NCT02035618

Brief Summary

Manual therapy combined with a protocol of therapeutic exercises will increase the beneficial effects on scapular kinematics, myofascial pain and function in subjects with shoulder impingement when compared to exercises only.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

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

September 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2014

Completed
Last Updated

January 15, 2014

Status Verified

January 1, 2014

Enrollment Period

1.8 years

First QC Date

January 10, 2014

Last Update Submit

January 13, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Scapular kinematics

    up to 3 months from the initial interview

Study Arms (2)

Exercises and manual therapy

EXPERIMENTAL
Other: ExercisesOther: Exercises + Manual Therapy

Exercises

ACTIVE COMPARATOR
Other: Exercises

Interventions

Strengthening and stretching

ExercisesExercises and manual therapy

Mobilization; massage; post-isometric relaxation; strengthening; stretching

Exercises and manual therapy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • history of non-traumatic onset of shoulder pain;
  • painful arc during active elevation of the arm;
  • one or more positive shoulder impingement tests (Neer, Hawkins and Jobe), or pain during passive or resisted external rotation of the arm at 90° of abduction;
  • pain with palpation of the rotator cuff tendons;
  • all subjects need also to be able to reach 150° of arm elevation as evaluated by visual observation.

You may not qualify if:

  • limitation of glenohumeral internal and external rotation as indicative of adhesive capsulitis;
  • body mass index \> 28kg/m2 as the amount of subcutaneous tissue can compromise the quality of the signal increasing soft tissue artifact;
  • numbness or tingling of the upper limb reproduced by cervical compression test;
  • history of clavicle, scapula or humerus fracture;
  • history of rotator cuff surgery;
  • systemic illnesses;
  • positive sulcus or apprehension tests as indicative of instability;
  • positive drop arm test as indicative of full thickness tear;
  • corticosteroid injection within 3 months prior to intervention, or physiotherapy within 6 months prior to intervention;
  • depressive symptoms as evaluated by the Beck Depression Inventory score ( \> 9 points) due to its influence on myofascial pain;
  • allergy to tape.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Camargo PR, Alburquerque-Sendin F, Avila MA, Haik MN, Vieira A, Salvini TF. Effects of Stretching and Strengthening Exercises, With and Without Manual Therapy, on Scapular Kinematics, Function, and Pain in Individuals With Shoulder Impingement: A Randomized Controlled Trial. J Orthop Sports Phys Ther. 2015 Dec;45(12):984-97. doi: 10.2519/jospt.2015.5939. Epub 2015 Oct 15.

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

ExerciseMusculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, PhD

Study Record Dates

First Submitted

January 10, 2014

First Posted

January 14, 2014

Study Start

September 1, 2010

Primary Completion

July 1, 2012

Last Updated

January 15, 2014

Record last verified: 2014-01