Central SensitisationNCT04765280
The Frequency of Central Sensitization in Patients With Chronic Musculoskeletal Pain
An observational study of Central Sensitisation and Chronic Musculoskeletal Disease, run by Marmara University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Central Sensitisation, Chronic Musculoskeletal Disease, Chronic Pain
- What is being tested?
- Central sensitization inventory, Short form-36 and Istanbul Low Back Pain Disability Index
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 30 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- Have musculoskeletal pain that lasts for at least 3 months
- Accepting to participate in the study
Who cannot join
- Have rheumatic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Central sensitization inventory, Short form-36, Istanbul Low Back Pain Disability Index, Disabilities of the Arm, Shoulder and Hand (DASH), Neck Pain and Disability scale
- Keywords
- central sensitization, central sensitization inventory, disability, chronic pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central sensitization inventoryDiagnostic test
Also called CSI
Standardized questionnaire to determine the level of central sensitization. Patients with a score of 40 and above are considered to have central sensitization.
Short form-36Other
Also called SF-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 IndexOther
Also called ILBPDI
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)Other
Also called Quick 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 scaleOther
Also called NPAD
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 ScoreOther
Also called KOOS
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 IndexOther
Also called WOMAC
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 scaleOther
Also called VAS
global pain score on a 0 to 10
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic musculoskeletal pain | Patients with any musculoskeletal pain for at least 3 months Receives: Diagnostic Test: Central sensitization inventory; Other: Short form-36; Other: Istanbul Low Back Pain Disability Index; Other: Disabilities of the Arm, Shoulder and Hand (DASH); Other: Neck Pain and Disability scale; Other: Knee Injury and Osteoarthritis Outcome Score; Other: Western Ontario and McMaster Universities Arthritis Index; Other: Visual analogue scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (7)
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)
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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
Measured: 6 months
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.
Measured: 6 months
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).
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Jan 2021
- Primary completion1 Mar 2023 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Central SensitisationStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Canan ŞANAL TOPRAK, Asst.Prof, Study chair, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765280
- Sponsor's protocol ID
- 09.2021.114
- Status last verified
- Nov 2022
- First submitted
- 19 Feb 2021
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 3272296Gervais-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.
PubMed 30178171Nijs 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.
PubMed 24930805Roldan-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.
PubMed 32232473Mayer 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.
PubMed 21951710Tanaka 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.
PubMed 31233655
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Central Sensitization and Disability in Patients With Chronic Musculoskeletal Pain in Physical Medicine and Rehabilitation Clinic.
- ClinicalTrials.gov ID
- NCT04765280
- Acronym / sponsor ID
- 09.2021.114
- Keywords
- central sensitization, central sensitization inventory, disability, chronic pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic musculoskeletal pain | – | Diagnostic Test: Central sensitization inventory, Other: Short form-36, Other: Istanbul Low Back Pain Disability Index, Other: Disabilities of the Arm, Shoulder and Hand (DASH), Other: Neck Pain and Disability scale, Other: Knee Injury and Osteoarthritis Outcome Score, Other: Western Ontario and McMaster Universities Arthritis Index, Other: Visual analogue scalePatients with any musculoskeletal pain for at least 3 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Have musculoskeletal pain that lasts for at least 3 months
- Accepting to participate in the study
Key exclusion criteria (1 listed)
- Have rheumatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Central sensitization inventoryAlso: CSIStandardized questionnaire to determine the level of central sensitization. Patients with a score of 40 and above are considered to have central sensitization. | Diagnostic test | Patients with chronic musculoskeletal pain |
| Short form-36Also: SF-36Standardized 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 | Patients with chronic musculoskeletal pain |
| Istanbul Low Back Pain Disability IndexAlso: ILBPDIStandardized 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 | Patients with chronic musculoskeletal pain |
| Disabilities of the Arm, Shoulder and Hand (DASH)Also: Quick DASHStandardized 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 | Patients with chronic musculoskeletal pain |
| Neck Pain and Disability scaleAlso: NPADStandardized 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 | Patients with chronic musculoskeletal pain |
| Knee Injury and Osteoarthritis Outcome ScoreAlso: KOOSStandardized 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 | Patients with chronic musculoskeletal pain |
| Western Ontario and McMaster Universities Arthritis IndexAlso: WOMACStandardized 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 | Patients with chronic musculoskeletal pain |
| Visual analogue scaleAlso: VASglobal pain score on a 0 to 10 | Other | Patients with chronic musculoskeletal pain |
Primary outcome
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.
7 secondary outcomes
VAS pain
Time frame: 6 months
SF-36
Time frame: 6 months
Istanbul Low Back Pain Disability Index (ILBPDI)
Time frame: 6 months
The Neck Pain and Disability scale (NPAD)
Time frame: 6 months
Quick DASH
Time frame: 6 months
KOOS
Time frame: 6 months
WOMAC
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Results publication: PubMed 3272296Woolf 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.
- Results publication: PubMed 30178171Gervais-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.
- Results publication: PubMed 24930805Nijs 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.
- Results publication: PubMed 32232473Roldan-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.
- Results publication: PubMed 21951710Mayer 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.
- Results publication: PubMed 31233655Tanaka 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.
- KOOSLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Canan ŞANAL TOPRAK, Asst.Prof study chair
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Sensitisation and Chronic Musculoskeletal Disease, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Sensitization Inventory (CSI) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04765280, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.