Observational Study of Hemiplegic Shoulder Pain After Recent Stroke

Completed

• Conditions: Stroke; Shoulder Pain; Hemiplegia
• Interventions: Other: ShoulderQ which is a shoulder pain questionnaire; Other: Clinical shoulder examination

• Registration Number: NCT02574000
• Lead Sponsor: St George's, University of London

Brief 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?

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 Timeline

• Study First Submitted: 2015-10-08
• Study First Submitted QC: 2015-10-09
• Study First Posted: 2015-10-12
• Study Start: 2015-11
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-16
• Last Update Posted: 2016-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single group baseline and follow-up	Clinical shoulder examination	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
Single group baseline and follow-up	ShoulderQ which is a shoulder pain questionnaire	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

Primary Outcome Measures

Name	Time	Method
Change from baseline NIH Stroke Score Upper limb (Motor Arm) at 8-10 weeks	within 72 hours and 8-10 weeks	Muscle Strength
Change from baseline Shoulder-Hand-Score at 8-10 weeks	within 72 hours and 8-10 weeks	Measurement of pain, oedema, passive range of shoulder abduction and passive range of shoulder external rotation
Change from baseline presence/absence of pain on palpation at 8-10 weeks	within 72 hours and 8-10 weeks	Palpation of shoulder joint line and surrounding soft tissues
Change from baseline presence/absence of inferior glenohumeral subluxation at 8-10 weeks	within 72 hours and 8-10 weeks	Palpable gap in sub-acromial region with arm dependent
Change from baseline severity of hemiplegic shoulder pain at 8-10 weeks	within 72 hours and 8-10 weeks	Questionnaire including visual analogue scales

Trial Locations

Locations (1)

St George's Hospital, Tooting; 🇬🇧 London, Greater London, United Kingdom