Clinical trial NCT04859673: Influence of Radial Extracorpeal Shock Wave in Hemiplegic Shoulder Patients
Official title: Influence of Radial Extracorpeal Shock Wave Therapy on Sonographic Findings in Patients With Hemiplegic Shoulder Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegia
Spastic
Keywords: Sonography
Pain
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The selected patients will be randomly assigned to two equal groups (study group (GI), and control group (GII).The study group (GI) will be treated by the radial extracorporeal shock wave in addition to design physical therapy program.

• The control group (GII) will be treated by sham radial extracorporeal shock wave in addition to the same design physical therapy program of (GI).
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 1. Patient's age ranges from 40 to 60 years. 2. Spasticity of upper limb ranges from mild to moderate (grade 1+: 2) according to modified aschworth scale (MAS).

  3. Patients with sufficient cognitive abilities that enables them to understand and follow instructions (Mini-Mental Scale \>24).

  4. Patient who understand the study process and signed the informed consent form.

  5. Patient with stroke more than 3 months ago. 8. 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:

  1. Patients who cannot express their own pain intensity.
  2. Patients with a history of trauma or surgery to the shoulder on the affected side.
  3. Patients with history of oral NSAIDs 3 days before this study or take warfarin medication with an international normalized ratio above 4.0.
  4. Patients with a history of shoulder pain before the stroke.

  6. Patients who have received a previous shoulder intra-articular injection or other interventions on the affected shoulder within one month before rESWT.

  7. Patients with cardiac pacemaker. 8. Patients who have osteoporosis. 9. Patients with psychological problems.

Primary outcomes:
measure: Evaluation of hemiplegic shoulder structural changes by ultrasonography
timeFrame: Baseline
Secondary outcomes:
measure: Pain assessment by using shoulder pain and disability index (SPADI).
timeFrame: Baseline
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
affiliation: Cairo University
name: Ibrahim A Abu-Ella, MSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilson RD, Chae J. Hemiplegic Shoulder Pain. Phys Med Rehabil Clin N Am. 2015 Nov;26(4):641-55. doi: 10.1016/j.pmr.2015.06.007. Epub 2015 Sep 9.