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Efficiency of Manual Therapy on Central Sensitization in Patients With Nonspecific Chronic Back Pain

Efficiency of Manual Therapy on Central Sensitization in Patients With Nonspecific Chronic Back Pain.A Randomized Controlled Study.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05937503
Enrollment
40
Registered
2023-07-10
Start date
2023-07-17
Completion date
2023-08-30
Last updated
2023-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Sensitization, Manual Therapy

Keywords

central sensitization, manual therapy, non-specific low back pain

Brief 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.

Detailed 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.

Interventions

OTHERmanual therapy

The manual therapy group will receive a 4-week manual therapy plus conventionel physiotherapy.

OTHERconventional physiotherapy

Control group will only receive conventionel physiotherapy intervention.

Sponsors

Atılım University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Participant will not informed about the intervention

Intervention model description

prospective randomized controlled study

Eligibility

Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain intensityUp to one monthA 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)
Central SensitizationUp to one monthCentral 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.

Secondary

MeasureTime frameDescription
Oswestry Disability IndexUp to one monthOswestry Disability Index (ODI) will be used to measure disability level
Health SurveyUp to one month36-item Short Form Health Survey Questionnaire (SF-36) will be used
Hospital Anxeity and depresssionUp to one monthHospital 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)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026