Observational Study of Hemiplegic Shoulder Pain After Recent Stroke

Overview

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?

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 2016

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.

Interventions

  • 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).

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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
  • 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
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • St George’s, University of London
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Martine Nadler, PhD, Principal Investigator, St George’s, University of London

References

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. doi: 10.1016/s1836-9553(10)70025-4.

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. doi: 10.1016/s1090-3801(02)00055-1.

Lindgren I, Jonsson AC, Norrving B, Lindgren A. Shoulder pain after stroke: a prospective population-based study. Stroke. 2007 Feb;38(2):343-8. doi: 10.1161/01.STR.0000254598.16739.4e. Epub 2006 Dec 21.

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. doi: 10.1191/0269215503cr612oa.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.