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Hemiplegic Shoulder Pain and Rotator Cuff Injuries

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02465853
Enrollment
42
Registered
2015-06-09
Start date
2015-01-31
Completion date
2017-12-31
Last updated
2018-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Pain, Stroke, Rotator Cuff Injuries

Keywords

hemiplegic shoulder pain, quality of Life, stroke

Brief summary

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

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.

Interventions

DRUGHyaluronic Acid

Injection Hyaluronic Acid in the experimental group

Injection 0.9% Physiological saline solution\<1.0 ml

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
15 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the change from baseline on hemiplegic shoulder sonography1 week , 4th week, 3 month and 6 monthuse sonographic to investigate the soft tissues surrounding the hemiplegic shoulder

Secondary

MeasureTime frameDescription
Quality of Life1 week , 4th week, 3 month and 6 monthStroke Specific Quality of Life Scale questionnaire
shoulder sensory1 week , 4th week, 3 month and 6 monthlight touch, pin prick, position sense
shoulder range of motion1 week , 4th week, 3 month and 6 monthgoniometer Shoulder abduction 0-180, flex 0-180, ext 0-60, internal rotation 0-90, external rotation 0-90
shoulder spasticity1 week , 4th week, 3 month and 6 monthmodified Ashworth scale
motor function1 week , 4th week, 3 month and 6 monthFual Meyer scale, brunnstrom motor recovery stage
shoulder pain1 week , 4th week, 3 month and 6 monthvisual analog scale

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026