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

Not Applicable

Not yet recruiting

• Conditions: Manual Therapy; Central Sensitization
• Interventions: Other: manual therapy; Other: conventional physiotherapy

• Registration Number: NCT05937503
• Lead Sponsor: Atılım University

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.

Study Timeline

• Study First Submitted: 2023-06-27
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-06
• Study First Posted: 2023-07-10
• Last Update Submitted: 2023-07-15
• Study Start: 2023-07-17
• Last Update Posted: 2023-07-18
• Primary Completion: 2023-08-30
• Study Completion: 2023-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional physiotherapy	conventional physiotherapy	Conventional physiotherapy group
Conventional physiotherapy	manual therapy	Conventional physiotherapy group
Manual therapy	conventional physiotherapy	Manual therapy group
Manual therapy	manual therapy	Manual therapy group

Primary Outcome Measures

Name	Time	Method
Pain intensity	Up to one month	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)
Central Sensitization	Up to one month	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.

Secondary Outcome Measures

Name	Time	Method
Hospital Anxeity and depresssion	Up to one month	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)
Oswestry Disability Index	Up to one month	Oswestry Disability Index (ODI) will be used to measure disability level
Health Survey	Up to one month	36-item Short Form Health Survey Questionnaire (SF-36) will be used

Trial Locations

Locations (2)

Atılım University; 🇹🇷 Ankara, Turkey

Naime Ulug; 🇹🇷 Ankara, Select State, Turkey