- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04273568
The Effect of Scapular Proprioceptive Neuromuscular Facilitation Techniques on Pain and Functionality in Subacromial Impingement Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
32 patients between the ages of 20-60 diagnosed with SIS were included in the study.
The patients were randomly divided into two groups. The exercise group received an exercise program of 12 sessions. Scapular PNF techniques were applied to the PNF group with the same exercise program. Patients were evaluated twice; one before and one after 6 weeks of treatment; using Visual Analogue Scale (VAS) for pain, algometer for PPT, digital goniometer for range of motion (ROM), The Disabilities of Arm, Shoulder and Hand (DASH) for functional status, lateral scapular slide test (LSST) for scapular dyskinesis, Travell and Simons criteria for trigger point and Hospital Anxiety and Depression Scale (HADS) for emotional state. At the end of treatment patient satisfaction was evaluated with Global Change Scale.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey, 34295
- Istanbul Aydin University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged between 20 and 60
- Diagnosed with SIS by MRI and clinical examination and a specialist physician
- Positive impingement tests (Hawkings, Neer and Jobe test) or painful motion arc (60 ° -120 °)
- Unilateral shoulder pain that has been going on for at least 3 months
- Signed voluntary consent form
Exclusion Criteria:
- Diagnosed with adhesive capsulitis or massive rotator cuff tear
- Having undergone upper limb surgery
- Presence of rheumatological systemic diseases
- Presence of Glenohumeral instability
- Having a neurological disease affecting the upper extremity
- Diagnosed with cervical radiculopathy
- Degenerative joint disorders
- Having communication problems
- Steroid injection therapy or physiotherapy in the past 6 months have been rehabilitated
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 |
|---|---|
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Experimental: Group1 (PNF group)
Scapular PNF and exercise program was applied to the PNF group.
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Rhythmic initiation and repetitive stretching techniques in scapula anterior elevation-posterior depression and anterior depression-posterior elevation patterns were applied twice a week for 6 weeks.
An exercise program consisting of exercises used in the conservative treatment of shoulder impingement syndrome for both groups was applied twice a week for 6 weeks.
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Active Comparator: Group 2 (Exercise group)
Exercise program was applied to the exercise group
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An exercise program consisting of exercises used in the conservative treatment of shoulder impingement syndrome for both groups was applied twice a week for 6 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline Pain intensity of the patients at 6 weeks
Time Frame: Baseline and 6 weeks
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Pain intensity of the patients at rest, during activity and at night was assessed using the VAS; Visual Analog Scale.
In this evaluation, individuals were told that the number "0" on the 10 cm long horizontal line expresses "no pain", and the number "10" indicates "unbearable pain" and that individuals should mark their intensity of pain on this line.
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Baseline and 6 weeks
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Change from Baseline Functional Status of the patients at 6 weeks
Time Frame: Baseline and 6 weeks
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The functional status of the patients were evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH).
DASH is a scale consisting of 30 questions that question the functional status and symptoms used in musculoskeletal disorders of the upper extremity.The number of Likert scale (1: no difficulty, 5: I can not do at all) is used in answering the questions and the total score obtained is between 0 and 100.
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Baseline and 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Shoulder Range of Motion (ROM)
Time Frame: Baseline and 6 weeks
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EHA evaluations of flexion, abduction, internal rotation and external rotation of the shoulder joint were performed in the supine position using the digital goniometer.
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Baseline and 6 weeks
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Pain Pressure Threshold (PPT)
Time Frame: Baseline and 6 weeks
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Pressure pain threshold was evaluated using the Algometer (dolorimeter).
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Baseline and 6 weeks
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Scapular dyskinesis
Time Frame: Baseline and 6 weeks
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Scapular Dyskinesis was evaluated with "The Lateral Scapular Slide Test (LSKT)".
In this test, the distance of the inferior angle of the scapula to the nearest spinous process at 3 different positions (0°, 40-45°, 90°) is measured, and a difference of 1 cm or more between the two sides in any of the three positions is considered positive for scapular dyskinesis.
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Baseline and 6 weeks
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Active trigger points
Time Frame: Baseline and 6 weeks
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Active trigger points were evaluated by palpation method according to Travell and Simons criteria.
Scalene, upper trapezius, levator scapula, supraspinatus, infraspinatus, subskapularis, teres minor, teres major, deltoid anterior, middle and posterior group fibers, pectoralis major, pectoralis minor, biceps brachii muscles were evaluated with palpation method in terms of trigger point presence.
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Baseline and 6 weeks
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Emotional state
Time Frame: Baseline and 6 weeks
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The emotional states of the cases were evaluated using the Hospital Anxiety and Depression Scale (HAD), which consists of 14 questions.
(HAD).
This scale has a 7-question anxiety (HAD-A) subscale that evaluates the anxiety state, and a 7-question depression (HAD-D) subscale that evaluates the state of depression, and a four-point likert scale is used to answer the questions.
For the total score of each sub-score, 0-7 points are normal, 8-10 points are at the border, and 11 points are defined as abnormal
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Baseline and 6 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Patient Satisfaction: Global Rating of Change (GRC) scale
Time Frame: At the end of the 6-weeks treatment
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Patient Satisfaction was assessed Global Rating of Change (GRC) scale.
The scale used included 5 points (-2: I am much worse.
-1: I am worse, 0: I am the same, +1: I am better, +2: I am much better).
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At the end of the 6-weeks treatment
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Collaborators and Investigators
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- tugbaakguller
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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