NCT02172079

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2014

Completed
Last Updated

June 24, 2014

Status Verified

June 1, 2014

Enrollment Period

1 year

First QC Date

June 22, 2014

Last Update Submit

June 23, 2014

Conditions

Keywords

shoulder impingement, manual therapy, pain, motion.

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and one week after intervention

Secondary Outcomes (1)

  • Changes in shoulder range of motion before and after the treatment

    Baseline and one week after the intervention

Study Arms (2)

Real mobilization-with-movement (MWM)

EXPERIMENTAL

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

Other: Real mobilization-with-movement (MWM)

Sham mobilization-with-movement (MWM)

SHAM COMPARATOR

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

Other: Sham mobilization-with-movement (MWM)

Interventions

Real mobilization-with-movement (MWM)
Sham mobilization-with-movement (MWM)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Francisco Alburquerque Sendín

Salamanca, Salamanca, 37008, Spain

Location

MeSH Terms

Conditions

Shoulder Impingement SyndromePain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Francisco Alburquerque Sendín, PT, PhD

    University of Salamanca

    PRINCIPAL INVESTIGATOR
  • César Fernández de las Peñas, PT, PhD

    Universidad Rey Juan Carlos

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Proffesor

Study Record Dates

First Submitted

June 22, 2014

First Posted

June 24, 2014

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

June 24, 2014

Record last verified: 2014-06

Locations