Clinical trial NCT05481710: Nociplastic Pain in Patients With Chronic Shoulder Pain
Official title: Investigation of the Profile of Patients With Chronic Shoulder Pain: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Shoulder Pain
Keywords: chronic pain
shoulder pain
nociplastic pain
predictors
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The current study will include patients with chronic shoulder pain who visit the Hand Surgery-Upper Limb and Microsurgery Department of the General Hospital KAT and healthy participants who study or work at the University of Thessaly.

Brief summary: The aim of this study was to investigate predictors of nociplastic shoulder pain. Factors of psychological distress, functionality, fitness, quality of life, quality of sleep, functioning of the parasympathetic system, and lifestyle will be examined. Patients with nociplastic pain will be identified using the classification system proposed by the IASP.

Detailed description: The main part of the study will include patients with chronic shoulder pain who visit the Hand Surgery-Upper Limb and Microsurgery Department of the General Hospital KAT. The measurements will be performed in one session. Once participants have been informed of the purpose and procedure of the study and given written consent, they will complete their demographics and a series of questionnaires and questions about their pain history. They will then be examined by a doctor and finally subjected to dynamometry, a functional test and two quantitative sensory tests.

Eligibility criteria: Inclusion Criteria:

* patients (men and women) with chronic shoulder pain (lasting more than 3 months, 3/10 Numeric Pain Rating Scale),
* aged 18-65 years
* mentally able to follow instructions or
* healthy volunteers
* aged 18-65
* who do not experience pain and have not received analgesic medication in the last trimester.

Exclusion Criteria:

* referred shoulder pain from different primary sources of pain (eg shoulder pain in women with mastectomy or stroke),
* pain manifested by movements in the neck,
* shoulder arthroplasty or fractures or dislocation of the shoulder, -
* diagnosis of chronic pain syndrome such as fibromyalgia, chronic fatigue syndrome, chronic regional pain syndrome, cancer diagnosis, osteoporosis, rheumatic inflammatory diseases,
* use of medication for neurological/psychiatric disorders,
* the presence of gastrointestinal or renal disease
* taking medication that may affect the assessment results, such as calcium channel blockers that could alter HRV,
* pregnancy or childbirth before 1 year will be excluded from the study.

Primary outcomes:
measure: Pressure Pain Threshold (PPT)
timeFrame: Only one time (baseline)
measure: Conditioned Pain Modulation (CPM)
timeFrame: Only one time (baseline)
measure: Nociplastic Pain Criteria
timeFrame: Only one time (baseline)
Secondary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: Only one time (baseline)
measure: Pain Distribution
timeFrame: Only one time (baseline)
measure: Heart Rate Variability (HRV)
timeFrame: Only one time (baseline)
measure: Range of motion
timeFrame: Only one time (baseline)
measure: Central Sensitization Inventory (CSI)
timeFrame: Only one time (baseline)
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Only one time (baseline)
measure: Brief Illness Perception Questionnaire (BIPQ)
timeFrame: Only one time (baseline)
measure: Pain Sensitivity Questionnaire (PSQ)
timeFrame: Only one time (baseline)
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Only one time (baseline)
measure: Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: Only one time (baseline)
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: Only one time (baseline)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Only one time (baseline)
measure: Work Ability Index (WAI)
timeFrame: Only one time (baseline)
measure: Tampa Scale Kinesiophobia (TSK)
timeFrame: Only one time (baseline)
measure: EuroQol-5 Dimension (EQ-5D)
timeFrame: Only one time (baseline)
measure: 3-Minute Step Test (3MST)
timeFrame: Only one time (baseline)
measure: Hand Grip
timeFrame: Only one time (baseline)
Other outcomes:
Locations:
city: Lamia
country: Greece
facility: Clinical Exercise Physiology and Rehabilitation Laboratory
state: Sterea Ellada
city: Athens
country: Greece
facility: KAT Attica General Hospital
Study officials:
affiliation: University of Thessaly
name: Paraskevi N. Bilika
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Thessaly
name: Eleni V. Kapreli
role: STUDY_DIRECTOR
References:
citation: Miller AB. The costs and benefits of breast cancer screening. Am J Prev Med. 1993 May-Jun;9(3):175-80.