Observational Study of Hemiplegic Shoulder Pain After Recent Stroke

Stroke Clinical Trial

— SPARS  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02574000
• Other study ID #: 15.0216
• Status: Completed
• Phase: N/A
• First received: October 8, 2015
• Last updated: August 16, 2016
• Start date: November 2015
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: St George's, University of London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemiplegia
• Shoulder Pain
• Stroke

Intervention

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.
• 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).

Locations

Country	Name	City	State
United Kingdom	St George's Hospital, Tooting	London	Greater London

Sponsors (1)

Lead Sponsor	Collaborator
St George's, University of London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

Blennerhassett JM, Gyngell K, Crean R. Reduced active control and passive range at the shoulder increase risk of shoulder pain during inpatient rehabilitation post-stroke: an observational study. J Physiother. 2010;56(3):195-9. — View Citation

Gamble GE, Barberan E, Laasch HU, Bowsher D, Tyrrell PJ, Jones AK. Poststroke shoulder pain: a prospective study of the association and risk factors in 152 patients from a consecutive cohort of 205 patients presenting with stroke. Eur J Pain. 2002;6(6):467-74. — View Citation

Lindgren I, Jönsson AC, Norrving B, Lindgren A. Shoulder pain after stroke: a prospective population-based study. Stroke. 2007 Feb;38(2):343-8. Epub 2006 Dec 21. — View Citation

Ratnasabapathy Y, Broad J, Baskett J, Pledger M, Marshall J, Bonita R. Shoulder pain in people with a stroke: a population-based study. Clin Rehabil. 2003 May;17(3):304-11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline severity of hemiplegic shoulder pain at 8-10 weeks	Questionnaire including visual analogue scales	within 72 hours and 8-10 weeks	No
Primary	Change from baseline Shoulder-Hand-Score at 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	No
Primary	Change from baseline NIH Stroke Score Upper limb (Motor Arm) at 8-10 weeks	Muscle Strength	within 72 hours and 8-10 weeks	No
Primary	Change from baseline presence/absence of pain on palpation at 8-10 weeks	Palpation of shoulder joint line and surrounding soft tissues	within 72 hours and 8-10 weeks	No
Primary	Change from baseline presence/absence of inferior glenohumeral subluxation at 8-10 weeks	Palpable gap in sub-acromial region with arm dependent	within 72 hours and 8-10 weeks	No