NCT01956240

Brief Summary

The purpose of this study is to verify the effects of a stretching protocol for the pectoralis minor muscle on its resting length and on the 3D kinematics of the scapula during arm flexion in asymptomatic subjects and patients with impingement syndrome with shortened pectoralis minor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2013

Shorter than P25 for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 12, 2015

Completed
Last Updated

May 19, 2015

Status Verified

May 1, 2015

Enrollment Period

2 months

First QC Date

September 21, 2013

Results QC Date

January 18, 2015

Last Update Submit

May 17, 2015

Conditions

Keywords

shoulderpectoralis minorstretchingscapular kinematics

Outcome Measures

Primary Outcomes (1)

  • Pectoralis Minor Length After Pectoralis Minor Stretching Protocol

    The change of the pectoralis minor muscle will be evaluated with a tape measure and electromagnetic device. The length of the muscle will be recorded in centimeters.

    6 weeks after stretching

Secondary Outcomes (1)

  • Scapular Kinematics After Pectoralis Minor Stretching Protocol

    6 weeks of stretching

Study Arms (2)

Stretching-Asymptomatic subjects

EXPERIMENTAL

The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.

Procedure: Stretching-Asymptomatic subjects

Stretching-Subjects with shoulder pain

EXPERIMENTAL

The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.

Procedure: Stretching-Subjects with shoulder pain

Interventions

The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.

Stretching-Asymptomatic subjects

The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.

Stretching-Subjects with shoulder pain

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Asymptomatic subjects were included if they did not have any positive test for SIS.
  • The subjects with shoulder pain were included if:
  • they had history of shoulder, at least one week;
  • years;
  • range of motion \> 150° evaluated with digital inclinometer;
  • one or more impingement tests positive - Neer (Neer, 1972), Hawkins (Hawkins and Kennedy, 1980) and Jobe (Jobe and Moynes, 1982) - associated with painful arc during arm elevation, or during external rotation with 90° of arm elevation;
  • Individuals from both groups also had to present with shortened PM muscle length.

You may not qualify if:

  • Individuals from both groups were excluded if they:
  • BMI (body mass index) \> 28kg/m2;
  • irradiated shoulder pain;
  • scoliosis;
  • history of shoulder pain with beginning traumatic;
  • history of fracture or surgery in upper limb and rotator cuff;
  • systemic illnesses;
  • tape allergy;
  • were pregnant;
  • physiotherapy at least 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UFSCar

São Carlos, São Paulo, 13565-905, Brazil

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

1. Participants may not have maximally elongated muscle; 2. Linear measurements such as that used to quantify muscle length cannot represent real structural changes; 3. Only chronic pain was evaluated.

Results Point of Contact

Title
Ms Dayana Patricia Rosa
Organization
Methodist University of Piracicaba

Study Officials

  • Dayana Rosa, PT

    UNIMEP

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Universidade Federal de São Carlos

Study Record Dates

First Submitted

September 21, 2013

First Posted

October 8, 2013

Study Start

June 1, 2013

Primary Completion

August 1, 2013

Study Completion

January 1, 2014

Last Updated

May 19, 2015

Results First Posted

February 12, 2015

Record last verified: 2015-05

Locations