Cognitive Behavioral Factors and Central Sensitization in Chronic Shoulder Pain

NCT ID: NCT03838471

Last Updated: 2019-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-03-25

Brief Summary

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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

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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

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Chronic Shoulder Pain

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Central sensitization symptoms

This group will contain persons with a clinically relevant degree of symptoms of CS (CSI score ≥40).

No interventions assigned to this group

No Central sensitization symptoms

This group will contain persons with a lower degree of symptoms of CS (CSI score \< 40).

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KAT General Hospital

OTHER

Sponsor Role collaborator

Vrije Universiteit Brussel

OTHER

Sponsor Role collaborator

Technological Education Institute of Sterea Ellada

OTHER

Sponsor Role lead

Responsible Party

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Eleni Kapreli

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eleni V Kapreli, MSc, PhD

Role: STUDY_CHAIR

Technological Educational Institute of Sterea Ellada

Paraskevi Bilika, BSc

Role: PRINCIPAL_INVESTIGATOR

Technological Educational Institute of Sterea Ellada

Locations

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KAT Hospital

Athens, , Greece

Site Status

Countries

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Greece

References

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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.

Reference Type BACKGROUND
PMID: 29329739 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29198933 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21951710 (View on PubMed)

Adams LM, Turk DC. Psychosocial factors and central sensitivity syndromes. Curr Rheumatol Rev. 2015;11(2):96-108. doi: 10.2174/1573397111666150619095330.

Reference Type BACKGROUND
PMID: 26088211 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23490634 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29751194 (View on PubMed)

Other Identifiers

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PHYSMSC2

Identifier Type: -

Identifier Source: org_study_id

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