Effect of Radial Extracorpeal Shock Wave on Pain and Function

Hemiplegia Clinical Trial

Official title:

Effect of Radial Extracorpeal Shock Wave on Pain and Function in Hemplegic Shoulder Pain Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04894097
• Other study ID #: Cairo University
• Status: Completed
• Phase: N/A
• Start date: May 20, 2021
• Est. completion date: September 1, 2021

Study information

• Verified date: February 2023
• Source: Delta University for Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the current study will be focused on the following issues. Evaluation of the effect of radial extracorporeal shock wave on the pressure pain threshold and disability in stroke hemiplegic shoulder.

Description:

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 extra-corporeal 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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:

• 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.

Related Conditions & MeSH terms

• Hemiplegia

Intervention

Device:
• radial extracorpeal shock wave
Swiss DolorClast® Master - Shockwave Therapy System will be used to apply the radial extracorporeal shock wave. It consists of master console, Evo Blue hand-piece, 15mm and 36mm interchangeable contact heads (applicators), contact gel, cart, and external compressor

Locations

Country	Name	City	State
Egypt	Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Delta University for Science and Technology

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The pain pressure threshold (PPT) assessment by using pressure algometer procedures	Pain pressure threshold measurement will be obtained in the same order for all patients.The pressure will be applied with 0.785 cm2 rubber tip at a rate of 1 kg/cm2/sec 27 at the site of measurement. The measurement will at the mid-belly of the deltoid of the painful shoulder. The tip of the algometer will be positioned on this specific point. By pushing the algometer, the force will be applied to the mid belly of deltoid gradually increased. The patients will not allowed to see the algometer display in any moment, and, as soon as the volunteers experience a painful sensation, they say "stop", the algometer will immediately release and the force (in Kpa) will be read from the display. Pain pressure threshold will be measured three times per patient on each site and the average will be calculated and will be used for analysis.	Baseline
Secondary	Shoulder range of motion assessment by using magnetic inclinometer	Total shoulder flexion will be measured with full elbow extension and leading with the thumb to ensure consistent rotation. The inclinometer will placed along the shaft of the humerus perpendicular to the plane of motion. Total shoulder abduction will be measured with full elbow extension and leading with the thumb to ensure consistent rotation. The inclinometer will placed along the shaft of the humerus perpendicular to the plane of motion.	Baseline