The Frequency of Central Sensitization in Patients With Chronic Musculoskeletal Pain

Chronic Pain Clinical Trial

Official title:

Evaluation of the Relationship Between Central Sensitization and Disability in Patients With Chronic Musculoskeletal Pain in Physical Medicine and Rehabilitation Clinic.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04765280
• Other study ID #: 09.2021.114
• Status: Active, not recruiting
• Start date: January 1, 2021
• Est. completion date: March 30, 2023

Study information

• Verified date: November 2022
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Central sensitization is as increased response to normal or sub-threshold stimuli of central nervous system and its close relationship with in many musculoskeletal diseases with chronic pain has been demonstrated in several studies. However, the effect of central sensitization on disability in these patients is not fully known. In this study, it was aimed to investigate the frequency of central sensitization and its effect on patients with chronic musculoskeletal pain who were admitted to physical medicine and rehabilitation outpatient clinics.

Description:

The term central sensitization (CS) was first used in 1988 and was explained as the increase in pain sensitivity with the amplification of neuron-derived signals in the central nervous system. With the development of CS, a decrease in the pain threshold and an increase in generalized sensitivity occur. There is no method for the diagnosis of CS is accepted as a gold standard. Clinical scales and quantitative sensory testing (QST) is used for this purpose widely. In addition, the well-known scale used for the evaluation of CS is the Central Sensitization Inventory (CSI), developed for detect CS in chronic pain patients. The use of CSI, which is more practical to use, is becoming widespread because QST takes time, is costly and requires experienced practitioners. The prevalence of chronic pain is reported as 30% in Europe and has an important place among diseases that cause disability worldwide. Until this time, the relationship between CS and many diseases that cause chronic pain has been revealed, and an increase in pain intensity, duration and prevalence has been detected in patients accompanied by CS. In addition to all these changes, the decrease in the treatment response of these patients makes the clinical management of individuals with pain sensitization even more difficult. Although the increase in the frequency of CS in patients with chronic pain is known, data on the incidence of this condition in various diseases with chronic pain is limited.The frequency of CS was mostly reported in patients with low back (37.8%) and neck pain (32.4%) and the authors reported that the higher rates of disability is seen in patients with high CSI scores. Similarly, in this study, it was planned to show the relationship between CS and disability in patients with chronic musculoskeletal pain.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: March 30, 2023
• Est. primary completion date: March 1, 2023
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Have musculoskeletal pain that lasts for at least 3 months

• Accepting to participate in the study

Exclusion Criteria:

• Have rheumatic disease

Related Conditions & MeSH terms

• Central Sensitisation
• Chronic Musculoskeletal Disease
• Chronic Pain
• Musculoskeletal Diseases
• Musculoskeletal Pain

Intervention

Diagnostic Test:
• Central sensitization inventory
Standardized questionnaire to determine the level of central sensitization. Patients with a score of 40 and above are considered to have central sensitization.

Other:
• Short form-36
Standardized questionnaire to investigate the quality of life in patients. The score of the scale is between 0-100. The higher scores are associated with greater deterioration in quality of life.
• Istanbul Low Back Pain Disability Index
Standardized questionnaire to investigate the disability in patients with low back pain. The score of the scale is between 0-90. It is accepted that the higher the score, the higher the disability.
• Disabilities of the Arm, Shoulder and Hand (DASH)
Standardized questionnaire to investigate the disability in patients with upper extremity musculoskeletal disorders. The score of the scale is between 0-100 It is accepted that the higher the score, the higher the disability.
• Neck Pain and Disability scale
Standardized questionnaire to investigate the disability in patients with neck pain. The score of the scale is between 0-100. It is accepted that the higher the score, the higher the disability.
• Knee Injury and Osteoarthritis Outcome Score
Standardized questionnaire to investigate the disability in patients with knee pain. The score of the scale is between 0-100It is accepted that the higher the score, the higher the disability.
• Western Ontario and McMaster Universities Arthritis Index
Standardized questionnaire to investigate the disability in patients with hip osteoarthritis. The score of the scale is between 0-240. It is accepted that the higher the score, the higher the disability.
• Visual analogue scale
global pain score on a 0 to 10

Locations

Country	Name	City	State
Turkey	Feyza Nur YUCEL	Sinop

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Gervais-Hupe J, Pollice J, Sadi J, Carlesso LC. Validity of the central sensitization inventory with measures of sensitization in people with knee osteoarthritis. Clin Rheumatol. 2018 Nov;37(11):3125-3132. doi: 10.1007/s10067-018-4279-8. Epub 2018 Sep 3. — View 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 — View Citation

Nijs J, Malfliet A, Ickmans K, Baert I, Meeus M. Treatment of central sensitization in patients with 'unexplained' chronic pain: an update. Expert Opin Pharmacother. 2014 Aug;15(12):1671-83. doi: 10.1517/14656566.2014.925446. Epub 2014 Jun 15. — View Citation

Roldan-Jimenez C, Perez-Cruzado D, Neblett R, Gatchel R, Cuesta-Vargas A. Central Sensitization in Chronic Musculoskeletal Pain Disorders in Different Populations: A Cross-Sectional Study. Pain Med. 2020 Nov 1;21(11):2958-2963. doi: 10.1093/pm/pnaa069. Er — View Citation

Tanaka K, Murata S, Nishigami T, Mibu A, Manfuku M, Shinohara Y, Tanabe A, Ono R. The central sensitization inventory predict pain-related disability for musculoskeletal disorders in the primary care setting. Eur J Pain. 2019 Oct;23(9):1640-1648. doi: 10. — View Citation

Woolf CJ, Thompson SW, King AE. Prolonged primary afferent induced alterations in dorsal horn neurones, an intracellular analysis in vivo and in vitro. J Physiol (Paris). 1988-1989;83(3):255-66. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central Sensitization Inventory (CSI)	25 somatic and psychosocial symptoms, which are frequently found in patients with central sensitization in part A, are questioned. In part B, the presence of diseases whose relationship with central sensitization is well defined is questioned in the patient without participating in scoring. Central sensitization is assumed in patients who score 40 or more over 100 points.	6 months
Secondary	VAS pain	The patients pain severity will be evaluated with a 10-cm horizontal visual analogue scale (VAS) ranging from "0 cm" (no discomfort) to "10 cm" (worst imaginable)	6 months
Secondary	SF-36	The 36-Item Short Form Survey (SF-36) is an oft-used, well-researched, self-reported measure of health.The scale was developed by Ware in 1987 and consists of 36 questions questioning 8 sub-parameters regarding the health status of the person.These parameters are physical function, pain, limitation due to physical and emotional problems, emotional well-being, social function, fatigue and general health perception.	6 months
Secondary	Istanbul Low Back Pain Disability Index (ILBPDI)	This scale was developed for assessing the severity of disability in chronic low back pain patients by Duruöz et.al in 2013. This scale consists of 18 questions in the form of a Likert scale that evaluates the limitation of daily life activities of patients in the last month.It is accepted that the higher the score, the higher disability.	6 months
Secondary	The Neck Pain and Disability scale (NPAD)	The NPAD is a composite index including 20 items which measure the intensity of neck pain and related disability.It is accepted that the higher the score, the higher disability	6 months
Secondary	Quick DASH	The Quick DASH is a shortened version of the questionnaire, which was created to detect symptoms and loss of function secondary to musculoskeletal problems of the upper extremity.There are 30 questions in the original form of the questionnaire, and the newly developed short version has been reduced to 11 questions in total. Beaton et al stated that with the quick questionnaire for arm, shoulder and hand problems, upper extremity functional evaluation can be made at rates similar to the original version.	6 months
Secondary	KOOS	The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL).	6 months
Secondary	WOMAC	The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: pain, stiffness and physical function.	6 months

External Links

•   KOOS
•   Neck pain and disability scale
•   SF-36
•   WOMAC