The Frequency of Central Sensitization in Patients With Chronic Musculoskeletal Pain

Overview

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.

Full Title of Study: “Evaluation of the Relationship Between Central Sensitization and Disability in Patients With Chronic Musculoskeletal Pain in Physical Medicine and Rehabilitation Clinic.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: December 1, 2021

Detailed Description

The term central sensitization (CS) was first used by Wolf 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 by Mayer et.al in 2011 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.In the study conducted by Roldan-Jimenez et al., the frequency of CS was mostly reported in patients with low back (37.8%) and neck pain (32.4%). Tanaka et al. reported higher rates of disability 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.

Interventions

  • Diagnostic Test: Central sensitization inventory
    • Standardized questionnaire to determine the level of central sensitization
  • Other: Short form-36
    • Standardized questionnaire to investigate the quality of life in patients
  • Other: Istanbul Low Back Pain Disability Index
    • Standardized questionnaire to investigate the disability in patients with low back pain
  • Other: Disabilities of the Arm, Shoulder and Hand (DASH)
    • Standardized questionnaire to investigate the disability in patients with upper extremity musculoskeletal disorders
  • Other: Neck Pain and Disability scale
    • Standardized questionnaire to investigate the disability in patients with neck pain
  • Other: Knee Injury and Osteoarthritis Outcome Score
    • Standardized questionnaire to investigate the disability in patients with knee pain
  • Other: Western Ontario and McMaster Universities Arthritis Index
    • Standardized questionnaire to investigate the disability in patients with hip osteoarthritis
  • Other: Visual analogue scale
    • global pain score on a 0 to 10

Arms, Groups and Cohorts

  • Patients with chronic musculoskeletal pain
    • Patients with any musculoskeletal pain for at least 3 months

Clinical Trial Outcome Measures

Primary Measures

  • Central Sensitization Inventory (CSI)
    • Time Frame: 6 months
    • 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.

Secondary Measures

  • VAS pain
    • Time Frame: 6 months
    • 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)
  • SF-36
    • Time Frame: 6 months
    • 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.
  • Istanbul Low Back Pain Disability Index (ILBPDI)
    • Time Frame: 6 months
    • 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.
  • The Neck Pain and Disability scale (NPAD)
    • Time Frame: 6 months
    • The NPAD is a composite index including 20 items which measure the intensity of neck pain and related disability.
  • Quick DASH
    • Time Frame: 6 months
    • 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.
  • KOOS
    • Time Frame: 6 months
    • 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).
  • WOMAC
    • Time Frame: 6 months
    • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Have musculoskeletal pain that lasts for at least 3 months – Accepting to participate in the study Exclusion Criteria:

  • Have rheumatic disease

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Investigator Details

  • Lead Sponsor
    • Marmara University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Canan ŞANAL TOPRAK, Asst.Prof, Study Chair, Marmara University
  • Overall Contact(s)
    • Feyza N YUCEL, specialist, 05385577059, dr.fny28@gmail.com

Citations Reporting on Results

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.

Gervais-Hupé 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.

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. Review.

Roldán-Jiménez C, Pérez-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.

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.

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: 10.1002/ejp.1443. Epub 2019 Aug 1.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.