Clinical trial NCT02574000: Observational Study of Hemiplegic Shoulder Pain After Recent Stroke
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Pain
Hemiplegia
Stroke
Lead sponsor: St George's, University of London
Sponsor class: OTHER
First posted: 2015-10-12
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults within 72 hours of stroke

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline severity of hemiplegic shoulder pain at 8-10 weeks
timeFrame: within 72 hours and 8-10 weeks
measure: Change from baseline Shoulder-Hand-Score at 8-10 weeks
timeFrame: within 72 hours and 8-10 weeks
measure: Change from baseline NIH Stroke Score Upper limb (Motor Arm) at 8-10 weeks
timeFrame: within 72 hours and 8-10 weeks
measure: Change from baseline presence/absence of pain on palpation at 8-10 weeks
timeFrame: within 72 hours and 8-10 weeks
measure: Change from baseline presence/absence of inferior glenohumeral subluxation at 8-10 weeks
timeFrame: within 72 hours and 8-10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St George's Hospital, Tooting
state: Greater London
Study officials:
affiliation: St George's, University of London
name: Martine Nadler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1016/s1090-3801(02)00055-1.
citation: 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.
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. doi: 10.1191/0269215503cr612oa.
citation: 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.