Hemiplegic Shoulder Pain and Rotator Cuff Injuries

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02465853
• Other study ID #: CMRPG8C0771
• Status: Completed
• Phase: N/A
• First received: December 16, 2014
• Last updated: February 22, 2018
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: August 2016
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Shoulder Pain
• Stroke
• Wounds and Injuries

Intervention

Drug:
• Hyaluronic Acid
Injection Hyaluronic Acid in the experimental group
• Physiological saline solution
Injection 0.9% Physiological saline solution<1.0 ml

Other:
• physical therapy and occupational therapy
rehabilitation

Locations

Country	Name	City	State
Taiwan	ChangGungMH	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Quality of Life	Stroke Specific Quality of Life Scale questionnaire	1 week , 4th week, 3 month and 6 month
Secondary	shoulder sensory	light touch, pin prick, position sense	1 week , 4th week, 3 month and 6 month
Secondary	shoulder pain	visual analog scale	1 week , 4th week, 3 month and 6 month
Secondary	shoulder spasticity	modified Ashworth scale	1 week , 4th week, 3 month and 6 month
Secondary	motor function	Fual Meyer scale, brunnstrom motor recovery stage	1 week , 4th week, 3 month and 6 month