Short-term Effects of Thoracic Manipulation in Shoulder Impingement

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Short-term Effects of Thoracic Manipulation on Scapular Kinematics, Muscle Activity and Pain in Shoulder Impingement. A Randomized Controlled Trial

Conditions
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Shoulder Impingement Syndrome

Intervention / Treatment
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* Procedure: Shoulder impingement_TSM
* Procedure: Asymptomatic_TSM
* Procedure: Shoulder impingement_sham
* Procedure: Asymptomatic_sham


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shoulder impingement_TSM<br>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<br>* A physiotherapist with 4 years of experience in manual therapy will administer the TSM targeting the middle thoracic spine of the subjects.<br>* Other names: (Spinal) Thrust;|
| Sham Comparator: Shoulder impingement_sham<br>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<br>* A physiotherapist with 4 years of experience in manual therapy administered the sham intervention targeting the middle thoracic spine of the subjects.<br>* Other names: Sham spinal manipulation;|
| Active Comparator: Asymptomatic_TSM<br>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<br>* A physiotherapist with 4 years of experience in manual therapy administered the TSM targeting the middle thoracic spine of the subjects.<br>* Other names: (Spinal) Thrust;|
| Sham Comparator: Asymptomatic_sham<br>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<br>* A physiotherapist with 4 years of experience in manual therapy administered the sham intervention targeting the middle thoracic spine of the subjects.<br>* Other names: Sham spinal manipulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in shoulder function from first to third day | 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. | Day 1; Day 2; Day 3 | 
| Change in scapular muscle activity from first to third day | 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. | Day 1; Day 2; Day 3 | 
| Change in shoulder pain from first to third day | 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. | Day 1; Day 2; Day 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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manual therapy, rehabilitation, shoulder, spine