Hemiplegic Shoulder Pain and Rotator Cuff Injuries

Overview

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.

Full Title of Study: “Clinical Outcome in Subacute Stroke Patients With Hemiplegic Shoulder Pain and Rotator Cuff Injuries After Hyaluronic Acid Injection”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: July 2017

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

  • Drug: Hyaluronic Acid
    • Injection Hyaluronic Acid in the experimental group
  • Drug: Physiological saline solution
    • Injection 0.9% Physiological saline solution<1.0 ml
  • Other: physical therapy and occupational therapy
    • rehabilitation

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo group
    • Injection 0.9% Physiological saline solution<2.5 ml and physical therapy and occupational therapy
  • Experimental: Hyaluronic Acid
    • injection Hyaluronic Acid 2.5ml and physical therapy and occupational therapy

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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
  • Quality of Life
    • Time Frame: 1 week , 4th week, 3 month and 6 month
    • Stroke Specific Quality of Life Scale questionnaire
  • shoulder sensory
    • Time Frame: 1 week , 4th week, 3 month and 6 month
    • light touch, pin prick, position sense
  • shoulder pain
    • Time Frame: 1 week , 4th week, 3 month and 6 month
    • visual analog scale
  • shoulder spasticity
    • Time Frame: 1 week , 4th week, 3 month and 6 month
    • modified Ashworth scale
  • motor function
    • Time Frame: 1 week , 4th week, 3 month and 6 month
    • Fual Meyer scale, brunnstrom motor recovery stage

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 15 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chang Gung Memorial Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Huang Yu Chi, Bachelor, Principal Investigator, Chang Gung Memorial Hospital

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