Short-term Effects of Thoracic Manipulation in Shoulder Impingement
2 other identifiers
interventional
110
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2013
Typical duration for not_applicable
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
February 4, 2014
CompletedFirst Posted
Study publicly available on registry
March 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedOctober 27, 2015
October 1, 2015
2 years
February 4, 2014
October 26, 2015
Conditions
Keywords
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
EXPERIMENTALFor 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.
Shoulder impingement_sham
SHAM COMPARATORFor 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.
Asymptomatic_TSM
ACTIVE COMPARATORFor 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
Asymptomatic_sham
SHAM COMPARATORFor 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.
Interventions
A physiotherapist with 4 years of experience in manual therapy will administer the TSM targeting the middle thoracic spine of the subjects.
A physiotherapist with 4 years of experience in manual therapy administered the TSM targeting the middle thoracic spine of the subjects.
A physiotherapist with 4 years of experience in manual therapy administered the sham intervention targeting the middle thoracic spine of the subjects.
A physiotherapist with 4 years of experience in manual therapy administered the sham intervention targeting the middle thoracic spine of the subjects.
Eligibility Criteria
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
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.
PMID: 28259517DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Paula R Camargo, doctor
Universidade Federal de Sao Carlos
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