Back to resultsShort-term Effects of Thoracic Manipulation in Shoulder Impingement
Primary Purpose
Shoulder Impingement Syndrome
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Shoulder impingement_TSM
Asymptomatic_TSM
Shoulder impingement_sham
Asymptomatic_sham
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Impingement Syndrome focused on measuring manual therapy, rehabilitation, shoulder, spine
Eligibility 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.
Sites / Locations
- Universidade Federal de São Carlos
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Sham Comparator
Active Comparator
Sham Comparator
Arm Label
Shoulder impingement_TSM
Shoulder impingement_sham
Asymptomatic_TSM
Asymptomatic_sham
Arm Description
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.
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.
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
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT02083796
First Posted
February 4, 2014
Last Updated
October 26, 2015
Sponsor
Universidade Federal de Sao Carlos
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02083796
Brief Title
Short-term Effects of Thoracic Manipulation in Shoulder Impingement
Official Title
Short-term Effects of Thoracic Manipulation on Scapular Kinematics, Muscle Activity and Pain in Shoulder Impingement. A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Sao Carlos
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome
Keywords
manual therapy, rehabilitation, shoulder, spine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Shoulder impingement_TSM
Arm Type
Experimental
Arm Description
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.
Arm Title
Shoulder impingement_sham
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Asymptomatic_TSM
Arm Type
Active Comparator
Arm Description
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
Arm Title
Asymptomatic_sham
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Shoulder impingement_TSM
Other Intervention Name(s)
Spine manipulation, Spinal manipulation, (Spinal) Thrust
Intervention Description
A physiotherapist with 4 years of experience in manual therapy will administer the TSM targeting the middle thoracic spine of the subjects.
Intervention Type
Procedure
Intervention Name(s)
Asymptomatic_TSM
Other Intervention Name(s)
Spine manipulation, Spinal manipulation, (Spinal) Thrust
Intervention Description
A physiotherapist with 4 years of experience in manual therapy administered the TSM targeting the middle thoracic spine of the subjects.
Intervention Type
Procedure
Intervention Name(s)
Shoulder impingement_sham
Other Intervention Name(s)
Sham spinal manipulation
Intervention Description
A physiotherapist with 4 years of experience in manual therapy administered the sham intervention targeting the middle thoracic spine of the subjects.
Intervention Type
Procedure
Intervention Name(s)
Asymptomatic_sham
Other Intervention Name(s)
Sham spinal manipulation
Intervention Description
A physiotherapist with 4 years of experience in manual therapy administered the sham intervention targeting the middle thoracic spine of the subjects.
Primary Outcome Measure Information:
Title
Change in scapular orientation from first to third day
Description
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.
Time Frame
Day 1; day 2; day 3
Secondary Outcome Measure Information:
Title
Change in shoulder function from first to third day
Description
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.
Time Frame
Day 1; Day 2; Day 3
Title
Change in scapular muscle activity from first to third day
Description
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.
Time Frame
Day 1; Day 2; Day 3
Title
Change in shoulder pain from first to third day
Description
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.
Time Frame
Day 1; Day 2; Day 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula R Camargo, doctor
Organizational Affiliation
Universidade Federal de Sao Carlos
Official's Role
Study Director
Facility Information:
Facility Name
Universidade Federal de São Carlos
City
São Carlos
State/Province
São Paulo
ZIP/Postal Code
13565-905
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
28259517
Citation
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.
Results Reference
derived
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Short-term Effects of Thoracic Manipulation in Shoulder Impingement
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