NCT02083796

Brief Summary

The hypothesis of this study is that thoracic spine manipulation would reduce pain in subjects with SIS and cause changes in scapular kinematics and muscle activity in subjects with impingement symptoms and in asymptomatic subjects. With this study, the investigators want to answer if possible changes in scapular motion and muscle activity following a TSM depend on the symptoms or if it is generic to individuals without shoulder dysfunction and not specific to subjects with shoulder impingement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2013

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

October 27, 2015

Status Verified

October 1, 2015

Enrollment Period

2 years

First QC Date

February 4, 2014

Last Update Submit

October 26, 2015

Conditions

Keywords

manual therapyrehabilitationshoulderspine

Outcome Measures

Primary Outcomes (1)

  • Change in scapular orientation from first to third day

    3D scapular kinematic (upward/downward rotation; internal/external rotation; anterior/posterior tilt) was assessed pre- and-post thoracic spinal manipulation and sham interventions at first and second days. At the third day of evaluation the measure was assessed only once.

    Day 1; day 2; day 3

Secondary Outcomes (3)

  • Change in shoulder function from first to third day

    Day 1; Day 2; Day 3

  • Change in scapular muscle activity from first to third day

    Day 1; Day 2; Day 3

  • Change in shoulder pain from first to third day

    Day 1; Day 2; Day 3

Study Arms (4)

Shoulder impingement_TSM

EXPERIMENTAL

For the manipulation intervention, the subjects were in a seated position and a thrust technique was performed. If no cavitation was detected with the manipulation, the thrust was repeated up to 3 times.

Procedure: Shoulder impingement_TSM

Shoulder impingement_sham

SHAM COMPARATOR

For the sham intervention, the subjects were positioned in the same seated position with the therapist holding the patient in the same position as for the thrust manipulation. In this position, the therapist applied all the same forces as done for a thrust-manipulation and held that position for a few seconds, but a thrust was not used.

Procedure: Shoulder impingement_sham

Asymptomatic_TSM

ACTIVE COMPARATOR

For the manipulation intervention, the subjects were in a seated position and a thrust technique was performed. If no cavitation was detected with the manipulation, the thrust was repeated up to 3 times

Procedure: Asymptomatic_TSM

Asymptomatic_sham

SHAM COMPARATOR

For the sham intervention, the subjects were positioned in the same seated position with the therapist holding the patient in the same position as for the thrust manipulation. In this position, the therapist applied all the same forces as done for a thrust-manipulation and held that position for a few seconds, but a thrust was not used.

Procedure: Asymptomatic_sham

Interventions

A physiotherapist with 4 years of experience in manual therapy will administer the TSM targeting the middle thoracic spine of the subjects.

Also known as: Spine manipulation, Spinal manipulation, (Spinal) Thrust
Shoulder impingement_TSM

A physiotherapist with 4 years of experience in manual therapy administered the TSM targeting the middle thoracic spine of the subjects.

Also known as: Spine manipulation, Spinal manipulation, (Spinal) Thrust
Asymptomatic_TSM

A physiotherapist with 4 years of experience in manual therapy administered the sham intervention targeting the middle thoracic spine of the subjects.

Also known as: Sham spinal manipulation
Shoulder impingement_sham

A physiotherapist with 4 years of experience in manual therapy administered the sham intervention targeting the middle thoracic spine of the subjects.

Also known as: Sham spinal manipulation
Asymptomatic_sham

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • positive Neer impingement test,
  • positive Hawkins impingement test,
  • positive Jobe test,
  • pain with passive or isometric resisted shoulder lateral rotation,
  • pain with active shoulder elevation,
  • pain with palpation of rotator cuff tendons,
  • pain in the C5 or C6 dermatome region.

You may not qualify if:

  • signs of "red flags" for spinal manipulation (eg, fracture, osteoporosis, malignancy, infection, and active inflammatory process),
  • pregnancy
  • systemic illnesses
  • if received physical therapy or manual therapy treatment within the 6 months prior to the evaluation
  • signs of complete rotator cuff tear or acute inflammation
  • cervical-thoracic spine related symptoms (ie, positive cervical compression test and excessive kyphosis)
  • scoliosis
  • glenohumeral instability (ie, positive apprehension, anterior drawer, or sulcus tests)
  • previous upper extremity fracture or shoulder surgery.
  • any positive test for shoulder impingement
  • signs of "red flags" for spinal manipulation (eg, fracture, osteoporosis, malignancy, infection, and active inflammatory process),
  • pregnancy
  • systemic illnesses
  • if received physical therapy or manual therapy treatment within the 6 months prior to the evaluation
  • signs of complete rotator cuff tear or acute inflammation
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de São Carlos

São Carlos, São Paulo, 13565-905, Brazil

Location

Related Publications (1)

  • Haik MN, Alburquerque-Sendin F, Camargo PR. Short-Term Effects of Thoracic Spine Manipulation on Shoulder Impingement Syndrome: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Aug;98(8):1594-1605. doi: 10.1016/j.apmr.2017.02.003. Epub 2017 Mar 1.

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Paula R Camargo, doctor

    Universidade Federal de Sao Carlos

    STUDY DIRECTOR

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
PRINCIPAL INVESTIGATOR
PI Title
Master

Study Record Dates

First Submitted

February 4, 2014

First Posted

March 11, 2014

Study Start

July 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

October 27, 2015

Record last verified: 2015-10

Locations