- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05104671
Thoracic Manipulation Versus Myofascial Release in Patients With Shoulder Impingement Syndrome
aims: • To investigate the effect of adding thoracic manipulation vs myofascial release to scapular stabilization exercise on pain intensity.
- To investigate the effect of adding thoracic manipulation vs myofascial release to scapular stabilization exercise on pain pressure threshold.
- To investigate the effect of adding thoracic manipulation vs myofascial release to scapular stabilization exercise on shoulder proprioception.
- To investigate the effect of adding thoracic manipulation vs myofascial release to scapular stabilization exercise on shoulder range of motion(ROM).
- To investigate the effect of adding thoracic manipulation vs myofascial release to scapular stabilization exercise on disability of shoulder and hand questionnaire(DASH).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Various researches have been done on rehabilitation of shoulder impingement by addressing either osseous structure or myofascial structure and found to be effective. But no studies could retrieve to compare these two: myofascial release and thoracic manipulation. (Dash & Deepak, 2020). so in this study we will investigate the effect of adding thoracic manipulation versus myofascial release in patients with shoulder impingement syndrome. we will investigate the effect on each of the following: pain intensity will measure by visual analogue scale.(VAS).
proprioception of the shoulder by isokinetic dynamometer. pain pressure threshold by algometer. function by DASH questionnaire and finally ROM by kinovea software.
The subjects will be arranged into three groups: Group I (control group) will receive scapular stabilization exercises.
- Group II will receive scapular stabilization exercises and thoracic manipulation combined with shoulder mobilization.
- Group III will receive scapular stabilization exercises and myofascial release by instrument assisted soft tissue mobilization techniques(IASTM).
the measurements will take before and after treatment programs and after one month of follow up.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt
- Cairo university
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Sixty patients with shoulder impingement syndrome from both genders their age will be ranged and divided into three groups from 25-40 years.
- History of shoulder pain for at least one month.
- Positive Neer's impingement test and Hawkins's kiennedy test.
- Presence of thoracic hypomobility from clinical evaluation.
- Provocation of pain above 60 degrees of flexion and abduction.
- Palpable trigger points on shoulder muscles.
Exclusion Criteria:
- History of Shoulder girdle fracture, dislocation and surgery
- Diagnosed with frozen shoulder or rotator cuff tear
- History of cervicobrachial pain
- Any neuromuscular pain in upper limb and use of corticosteroids or pain subsiding medication
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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Active Comparator: Scapular stabilization exercises
Group I (control group) will receive scapular stabilization exercises.
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General Instructions: For all exercises, perform the retraction of the scapula, without performing the elevation of the shoulders, taking the lower angle of the scapula "back and down". The exercise intensity was described as repetitions, sets, and holding time. Commonly, 10-20 repetitions and three to five sets held for 3-10 seconds were performed.and the exercises will be:
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Experimental: Thoracic manipulation.
Group II will receive scapular stabilization exercises and thoracic manipulation.
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General Instructions: For all exercises, perform the retraction of the scapula, without performing the elevation of the shoulders, taking the lower angle of the scapula "back and down". The exercise intensity was described as repetitions, sets, and holding time. Commonly, 10-20 repetitions and three to five sets held for 3-10 seconds were performed.and the exercises will be:
• Thoracic Thrust Manipulation: The participants were in high sitting and in prone lying position.
The therapist was standing next to the patient in a diagonal stance and also behind the patient during high sitting.
Thoracic thrust manipulation demonstrated to manipulate specific thoracic segment mainly mid thoracic.
Other Names:
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Experimental: Myofascial release
Group III will receive scapular stabilization exercises and myofascial release by instrument assisted soft tissue mobilization techniques.
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General Instructions: For all exercises, perform the retraction of the scapula, without performing the elevation of the shoulders, taking the lower angle of the scapula "back and down". The exercise intensity was described as repetitions, sets, and holding time. Commonly, 10-20 repetitions and three to five sets held for 3-10 seconds were performed.and the exercises will be:
The subject will be treated with IASTM.applied to the pectoral muscles and medial brachium with the subject in supine and the glenohumeral joint(GH).
placed in 120 º abduction to place adequate tension on the selected tissues in the style of pectoral tightness test .The IASTM technique was performed for 20 seconds parallel to the muscle fibers followed by 20 seconds perpendicular to the muscle fibers with the instrument held at a 45 º angle to the skin.The same IASTM protocol of 20 seconds parallel to the muscle fibers and 20 seconds perpendicular to the muscle fibers was applied to the posterior cuff musculature of the GH joint with the subject in prone and arms in 90 º abduction and internal rotation draped over the side of the plinth .
While in the same position, the technique was applied to the periscapular musculature including the, trapezoids, rhomboids, teres minor, teres major, and latissimus dorsi.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain in shoulder movement
Time Frame: change from max pain point at 2 months
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will be measured by Visual analog scale(VAS).
It consists of a line, often 10 cm long(100mm); its ends are generally labelled with verbal pain anchors (e.g., "no pain" and "pain as bad as it could be").
Patients are asked to indicate the point along the line that best reflects their pain intensity.
The majority of the studies showed that visual analogue scale is a valid and reliable scale.
Also, it is an interval scale.
So, in clinical practice we can use this scale in case of pain measurement as an outcome measure tool.
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change from max pain point at 2 months
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shoulder function
Time Frame: change from limitation of function at 2 months
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by DASH is a reliable and valid tool for the assessment of shoulder pain and disability in both clinical practice and research.
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change from limitation of function at 2 months
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Shoulder Proprioception (joint of position error)
Time Frame: change from poor proprioception at 2 months
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will be measured by isokinetic dynamometer.
Isokinetic dynamometry is considered a valid instrument for assessing muscle strength, and it is often used as a reference standard for other strength assessments.
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change from poor proprioception at 2 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Shoulder ROM
Time Frame: change from limitation in shoulder ROM at 2 months
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will be measured by Kinovea.
Kinovea is a free software used for the analysis, comparison, and evaluation of sports and training.
it is a reliable tool for measuring shoulder flexion, abduction, and Internal rotation&external rotation in healthy individuals.
Thus, it could be used as a simple alternative to universal goniometry.
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change from limitation in shoulder ROM at 2 months
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Pain pressure threshold in shoulder muscles
Time Frame: change from baseline pain pressure threshold at 2 months
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that Pressure algometer is a worthwhile tool in the diagnosis and treatment evaluation of different orthopedic disorders. .
Three consecutive Pressure pain threshold measurements were taken at each point with 20 s rest between measurements, and the mean of the three trials will be used for analysis.
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change from baseline pain pressure threshold at 2 months
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Collaborators and Investigators
Sponsor
Collaborators
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
- shoulder impingement (Project of Beijing Academic Star)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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