Clinical trial NCT03838471: Cognitive Behavioral Factors and Central Sensitization in Chronic Shoulder Pain
Official title: Correlation Between Symptoms of Central Sensitization and Cognitive Behavioral Factors in People With Chronic Shoulder Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Shoulder Pain
Keywords: CSI
kinesiophobia
Central Nervous System Sensitization
Catastrophizing
Illness Behavior
Lead sponsor: Technological Education Institute of Sterea Ellada
Sponsor class: OTHER
Collaborators: name: KAT General Hospital
name: Vrije Universiteit Brussel
First posted: 2019-02-12
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

(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).

Exclusion Criteria:

1. recent shoulder dislocation (1 year prior) and/or systemic diseases such as rheumatoid arthritis, fibromyalgia and/or polymyalgia rheumatic
2. shoulder pain considered to be originated from the cervical region, and other traumas,
3. neurological dysfunction (ie, multiple sclerosis or stroke), osteoporosis, haemophilia and/or cancer
4. shoulder surgery
5. participants with shoulder pain after post fracture
6. Being pregnant or given birth in the preceding year
7. Overconsumption of alcohol or any other recreational drug2
8. Cognitive impairment
9. 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.

Primary outcomes:
measure: Central sensitization inventory (CSI)
timeFrame: 10 min
measure: Oxford Shoulder Score (OSS)
timeFrame: 10 min
measure: Tampa Scale for Kinesiophobia
timeFrame: 10 min
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 10 min
measure: Pain Catastrophizing Scale
timeFrame: 10 min
measure: Brief Illness Perception Questionnaire
timeFrame: 3 min
measure: Arm Endurance Test
timeFrame: 5 min
measure: Numeric Pain Rating Scale
timeFrame: 1 min
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: KAT Hospital
Study officials:
affiliation: Technological Educational Institute of Sterea Ellada
name: Eleni V Kapreli, MSc, PhD
role: STUDY_CHAIR
affiliation: Technological Educational Institute of Sterea Ellada
name: Paraskevi Bilika, BSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Cuesta-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.
citation: Mayer 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.
citation: Adams LM, Turk DC. Psychosocial factors and central sensitivity syndromes. Curr Rheumatol Rev. 2015;11(2):96-108. doi: 10.2174/1573397111666150619095330.
citation: Neblett 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.
citation: Coronado 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.