## Protocol Section
### Identification Module
**NCT ID:** NCT02172079

**Brief Title:** Mobilization With Movement for Shoulder Impingement

**Official Title:** Effects of Mobilization-with-Movement on Pain and Range of Motion in Unilateral Shoulder Impingement Syndrome: A Randomized Controlled Trial

#### Organization Study ID Info
**ID:** USAL201000048540
#### Organization
**Class:** OTHER
**Full Name:** Universidad Rey Juan Carlos
### Status Module
#### Completion Date
**Date:** 2014-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-06-24

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-06-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-01

**Type:** ACTUAL

#### Start Date
**Date:** 2013-01

**Status Verified Date:** 2014-06

#### Study First Post Date
**Date:** 2014-06-24
**Type:** ESTIMATED
**Study First Submit Date:** 2014-06-22
**Study First Submit QC Date:** 2014-06-23
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of Salamanca

#### Lead Sponsor

**Class:** OTHER

**Name:** César Fernández-de-las-Peñas

#### Responsible Party

**Investigator Affiliation:** Universidad Rey Juan Carlos

**Investigator Full Name:** César Fernández-de-las-Peñas

**Investigator Title:** Proffesor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Controversy exists regarding the effectiveness of manual therapy techniques for the management of impingement syndrome. However, no adequately powered clinical trials have examined the effects of mobilization-with-movement. The purpose of the current study was to perform a randomized controlled trial comparing the effects of real MWM to a group receiving a sham intervention on shoulder pain at different moments and active shoulder range of motion in an adequately powered sample of patients with shoulder impingement syndrome.

### Conditions Module

**Conditions:**

- Shoulder Impingement Syndrome

**Keywords:**

- shoulder impingement, manual therapy, pain, motion.

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 42

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** For the MWM group, an accessory posterior-lateral gliding movement in the humeral head combined with a movement of active shoulder flexion will be applied. One hand will be placed over the scapula posteriorly while the thenar eminence of the other hand will be placed over the anterior aspect of the head of the humerus

**Intervention Names:**

- Other: Real mobilization-with-movement (MWM)

**Label:** Real mobilization-with-movement (MWM)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The sham condition will replicate the treatment condition except for the hand positioning. The therapist locates one hand over the belly of the pectoralis major muscle and the other over scapula without applying any pressure. The patient will be asked to move the arm in a similar manner as in the MWM group

**Intervention Names:**

- Other: Sham mobilization-with-movement (MWM)

**Label:** Sham mobilization-with-movement (MWM)

**Type:** SHAM_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Real mobilization-with-movement (MWM)

**Name:** Real mobilization-with-movement (MWM)

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Sham mobilization-with-movement (MWM)

**Name:** Sham mobilization-with-movement (MWM)

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Participants were asked to rate the intensity of their pain using an 11-point numerical pain rating scale (NPRS; 0: no pain; 10: maximum pain) for 3 scores of perceived pain: 1, the intensity of shoulder pain experienced in the last 24h; 2, the intensity of shoulder pain at night; 3, the intensity of shoulder pain during shoulder flexion.

**Measure:** Changes in the intensity of shoulder pain before and after the treatment

**Time Frame:** Baseline and one week after intervention

#### Secondary Outcomes

**Description:** A universal goniometer was used to assess the participant's shoulder range of motion in the following motions:

* Pain-free and maximum (painful) range of motion in shoulder flexion
* Pain-free range of motion in shoulder extension
* Pain-free range of motion in shoulder abduction
* Pain-free range of motion in shoulder external rotation
* Pain-free range of motion in shoulder medial (internal) rotation

**Measure:** Changes in shoulder range of motion before and after the treatment

**Time Frame:** Baseline and one week after the intervention

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* history of shoulder pain of \> 3months duration
* pain localized at the proximal anterolateral shoulder region
* medical diagnosis of shoulder impingement syndrome
* at least 2 positive impingement tests including Neer, Hawking, or Jobe test

Exclusion Criteria:

* diagnosis of fibromyalgia
* pregnancy
* a history of traumatic onset of shoulder pain
* other histories of shoulder injury
* ligamentous laxity based on a positive Sulcus test and apprehension test
* numbness or tingling in the upper extremity
* previous shoulder or cervical spine surgery
* corticosteroid injection on the shoulder within 1 year of the study
* physical therapy 6 months prior to the study

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Salamanca

**Country:** Spain

**Facility:** Francisco Alburquerque Sendín

**Zip:** 37008

#### Overall Officials

**Official 1:**

**Affiliation:** University of Salamanca

**Name:** Francisco Alburquerque Sendín, PT, PhD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Universidad Rey Juan Carlos

**Name:** César Fernández de las Peñas, PT, PhD

**Role:** STUDY_CHAIR

## 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: Shoulder Impingement Syndrome

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- 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

### Misc Info Module

- Version Holder: 2024-05-24
