Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2025-12-28 @ 4:05 PM
Study NCT ID:
NCT03326466
Status:
UNKNOWN
Last Update Posted:
2019-02-21
First Post:
2017-10-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Muscle Function, Central Nervous System Sensitization, and Pain Profiling in Patients With Subacromial Pain (SAP-CNSS).
Sponsor:
Hvidovre University Hospital
Organization:
Study Overview
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.
Status:
UNKNOWN
Status Verified Date:
2019-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: