NCT02463526

Brief Summary

Participants will be initially assessed for their suitability for inclusion in the study and will undergo a physical screening of the affected shoulder and cervical spine by an experienced physiotherapist. After, participants will be attended 72 hours after data recording of the baseline measures (range of motion with a goniometer, pressure pain threshold with a algometer, and peak force with a dynamometer) for four sessions per week with 24 hours of interval between sessions. At each experimental week session, each participant will receive one of the two treatment conditions (MWM or sham) and then will repeats the assessment. In the following week, there will be a crossover condition of each individual and 24 hours after the last treatment session, the examiner will do the last assessment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable

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

April 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 4, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 22, 2015

Status Verified

December 1, 2015

Enrollment Period

8 months

First QC Date

April 30, 2015

Last Update Submit

December 20, 2015

Conditions

Keywords

Shoulder Impingement SyndromeMulligan's Mobilization with MovementPhysical Therapy

Outcome Measures

Primary Outcomes (1)

  • Pressure Pain Threshold

    The pressure pain threshold will be assessed with a algometer and the unit of measure is the kilogram per square centimeter.

    72 hours before the treatment starts, 24 hours after the last MWM or Shaw treatment, and 24 hours after the last treatment.

Secondary Outcomes (2)

  • Range of Motion

    72 hours before the treatment starts, 24 hours after the last MWM or Shaw treatment, and 24 hours after the last treatment.

  • Peak Force

    72 hours before the treatment starts, 24 hours after the last MWM or Shaw treatment, and 24 hours after the last treatment.

Study Arms (2)

Group 1 - MWM condition/Sham condition

EXPERIMENTAL

Subjects will receive treatment for 4 times with Mulligan's Mobilization with Movement (MWM) condition, and after 72 hrs, will be treated 4 times with the sham condition.

Other: Mobilization with Movement (MWM) condition/ Sham conditionOther: Sham condition/ Mobilization with Movement (MWM) condition

Group 2 - Sham condition/MWM condition

EXPERIMENTAL

Subjects will receive treatment for 4 times with sham condition, and after 72 hrs, will be treated 4 times with the Mulligan's Mobilization with Movement (MWM) condition.

Other: Mobilization with Movement (MWM) condition/ Sham conditionOther: Sham condition/ Mobilization with Movement (MWM) condition

Interventions

The treatment condition consists in the application of a posterolateral glide (MWM) in the affected shoulder. Subjects will be seated and the therapist will stay beside the participants on the opposite side to the affected shoulder. One hand will be placed over the scapula posteriorly while the thenar eminence of the other hand will be placed over the humerus head anterior aspect. A posterior glide will be applied to the humeral head. Three sets of 10 repetitions will be applied with a 30 seconds rest interval between each set. Sham condition will replicate treatment condition except for the hand positioning. The therapist will place one hand along the clavicle and the other on the humeral head posterior aspect of the affected shoulder. A simulated anterior glide will be performed.

Group 1 - MWM condition/Sham conditionGroup 2 - Sham condition/MWM condition

The Sham condition consists in the application of a simulated anterior glide in the affected shoulder. Subjects will be seated and the therapist will stay beside the participants on the opposite side to the affected shoulder. The therapist will place one hand along the clavicle and the other on the humeral head posterior aspect of the affected shoulder. A simulated anterior glide will be performed. Three sets of 10 repetitions will be applied with a 30 seconds rest interval between each set. The treatment condition will replicate treatment condition except for the hand positioning. The therapist will place one hand over the scapula posteriorly while the thenar eminence of the other hand will be placed over the anterior humerus head. A posterior glide will be applied to the humeral head.

Group 1 - MWM condition/Sham conditionGroup 2 - Sham condition/MWM condition

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 \>1-week duration, localized at the proximal anterolateral shoulder region consistent to Shoulder Impingement Syndrome (SIS);
  • at least 1 positive impingement test (Jobe's test, Neer's test, Hawkins-Kennedy's Test) associated with painful range of motion during arm elevation; or pain during external rotation with the arm in 90 degrees of elevation in the coronal plane.

You may not qualify if:

  • fibromyalgia (based on self-report),pregnancy, a history of onset of symptoms because of traumatic injury, other histories of shoulder injury, torn tendons, ligamentous laxity based on positive Sulcus test and apprehension test, numbness or tingling in the upper extremity, previous shoulder or neck surgery, systemic illnesses, body mass index \> 28kg/m2, corticosteroid injection 3 months before evaluation, physical therapy 3 months before evaluation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UFSCar

São Carlos, São Paulo, CEP 13565-905, Brazil

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Movement

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Physiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Francisco Alburquerque-Sendín, Professor

    Universidade Federal de Sao Carlos

    STUDY DIRECTOR
  • Tania Salvini, Professor

    Universidade Federal de Sao Carlos

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master students

Study Record Dates

First Submitted

April 30, 2015

First Posted

June 4, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 22, 2015

Record last verified: 2015-12

Locations