- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06953895
The Immediate Effect of Mulligan's Mobilization With Movement on Shoulder Girdle' Pain, Range of Motion and Muscle Activity, in Subjects With Shoulder Impingement Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Porto, Portugal, 4200-072
- E2S | P.PORTO - Escola Superior de Saúde do Politécnico do Porto
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Participants had superolateral shoulder pain and two out of four specified objective signs and symptoms:
- positive Neer test;
- positive Hawkins-Kennedy test;
- painful limitation of active arm elevation (flexion, abduction, scaption);
- pain or limitation with functional movement patterns of hand behind back or hand behind head.
Exclusion Criteria:
- physician diagnosis of adhesive capsulitis;
- grade III rotator cuff tear;
- calcific tendinosis confirmed by radiology;
- systemic or neurological disorder;
- cervical radiculopathy; a history of shoulder surgery;
- corticosteroid injection within the past month;
- subjects who had received physical therapy intervention for their shoulder within the past three months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
The Mulligan's MWM group received mobilization with movement in the glenohumeral joint, as described by Mulligan.
The participant was seated, and the physiotherapist was placed on the opposite side to the affected shoulder with the thenar eminence of one hand over the anterior aspect of the humeral head, and the other hand over the spine of the scapula posteriorly of the affected shoulder.
The hand over the humeral head performed a posterolateral glide, while the other hand stabilized the scapula.
This maneuver was sustained while the participant asked to raise the arm in scapular plan (as explained above) without pain.
The physiotherapist previously determined the amount of posterolateral pressure which was the best to abolish the pain during shoulder scaption for each participant.
|
The Mulligan's MWM group received mobilization with movement in the glenohumeral joint, as described by Mulligan.
The participant was seated, and the physiotherapist was placed on the opposite side to the affected shoulder with the thenar eminence of one hand over the anterior aspect of the humeral head, and the other hand over the spine of the scapula posteriorly of the affected shoulder.
The hand over the humeral head performed a posterolateral glide, while the other hand stabilized the scapula.
This maneuver was sustained while the participant asked to raise the arm in scapular plan (as explained above) without pain.
The physiotherapist previously determined the amount of posterolateral pressure which was the best to abolish the pain during shoulder scaption for each participant.
The participants performed three sets of 10 trials with a resting time of 30 seconds between each set.
After intervention was allowed a resting time of three minutes.
Other Names:
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Placebo Comparator: Placebo Group
In the Placebo group, no effective intervention was performed, the participant was asked to raise the affected arm in scapular plane without pain, while the physiotherapist placed their hands-on shoulder, with the same manual contacts described in Mulligan's MWM group, but without performing any pressure.
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In the Placebo group, no effective intervention was performed, the participant was asked to raise the affected arm in scapular plane without pain, while the physiotherapist placed their hands-on shoulder, with the same manual contacts described in Mulligan's MWM group, but without performing any pressure. The participants performed three sets of 10 trials with a resting time of 30 seconds between each set. After intervention was allowed a resting time of three minutes. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: baseline
|
The participant was asked to rate the pain intensity in Neer impingement signal and Hawkins-Kennedy impingement test, using a 100 mm visual analogue scale.
|
baseline
|
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Pain Pressure Threshold on the lateral aspect of shoulder
Time Frame: baseline
|
Pressure algometry was performed to assess PPT on the lateral aspect of shoulder.
A hand-held electronic pressure algometer Force One FDIX (Wagner Instruments, Greenwich CT, United States of America) with a 1 cm2 rubber-tipped probe area was applied perpendicular to the skin at a rate of 1 kg per second.
The PPT was measured over the most sensitive point to manual palpation of the lateral aspect of shoulder.
This region was marked with a permanent marker so that the same point could be used pre- and post-intervention.
The researcher instructed the participant to say "ouch" as soon as sensation changed from feeling pressure to feeling pain.
Three trials were performed, with a resting time of 30 seconds and a subsequent analysis of its average.
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baseline
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Shoulder ROM
Time Frame: baseline
|
Photogrammetry was performed to assess ROM of shoulder scaption until onset of pain.
The ROM was recorded by photography, using a digital camera (30 frames/ second) placed in a perpendicular position to the plane of motion, at a distance of 3 meters from a flat surface.
The photography was subsequently analyzed by a postural analysis software (SAPo version 0.69, open source software).
To ensure consistent reference points, spherical markers were placed on the skin: one over the acromion and the last over the lateral epicondyle.
The participant was asked to raise the arm until feeling pain, with elbow fully extended and thumb pointed up along a flat vertical surface positioned 30º anterior to the frontal plane.
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baseline
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Shoulder muscle activity
Time Frame: baseline
|
Surface electromyography (sEMG) was performed to assess the muscle activity of trapezius (upper, middle and lower) and SA, during concentric and eccentric phases of shoulder scaption.
The muscle activity was recorded by BioPlux research device (Plux wireless biosignals S.A., Arruda dos Vinhos, Portugal) with 12-bit analog channels and a sampling frequency of 1000 Hz, using double differential electrode leads.
To perform sEMG, the participant's hair was shaved, an abrasive cream was used to remove dead cells from the skin's surface, and the skin was cleaned with isopropyl alcohol (70%) to remove oil and remaining dead cells.
An electrode impedance checker (Noraxon Corporate, Scottsdale AZ, United States of America) was used to ensure that impedance levels were less than 5 KΩ, which was considered to signify the satisfactory acquisition of the sEMG signal.
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baseline
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00853
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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