Observational Study of Hemiplegic Shoulder Pain After Recent Stroke

NCT02574000 | Completed

• 1 other identifier: 15.0216
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational study to address the following questions.

1. 1.How many people develop stroke-shoulder pain within 3 days of stroke?
2. 2.How many people have stroke shoulder pain at 8-10 weeks after stroke?
3. 3.Does having stroke-shoulder pain within 3 days of stroke predict the likelihood of having stroke-shoulder pain at 8-10 weeks?
4. 4.What are the best bedside examination tests to identify stroke-shoulder pain?

Conditions

Shoulder Pain; Hemiplegia; Stroke

Outcome Measures

Primary Outcomes (5)

• Change from baseline severity of hemiplegic shoulder pain at 8-10 weeks

  Questionnaire including visual analogue scales

  within 72 hours and 8-10 weeks

• 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

• Change from baseline NIH Stroke Score Upper limb (Motor Arm) at 8-10 weeks

  Muscle Strength

  within 72 hours and 8-10 weeks

• 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

• 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

Study Arms (1)

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

Other: ShoulderQ which is a shoulder pain questionnaire; Other: Clinical shoulder examination

Interventions

ShoulderQ which is a shoulder pain questionnaire OTHER

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

Single group baseline and follow-up

Clinical shoulder examination 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).

Single group baseline and follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults within 72 hours of stroke

You may qualify if:

• \- Clinical diagnosis of haemorrhagic or ischaemic stroke

You may not qualify if:

• 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

Sponsors & Collaborators

• St George's, University of London: lead

Study Sites (1)

St George's Hospital, Tooting

London, Greater London, SW17 0QT, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 20795926 BACKGROUND

• 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.

  PMID: 12413435 BACKGROUND

• 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.

  PMID: 17185637 BACKGROUND

• 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.

  PMID: 12735538 BACKGROUND

• 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.

  PMID: 32026814 DERIVED

MeSH Terms

Conditions

Shoulder Pain; Hemiplegia; Stroke

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Martine Nadler, PhD

  St George's, University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: October 12, 2015
• Study Start: November 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 17, 2016

Record last verified: 2016-08

Locations

GB (1)