Subacromial Impingement SyndromeNCT03326466
Muscle Function, Central Nervous System Sensitization, and Pain Profiling in Patients With Subacromial Pain (SAP-CNSS).
An observational study of Subacromial Impingement Syndrome and Central Nervous System Sensitization, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
In this case-control study, the investigators compare shoulder muscle function, pain, and central nervous system sensitization in patients with Subacromial Pain (SAP) to that in healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Subacromial Impingement Syndrome, Central Nervous System Sensitization
- How many people
- 72 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Nov 2017to 31 Jul 2020
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subacromial Pain.
Who may be able to join
- Have had SAP during the last two weeks or more.
- Have positive results from minimum 3 out of 5 clinical tests.
- Have experienced pain ranking 4 or above on the VRS scale within the last 7 days.
- Are able to speak and understand Danish.
- Have given informed consent to participate in the study after they have fully understood the content of the study.
Who cannot join
- Have acquired traumatic shoulder injury, and this is onset/cause for current shoulder pain, e.g. fall on shoulder.
- Have received a corticosteroid injection within the last six weeks.
- Report having had a shoulder fracture within 6 months.
- Report having had surgery on the affected shoulder.
- Report having radiologically verified glenohumeral osteoarthritis.
- Have a luxation or sub-luxation of the glenohumeral or the acromioclavicular joint, clinically suspected labrum lesion, clinically suspected complete traumatic tear of the rotator cuff, frozen shoulder, suspected competing diagnoses (i.e. rheumatoid arthritis, cancer, neurological disorders, and fibromyalgia).
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- Have a history of diagnosed major psychiatric disorder.
- Have a history of illicit drug use; be currently abusing alcohol or currently withdrawing from alcohol abuse.
- Have a history of heart disease.
- Are pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Subacromial Shoulder Pain and Central Nervous System Sensitization Trial (SAP-CNSS):Central Nervous System Sensitization, Muscle Function, and Pain Profiling in Patients With Subacromial Pain and in Healthy Controls.
In this case-control study, the investigators compare shoulder muscle function, pain, and central nervous system sensitization in patients with Subacromial Pain (SAP) to that in healthy controls. The investigators also examine if a relationship exists between shoulder symptom duration and central sensitization, shoulder muscle function and shoulder pain distribution in patients with SAP.
Read the detailed description
Subacromial pain (SAP), also referred to as subacromial impingement syndrome, is characterized by pain in the shoulder joint, which is aggravated by elevation of the arm and / or during overhead activities. Subacromial pain has been suggested to be an "end station" to numerous pathologies of the shoulder and can be considered to include a variety of symptoms, and not to be seen only as a single diagnosis. In Denmark, SAP is frequently reported as a cause of pain in the shoulder joint, and based on studies from Sweden and the Netherlands, is estimated to cost the Danish society around 1.35 billion. DKK annually.
The primary aim of this study is to compare central nervous system sensitization (central sensitization), shoulder muscle function and shoulder pain distribution in patients with subacromial pain to that in pain free healthy matched controls.
The secondary aim of this study is to investigate if (symptom) dose/response relationships exist between shoulder symptom duration and: central sensitization, shoulder muscle function and shoulder pain distribution in patients with subacromial pain.
Although the present study is exploratory, it is the working hypothesis that i) patients with subacromial pain have increased central sensitization, reduced shoulder muscle function, and increased pain distribution when compared to healthy controls, and ii) symptom dose/response relationships exist, indicated by increased central sensitization, reduced shoulder muscle function, and increased pain distribution with longer symptom duration in patients with subacromial pain.
The methodology includes: surface EMG recordings to quantify shoulder muscle activity; dynamometry to quantify maximal voluntary contraction force and submaximal isometric force steadiness; mechanical and computer-controlled algometry to quantify CNS sensitization; computerized pain drawings to quantify pain distribution; and patient-reported assessments of shoulder pain (SPADI) and catastrophizing (PCS).
The study does not include any intervention.
The present study is considered exploratory and the first in a line of studies using these outcome measures in this patient population. All outcomes listed below are valued equally, as the study is exploratory. All analyses will be used to indicate effect sizes in order to plan for subsequent follow-up studies.
Although the study is considered exploratory, the statistical approach includes the pre-defined primary and secondary analyses outlined below.
Primary analysis: The primary analysis will compare 36 included patients to 36 matched healthy controls regarding the 3 main outcomes: shoulder muscle function, CNS sensitization and shoulder pain distribution.
Secondary analysis: The secondary analysis will compare the three subgroups of patients differing in their symptom duration (0.5-3 months of pain, 3-6 months of pain and +6 months of pain), regarding the 3 main outcomes: CNS sensitization, shoulder muscle function, and shoulder pain distribution, to indicate (symptom) dose/response relationships, using descriptive statistics. The symptom duration groups may be redefined, if recruitment is slow for one or more of the groups outlined above.
Collaborators:
Thomas Bandholm, PT, Professor, PhD. PMR-C.
Kristian Thorborg, PT, Associate Professor, PhD. Department of Clinical Medicine, University of Copenhagen, Amager/Hvidovre Hospital.
Thomas Graven-Nielsen, Professor, Director. CNAP.
Michael Skovdal Rathleff, PT, PhD. Department of Health Science and Technology Aalborg University.
Shellie Boudreau, Associate Professor. Department of Health Science and Technology Aalborg University.
Louisa Wilquin, PT. School of Physiotherapy, Metropolitan University College Copenhagen.
Mikkel Bek Clausen, PT, PhD-fellow. Department of Clinical Medicine, University of Copenhagen, Amager/Hvidovre Hospital.
Markus Due Jacobsen, PhD. National Research Center for the Working Environment.
Lars Andersen, Professor, PhD. National Research Center for the Working Environment.
- Keywords
- Subacromial Impingement Syndrome, Central Nervous System Sensitization, Muscle Function, EMG, Force Steadiness, CUFF Algometry, Manual Algometry, Pain, Maximal Voluntary Isometric Contraction
- Medical subject headings
- Shoulder Impingement Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with SAP | Not described | |
| Healthy Controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Voluntary Strength.
Unit of Measure: Nm/Kg.
Measured: Baseline assessment, no follow-up (cross-sectional study).
Submaximal Voluntary Force Steadiness
Unit of Measure: Nm/Kg.
Measured: Baseline assessment, no follow-up (cross-sectional study).
Maximal EMG
Unit of Measure: mV/s. Will be recorded during the measurement of Maximal Voluntary Strength.
Measured: Baseline assessment, no follow-up (cross-sectional study).
Submaximal EMG.
Unit of Measure: mV/s. Will be recorded during the Measurement of Force Steadiness.
Measured: Baseline assessment, no follow-up (cross-sectional study).
Central Nervous System Sensitization - Manual Algometry.
Unit of Measure: kPa/s
Measured: Baseline assessment, no follow-up (cross-sectional study).
Central Nervous System Sensitization - Cuff Algometry.
Unit of Measure: kPa/s.
Measured: Baseline assessment, no follow-up (cross-sectional study).
Patient Reported Outcome - Pain Mapping.
Subject will draw their pain as accurately as possible on a high resolution 3D body schema.
Area of Pain is quantified as total number of pixels, and will be expressed as percentage of body area.
Measured: Baseline assessment, no follow-up (cross-sectional study).
Patient Reported Outcome - Shoulder Pain And Disability Index (SPADI).
Questionnaire contains 13 items with a possible score from 0-100 (0=no disability).
Measured: Baseline assessment, no follow-up (cross-sectional study).
Patient Reported Outcome - Pain Catastrophizing Scale (PCS).
Questionnaire contains 13 items with a possible score 0-52. Higher score indicates higher level of pain catastrophizing.
Measured: Baseline assessment, no follow-up (cross-sectional study).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start13 Nov 2017
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial Impingement SyndromeStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Physical Medicine and Rehabilitation Research - Copenhagen (PMR-C)., Metropolitan University College, Center for Neuroplasticity and Pain (CNAP)., National Research Center for the Working Environment.
- Responsible party
- Principal investigator, Bjarki Haraldsson, Hvidovre University Hospital
- Investigators
- Thomas Bandholm, PhD, Study chair, Professor, Head of Research, PMR-C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326466
- Sponsor's protocol ID
- SAP-CNSS
- Status last verified
- Feb 2019
- First submitted
- 12 Oct 2017
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We intend to make the data set - containing de-identified individual-patient data - publically available no later than 6 months after publication, consistent with the recent proposal from the International Committee of Medical Journal Editors (ICMJE), if it complies with national regulations, e.g. the Danish Data Protection Agency.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Subacromial Shoulder Pain and Central Nervous System Sensitization Trial (SAP-CNSS):Central Nervous System Sensitization, Muscle Function, and Pain Profiling in Patients With Subacromial Pain and in Healthy Controls.
- ClinicalTrials.gov ID
- NCT03326466
- Acronym / sponsor ID
- SAP-CNSS
- Keywords
- Subacromial Impingement Syndrome, Central Nervous System Sensitization, Muscle Function, EMG, Force Steadiness, CUFF Algometry, Manual Algometry, Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Physical Medicine and Rehabilitation Research - Copenhagen (PMR-C)., Metropolitan University College, Center for Neuroplasticity and Pain (CNAP)., National Research Center for the Working Environment.
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 31 Oct 2017 (actual)
- 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.
In this case-control study, the investigators compare shoulder muscle function, pain, and central nervous system sensitization in patients with Subacromial Pain (SAP) to that in healthy controls. The investigators also examine if a relationship exists between shoulder symptom duration and central sensitization, shoulder muscle function and shoulder pain distribution in patients with SAP.
Detailed description
Subacromial pain (SAP), also referred to as subacromial impingement syndrome, is characterized by pain in the shoulder joint, which is aggravated by elevation of the arm and / or during overhead activities. Subacromial pain has been suggested to be an "end station" to numerous pathologies of the shoulder and can be considered to include a variety of symptoms, and not to be seen only as a single diagnosis. In Denmark, SAP is frequently reported as a cause of pain in the shoulder joint, and based on studies from Sweden and the Netherlands, is estimated to cost the Danish society around 1.35 billion. DKK annually.
The primary aim of this study is to compare central nervous system sensitization (central sensitization), shoulder muscle function and shoulder pain distribution in patients with subacromial pain to that in pain free healthy matched controls.
The secondary aim of this study is to investigate if (symptom) dose/response relationships exist between shoulder symptom duration and: central sensitization, shoulder muscle function and shoulder pain distribution in patients with subacromial pain.
Although the present study is exploratory, it is the working hypothesis that i) patients with subacromial pain have increased central sensitization, reduced shoulder muscle function, and increased pain distribution when compared to healthy controls, and ii) symptom dose/response relationships exist, indicated by increased central sensitization, reduced shoulder muscle function, and increased pain distribution with longer symptom duration in patients with subacromial pain.
The methodology includes: surface EMG recordings to quantify shoulder muscle activity; dynamometry to quantify maximal voluntary contraction force and submaximal isometric force steadiness; mechanical and computer-controlled algometry to quantify CNS sensitization; computerized pain drawings to quantify pain distribution; and patient-reported assessments of shoulder pain (SPADI) and catastrophizing (PCS).
The study does not include any intervention.
The present study is considered exploratory and the first in a line of studies using these outcome measures in this patient population. All outcomes listed below are valued equally, as the study is exploratory. All analyses will be used to indicate effect sizes in order to plan for subsequent follow-up studies.
Although the study is considered exploratory, the statistical approach includes the pre-defined primary and secondary analyses outlined below.
Primary analysis: The primary analysis will compare 36 included patients to 36 matched healthy controls regarding the 3 main outcomes: shoulder muscle function, CNS sensitization and shoulder pain distribution.
Secondary analysis: The secondary analysis will compare the three subgroups of patients differing in their symptom duration (0.5-3 months of pain, 3-6 months of pain and +6 months of pain), regarding the 3 main outcomes: CNS sensitization, shoulder muscle function, and shoulder pain distribution, to indicate (symptom) dose/response relationships, using descriptive statistics. The symptom duration groups may be redefined, if recruitment is slow for one or more of the groups outlined above.
Collaborators:
Thomas Bandholm, PT, Professor, PhD. PMR-C.
Kristian Thorborg, PT, Associate Professor, PhD. Department of Clinical Medicine, University of Copenhagen, Amager/Hvidovre Hospital.
Thomas Graven-Nielsen, Professor, Director. CNAP.
Michael Skovdal Rathleff, PT, PhD. Department of Health Science and Technology Aalborg University.
Shellie Boudreau, Associate Professor. Department of Health Science and Technology Aalborg University.
Louisa Wilquin, PT. School of Physiotherapy, Metropolitan University College Copenhagen.
Mikkel Bek Clausen, PT, PhD-fellow. Department of Clinical Medicine, University of Copenhagen, Amager/Hvidovre Hospital.
Markus Due Jacobsen, PhD. National Research Center for the Working Environment.
Lars Andersen, Professor, PhD. National Research Center for the Working Environment.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with SAP | – | – |
| Healthy Controls | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subacromial Pain.
Key inclusion criteria (5 listed)
- Have had SAP during the last two weeks or more.
- Have positive results from minimum 3 out of 5 clinical tests.
- Have experienced pain ranking 4 or above on the VRS scale within the last 7 days.
- Are able to speak and understand Danish.
- Have given informed consent to participate in the study after they have fully understood the content of the study.
Key exclusion criteria (10 listed)
- Have acquired traumatic shoulder injury, and this is onset/cause for current shoulder pain, e.g. fall on shoulder.
- Have received a corticosteroid injection within the last six weeks.
- Report having had a shoulder fracture within 6 months.
- Report having had surgery on the affected shoulder.
- Report having radiologically verified glenohumeral osteoarthritis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maximal Voluntary Strength.
Time frame: Baseline assessment, no follow-up (cross-sectional study).
Unit of Measure: Nm/Kg.
Submaximal Voluntary Force Steadiness
Time frame: Baseline assessment, no follow-up (cross-sectional study).
Unit of Measure: Nm/Kg.
Maximal EMG
Time frame: Baseline assessment, no follow-up (cross-sectional study).
Unit of Measure: mV/s. Will be recorded during the measurement of Maximal Voluntary Strength.
Submaximal EMG.
Time frame: Baseline assessment, no follow-up (cross-sectional study).
Unit of Measure: mV/s. Will be recorded during the Measurement of Force Steadiness.
Central Nervous System Sensitization - Manual Algometry.
Time frame: Baseline assessment, no follow-up (cross-sectional study).
Unit of Measure: kPa/s
Central Nervous System Sensitization - Cuff Algometry.
Time frame: Baseline assessment, no follow-up (cross-sectional study).
Unit of Measure: kPa/s.
Patient Reported Outcome - Pain Mapping.
Time frame: Baseline assessment, no follow-up (cross-sectional study).
Subject will draw their pain as accurately as possible on a high resolution 3D body schema. Area of Pain is quantified as total number of pixels, and will be expressed as percentage of body area.
Patient Reported Outcome - Shoulder Pain And Disability Index (SPADI).
Time frame: Baseline assessment, no follow-up (cross-sectional study).
Questionnaire contains 13 items with a possible score from 0-100 (0=no disability).
Patient Reported Outcome - Pain Catastrophizing Scale (PCS).
Time frame: Baseline assessment, no follow-up (cross-sectional study).
Questionnaire contains 13 items with a possible score 0-52. Higher score indicates higher level of pain catastrophizing.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Individual participant dataSharing planned: Yes. We intend to make the data set - containing de-identified individual-patient data - publically available no later than 6 months after publication, consistent with the recent proposal from the International Committee of Medical Journal Editors (ICMJE), if it complies with national regulations, e.g. the Danish Data Protection Agency.
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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.
Thomas Bandholm, PhD study chair
Professor, Head of Research, PMR-C.
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 Subacromial Impingement Syndrome and Central Nervous System Sensitization, run by Hvidovre University Hospital at 1 site in Denmark.
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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 21 Feb 2019. 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 Denmark. 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?
Results are not available in the source record.
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?
Maximal Voluntary Strength. (time frame: Baseline assessment, no follow-up (cross-sectional study).). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2019.