Hemiplegic Shoulder Pain and Rotator Cuff Injuries

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Hyaluronic Acid Drug
    Other Names: sodium hyaluronate
    Intervention Desc: Injection Hyaluronic Acid in the experimental group
    ARM 1: Kind: Experimental
    Label: Hyaluronic Acid
    Description: injection Hyaluronic Acid 2.5ml and physical therapy and occupational therapy
  • Physiological saline solution Drug
    Other Names: saline
    Intervention Desc: Injection 0.9% Physiological saline solution<1.0 ml
    ARM 1: Kind: Experimental
    Label: Placebo group
    Description: Injection 0.9% Physiological saline solution<1.0 ml and physical therapy and occupational therapy
  • Physical therapy and occupational therapy Other
    Intervention Desc: rehabilitation
    ARM 1: Kind: Experimental
    Label: Placebo group
    Description: Injection 0.9% Physiological saline solution<1.0 ml and physical therapy and occupational therapy
    ARM 2: Kind: Experimental
    Label: Hyaluronic Acid
    Description: injection Hyaluronic Acid 2.5ml and physical therapy and occupational therapy

Trial Design

  • Allocation: Non-Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary the change from baseline on hemiplegic shoulder sonography 1 week , 4th week, 3 month and 6 month No
Secondary shoulder range of motion 1 week , 4th week, 3 month and 6 month No
Secondary Quality of Life 1 week , 4th week, 3 month and 6 month No
Secondary shoulder sensory 1 week , 4th week, 3 month and 6 month No
Secondary shoulder pain 1 week , 4th week, 3 month and 6 month No
Secondary shoulder spasticity 1 week , 4th week, 3 month and 6 month No
Secondary motor function 1 week , 4th week, 3 month and 6 month No

Sponsors