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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05937503
Other study ID # E-59394181-604.01.02-33380
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 17, 2023
Est. completion date August 30, 2023

Study information

Verified date July 2023
Source Atilim University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Central sensitization (CS) is defined as the increased responsiveness of nociceptive neurons in the central nervous system to normal or subthreshold afferent input. CS has been proposed as an underlying mechanism of chronic pain in musculoskeletal disorders including low back pain (LBP). The aim of this study is to investigate the effect of manual therapy on central sensitization in patients with nonspecific chronic LBP.


Description:

A total of 40 LBP patients aged between 24-64 with CSS will be randomized into two groups. The manual therapy group will receive a 4-week manual therapy (two sessions/week) plus the conventional physiotherapy program, while the control group will only receive conventional physiotherapy. Before and after the interventions pain intensity (VAS), and scores of three questionnaires: Oswestry Disability Index (ODI), Central Sensitization Inventory (CSI), and the 36-item Short Form Health Survey Questionnaire (SF-36) will be recorded.The outcomes of the study will be analyzed by appropriate statistical methods.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date August 30, 2023
Est. primary completion date August 30, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 64 Years
Eligibility Inclusion Criteria: - non-spesific low back pain patients with pain longer than 12 weeks - aged between 20-64 years male and female participants Exclusion Criteria: - concomitant disease that would interfere with treatment - pregnancy - have had any spinal surgery or fracture

Study Design


Related Conditions & MeSH terms


Intervention

Other:
manual therapy
The manual therapy group will receive a 4-week manual therapy plus conventionel physiotherapy.
conventional physiotherapy
Control group will only receive conventionel physiotherapy intervention.

Locations

Country Name City State
Turkey Atilim University Ankara
Turkey Naime Ulug Ankara Select State

Sponsors (1)

Lead Sponsor Collaborator
Atilim University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain intensity A 10 cm Visual Analog Scale will be used to determine the severity of pain, with numbers ranging from "0" (no pain) to "10" (unbearable pain) Up to one month
Primary Central Sensitization Central Sensitization Inventory (CSI) scale will be used severity of central sensitization.The total score range of the scale, which consists of a total of 25 questions, is between 0-100 points. Central sensitization with a score of 40 and above is considered positive. An increase in the total score indicates an increase in the level of central sensitization. Up to one month
Secondary Oswestry Disability Index Oswestry Disability Index (ODI) will be used to measure disability level Up to one month
Secondary Health Survey 36-item Short Form Health Survey Questionnaire (SF-36) will be used Up to one month
Secondary Hospital Anxeity and depresssion Hospital Anxeity and Depression Scale will be used. The cut-off points for caseness of anxiety or depression is 8/21 for anxiety or depression. For anxiety (HADS-A) this gave a specificity of 0.78 and a sensitivity of 0.9. For depression (HADS-D) this gave a specificity of 0.79 and a sensitivity of 0.83.
The scores of the scale are as follows: 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)
Up to one month
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