Hemiplegic Shoulder Pain and Rotator Cuff Injuries

February 22, 2018 updated by: Chang Gung Memorial Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 833
        • ChangGungMH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the change from baseline on hemiplegic shoulder sonography
Time Frame: 1 week , 4th week, 3 month and 6 month
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
Time Frame: 1 week , 4th week, 3 month and 6 month
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
Time Frame: 1 week , 4th week, 3 month and 6 month
Stroke Specific Quality of Life Scale questionnaire
1 week , 4th week, 3 month and 6 month
shoulder sensory
Time Frame: 1 week , 4th week, 3 month and 6 month
light touch, pin prick, position sense
1 week , 4th week, 3 month and 6 month
shoulder pain
Time Frame: 1 week , 4th week, 3 month and 6 month
visual analog scale
1 week , 4th week, 3 month and 6 month
shoulder spasticity
Time Frame: 1 week , 4th week, 3 month and 6 month
modified Ashworth scale
1 week , 4th week, 3 month and 6 month
motor function
Time Frame: 1 week , 4th week, 3 month and 6 month
Fual Meyer scale, brunnstrom motor recovery stage
1 week , 4th week, 3 month and 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

December 16, 2014

First Submitted That Met QC Criteria

June 4, 2015

First Posted (Estimate)

June 9, 2015

Study Record Updates

Last Update Posted (Actual)

February 26, 2018

Last Update Submitted That Met QC Criteria

February 22, 2018

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMRPG8C0771

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

no available now

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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