NCT05955820

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2023

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

9 months

First QC Date

July 8, 2023

Last Update Submit

July 13, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    Baseline

  • 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

    Baseline

Study Arms (2)

Conventional exercises for impingement syndrome

EXPERIMENTAL

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

Device: Dumbbells

Suspension system exercises for impingement syndrome

EXPERIMENTAL

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

Device: Suspension system

Interventions

Participants will be tested by four exercises designed for impingement syndrome using the suspension system

Also known as: Neurac system
Suspension system exercises for impingement syndrome
DumbbellsDEVICE

Participants will be tested by four exercises designed for impingement syndrome using Dumbbells

Conventional exercises for impingement syndrome

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university faculty of physical therapy

Cairo, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 27727288BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROF.DR.Enass Fawzy Youssif

Study Record Dates

First Submitted

July 8, 2023

First Posted

July 21, 2023

Study Start

September 21, 2022

Primary Completion

June 23, 2023

Study Completion

July 8, 2023

Last Updated

July 21, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations