder. Physiotherapy specialists often disagree about which type of exercise is most appropriate. Manual Physiotherapy combined with guided exercise is a commonly applied clinical treatment, but no proof of its effectiveness has been shown. Clinical trials comparing results of treating subacromial syndrome of the shoulder with guided self-treatment and conventional physiotherapy yielded a slightly higher improvement, basically because patients suffered from chronic tendinitis and the treatment period lasted only two weeks. That is the reason why the investigators propose a long-term follow-up study and a more complete assessment of effectiveness of the exercise prescribed to improved this pathology.

Objectives:

* Assessment of effectiveness of two different types of treatment of subacromial syndrome of the shoulder.
* Comparison of effectiveness of both treatments in order to select that one yielding better results as the one to be applied as a routine practice.

Patients will be assigned one of the following treatments:

* Group 1: patients will be taught exercises in groups of six people, on a daily basis for twelve sessions.
* Group 2: patients will be taught the same exercise as Group 1, individually, and will receive manual therapy consisting of muscular and joint re-centering.

A modified version of the Constant scale will be used to assess mobility and pain shoulder.

### Conditions Module

**Conditions:**

- Mobility

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 89

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients will be taught exercises in groups of six persons, on a daily basis for twelve sessions.

**Intervention Names:**

- Other: Group exercises

**Label:** Group Therapy Exercises

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Patients will be taught the same exercises as in a Group 1, individually, and will receive manual therapy consisting of muscular and joint re-centering

**Intervention Names:**

- Other: Individual exercises

**Label:** Individual Manual Therapy Exercises

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Individual Manual Therapy Exercises

**Name:** Individual exercises

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Group Therapy Exercises

**Name:** Group exercises

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** The assessment of pain with a visual analogue scale.

**Time Frame:** Six Months

**Measure:** The mobility (joint range of motion) with a goniometer.

**Time Frame:** Six Months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* History of shoulder pain defined as at least 2 positive results in subacromial impingement tests.
* Self-perceived pain reported by the patient under clinical examination of the shoulder.
* A minimum of 90º mobility in flexion.

Exclusion Criteria:

* Luxation, a history of surgery, or evidence the current shoulder pain or other symptoms under cervical examination or other shoulder bone disease, except for acromioclavicular joint arthrosis.
* Patients were receiving other physiotherapy or rehabilitation treatments.
* Patients had been treated for SIS (subacromial impingement syndrome) with injection of anti-inflammatory or analgesic drugs in the last month.

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

## Derived Section

### 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: LOW

- As Found: Unknown

- ID: M21476

- Name: Shoulder Impingement Syndrome

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
