Cognitive Behavioral Factors and Central Sensitization in Chronic Shoulder Pain

September 15, 2019 updated by: Eleni Kapreli, Technological Education Institute of Sterea Ellada

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece
        • KAT Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
10 min
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.
10 min
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.
10 min
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.
10 min
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.
10 min
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.
3 min
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).
5 min
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.
1 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technological Education Institute of Sterea Ellada

Collaborators

KAT General Hospital
Vrije Universiteit Brussel

Investigators

  • Study Chair: Eleni V Kapreli, MSc, PhD, Technological Educational Institute of Sterea Ellada
  • Principal Investigator: Paraskevi Bilika, BSc, Technological Educational Institute of Sterea Ellada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Actual)

February 18, 2019

Study Completion (Actual)

March 25, 2019

Study Registration Dates

First Submitted

February 10, 2019

First Submitted That Met QC Criteria

February 10, 2019

First Posted (Actual)

February 12, 2019

Study Record Updates

Last Update Posted (Actual)

September 17, 2019

Last Update Submitted That Met QC Criteria

September 15, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHYSMSC2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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