Hemiplegic Shoulder Pain and Rotator Cuff Injuries
Primary Purpose
Shoulder Pain, Stroke, Rotator Cuff Injuries
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Hyaluronic Acid
Physiological saline solution
physical therapy and occupational therapy
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain focused on measuring hemiplegic shoulder pain, quality of Life, stroke
Eligibility Criteria
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
Sites / Locations
- ChangGungMH
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo group
Hyaluronic Acid
Arm Description
Injection 0.9% Physiological saline solution<2.5 ml and physical therapy and occupational therapy
injection Hyaluronic Acid 2.5ml and physical therapy and occupational therapy
Outcomes
Primary Outcome Measures
the change from baseline on hemiplegic shoulder sonography
use sonographic to investigate the soft tissues surrounding the hemiplegic shoulder
Secondary Outcome Measures
shoulder range of motion
goniometer Shoulder abduction 0-180, flex 0-180, ext 0-60, internal rotation 0-90, external rotation 0-90
Quality of Life
Stroke Specific Quality of Life Scale questionnaire
shoulder sensory
light touch, pin prick, position sense
shoulder pain
visual analog scale
shoulder spasticity
modified Ashworth scale
motor function
Fual Meyer scale, brunnstrom motor recovery stage
Full Information
NCT ID
NCT02465853
First Posted
December 16, 2014
Last Updated
February 22, 2018
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02465853
Brief Title
Hemiplegic Shoulder Pain and Rotator Cuff Injuries
Official Title
Clinical Outcome in Subacute Stroke Patients With Hemiplegic Shoulder Pain and Rotator Cuff Injuries After Hyaluronic Acid Injection
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Stroke, Rotator Cuff Injuries
Keywords
hemiplegic shoulder pain, quality of Life, stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Non-Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Injection 0.9% Physiological saline solution<2.5 ml and physical therapy and occupational therapy
Arm Title
Hyaluronic Acid
Arm Type
Experimental
Arm Description
injection Hyaluronic Acid 2.5ml and physical therapy and occupational therapy
Intervention Type
Drug
Intervention Name(s)
Hyaluronic Acid
Other Intervention Name(s)
sodium hyaluronate
Intervention Description
Injection Hyaluronic Acid in the experimental group
Intervention Type
Drug
Intervention Name(s)
Physiological saline solution
Other Intervention Name(s)
saline
Intervention Description
Injection 0.9% Physiological saline solution<1.0 ml
Intervention Type
Other
Intervention Name(s)
physical therapy and occupational therapy
Intervention Description
rehabilitation
Primary Outcome Measure Information:
Title
the change from baseline on hemiplegic shoulder sonography
Description
use sonographic to investigate the soft tissues surrounding the hemiplegic shoulder
Time Frame
1 week , 4th week, 3 month and 6 month
Secondary Outcome Measure Information:
Title
shoulder range of motion
Description
goniometer Shoulder abduction 0-180, flex 0-180, ext 0-60, internal rotation 0-90, external rotation 0-90
Time Frame
1 week , 4th week, 3 month and 6 month
Title
Quality of Life
Description
Stroke Specific Quality of Life Scale questionnaire
Time Frame
1 week , 4th week, 3 month and 6 month
Title
shoulder sensory
Description
light touch, pin prick, position sense
Time Frame
1 week , 4th week, 3 month and 6 month
Title
shoulder pain
Description
visual analog scale
Time Frame
1 week , 4th week, 3 month and 6 month
Title
shoulder spasticity
Description
modified Ashworth scale
Time Frame
1 week , 4th week, 3 month and 6 month
Title
motor function
Description
Fual Meyer scale, brunnstrom motor recovery stage
Time Frame
1 week , 4th week, 3 month and 6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huang Yu Chi, Bachelor
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
ChangGungMH
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
no available now
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Hemiplegic Shoulder Pain and Rotator Cuff Injuries
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