Observational Study of Hemiplegic Shoulder Pain After Recent Stroke (SPARS)

August 16, 2016 updated by: St George's, University of London

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

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

163

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, SW17 0QT
        • St George's Hospital, Tooting

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults within 72 hours of stroke

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Single group baseline and follow-up

Single group of adult stroke patients assessed using ShoulderQ shoulder pain questionnaire and Clinical shoulder examination at two time-points:

Baseline: within 72 hours post-stroke Follow-up: at 8-10 weeks post-stroke
Other: ShoulderQ which is a shoulder pain questionnaire
Questions regarding shoulder pain at rest, during movement and at night with visual analogue scales. Factors affecting shoulder pain.
Other: Clinical shoulder examination
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within 72 hours and 8-10 weeks
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
within 72 hours and 8-10 weeks
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
within 72 hours and 8-10 weeks
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
within 72 hours and 8-10 weeks
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
within 72 hours and 8-10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St George's, University of London

Investigators

  • Principal Investigator: Martine Nadler, PhD, St George's, University of London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

October 8, 2015

First Submitted That Met QC Criteria

October 9, 2015

First Posted (Estimate)

October 12, 2015

Study Record Updates

Last Update Posted (Estimate)

August 17, 2016

Last Update Submitted That Met QC Criteria

August 16, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15.0216

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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