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Thoracic Manipulation Versus Myofascial Release in Patients With Shoulder Impingement Syndrome

Primary Purpose

Impingement Shoulder

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
scapular stabilization exercises.
Thoracic manipulation.
Myofascial release.
Sponsored by
manar sameh el taher
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impingement Shoulder

Eligibility Criteria

25 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Sixty patients with shoulder impingement syndrome from both genders their age will be ranged and divided into three groups from 25-40 years.
  2. History of shoulder pain for at least one month.
  3. Positive Neer's impingement test and Hawkins's kiennedy test.
  4. Presence of thoracic hypomobility from clinical evaluation.
  5. Provocation of pain above 60 degrees of flexion and abduction.
  6. Palpable trigger points on shoulder muscles.

Exclusion Criteria:

  1. History of Shoulder girdle fracture, dislocation and surgery
  2. Diagnosed with frozen shoulder or rotator cuff tear
  3. History of cervicobrachial pain
  4. Any neuromuscular pain in upper limb and use of corticosteroids or pain subsiding medication

Sites / Locations

  • Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Scapular stabilization exercises

Thoracic manipulation.

Myofascial release

Arm Description

Group I (control group) will receive scapular stabilization exercises.

Group II will receive scapular stabilization exercises and thoracic manipulation.

Group III will receive scapular stabilization exercises and myofascial release by instrument assisted soft tissue mobilization techniques.

Outcomes

Primary Outcome Measures

Pain in shoulder movement
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.
shoulder function
by DASH is a reliable and valid tool for the assessment of shoulder pain and disability in both clinical practice and research.
Shoulder Proprioception (joint of position error)
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.

Secondary Outcome Measures

Shoulder ROM
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.
Pain pressure threshold in shoulder muscles
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.

Full Information

First Posted
July 18, 2021
Last Updated
August 22, 2022
Sponsor
manar sameh el taher
Collaborators
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05104671
Brief Title
Thoracic Manipulation Versus Myofascial Release in Patients With Shoulder Impingement Syndrome
Official Title
Thoracic Manipulation Versus Myofascial Release in Patients With Shoulder Impingement Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
August 15, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
manar sameh el taher
Collaborators
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impingement Shoulder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Scapular stabilization exercises
Arm Type
Active Comparator
Arm Description
Group I (control group) will receive scapular stabilization exercises.
Arm Title
Thoracic manipulation.
Arm Type
Experimental
Arm Description
Group II will receive scapular stabilization exercises and thoracic manipulation.
Arm Title
Myofascial release
Arm Type
Experimental
Arm Description
Group III will receive scapular stabilization exercises and myofascial release by instrument assisted soft tissue mobilization techniques.
Intervention Type
Other
Intervention Name(s)
scapular stabilization exercises.
Intervention Description
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: towel slide Scapular Clock: Scapular Proprioceptive Neuromuscular facilitation: Inferior Glide. Scapular Orientation Exercise (SOE): Protraction and retraction in front of a mirror:
Intervention Type
Other
Intervention Name(s)
Thoracic manipulation.
Other Intervention Name(s)
scapular stabilization exercises
Intervention Description
• 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.
Intervention Type
Other
Intervention Name(s)
Myofascial release.
Other Intervention Name(s)
scapular stabilization exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain in shoulder movement
Description
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.
Time Frame
change from max pain point at 2 months
Title
shoulder function
Description
by DASH is a reliable and valid tool for the assessment of shoulder pain and disability in both clinical practice and research.
Time Frame
change from limitation of function at 2 months
Title
Shoulder Proprioception (joint of position error)
Description
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.
Time Frame
change from poor proprioception at 2 months
Secondary Outcome Measure Information:
Title
Shoulder ROM
Description
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.
Time Frame
change from limitation in shoulder ROM at 2 months
Title
Pain pressure threshold in shoulder muscles
Description
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.
Time Frame
change from baseline pain pressure threshold at 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
manar sameh, master
Phone
01093050516
Email
manareltaher@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
nabil mahmoud, Lecturer
Phone
01200133613
Email
Nabil.mahmoud@cu.edu.eg
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sameh
Phone
01093050516
Email
manareltaher@gmail.com
First Name & Middle Initial & Last Name & Degree
mahmoud
Email
Nabil.mahmoud@cu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Undecided

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Thoracic Manipulation Versus Myofascial Release in Patients With Shoulder Impingement Syndrome

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