An interventional study of manual therapy and conventional physiotherapy in Central Sensitization and Manual Therapy, sponsored by Atılım University. Not yet recruiting at 2 sites in Turkey. Open to participants aged 20 Years to 64 Years. Per ClinicalTrials.gov, last updated 2023-07-18.
Sponsored by Atılım University · Not applicable, Interventional, and Treatment
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.
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →Atılım University is the lead sponsor of 35 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Manual therapy group
Other: manual therapy · Other: conventional physiotherapy
Conventional physiotherapy group
Other: manual therapy · Other: conventional physiotherapy
The manual therapy group will receive a 4-week manual therapy plus conventionel physiotherapy.
Also known as: conventional physiotherapy
Control group will only receive conventionel physiotherapy intervention.
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)
Time frame: Up to one month
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.
Time frame: Up to one month
Oswestry Disability Index
Oswestry Disability Index (ODI) will be used to measure disability level
Time frame: Up to one month
Health Survey
36-item Short Form Health Survey Questionnaire (SF-36) will be used
Time frame: Up to one month
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)
Time frame: Up to one month
Plan to share: No
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This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Atılım University