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Suspension System on Impingement Syndrome

Primary Purpose

Impingement Syndrome

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Suspension system
Dumbbells
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impingement Syndrome

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Fifty-eight subjects with SIS (more than three months). Their age ranges from 20-45 years old Level of pain (at least 2/10 on VAS) Body mass index (BMI) between 18-25 Subjects must show positive results in at least two of the following tests: Neer's impingement test, Hawkins-Kennedy test, supraspinatus (empty can) test, apprehension and relocation test. Exclusion Criteria: The subjects will be excluded if they had: Received physiotherapy at last 3 months. Received corticosteroids injection in subacromial space at last 3 months. Received anti-inflammatory medications. Have a fracture or dislocation in shoulder, neck and thoracic regions. Have an acute rotator cuff tear. Have tumor or malignancy in shoulder region. Have neurologic problems in shoulder, neck and thoracic regions. Have cooperation difficulties due to cognitive disorders.

Sites / Locations

  • Cairo university faculty of physical therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Conventional exercises for impingement syndrome

Suspension system exercises for impingement syndrome

Arm Description

Four exercises (prone extension, side-lying external rotation, side-lying forward flexion, prone horizontal abduction with external rotation) will be performed for three sets of 10 repetitions

Four exercises (Kneeling shoulder extension, Supine/ standing / kneeling row, sitting press up, kneeling push up) will be performed for 3-6 sets of 10 repetitions

Outcomes

Primary Outcome Measures

Improvement in active shoulder ROM
Proprioception will be tested by using inclinometer to determine patient's active shoulder range of motion for internal and external rotation, flexion, and extension
Improvement in functional performance
Assessment of function using SPADI subscale which contains 13 items that assess two domains; a 5-item subscale that measures pain and 8-item subscale that measures disability. In addition, Several non-specific strength/power tests may assist in determining the level of functional performance of the patients

Secondary Outcome Measures

Full Information

First Posted
July 8, 2023
Last Updated
July 13, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05955820
Brief Title
Suspension System on Impingement Syndrome
Official Title
Effect of a Selected Suspension System Exercise Program on Patients With Subacromial Impingement Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 21, 2022 (Actual)
Primary Completion Date
June 23, 2023 (Actual)
Study Completion Date
July 8, 2023 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
To investigate the effect of shoulder exercise using a selected suspension system exercise program on pain, disability, functional performance and proprioception in patients with subacromial impingement syndrome.
Detailed Description
Two groups were assigned to this study, the first one received four conventional exercises that designed for shoulder impingement syndrome, the second group received the same four conventional exercises plus four selected suspension system exercises. The sessions were conducted three times per week fir four weeks.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional exercises for impingement syndrome
Arm Type
Experimental
Arm Description
Four exercises (prone extension, side-lying external rotation, side-lying forward flexion, prone horizontal abduction with external rotation) will be performed for three sets of 10 repetitions
Arm Title
Suspension system exercises for impingement syndrome
Arm Type
Experimental
Arm Description
Four exercises (Kneeling shoulder extension, Supine/ standing / kneeling row, sitting press up, kneeling push up) will be performed for 3-6 sets of 10 repetitions
Intervention Type
Device
Intervention Name(s)
Suspension system
Other Intervention Name(s)
Neurac system
Intervention Description
Participants will be tested by four exercises designed for impingement syndrome using the suspension system
Intervention Type
Device
Intervention Name(s)
Dumbbells
Intervention Description
Participants will be tested by four exercises designed for impingement syndrome using Dumbbells
Primary Outcome Measure Information:
Title
Improvement in active shoulder ROM
Description
Proprioception will be tested by using inclinometer to determine patient's active shoulder range of motion for internal and external rotation, flexion, and extension
Time Frame
Baseline
Title
Improvement in functional performance
Description
Assessment of function using SPADI subscale which contains 13 items that assess two domains; a 5-item subscale that measures pain and 8-item subscale that measures disability. In addition, Several non-specific strength/power tests may assist in determining the level of functional performance of the patients
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Fifty-eight subjects with SIS (more than three months). Their age ranges from 20-45 years old Level of pain (at least 2/10 on VAS) Body mass index (BMI) between 18-25 Subjects must show positive results in at least two of the following tests: Neer's impingement test, Hawkins-Kennedy test, supraspinatus (empty can) test, apprehension and relocation test. Exclusion Criteria: The subjects will be excluded if they had: Received physiotherapy at last 3 months. Received corticosteroids injection in subacromial space at last 3 months. Received anti-inflammatory medications. Have a fracture or dislocation in shoulder, neck and thoracic regions. Have an acute rotator cuff tear. Have tumor or malignancy in shoulder region. Have neurologic problems in shoulder, neck and thoracic regions. Have cooperation difficulties due to cognitive disorders.
Facility Information:
Facility Name
Cairo university faculty of physical therapy
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27727288
Citation
Chen L, Chen J, Peng Q, Chen J, Zou Y, Liu G. Effect of Sling Exercise Training on Balance in Patients with Stroke: A Meta-Analysis. PLoS One. 2016 Oct 11;11(10):e0163351. doi: 10.1371/journal.pone.0163351. eCollection 2016.
Results Reference
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Suspension System on Impingement Syndrome

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