Shoulder PainSPARSNCT02574000
Observational Study of Hemiplegic Shoulder Pain After Recent Stroke
An observational study of Shoulder Pain and Hemiplegia, run by St George's, University of London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain, Hemiplegia, Stroke
- What is being tested?
- ShoulderQ which is a shoulder pain questionnaire and Clinical shoulder examination
- How many people
- 163 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2015to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults within 72 hours of stroke
Who may be able to join
- Clinical diagnosis of haemorrhagic or ischaemic stroke
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St George's Hospital, Tooting
London, Greater London, SW17 0QT
About this study
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.
This is an observational study to address the following questions.
- How many people develop stroke-shoulder pain within 3 days of stroke?
- How many people have stroke shoulder pain at 8-10 weeks after stroke?
- Does having stroke-shoulder pain within 3 days of stroke predict the likelihood of having stroke-shoulder pain at 8-10 weeks?
- What are the best bedside examination tests to identify stroke-shoulder pain?
Read the 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.
- Conditions
- Shoulder Pain, Hemiplegia, Stroke
- Being tested
- ShoulderQ which is a shoulder pain questionnaire, Clinical shoulder examination
- Medical subject headings
- Shoulder Pain, Hemiplegia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShoulderQ which is a shoulder pain questionnaireOther
Questions regarding shoulder pain at rest, during movement and at night with visual analogue scales. Factors affecting shoulder pain.
Clinical shoulder examinationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: ShoulderQ which is a shoulder pain questionnaire; Other: Clinical shoulder examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline severity of hemiplegic shoulder pain at 8-10 weeks
Questionnaire including visual analogue scales
Measured: 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
Measured: within 72 hours and 8-10 weeks
Change from baseline NIH Stroke Score Upper limb (Motor Arm) at 8-10 weeks
Muscle Strength
Measured: 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
Measured: 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
Measured: within 72 hours and 8-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martine Nadler, PhD, Principal investigator, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574000
- Sponsor's protocol ID
- 15.0216
- Acronym
- SPARS
- Status last verified
- Aug 2016
- First submitted
- 8 Oct 2015
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20795926Gamble 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.
PubMed 12413435Lindgren 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.
PubMed 17185637Ratnasabapathy 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.
PubMed 12735538Nadler 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.
PubMed 32026814
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02574000
- Acronym / sponsor ID
- SPARS / 15.0216
- Conditions
- Shoulder Pain, Hemiplegia, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 12 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study to address the following questions.
- How many people develop stroke-shoulder pain within 3 days of stroke?
- How many people have stroke shoulder pain at 8-10 weeks after stroke?
- Does having stroke-shoulder pain within 3 days of stroke predict the likelihood of having stroke-shoulder pain at 8-10 weeks?
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group baseline and follow-up | – | Other: ShoulderQ which is a shoulder pain questionnaire, Other: Clinical shoulder examinationSingle 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults within 72 hours of stroke
Key inclusion criteria (1 listed)
- Clinical diagnosis of haemorrhagic or ischaemic stroke
Key exclusion criteria (8 listed)
- Transient Ischaemic attack,
- Neurological symptoms due to causes other than acute stroke,
- Unconscious,
- Severe behavioural disturbance,
- Severe agitation,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ShoulderQ which is a shoulder pain questionnaireQuestions regarding shoulder pain at rest, during movement and at night with visual analogue scales. Factors affecting shoulder pain. | Other | Single group baseline and follow-up |
| Clinical shoulder examinationShoulder-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). | Other | Single group baseline and follow-up |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
- Background: PubMed 20795926Blennerhassett 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.
- Background: PubMed 12413435Gamble 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.
- Background: PubMed 17185637Lindgren 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.
- Background: PubMed 12735538Ratnasabapathy 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.
- Derived from this study: PubMed 32026814Nadler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine Nadler, PhD principal investigator
St George's, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Pain and Hemiplegia, run by St George's, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline severity of hemiplegic shoulder pain at 8-10 weeks (time frame: within 72 hours and 8-10 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02574000, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2016.