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Ultrasound Versus Kinesiotaping in Shoulder Impingement Syndrome (US-SIS-KT)

Primary Purpose

Shoulder Impingement Syndrome

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
scapular stabilization exercises
ultrasound
Kinesio Tape
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement Syndrome focused on measuring ultrasound, kinesiotaping, Shoulder Impingement Syndrome, shoulder pain, shoulder range of motion

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Patients with shoulder impingement syndrome from both genders their age will be ranged and divided into three groups from 20-50 years. History of shoulder pain for one month. Positive Neer's impingement test and Hawkin's kiennedy test. Provocation of pain above 60 degrees of flexion and abduction. 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

Sites / Locations

  • Mahmoud Ahmed Kashef

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

control group

study group (A)

study group (B)

Arm Description

will receive scapular stabilization exercises 3 times per week for 4 weeks.

will receive scapular stabilization exercises and Kinesiotape 3 times per week for 4 weeks

will receive scapular stabilization exercises and Ultrasound 3 times per week for 4 weeks.

Outcomes

Primary Outcome Measures

severity of pain
Assessed By visual analogue scale (VAS) , The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health) orientated from the left (worst) to the right (best).
Range Of Motion
assessed By Digital Goniometer
Function
assessed by disability of arm and hand quick questionnaire (quick DASH).
Hand strength
assessed by hand dynamometer.

Secondary Outcome Measures

Full Information

First Posted
March 9, 2023
Last Updated
October 12, 2023
Sponsor
Cairo University
Collaborators
Heliopolis University
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1. Study Identification

Unique Protocol Identification Number
NCT05779033
Brief Title
Ultrasound Versus Kinesiotaping in Shoulder Impingement Syndrome
Acronym
US-SIS-KT
Official Title
Ultrasound Versus Kinesiotaping in Relation to Scapular Stabilization Exercises in Shoulder Impingement Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 9, 2023 (Actual)
Primary Completion Date
September 1, 2023 (Actual)
Study Completion Date
October 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Heliopolis University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
studying the effect of ultrasound and kinesiotaping in shoulder impingement syndrome in reliefing pain and increase range of motion in subjects with shoulder impingement syndrome .
Detailed Description
Shoulder pain is a common presenting complaint from patients of all ages in daily clinical practice, affecting approximately one-third of individuals during their lifetime. Such pain may lead to the impairment of shoulder joint function and to severe reduction in quality of life. Shoulder impingement syndrome. Ultrasound (US) is a physical therapy agent that is frequently used as an adjunctive treatment for shoulder pain. US has thermal and biophysical ffects which provide analgesia increases nutrition and increases blood circulation. Kinesio taping method (KT), has been widely used also for many musculoskeletal diseases including shoulder problems. Most of taping methods are aimed to provide a mechanical stimulus for proprioception or to decrease pain by lifting skin and subcutaneous tissues. To investigate the effect of adding ultrasound versus Kinesiotaping to exercise program on pain intensity. To investigate the effect of adding ultrasound versus Kinesiotaping to exercise program on shoulder ROM. To investigate the effect of adding ultrasound versus Kinesiotaping to exercise program on shoulder function. To investigate the effect of adding ultrasound versus Kinesiotaping to exercise program on hand strength.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome
Keywords
ultrasound, kinesiotaping, Shoulder Impingement Syndrome, shoulder pain, shoulder range of motion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients with shoulder impingement syndrome from both genders will participate in this study after approval of ethical committee of the faculty of physical therapy, Cairo University, and all participants provided written informed consent. Sample size: estimate 45 patients until we measure power analysis The subjects will be arranged into three groups: Group I (control group) will receive scapular stabilization exercises 3 times per week for 4 weeks. Group II will receive scapular stabilization exercises and Kinesiotape 3 times per week for 4 weeks. Group III will receive scapular stabilization exercises and Ultrasound 3 times per week for 4 weeks.
Masking
Participant
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
will receive scapular stabilization exercises 3 times per week for 4 weeks.
Arm Title
study group (A)
Arm Type
Active Comparator
Arm Description
will receive scapular stabilization exercises and Kinesiotape 3 times per week for 4 weeks
Arm Title
study group (B)
Arm Type
Active Comparator
Arm Description
will receive scapular stabilization exercises and Ultrasound 3 times per week for 4 weeks.
Intervention Type
Behavioral
Intervention Name(s)
scapular stabilization exercises
Intervention Description
scapular stabilization exercises 3 times per week for 4 weeks.
Intervention Type
Device
Intervention Name(s)
ultrasound
Other Intervention Name(s)
US
Intervention Description
Ultrasound 3 times per week for 4 weeks.continuous US operated at a frequency of 1 MHz and at an intensity of 1.5 W/cm2 for 5 minutes
Intervention Type
Other
Intervention Name(s)
Kinesio Tape
Other Intervention Name(s)
KT
Intervention Description
Kinesiotape 3 times per week for 4 weeks. We will apply taping to two muscles (deltoideus and supraspinatus). A "Y' tape was placed over the deltoid muscle using the muscle stimulation (KT strip arms were located by stretching slightly by 15%-25%) and mechanical correction techniques (KT strip arms were located with maximal stretching). Another "Y" tape was placed over the supraspinatus muscle using the muscle inhibition technique (the starting point of the tape was attached to the sub acromial-greater tubercle with submaximal (75%) stretching and without stretching on strip arms).
Primary Outcome Measure Information:
Title
severity of pain
Description
Assessed By visual analogue scale (VAS) , The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health) orientated from the left (worst) to the right (best).
Time Frame
4 weeks
Title
Range Of Motion
Description
assessed By Digital Goniometer
Time Frame
4 weeks
Title
Function
Description
assessed by disability of arm and hand quick questionnaire (quick DASH).
Time Frame
4 weeks
Title
Hand strength
Description
assessed by hand dynamometer.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Patients with shoulder impingement syndrome from both genders their age will be ranged and divided into three groups from 20-50 years. History of shoulder pain for one month. Positive Neer's impingement test and Hawkin's kiennedy test. Provocation of pain above 60 degrees of flexion and abduction. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan hu ahmed, professor
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Mahmoud Ahmed Kashef
City
Cairo
ZIP/Postal Code
0325
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
(age-severity of pain-range of motion function level of shoulder joint)'s of patients will be shared
IPD Sharing Time Frame
4 weeks
IPD Sharing Access Criteria
paper concent
Citations:
PubMed Identifier
33155484
Citation
Letafatkar A, Rabiei P, Kazempour S, Alaei-Parapari S. Comparing the effects of no intervention with therapeutic exercise, and exercise with additional Kinesio tape in patients with shoulder impingement syndrome. A three-arm randomized controlled trial. Clin Rehabil. 2021 Apr;35(4):558-567. doi: 10.1177/0269215520971764. Epub 2020 Nov 6.
Results Reference
result
PubMed Identifier
29703659
Citation
Gunay Ucurum S, Kaya DO, Kayali Y, Askin A, Tekindal MA. Comparison of different electrotherapy methods and exercise therapy in shoulder impingement syndrome: A prospective randomized controlled trial. Acta Orthop Traumatol Turc. 2018 Jul;52(4):249-255. doi: 10.1016/j.aott.2018.03.005. Epub 2018 Apr 25.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/29703659/
Description
Comparison of different electrotherapy methods and exercise therapy in shoulder impingement syndrome: A prospective randomized controlled trial
URL
https://pubmed.ncbi.nlm.nih.gov/33155484/
Description
Comparing the effects of no intervention with therapeutic exercise, and exercise with additional Kinesio tape in patients with shoulder impingement syndrome. A three-arm randomized controlled trial

Learn more about this trial

Ultrasound Versus Kinesiotaping in Shoulder Impingement Syndrome

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