Nociplastic Pain in Patients With Chronic Shoulder Pain

Chronic Shoulder Pain Clinical Trial

Official title:

Investigation of the Profile of Patients With Chronic Shoulder Pain: A Cross-sectional Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05481710
• Other study ID #: 5
• Status: Recruiting
• Start date: July 18, 2022
• Est. completion date: November 2023

Study information

• Verified date: June 2023
• Source: Clinical Exercise Physiology and Rehabilitation Reasearch Laboratory
• Contact: Paraskevi N. Bilika
• Phone: +306982150029
• Email: pbilika[@]uth.gr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: November 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Shoulder Pain
• Shoulder Pain

Intervention

Diagnostic Test:
• Nociplastic Pain Criteria
All participants will be assessed with the specific nociplastic pain criteria

Locations

Country	Name	City	State
Greece	KAT Attica General Hospital	Athens
Greece	Clinical Exercise Physiology and Rehabilitation Laboratory	Lamia	Sterea Ellada

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Exercise Physiology and Rehabilitation Reasearch Laboratory

Country where clinical trial is conducted

Greece, 

References & Publications (1)

Nijs J, Lahousse A, Kapreli E, Bilika P, Saracoglu I, Malfliet A, Coppieters I, De Baets L, Leysen L, Roose E, Clark J, Voogt L, Huysmans E. Nociplastic Pain Criteria or Recognition of Central Sensitization? Pain Phenotyping in the Past, Present and Future. J Clin Med. 2021 Jul 21;10(15):3203. doi: 10.3390/jcm10153203. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure Pain Threshold (PPT)	PPT will be used to assess the pain sensitivity	Only one time (baseline)
Primary	Conditioned Pain Modulation (CPM)	CPM will be used to examine the descending inhibition of nociceptive signals	Only one time (baseline)
Primary	Nociplastic Pain Criteria	The grading system for recognition of nociplastic pain will be used (Kosek et al. 2021).	Only one time (baseline)
Secondary	Numeric Pain Rating Scale	Pain intensity will be assessed with Numeric Pain Rating Scale. Participants will score from 0 (no pain) to 10 (the worst pain they have ever experienced).	Only one time (baseline)
Secondary	Pain Distribution	Pain location will be recorded using the Pain Distribution App (PDA) which is a self-reported tool to assess the distribution and spread of body pain areas. The PDA has demonstrated reliability.	Only one time (baseline)
Secondary	Heart Rate Variability (HRV)	HRV testing will be used to assess the function of autonomic nervous system	Only one time (baseline)
Secondary	Range of motion	Active and passive range of motion will be measured using a goniometer. It will be assessed the flexion, abduction, and external rotation. Participants will be a standing position for flexion and abduction assessment and in prone position for external rotation.	Only one time (baseline)
Secondary	Central Sensitization Inventory (CSI)	CSI wiil be used to assess the CS symptoms	Only one time (baseline)
Secondary	Hospital Anxiety and Depression Scale (HADS)	Anxiety and depression will be measured with Hospital Anxiety and Depression Scale (HADS). HADS includes 14 items, 7 for Anxiety and 7 for Depression. The overall score range 0-42 and 0-21 for the different categories. A cut-off 8/21 has been recommended.	Only one time (baseline)
Secondary	Brief Illness Perception Questionnaire (BIPQ)	BIPQ will be used to estimate the perception of pain severity	Only one time (baseline)
Secondary	Pain Sensitivity Questionnaire (PSQ)	PSQ is a self-reported tool and it will be used to assess pain sensitivity	Only one time (baseline)
Secondary	Pain Catastrophizing Scale (PCS)	PCS is a self-reported scale which estimates the catastrophization	Only one time (baseline)
Secondary	Pain Self-Efficacy Questionnaire (PSEQ)	PSEQ will be used to estimate the self-efficacy	Only one time (baseline)
Secondary	Shoulder Pain and Disability Index (SPADI)	SPADI is a self-reported questionnaire and it will be used to assess the disability	Only one time (baseline)
Secondary	Pittsburgh Sleep Quality Index (PSQI)	The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults.	Only one time (baseline)
Secondary	Work Ability Index (WAI)	WAI will be used to assess the work ability	Only one time (baseline)
Secondary	Tampa Scale Kinesiophobia (TSK)	TSK is a self-reported scale and it will be used to assess the kinesiophobia	Only one time (baseline)
Secondary	EuroQol-5 Dimension (EQ-5D)	EQ-5D will be used to assess the quality of life	Only one time (baseline)
Secondary	3-Minute Step Test (3MST)	3MST will be used to assess the cardiovascular capacity	Only one time (baseline)
Secondary	Hand Grip	Hand Grip will be used to assess the strength of forearm muscles	Only one time (baseline)

External Links

•   Psychometric properties of quantitative sensory testing focusing on healthy and patients with shoulder pain: a systematic review protocol