Chronic Shoulder PainNCT03838471
Cognitive Behavioral Factors and Central Sensitization in Chronic Shoulder Pain
An observational study of Chronic Shoulder Pain, run by Technological Education Institute of Sterea Ellada at 1 site in Greece.
Trial summary
The objective of this study is to examine the relationship between symptoms of central sensitization (CS) and important cognitive behavioral and psychosocial factors in patients with chronic shoulder pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Shoulder Pain
- How many people
- 64 participants
- Where
- 1 siteGreece
- Study dates
- 1 Dec 2018to 25 Mar 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 64 participants suffering from chronic unilateral shoulder pain will be recruited from an orthopedic clinic and a chronic pain clinic. Chronic pain will be defined as pain lasting for 3 or more months. Pain intensity will be at least 3 on a 0-10 numerical pain rating scale on most days of the last 3 months. Shoulder pain conditions will include non-specific shoulder pain, subacromial pain sydrome, rotator cuff tendinopathy, instabillity without trauma, SLAP lession, adhesive capsulitis, acromioclavicular pathology and/or shoulder osteoarthritis. Diagnosis will be carried out by a clinician and the criteria will be controlled in a short interview.
Who may be able to join
- (1)chronic unilateral shoulder pain (Chronic pain will be defined as pain lasting for 3 or more months. Also, pain intensity will be at least 3 on a 0-10 numerical pain rating scale on most days of the last 3 months).
Who cannot join
- recent shoulder dislocation (1 year prior) and/or systemic diseases such as rheumatoid arthritis, fibromyalgia and/or polymyalgia rheumatic
- shoulder pain considered to be originated from the cervical region, and other traumas,
- neurological dysfunction (ie, multiple sclerosis or stroke), osteoporosis, haemophilia and/or cancer
- shoulder surgery
- participants with shoulder pain after post fracture
- Being pregnant or given birth in the preceding year
Show all 10Show fewer
- Overconsumption of alcohol or any other recreational drug2
- Cognitive impairment
- inability to provide informed consent and/or complete written questionnaires
- If participants use medication with a known influence on the central nervous system (eg, anti-epileptic and antidepressant, analgesics, and/or NSAID's), it should be stable in medication intake for at least 1 month prior to his/her participation to be included in this study (Kuppers et al. 2017). Patients are required to continue usual care at least 6 weeks prior to study participation to obtain a steady state.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Symptoms of Central Sensitization and Cognitive Behavioral Factors in People With Chronic Shoulder Pain
The objective of this study is to examine the relationship between symptoms of central sensitization (CS) and important cognitive behavioral and psychosocial factors in patients with chronic shoulder pain.
Read the detailed description
Participants, both male and female, with chronic shoulder pain for at least 3 months will be included in the study. They will complete several questionnaires and a functional test. Spearman's correlation will be used to analyze associations between symptoms of CS and pain behavior, functioning, pain, pain catastrophizing, kinesiophobia, and illness perceptions.
Additionally, a between-group analysis will be performed to compare patients with and without clinically relevant symptoms of CS.
- Conditions
- Chronic Shoulder Pain
- Keywords
- CSI, kinesiophobia, Central Nervous System Sensitization, Catastrophizing, Illness Behavior
- Medical subject headings
- Kinesiophobia, Illness Behavior
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 |
|---|---|---|
| Central sensitization symptoms | This group will contain persons with a clinically relevant degree of symptoms of CS (CSI score ≥40). | |
| No Central sensitization symptoms | This group will contain persons with a lower degree of symptoms of CS (CSI score < 40). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central sensitization inventory (CSI)
The CSI contains a "part A" of 25 statements related to current health symptoms, indicative of central sensitisation (scored on a 5-point Likert scale ranging from 0-4). A mean score of 40 is the cut off value for central sensitization (Neblett et al 2013). The CSI has proven psychometric strength (Mayer et al 2012; Neblett et al. 2018).
Measured: 10 min
Oxford Shoulder Score (OSS)
The Oxford Shoulder Score (OSS) is a 12-item patient-reported outcomespecifically designed and developed for assessing the impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems. Substantial evidence from clinical studies shows that the PRO has high internal consistency and is a valid and reliable measure of patient well-being. The intraclass correlation has been calculated as 0.83 (Ekeberg,2008 ). In this study, • Self-report functional will be assessed with the Oxford Shoulder Score.
Measured: 10 min
Tampa Scale for Kinesiophobia
To measure kinesiophobia, the Tampa Scale for Kinesiophobia was used. Patients have to score 17 opinions on a 4-point Likert scale (1 = highly disagree, 4 = highly agree). Scores ≥37/68 indicate kinesiophobia. This questionnaire has good internal consistency and test-retest reliability.
Measured: 10 min
Hospital Anxiety and Depression Scale (HADS)
Hospital Anxiety and Depression Scale (HADS) is commonly used to determine the levels of anxiety and depression. The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. A number of researchers have explored HADS data to establish the cut-off points for caseness of anxiety or depression. Bjelland et al (2002)[2] through a literature review of a large number of studies identified a cut-off point of 8/21 for anxiety or depression. For anxiety (HADS-A) this gave a specificity of 0.78 and a sensitivity of 0.9. For depression (HADS-D) this gave a specificity of 0.79 and a sensitivity of 0.83.
Measured: 10 min
Pain Catastrophizing Scale
To measure the extent of pain catastrophizing, we will be used the Pain Catastrophizing Scale, which consists of 13 items exploring pain-related cognition, which the patient has to score on a 5-point Likert scale (0 = not at all, 4 = all the time). Scores ≥30/52 reveal a clinically relevant degree of catastrophizing. This questionnaire is found to have good internal consistency and test-retest reliability, as well as proven construct and criterion validity.
Measured: 10 min
Brief Illness Perception Questionnaire
Patients' illness perceptions will be measured based on the Brief Illness Perception Questionnaire. The patient has to rate 8 statements on a 10-point scale (1-10). The higher the score, the greater is the extent to which the patient's illness perceptions are threatening him or her.
Measured: 3 min
Arm Endurance Test
Pain behavior will be assessed using the arm Endurance Test. This test measured the time the patient could hold both arms horizontally out to the side describing small circles. The tester continued timing while the fingers remained above a line level with the elbow when the arm was dependent (Hardind et al. 1994).
Measured: 5 min
Numeric Pain Rating Scale
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. The most commonly used is the 11-item NPRS. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").The NPRS is a valid and reliable scale to measure pain intensity. In this study, will rate current pain intensity and mean pain intensity durind the past 7 days.
Measured: 1 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start1 Dec 2018
- Primary completion18 Feb 2019
- Study completion25 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technological Education Institute of Sterea Ellada
- Sponsor type
- University, hospital or other
- Collaborators
- KAT General Hospital, Vrije Universiteit Brussel
- Responsible party
- Principal investigator, Eleni Kapreli, Technological Education Institute of Sterea Ellada
- Investigators
- Eleni V Kapreli, MSc, PhD, Study chair, Technological Educational Institute of Sterea ElladaParaskevi Bilika, BSc, Principal investigator, Technological Educational Institute of Sterea Ellada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838471
- Sponsor's protocol ID
- PHYSMSC2
- Status last verified
- Sep 2019
- First submitted
- 10 Feb 2019
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huysmans E, Ickmans K, Van Dyck D, Nijs J, Gidron Y, Roussel N, Polli A, Moens M, Goudman L, De Kooning M. Association Between Symptoms of Central Sensitization and Cognitive Behavioral Factors in People With Chronic Nonspecific Low Back Pain: A Cross-sectional Study. J Manipulative Physiol Ther. 2018 Feb;41(2):92-101. doi: 10.1016/j.jmpt.2017.08.007. Epub 2018 Jan 10.
PubMed 29329739Cuesta-Vargas AI, Neblett R, Chiarotto A, Kregel J, Nijs J, van Wilgen CP, Pitance L, Knezevic A, Gatchel RJ, Mayer TG, Viti C, Roldan-Jimenez C, Testa M, Caumo W, Jeremic-Knezevic M, Luciano JV. Dimensionality and Reliability of the Central Sensitization Inventory in a Pooled Multicountry Sample. J Pain. 2018 Mar;19(3):317-329. doi: 10.1016/j.jpain.2017.11.006. Epub 2017 Dec 2.
PubMed 29198933Mayer TG, Neblett R, Cohen H, Howard KJ, Choi YH, Williams MJ, Perez Y, Gatchel RJ. The development and psychometric validation of the central sensitization inventory. Pain Pract. 2012 Apr;12(4):276-85. doi: 10.1111/j.1533-2500.2011.00493.x. Epub 2011 Sep 27.
PubMed 21951710Adams LM, Turk DC. Psychosocial factors and central sensitivity syndromes. Curr Rheumatol Rev. 2015;11(2):96-108. doi: 10.2174/1573397111666150619095330.
PubMed 26088211Neblett R, Cohen H, Choi Y, Hartzell MM, Williams M, Mayer TG, Gatchel RJ. The Central Sensitization Inventory (CSI): establishing clinically significant values for identifying central sensitivity syndromes in an outpatient chronic pain sample. J Pain. 2013 May;14(5):438-45. doi: 10.1016/j.jpain.2012.11.012. Epub 2013 Mar 13.
PubMed 23490634Coronado RA, George SZ. The Central Sensitization Inventory and Pain Sensitivity Questionnaire: An exploration of construct validity and associations with widespread pain sensitivity among individuals with shoulder pain. Musculoskelet Sci Pract. 2018 Aug;36:61-67. doi: 10.1016/j.msksp.2018.04.009. Epub 2018 May 3.
PubMed 29751194
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Symptoms of Central Sensitization and Cognitive Behavioral Factors in People With Chronic Shoulder Pain
- ClinicalTrials.gov ID
- NCT03838471
- Acronym / sponsor ID
- PHYSMSC2
- Conditions
- Chronic Shoulder Pain
- Keywords
- CSI, kinesiophobia, Central Nervous System Sensitization, Catastrophizing, Illness Behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Technological Education Institute of Sterea ElladaUniversity, hospital or other
- Collaborators
- KAT General Hospital, Vrije Universiteit Brussel
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 18 Feb 2019 (actual)
- Study completion
- 25 Mar 2019 (actual)
- First posted
- 12 Feb 2019 (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.
The objective of this study is to examine the relationship between symptoms of central sensitization (CS) and important cognitive behavioral and psychosocial factors in patients with chronic shoulder pain.
Detailed description
Participants, both male and female, with chronic shoulder pain for at least 3 months will be included in the study. They will complete several questionnaires and a functional test. Spearman's correlation will be used to analyze associations between symptoms of CS and pain behavior, functioning, pain, pain catastrophizing, kinesiophobia, and illness perceptions.
Additionally, a between-group analysis will be performed to compare patients with and without clinically relevant symptoms of CS.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Central sensitization symptoms | – | –This group will contain persons with a clinically relevant degree of symptoms of CS (CSI score ≥40). |
| No Central sensitization symptoms | – | –This group will contain persons with a lower degree of symptoms of CS (CSI score < 40). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 64 participants suffering from chronic unilateral shoulder pain will be recruited from an orthopedic clinic and a chronic pain clinic. Chronic pain will be defined as pain lasting for 3 or more months. Pain intensity will be at least 3 on a 0-10 numerical pain rating scale on most days of the last 3 months. Shoulder pain conditions will include non-specific shoulder pain, subacromial pain sydrome, rotator cuff tendinopathy, instabillity without trauma, SLAP lession, adhesive capsulitis, acromioclavicular pathology and/or shoulder osteoarthritis. Diagnosis will be carried out by a clinician and the criteria will be controlled in a short interview.
Key inclusion criteria (1 listed)
- (1)chronic unilateral shoulder pain (Chronic pain will be defined as pain lasting for 3 or more months. Also, pain intensity will be at least 3 on a 0-10 numerical pain rating scale on most days of the last 3 months).
Key exclusion criteria (10 listed)
- recent shoulder dislocation (1 year prior) and/or systemic diseases such as rheumatoid arthritis, fibromyalgia and/or polymyalgia rheumatic
- shoulder pain considered to be originated from the cervical region, and other traumas,
- neurological dysfunction (ie, multiple sclerosis or stroke), osteoporosis, haemophilia and/or cancer
- shoulder surgery
- participants with shoulder pain after post fracture
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
Central sensitization inventory (CSI)
Time frame: 10 min
The CSI contains a "part A" of 25 statements related to current health symptoms, indicative of central sensitisation (scored on a 5-point Likert scale ranging from 0-4). A mean score of 40 is the cut off value for central sensitization (Neblett et al 2013). The CSI has proven psychometric strength (Mayer et al 2012; Neblett et al. 2018).
Oxford Shoulder Score (OSS)
Time frame: 10 min
The Oxford Shoulder Score (OSS) is a 12-item patient-reported outcomespecifically designed and developed for assessing the impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems. Substantial evidence from clinical studies shows that the PRO has high internal consistency and is a valid and reliable measure of patient well-being. The intraclass correlation has been calculated as 0.83 (Ekeberg,2008 ). In this study, • Self-report functional will be assessed with the Oxford Shoulder Score.
Tampa Scale for Kinesiophobia
Time frame: 10 min
To measure kinesiophobia, the Tampa Scale for Kinesiophobia was used. Patients have to score 17 opinions on a 4-point Likert scale (1 = highly disagree, 4 = highly agree). Scores ≥37/68 indicate kinesiophobia. This questionnaire has good internal consistency and test-retest reliability.
Hospital Anxiety and Depression Scale (HADS)
Time frame: 10 min
Hospital Anxiety and Depression Scale (HADS) is commonly used to determine the levels of anxiety and depression. The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. A number of researchers have explored HADS data to establish the cut-off points for caseness of anxiety or depression. Bjelland et al (2002)[2] through a literature review of a large number of studies identified a cut-off point of 8/21 for anxiety or depression. For anxiety (HADS-A) this gave a specificity of 0.78 and a sensitivity of 0.9. For depression (HADS-D) this gave a specificity of 0.79 and a sensitivity of 0.83.
Pain Catastrophizing Scale
Time frame: 10 min
To measure the extent of pain catastrophizing, we will be used the Pain Catastrophizing Scale, which consists of 13 items exploring pain-related cognition, which the patient has to score on a 5-point Likert scale (0 = not at all, 4 = all the time). Scores ≥30/52 reveal a clinically relevant degree of catastrophizing. This questionnaire is found to have good internal consistency and test-retest reliability, as well as proven construct and criterion validity.
Brief Illness Perception Questionnaire
Time frame: 3 min
Patients' illness perceptions will be measured based on the Brief Illness Perception Questionnaire. The patient has to rate 8 statements on a 10-point scale (1-10). The higher the score, the greater is the extent to which the patient's illness perceptions are threatening him or her.
Arm Endurance Test
Time frame: 5 min
Pain behavior will be assessed using the arm Endurance Test. This test measured the time the patient could hold both arms horizontally out to the side describing small circles. The tester continued timing while the fingers remained above a line level with the elbow when the arm was dependent (Hardind et al. 1994).
Numeric Pain Rating Scale
Time frame: 1 min
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. The most commonly used is the 11-item NPRS. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").The NPRS is a valid and reliable scale to measure pain intensity. In this study, will rate current pain intensity and mean pain intensity durind the past 7 days.
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 Sep 2019.
- Background: PubMed 29329739Huysmans E, Ickmans K, Van Dyck D, Nijs J, Gidron Y, Roussel N, Polli A, Moens M, Goudman L, De Kooning M. Association Between Symptoms of Central Sensitization and Cognitive Behavioral Factors in People With Chronic Nonspecific Low Back Pain: A Cross-sectional Study. J Manipulative Physiol Ther. 2018 Feb;41(2):92-101. doi: 10.1016/j.jmpt.2017.08.007. Epub 2018 Jan 10.
- Background: PubMed 29198933Cuesta-Vargas AI, Neblett R, Chiarotto A, Kregel J, Nijs J, van Wilgen CP, Pitance L, Knezevic A, Gatchel RJ, Mayer TG, Viti C, Roldan-Jimenez C, Testa M, Caumo W, Jeremic-Knezevic M, Luciano JV. Dimensionality and Reliability of the Central Sensitization Inventory in a Pooled Multicountry Sample. J Pain. 2018 Mar;19(3):317-329. doi: 10.1016/j.jpain.2017.11.006. Epub 2017 Dec 2.
- Background: PubMed 21951710Mayer TG, Neblett R, Cohen H, Howard KJ, Choi YH, Williams MJ, Perez Y, Gatchel RJ. The development and psychometric validation of the central sensitization inventory. Pain Pract. 2012 Apr;12(4):276-85. doi: 10.1111/j.1533-2500.2011.00493.x. Epub 2011 Sep 27.
- Background: PubMed 26088211Adams LM, Turk DC. Psychosocial factors and central sensitivity syndromes. Curr Rheumatol Rev. 2015;11(2):96-108. doi: 10.2174/1573397111666150619095330.
- Background: PubMed 23490634Neblett R, Cohen H, Choi Y, Hartzell MM, Williams M, Mayer TG, Gatchel RJ. The Central Sensitization Inventory (CSI): establishing clinically significant values for identifying central sensitivity syndromes in an outpatient chronic pain sample. J Pain. 2013 May;14(5):438-45. doi: 10.1016/j.jpain.2012.11.012. Epub 2013 Mar 13.
- Background: PubMed 29751194Coronado RA, George SZ. The Central Sensitization Inventory and Pain Sensitivity Questionnaire: An exploration of construct validity and associations with widespread pain sensitivity among individuals with shoulder pain. Musculoskelet Sci Pract. 2018 Aug;36:61-67. doi: 10.1016/j.msksp.2018.04.009. Epub 2018 May 3.
- Individual participant dataSharing planned: No
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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.
Eleni V Kapreli, MSc, PhD study chair
Technological Educational Institute of Sterea Ellada
Paraskevi Bilika, BSc principal investigator
Technological Educational Institute of Sterea Ellada
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 Chronic Shoulder Pain, run by Technological Education Institute of Sterea Ellada at 1 site in Greece.
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 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: finished, as of the sponsor's last update on 17 Sep 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 Greece. 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?
Central sensitization inventory (CSI) (time frame: 10 min). The study lists 8 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 NCT03838471, which also lists 6 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 Sep 2019.