Shoulder Impingement SyndromeNCT02463526
Effects of Mulligan's Technique in Subjects With Shoulder Impingement Syndrome
A study of Shoulder Impingement Syndrome, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
Participants will be initially assessed for their suitability for inclusion in the study and will undergo a physical screening of the affected shoulder and cervical spine by an experienced physiotherapist. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Impingement Syndrome
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2015to Dec 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- history of shoulder pain of >1-week duration, localized at the proximal anterolateral shoulder region consistent to Shoulder Impingement Syndrome (SIS);
- at least 1 positive impingement test (Jobe's test, Neer's test, Hawkins-Kennedy's Test) associated with painful range of motion during arm elevation; or pain during external rotation with the arm in 90 degrees of elevation in the coronal plane.
Who cannot join
- fibromyalgia (based on self-report),pregnancy, a history of onset of symptoms because of traumatic injury, other histories of shoulder injury, torn tendons, ligamentous laxity based on positive Sulcus test and apprehension test, numbness or tingling in the upper extremity, previous shoulder or neck surgery, systemic illnesses, body mass index > 28kg/m2, corticosteroid injection 3 months before evaluation, physical therapy 3 months before evaluation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Mulligan's Technique on Range of Movement, Pressure Pain Threshold, Muscle Strength, and Functionality in Subjects With Shoulder Impingement Syndrome
Participants will be initially assessed for their suitability for inclusion in the study and will undergo a physical screening of the affected shoulder and cervical spine by an experienced physiotherapist. After, participants will be attended 72 hours after data recording of the baseline measures (range of motion with a goniometer, pressure pain threshold with a algometer, and peak force with a dynamometer) for four sessions per week with 24 hours of interval between sessions. At each experimental week session, each participant will receive one of the two treatment conditions (MWM or sham) and then will repeats the assessment. In the following week, there will be a crossover condition of each individual and 24 hours after the last treatment session, the examiner will do the last assessment.
- Conditions
- Shoulder Impingement Syndrome
- Being tested
- Mobilization with Movement (MWM) condition/ Sham condition, Sham condition/ Mobilization with Movement (MWM) condition
- Keywords
- Shoulder Impingement Syndrome, Mulligan's Mobilization with Movement, Physical Therapy
- 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.
Mobilization with Movement (MWM) condition/ Sham conditionOther
The treatment condition consists in the application of a posterolateral glide (MWM) in the affected shoulder. Subjects will be seated and the therapist will stay beside the participants on the opposite side to the affected shoulder. One hand will be placed over the scapula posteriorly while the thenar eminence of the other hand will be placed over the humerus head anterior aspect. A posterior glide will be applied to the humeral head. Three sets of 10 repetitions will be applied with a 30 seconds rest interval between each set. Sham condition will replicate treatment condition except for the hand positioning. The therapist will place one hand along the clavicle and the other on the humeral head posterior aspect of the affected shoulder. A simulated anterior glide will be performed.
Sham condition/ Mobilization with Movement (MWM) conditionOther
The Sham condition consists in the application of a simulated anterior glide in the affected shoulder. Subjects will be seated and the therapist will stay beside the participants on the opposite side to the affected shoulder. The therapist will place one hand along the clavicle and the other on the humeral head posterior aspect of the affected shoulder. A simulated anterior glide will be performed. Three sets of 10 repetitions will be applied with a 30 seconds rest interval between each set. The treatment condition will replicate treatment condition except for the hand positioning. The therapist will place one hand over the scapula posteriorly while the thenar eminence of the other hand will be placed over the anterior humerus head. A posterior glide will be applied to the humeral head.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - MWM condition/Sham condition | Experimental | Subjects will receive treatment for 4 times with Mulligan's Mobilization with Movement (MWM) condition, and after 72 hrs, will be treated 4 times with the sham condition. Receives: Other: Mobilization with Movement (MWM) condition/ Sham condition; Other: Sham condition/ Mobilization with Movement (MWM) condition |
| Group 2 - Sham condition/MWM condition | Experimental | Subjects will receive treatment for 4 times with sham condition, and after 72 hrs, will be treated 4 times with the Mulligan's Mobilization with Movement (MWM) condition. Receives: Other: Mobilization with Movement (MWM) condition/ Sham condition; Other: Sham condition/ Mobilization with Movement (MWM) condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Pain Threshold
The pressure pain threshold will be assessed with a algometer and the unit of measure is the kilogram per square centimeter.
Measured: 72 hours before the treatment starts, 24 hours after the last MWM or Shaw treatment, and 24 hours after the last treatment.
Secondary outcomes (2)
Range of Motion
The range of motion will be assessed with a goniometer and the unit of measure is the degree
Measured: 72 hours before the treatment starts, 24 hours after the last MWM or Shaw treatment, and 24 hours after the last treatment.
Peak Force
The Peak Force will be assessed with a handheld dynamometer and the unit of measure is the kilogram.
Measured: 72 hours before the treatment starts, 24 hours after the last MWM or Shaw treatment, and 24 hours after the last treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, João Flávio Guimarães, Universidade Federal de Sao Carlos
- Investigators
- Francisco Alburquerque-Sendín, Professor, Study director, Universidade Federal de Sao CarlosTania Salvini, Professor, Study chair, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463526
- Sponsor's protocol ID
- U1111-1154-7379
- Other IDs
- 28898014.3.0000.5504
- Status last verified
- Dec 2015
- First submitted
- 30 Apr 2015
- Last updated
- 22 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mulligan's Technique on Range of Movement, Pressure Pain Threshold, Muscle Strength, and Functionality in Subjects With Shoulder Impingement Syndrome
- ClinicalTrials.gov ID
- NCT02463526
- Acronym / sponsor ID
- U1111-1154-7379
- Conditions
- Shoulder Impingement Syndrome
- Keywords
- Shoulder Impingement Syndrome, Mulligan's Mobilization with Movement, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Apr 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Jun 2015 (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.
Participants will be initially assessed for their suitability for inclusion in the study and will undergo a physical screening of the affected shoulder and cervical spine by an experienced physiotherapist. After, participants will be attended 72 hours after data recording of the baseline measures (range of motion with a goniometer, pressure pain threshold with a algometer, and peak force with a dynamometer) for four sessions per week with 24 hours of interval between sessions. At each experimental week session, each participant will receive one of the two treatment conditions (MWM or sham) and then will repeats the assessment. In the following week, there will be a crossover condition of each individual and 24 hours after the last treatment session, the examiner will do the last assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - MWM condition/Sham condition | Experimental | Other: Mobilization with Movement (MWM) condition/ Sham condition, Other: Sham condition/ Mobilization with Movement (MWM) conditionSubjects will receive treatment for 4 times with Mulligan's Mobilization with Movement (MWM) condition, and after 72 hrs, will be treated 4 times with the sham condition. |
| Group 2 - Sham condition/MWM condition | Experimental | Other: Mobilization with Movement (MWM) condition/ Sham condition, Other: Sham condition/ Mobilization with Movement (MWM) conditionSubjects will receive treatment for 4 times with sham condition, and after 72 hrs, will be treated 4 times with the Mulligan's Mobilization with Movement (MWM) condition. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- history of shoulder pain of >1-week duration, localized at the proximal anterolateral shoulder region consistent to Shoulder Impingement Syndrome (SIS);
- at least 1 positive impingement test (Jobe's test, Neer's test, Hawkins-Kennedy's Test) associated with painful range of motion during arm elevation; or pain during external rotation with the arm in 90 degrees of elevation in the coronal plane.
Key exclusion criteria (1 listed)
- fibromyalgia (based on self-report),pregnancy, a history of onset of symptoms because of traumatic injury, other histories of shoulder injury, torn tendons, ligamentous laxity based on positive Sulcus test and apprehension test, numbness or tingling in the upper extremity, previous shoulder or neck surgery, systemic illnesses, body mass index > 28kg/m2, corticosteroid injection 3 months before evaluation, physical therapy 3 months before evaluation.
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 |
|---|---|---|
| Mobilization with Movement (MWM) condition/ Sham conditionThe treatment condition consists in the application of a posterolateral glide (MWM) in the affected shoulder. Subjects will be seated and the therapist will stay beside the participants on the opposite side to the affected shoulder. One hand will be placed over the scapula posteriorly while the thenar eminence of the other hand will be placed over the humerus head anterior aspect. A posterior glide will be applied to the humeral head. Three sets of 10 repetitions will be applied with a 30 seconds rest interval between each set. Sham condition will replicate treatment condition except for the hand positioning. The therapist will place one hand along the clavicle and the other on the humeral head posterior aspect of the affected shoulder. A simulated anterior glide will be performed. | Other | Group 1 - MWM condition/Sham condition, Group 2 - Sham condition/MWM condition |
| Sham condition/ Mobilization with Movement (MWM) conditionThe Sham condition consists in the application of a simulated anterior glide in the affected shoulder. Subjects will be seated and the therapist will stay beside the participants on the opposite side to the affected shoulder. The therapist will place one hand along the clavicle and the other on the humeral head posterior aspect of the affected shoulder. A simulated anterior glide will be performed. Three sets of 10 repetitions will be applied with a 30 seconds rest interval between each set. The treatment condition will replicate treatment condition except for the hand positioning. The therapist will place one hand over the scapula posteriorly while the thenar eminence of the other hand will be placed over the anterior humerus head. A posterior glide will be applied to the humeral head. | Other | Group 1 - MWM condition/Sham condition, Group 2 - Sham condition/MWM condition |
Primary outcome
Pressure Pain Threshold
Time frame: 72 hours before the treatment starts, 24 hours after the last MWM or Shaw treatment, and 24 hours after the last treatment.
The pressure pain threshold will be assessed with a algometer and the unit of measure is the kilogram per square centimeter.
2 secondary outcomes
Range of Motion
Time frame: 72 hours before the treatment starts, 24 hours after the last MWM or Shaw treatment, and 24 hours after the last treatment.
Peak Force
Time frame: 72 hours before the treatment starts, 24 hours after the last MWM or Shaw treatment, and 24 hours after the last treatment.
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 22 Dec 2015.
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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.
Francisco Alburquerque-Sendín, Professor study director
Universidade Federal de Sao Carlos
Tania Salvini, Professor study chair
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 of 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 2 inclusion and 1 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 22 Dec 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. 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?
Pressure Pain Threshold (time frame: 72 hours before the treatment starts, 24 hours after the last MWM or Shaw treatment, and 24 hours after the last treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2015.