NCT04765280

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2023

Completed
Last Updated

January 19, 2023

Status Verified

November 1, 2022

Enrollment Period

2.2 years

First QC Date

February 19, 2021

Last Update Submit

January 18, 2023

Conditions

Keywords

central sensitizationcentral sensitization inventorydisabilitychronic pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • VAS pain

    6 months

  • SF-36

    6 months

  • Istanbul Low Back Pain Disability Index (ILBPDI)

    6 months

  • The Neck Pain and Disability scale (NPAD)

    6 months

  • Quick DASH

    6 months

  • +2 more secondary outcomes

Study Arms (1)

Patients with chronic musculoskeletal pain

Patients with any musculoskeletal pain for at least 3 months

Diagnostic Test: Central sensitization inventoryOther: Short form-36Other: Istanbul Low Back Pain Disability IndexOther: Disabilities of the Arm, Shoulder and Hand (DASH)Other: Neck Pain and Disability scaleOther: Knee Injury and Osteoarthritis Outcome ScoreOther: Western Ontario and McMaster Universities Arthritis IndexOther: Visual analogue scale

Interventions

Standardized questionnaire to determine the level of central sensitization. Patients with a score of 40 and above are considered to have central sensitization.

Also known as: CSI
Patients with chronic musculoskeletal pain

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.

Also known as: SF-36
Patients with chronic musculoskeletal pain

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.

Also known as: ILBPDI
Patients with chronic musculoskeletal pain

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.

Also known as: Quick DASH
Patients with chronic musculoskeletal pain

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.

Also known as: NPAD
Patients with chronic musculoskeletal pain

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.

Also known as: KOOS
Patients with chronic musculoskeletal pain

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.

Also known as: WOMAC
Patients with chronic musculoskeletal pain

global pain score on a 0 to 10

Also known as: VAS
Patients with chronic musculoskeletal pain

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • Have rheumatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Feyza Nur YUCEL

Sinop, 57200, Turkey (Türkiye)

Location

Related Publications (6)

  • 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-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.

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Canan ŞANAL TOPRAK, Asst.Prof

    Marmara University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2021

First Posted

February 21, 2021

Study Start

January 1, 2021

Primary Completion

March 1, 2023

Study Completion

March 30, 2023

Last Updated

January 19, 2023

Record last verified: 2022-11

Locations