The Frequency of Central Sensitization in Patients With Chronic Musculoskeletal Pain

January 18, 2023 updated by: Marmara University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

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

  • Turkey
      • Sinop, Turkey, 57200
        • Feyza Nur YUCEL

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The patients aged 18-75 years diagnosed with chronic musculoskeletal disorders will be recruited from a PMR outpatient clinic of a state hospital

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Have rheumatic disease

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: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with chronic musculoskeletal pain
Patients with any musculoskeletal pain for at least 3 months
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 Names:
  • CSI
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.
Other Names:
  • SF-36
Other: 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.
Other Names:
  • ILBPDI
Other: 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.
Other Names:
  • Quick DASH
Other: 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.
Other Names:
  • NPAD
Other: 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.
Other Names:
  • KOOS
Other: 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.
Other Names:
  • WOMAC
Other: Visual analogue scale
global pain score on a 0 to 10
Other Names:
  • VAS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
6 months
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.
6 months
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.It is accepted that the higher the score, the higher disability.
6 months
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.It is accepted that the higher the score, the higher disability
6 months
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.
6 months
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).
6 months
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.
6 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Canan Şanal Toprak, Asst.Prof, Marmara University

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

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 09.2021.114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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