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Clinical Trials/NCT04859673
NCT04859673
Completed
Not Applicable

Influence of Radial Extracorpeal Shock Wave Therapy on Sonographic Findings in Patients With Hemiplegic Shoulder Pain

Delta University for Science and Technology1 site in 1 country30 target enrollmentJune 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemiplegia
Sponsor
Delta University for Science and Technology
Enrollment
30
Locations
1
Primary Endpoint
Evaluation of hemiplegic shoulder structural changes by ultrasonography
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The purposes of this study are to examine sonographic structural changes pre and post the radial extracorporeal shock wave intervention in hemiplegic shoulder pain, and to assess the relationships between sonographic structural changes and hemiplegic shoulder pain.

Detailed Description

Painful shoulder is a common complication following hemiplegic stroke. This pain may interfere with functional improvement, the patient's quality of life, and it may impede the process of rehabilitation. Further understanding of rotator cuff tendon impairment and other shoulder soft tissue structural abnormalities in stroke patients may help clinicians in assigning more complete therapeutic plans to hemiplegic patients. The radial extracorporeal shock wave therapy has promising results in patients with musculoskeletal problems and in those with various causes of HSP, including spasticity, rotator cuff problems, adhesive capsulitis, and complex regional pain syndrome .The purposes of this study are to examine sonographic structural changes pre and post the radial extracorporeal shock wave intervention in hemiplegic shoulder pain, as well as to explore the relationships between sonographic structural changes and hemiplegic shoulder pain. This study will be a benefit in the physical therapy field and may guide rehabilitation programs of physical therapy towards better results through decreasing time needed to perform activity of daily living, decreasing dependency and making patient an active member in society.

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
September 1, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ibrahim Ahmed Ibrahim Abu Ella

assistant lecturer

Delta University for Science and Technology

Eligibility Criteria

Inclusion Criteria

  • Patient's age ranges from 40 to 60 years.
  • Spasticity of upper limb ranges from mild to moderate (grade 1+: 2) according to modified aschworth scale (MAS).
  • Patients with sufficient cognitive abilities that enables them to understand and follow instructions (Mini-Mental Scale \>24).
  • Patient who understand the study process and signed the informed consent form.
  • Patient with stroke more than 3 months ago.
  • Patient with shoulder pain and limited range of motion (ROM) or loss of motion in the proximal arm on the hemiplegic side.

Exclusion Criteria

  • The following patients will be excluded from the study:
  • Patients who cannot express their own pain intensity.
  • Patients with a history of trauma or surgery to the shoulder on the affected side.
  • Patients with history of oral NSAIDs 3 days before this study or take warfarin medication with an international normalized ratio above 4.
  • Patients with a history of shoulder pain before the stroke.
  • Patients who have received a previous shoulder intra-articular injection or other interventions on the affected shoulder within one month before rESWT.
  • Patients with cardiac pacemaker.
  • Patients who have osteoporosis.
  • Patients with psychological problems.

Outcomes

Primary Outcomes

Evaluation of hemiplegic shoulder structural changes by ultrasonography

Time Frame: Baseline

Ultrasonography evaluation includes long head of biceps tendon ,subscapularis tendon, supraspinatus tendon, infraspinatus tendon. Each abnormal ultrasound (US) finding will be assigned a score of one (1) if present or zero (0) if absent. Long head of biceps effusion, sub acromial sub deltoid bursa effusion, subluxation, and adhesive capsulitis scored. Tendon tear, tendinosis, and tendon degeneration will be similarly scored for each of the four examined tendons per shoulder. The sum of these scores yielded a raw ultrasound (US) score; such that the minimum score was zero (normal examination) while the maximum score amounted to sixteen .The raw US scores will be further grouped into graded US scores, such that scores of 0, 1-2, 3-4, 5-6, and more than 6 abnormal sonographic findings represented normal shoulder, mild damage, moderate damage, severe damage, and intense damage, respectively

Secondary Outcomes

  • Pain assessment by using shoulder pain and disability index (SPADI).(Baseline)

Study Sites (1)

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