Hemiplegic Shoulder Pain and Rotator Cuff Injuries

Study Overview
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Brief Summary
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Hemiplegic shoulder pain (HSP) is one of most complications after stroke. HSP would impede rehabilitation programs and the motor recovery of affected upper extremity. HSP was associated with impaired daily life activities and prolong hospital stay after stroke. Therefore, effective managements is important in stroke patients with HSP. Rotator cuffs injuries are related to HSP. Clinically, hyaluronic acid (HA) is used for rotator cuff injuries. Previous researchers reported that HA could provide pain relief, improved motion, and increased daily activities. In this study, fifty subacute stoke patients will be enrolled. These patients will be allocated into group A and B randomly. The patients in group A received HA injection while patients in group B received normal saline injection. Patients from both groups received injection for 3 times each on the 1st, 2nd, 3rd week. All the patients will still receive rehabilitation programs of physical therapy and occupational therapy. Each patient will receive physical, sonographic examinations, and stroke Specific Quality of Life Scale (SSQOL). The aims of this study are to investigate the benefits of HA injection on pain relief, motor function recovery, and life quality in subacute stroke patients with HSP before and after HA injection.

Detailed Description
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In this study, a two-year program is expected to receive a total cases of 50 subacute stroke patients with hemiplegic shoulder pain. The patients are randomly divided into two groups. In experimental group, the patients (25 people) will accept the shoulder hyaluronic acid injections for pain management. In control group, the patients (25 people) will receive 0.9% physiological saline injections. All participants will receive total 3 times shoulder injections at the 1st, 2nd, 3rd week. Except shoulder injections, stroke patients may receive regular rehabilitation program including physical therapy and occupational therapy. All measurements including shoulder sonography, physical examinations, and the questionnaire for life quality (SSQOL) will be conducted before the first injection, after completing shoulder injection, and 3/6 months after shoulder injection. Shoulder sonography is used to investigate shoulder soft tissue condition of hemiplegic shoulder including biceps tendon, infraspinatus tendon, supraspinatus tendon, subscapularis tendon, and subdeltoid bursa in this study. The physical examination includes all shoulder motion plane, shoulder sensory (light touch, pinprick, and position sense) and motor function (Fual Meyer scale and brunnstrom motor recovery stage), shoulder spasticity measured by modified Ashworth scale, and hemiplegic shoulder pain by visual analog scale. The investigators use Stroke Specific Quality of Life Scale to evaluate the quality of life in stroke patients with HSP. In this study, the investigators want to explore the short and long term effects of HA injection on pain relief, motor function recovery, and life quality in stroke patients with HSP.

Official Title
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Clinical Outcome in Subacute Stroke Patients With Hemiplegic Shoulder Pain and Rotator Cuff Injuries After Hyaluronic Acid Injection

Conditions
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Shoulder Pain, Stroke, Rotator Cuff Injuries

Intervention / Treatment
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* Drug: Hyaluronic Acid
* Drug: Physiological saline solution
* Other: physical therapy and occupational therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subacute stroke patients with hemiplegic shoulder pain Exclusion Criteria: previous shoulder pain or injury in recent 6 months local infection near the injection area shoulder arthropathy systemic neuromuscular disease; severe cardiovascular or pulmoanry disease impaired cognition function leading to poor communication

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br>Injection 0.9% Physiological saline solution<2.5 ml and physical therapy and occupational therapy | Drug: Physiological saline solution<br>* Injection 0.9% Physiological saline solution<1.0 ml<br>* Other names: saline;Other: physical therapy and occupational therapy<br>* rehabilitation<br>|
| Experimental: Hyaluronic Acid<br>injection Hyaluronic Acid 2.5ml and physical therapy and occupational therapy | Drug: Hyaluronic Acid<br>* Injection Hyaluronic Acid in the experimental group<br>* Other names: sodium hyaluronate;Other: physical therapy and occupational therapy<br>* rehabilitation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change from baseline on hemiplegic shoulder sonography | use sonographic to investigate the soft tissues surrounding the hemiplegic shoulder | 1 week , 4th week, 3 month and 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| shoulder range of motion | goniometer Shoulder abduction 0-180, flex 0-180, ext 0-60, internal rotation 0-90, external rotation 0-90 | 1 week , 4th week, 3 month and 6 month | 
| Quality of Life | Stroke Specific Quality of Life Scale questionnaire | 1 week , 4th week, 3 month and 6 month | 
| shoulder sensory | light touch, pin prick, position sense | 1 week , 4th week, 3 month and 6 month | 
| shoulder pain | visual analog scale | 1 week , 4th week, 3 month and 6 month | 
| shoulder spasticity | modified Ashworth scale | 1 week , 4th week, 3 month and 6 month | 
| motor function | Fual Meyer scale, brunnstrom motor recovery stage | 1 week , 4th week, 3 month and 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemiplegic shoulder pain, stroke, quality of Life