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Short-term Effects of Thoracic Manipulation in Shoulder Impingement

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ClinicalTrials.gov Identifier: NCT02083796
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : October 27, 2015
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Melina Nevoeiro Haik, Universidade Federal de Sao Carlos

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.

Condition or disease Intervention/treatment Phase
Shoulder Impingement Syndrome Procedure: Shoulder impingement_TSM Procedure: Asymptomatic_TSM Procedure: Shoulder impingement_sham Procedure: Asymptomatic_sham Not Applicable

Detailed Description:
Subjects with shoulder impingement signs will be evaluated and will be compared with subjects asymptomatic for shoulder symptoms. Both subjects will be randomly assigned to one of two intervention groups: thoracic spinal manipulation (TSM) or sham intervention. We want to know if possible changes in scapular motion and muscle activity following a TSM depend on the symptoms or if it is generic to everyone. Also, we want to know if TSM reduces shoulder pain immediately and in a short-therm period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Short-term Effects of Thoracic Manipulation on Scapular Kinematics, Muscle Activity and Pain in Shoulder Impingement. A Randomized Controlled Trial
Study Start Date : July 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Arm Intervention/treatment
Experimental: Shoulder impingement_TSM
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
A physiotherapist with 4 years of experience in manual therapy will administer the TSM targeting the middle thoracic spine of the subjects.
Other Names:
  • Spine manipulation
  • Spinal manipulation
  • (Spinal) Thrust

Sham Comparator: Shoulder impingement_sham
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
A physiotherapist with 4 years of experience in manual therapy administered the sham intervention targeting the middle thoracic spine of the subjects.
Other Name: Sham spinal manipulation

Active Comparator: Asymptomatic_TSM
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
A physiotherapist with 4 years of experience in manual therapy administered the TSM targeting the middle thoracic spine of the subjects.
Other Names:
  • Spine manipulation
  • Spinal manipulation
  • (Spinal) Thrust

Sham Comparator: Asymptomatic_sham
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
A physiotherapist with 4 years of experience in manual therapy administered the sham intervention targeting the middle thoracic spine of the subjects.
Other Name: Sham spinal manipulation




Primary Outcome Measures :
  1. Change in scapular orientation from first to third day [ Time Frame: Day 1; day 2; day 3 ]
    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.


Secondary Outcome Measures :
  1. Change in shoulder function from first to third day [ Time Frame: Day 1; Day 2; Day 3 ]
    Shoulder function was assessed at the beginning of each data collection day (days 1 to 3) using Disabilities of the Arm, Shoulder and Hand (DASH) and Western Ontario Rotator Cuff Index (WORC) questionnaires.

  2. Change in scapular muscle activity from first to third day [ Time Frame: Day 1; Day 2; Day 3 ]
    3D scapular kinematic 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.

  3. Change in shoulder pain from first to third day [ Time Frame: Day 1; Day 2; Day 3 ]
    Shoulder pain 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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria (symptomatic subjects): To present with at least 3 of the following findings:

  • 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.

Exclusion Criteria (symptomatic subjects):

  • 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.

Exclusion Criteria (asymptomatic subjects):

  • 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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083796


Locations
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Brazil
Universidade Federal de São Carlos
São Carlos, São Paulo, Brazil, 13565-905
Sponsors and Collaborators
Universidade Federal de Sao Carlos
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Study Director: Paula R Camargo, doctor Universidade Federal de Sao Carlos
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Melina Nevoeiro Haik, Master, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier: NCT02083796    
Other Study ID Numbers: Haik-0607
Ethics Committee 465/2011 ( Other Grant/Funding Number: FAPESP / 2013/07120-1 )
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: October 27, 2015
Last Verified: October 2015
Keywords provided by Melina Nevoeiro Haik, Universidade Federal de Sao Carlos:
manual therapy
rehabilitation
shoulder
spine
Additional relevant MeSH terms:
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Shoulder Impingement Syndrome
Joint Diseases
Musculoskeletal Diseases
Shoulder Injuries
Wounds and Injuries