NCT05950880

Brief Summary

Purposes of the study To investigate the effect of adding High-Intensity Exercises to conventional physical therapy in patients with Shoulder Impingement Syndrome

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2023

Completed
Last Updated

April 1, 2024

Status Verified

March 1, 2024

Enrollment Period

12 months

First QC Date

July 5, 2023

Last Update Submit

March 28, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • pain and function

    Shoulder pain and disability index (SPADI)

    Change from Baseline pain and function at 6 weaks

  • Supraspinatus muscle thickness

    Diagnostic Ultrasound

    Change from Baseline Supraspinatus muscle thickness at 6 weaks

Secondary Outcomes (4)

  • Sub acromial space (Acromiohumeral distance).

    Change from Baseline Sub acromial space at 6 weaks

  • External and internal rotators muscle strength.

    Change from Baseline External and internal rotators muscle strength at 6 weaks

  • supuraspinatus muscle strength

    Change from Baseline supuraspinatus muscle strength at 6 weaks

  • shoulder performance

    Change from Baseline shoulder performance at 6 weaks

Study Arms (2)

High intensity exercise + Conventional physical therapy

EXPERIMENTAL

Patients in this group will receive High-intensity exercise + Conventional physical therapy

Other: High intensity shoulder exerciseOther: Conventional physical therapy

Conventional physical therapy

ACTIVE COMPARATOR

Patients in this group will receive Conventional physical therapy

Other: Conventional physical therapy

Interventions

Exercises that target the rotator cuff muscles using 90% of one repetition maximum only for 5 repetitions

High intensity exercise + Conventional physical therapy

Conventional physical therapy consisting of scapular stabilization exercises, posterior capsule stretch, and rotator cuff activation exercises

Conventional physical therapyHigh intensity exercise + Conventional physical therapy

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Athletic patients
  • Age of the patients between 18 - 35 years
  • Unilateral shoulder pain more than 3 months.
  • Positive Hawkins test.
  • Positive empty or full cane test.
  • Pain at night or incapable of lying on the shoulder.
  • Pain with active shoulder elevation in the scapular plane.
  • History of pain in the C5-C6 dermatome.
  • Pain with palpation of the rotator cuff tendons.
  • The patient had pain with resisted isometric abduction

You may not qualify if:

  • History of shoulder instability (positive Sulcus sign, positive apprehension test, and history of shoulder dislocation).
  • Clinical sign of cervical radiculopathy.
  • History of acromio -clavicular pain.
  • Rheumatoid Arthritis.
  • Adhesive capsulitis.
  • Tumors
  • Labrum lesions
  • Capsular or ligamentous tears or avulsions
  • Cartilage lesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

facult of physical therapy,MTI

Cairo, Egypt

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Study Officials

  • Abdallah Gamiel, MSc

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr

Study Record Dates

First Submitted

July 5, 2023

First Posted

July 18, 2023

Study Start

January 1, 2023

Primary Completion

December 25, 2023

Study Completion

December 25, 2023

Last Updated

April 1, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations