Observational Study of Hemiplegic Shoulder Pain After Recent Stroke

NCT ID: NCT02574000

Last Updated: 2016-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

163 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-07-31

Brief Summary

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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

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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.

Conditions

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Shoulder Pain Hemiplegia Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

ShoulderQ which is a shoulder pain questionnaire

Intervention Type OTHER

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

Clinical shoulder examination

Intervention Type 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).

Interventions

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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.

Intervention Type 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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St George's, University of London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martine Nadler, PhD

Role: PRINCIPAL_INVESTIGATOR

St George's, University of London

Locations

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St George's Hospital, Tooting

London, Greater London, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 20795926 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12413435 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17185637 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12735538 (View on PubMed)

Nadler M, Pauls M, Cluckie G, Moynihan B, Pereira AC. Shoulder pain after recent stroke (SPARS): hemiplegic shoulder pain incidence within 72hours post-stroke and 8-10 week follow-up (NCT 02574000). Physiotherapy. 2020 Jun;107:142-149. doi: 10.1016/j.physio.2019.08.003. Epub 2019 Aug 9.

Reference Type DERIVED
PMID: 32026814 (View on PubMed)

Other Identifiers

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15.0216

Identifier Type: -

Identifier Source: org_study_id

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