Short-term Effects of Thoracic Manipulation in Shoulder Impingement

Shoulder Impingement Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02083796
• Other study ID #: Haik-0607
• Secondary ID: Ethics Committee
• Status: Completed
• Phase: N/A
• First received: February 4, 2014
• Last updated: October 26, 2015
• Start date: July 2013
• Est. completion date: July 2015

Study information

• Verified date: October 2015
• Source: Universidade Federal de Sao Carlos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Shoulder Impingement Syndrome

Intervention

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

Locations

Country	Name	City	State
Brazil	Universidade Federal de São Carlos	São Carlos	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal de Sao Carlos	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes