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Completed

NCT Number: NCT02574000

Observational Study of Hemiplegic Shoulder Pain After Recent Stroke

This is an observational study to address the following questions.

1. How many people develop stroke-shoulder pain within 3 days of stroke? 2. How many people have stroke shoulder pain at 8-10 weeks after stroke? 3. Does having stroke-shoulder pain within 3 days of stroke predict the likelihood of having stroke-shoulder pain at 8-10 weeks? 4. What are the best bedside examination tests to identify stroke-shoulder pain?

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Key information

Conditions

Shoulder Pain Arthralgia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiplegia Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Pain Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St George's Hospital, Tooting

London, Greater London, SW17 0QT, United Kingdom

About this study

Patients will be assessed very early after stroke (within 72 hours) and followed up 8-10 weeks later. Findings will enable planning of fully-powered randomised controlled trials of both, pain-prevention strategies and treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of haemorrhagic or ischaemic stroke

Exclusion criteria

  • Transient Ischaemic attack,
  • Neurological symptoms due to causes other than acute stroke,
  • Unconscious,
  • Severe behavioural disturbance,
  • Severe agitation,
  • Severe dementia,
  • For palliation,
  • Totally unable to communicate using any method - written, verbal, pictures, gesture

Treatment and study plan

ShoulderQ which is a shoulder pain questionnaire

Other

Questions regarding shoulder pain at rest, during movement and at night with visual analogue scales. Factors affecting shoulder pain.

Clinical shoulder examination

Other

Shoulder-Hand-Score (measuring pain, oedema, passive range of movement), muscle strength (using Oxford scale and National Institute of Health Stroke Scale (NIHSS) upper limbe motor and shoulder joint palpation (recording subluxation and soft-tissue pain).

Primary outcomes

  1. Change from baseline severity of hemiplegic shoulder pain at 8-10 weeks

    Time frame: within 72 hours and 8-10 weeks

    Questionnaire including visual analogue scales

  2. Change from baseline Shoulder-Hand-Score at 8-10 weeks

    Time frame: within 72 hours and 8-10 weeks

    Measurement of pain, oedema, passive range of shoulder abduction and passive range of shoulder external rotation

  3. Change from baseline NIH Stroke Score Upper limb (Motor Arm) at 8-10 weeks

    Time frame: within 72 hours and 8-10 weeks

    Muscle Strength

  4. Change from baseline presence/absence of pain on palpation at 8-10 weeks

    Time frame: within 72 hours and 8-10 weeks

    Palpation of shoulder joint line and surrounding soft tissues

  5. Change from baseline presence/absence of inferior glenohumeral subluxation at 8-10 weeks

    Time frame: within 72 hours and 8-10 weeks

    Palpable gap in sub-acromial region with arm dependent

Sponsors and collaborators

Lead sponsor

St George's, University of London

Other

Registry information

Official study title

Observational Study to Investigate Proportion of Patients With Hemiplegic Shoulder Pain Within 72 Hours Post-stroke and at Follow-up 8-10 Weeks Later.

Acronym: SPARS

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 12, 2015
Registry last updated
Aug 17, 2016

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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