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Mobilization With Movement for Shoulder Impingement

Primary Purpose

Shoulder Impingement Syndrome

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Real mobilization-with-movement (MWM)
Sham mobilization-with-movement (MWM)
Sponsored by
César Fernández-de-las-Peñas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement Syndrome focused on measuring shoulder impingement, manual therapy, pain, motion.

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Francisco Alburquerque Sendín

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Real mobilization-with-movement (MWM)

Sham mobilization-with-movement (MWM)

Arm 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

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

Outcomes

Primary Outcome Measures

Changes in the intensity of shoulder pain before and after the treatment
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.

Secondary Outcome Measures

Changes in shoulder range of motion before and after the treatment
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

Full Information

First Posted
June 22, 2014
Last Updated
June 23, 2014
Sponsor
César Fernández-de-las-Peñas
Collaborators
University of Salamanca
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1. Study Identification

Unique Protocol Identification Number
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
César Fernández-de-las-Peñas
Collaborators
University of Salamanca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome
Keywords
shoulder impingement, manual therapy, pain, motion.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real mobilization-with-movement (MWM)
Arm Type
Experimental
Arm 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
Arm Title
Sham mobilization-with-movement (MWM)
Arm Type
Sham Comparator
Arm 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 Type
Other
Intervention Name(s)
Real mobilization-with-movement (MWM)
Intervention Type
Other
Intervention Name(s)
Sham mobilization-with-movement (MWM)
Primary Outcome Measure Information:
Title
Changes in the intensity of shoulder pain before and after the treatment
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.
Time Frame
Baseline and one week after intervention
Secondary Outcome Measure Information:
Title
Changes in shoulder range of motion before and after the treatment
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
Time Frame
Baseline and one week after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Alburquerque Sendín, PT, PhD
Organizational Affiliation
University of Salamanca
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
César Fernández de las Peñas, PT, PhD
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Study Chair
Facility Information:
Facility Name
Francisco Alburquerque Sendín
City
Salamanca
ZIP/Postal Code
37008
Country
Spain

12. IPD Sharing Statement

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Mobilization With Movement for Shoulder Impingement

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