Shoulder Impingement SyndromeNCT02083796
Short-term Effects of Thoracic Manipulation in Shoulder Impingement
A study testing Shoulder impingement_TSM and Asymptomatic_TSM in people with Shoulder Impingement Syndrome, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Impingement Syndrome
- What is being tested?
- Shoulder impingement_TSM and Asymptomatic_TSM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2013to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- 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)
Show all 19Show fewer
- 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
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de São Carlos
São Carlos, São Paulo, 13565-905
About this study
Official title: Short-term Effects of Thoracic Manipulation on Scapular Kinematics, Muscle Activity and Pain in Shoulder Impingement. A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Shoulder Impingement Syndrome
- Being tested
- Shoulder impingement_TSM, Asymptomatic_TSM, Shoulder impingement_sham, Asymptomatic_sham
- Keywords
- manual therapy, rehabilitation, shoulder, spine
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder impingement_TSMProcedure or surgery
Also called Spine manipulation, Spinal manipulation, (Spinal) Thrust
A physiotherapist with 4 years of experience in manual therapy will administer the TSM targeting the middle thoracic spine of the subjects.
Asymptomatic_TSMProcedure or surgery
Also called Spine manipulation, Spinal manipulation, (Spinal) Thrust
A physiotherapist with 4 years of experience in manual therapy administered the TSM targeting the middle thoracic spine of the subjects.
Shoulder impingement_shamProcedure or surgery
Also called Sham spinal manipulation
A physiotherapist with 4 years of experience in manual therapy administered the sham intervention targeting the middle thoracic spine of the subjects.
Asymptomatic_shamProcedure or surgery
Also called Sham spinal manipulation
A physiotherapist with 4 years of experience in manual therapy administered the sham intervention targeting the middle thoracic spine of the subjects.
| Study group | Role | What they receive |
|---|---|---|
| Shoulder impingement_TSM | Experimental | 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. Receives: Procedure: Shoulder impingement_TSM |
| Shoulder impingement_sham | Sham comparator | 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. Receives: Procedure: Shoulder impingement_sham |
| Asymptomatic_TSM | Active comparator | 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 Receives: Procedure: Asymptomatic_TSM |
| Asymptomatic_sham | Sham comparator | 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. Receives: Procedure: Asymptomatic_sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1; day 2; day 3
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Day 1; Day 2; Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startJul 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder Impingement SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Melina Nevoeiro Haik, Universidade Federal de Sao Carlos
- Investigators
- Paula R Camargo, doctor, Study director, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083796
- Sponsor's protocol ID
- Haik-0607
- Other IDs
- Ethics Committee 465/2011
- Status last verified
- Oct 2015
- First submitted
- 4 Feb 2014
- Last updated
- 27 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28259517
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of Thoracic Manipulation on Scapular Kinematics, Muscle Activity and Pain in Shoulder Impingement. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02083796
- Acronym / sponsor ID
- Haik-0607
- Conditions
- Shoulder Impingement Syndrome
- Keywords
- manual therapy, rehabilitation, shoulder, spine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jul 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 11 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Shoulder impingement_TSM | Experimental | Procedure: Shoulder impingement_TSMFor 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 comparator | Procedure: Shoulder impingement_shamFor 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 comparator | Procedure: Asymptomatic_TSMFor 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 comparator | Procedure: Asymptomatic_shamFor 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shoulder impingement_TSMAlso: Spine manipulation, Spinal manipulation, (Spinal) ThrustA physiotherapist with 4 years of experience in manual therapy will administer the TSM targeting the middle thoracic spine of the subjects. | Procedure or surgery | Shoulder impingement_TSM |
| Asymptomatic_TSMAlso: Spine manipulation, Spinal manipulation, (Spinal) ThrustA physiotherapist with 4 years of experience in manual therapy administered the TSM targeting the middle thoracic spine of the subjects. | Procedure or surgery | Asymptomatic_TSM |
| Shoulder impingement_shamAlso: Sham spinal manipulationA physiotherapist with 4 years of experience in manual therapy administered the sham intervention targeting the middle thoracic spine of the subjects. | Procedure or surgery | Shoulder impingement_sham |
| Asymptomatic_shamAlso: Sham spinal manipulationA physiotherapist with 4 years of experience in manual therapy administered the sham intervention targeting the middle thoracic spine of the subjects. | Procedure or surgery | Asymptomatic_sham |
Primary outcome
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.
3 secondary outcomes
Change in shoulder function from first to third day
Time frame: Day 1; Day 2; Day 3
Change in scapular muscle activity from first to third day
Time frame: Day 1; Day 2; Day 3
Change in shoulder pain from first to third day
Time frame: Day 1; Day 2; Day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2015.
- Derived from this study: PubMed 28259517Haik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula R Camargo, doctor study director
Universidade Federal de Sao Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shoulder impingement_TSM and Asymptomatic_TSM in people with Shoulder Impingement Syndrome, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in scapular orientation from first to third day (time frame: Day 1; day 2; day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02083796, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2015.