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NCT Number: NCT02465853

Hemiplegic Shoulder Pain and Rotator Cuff Injuries

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.

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Key information

Conditions

Shoulder Pain Arthralgia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rotator Cuff Injuries Rupture Shoulder Injuries Signs and Symptoms Stroke Tendon Injuries Vascular Diseases Wounds and Injuries

Age range

15 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ChangGungMH

Kaohsiung City, 833, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyaluronic acid

Drug

Injection Hyaluronic Acid in the experimental group

Other names: sodium hyaluronate

Physiological saline solution

Drug

Injection 0.9% Physiological saline solution<1.0 ml

Other names: saline

physical therapy and occupational therapy

Other

rehabilitation

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Quality of Life

    Time frame: 1 week , 4th week, 3 month and 6 month

    Stroke Specific Quality of Life Scale questionnaire

  3. shoulder sensory

    Time frame: 1 week , 4th week, 3 month and 6 month

    light touch, pin prick, position sense

  4. shoulder pain

    Time frame: 1 week , 4th week, 3 month and 6 month

    visual analog scale

  5. shoulder spasticity

    Time frame: 1 week , 4th week, 3 month and 6 month

    modified Ashworth scale

  6. motor function

    Time frame: 1 week , 4th week, 3 month and 6 month

    Fual Meyer scale, brunnstrom motor recovery stage

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 9, 2015
Registry last updated
Feb 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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