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

Primary Purpose

Central Sensitization, Manual Therapy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
manual therapy
conventional physiotherapy
Sponsored by
Atılım University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Sensitization focused on measuring central sensitization, manual therapy, non-specific low back pain

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Naime Ulug
  • Atılım University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Manual therapy

Conventional physiotherapy

Arm Description

Manual therapy group

Conventional physiotherapy group

Outcomes

Primary Outcome Measures

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)
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.

Secondary Outcome Measures

Oswestry Disability Index
Oswestry Disability Index (ODI) will be used to measure disability level
Health Survey
36-item Short Form Health Survey Questionnaire (SF-36) will be used
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)

Full Information

First Posted
June 27, 2023
Last Updated
July 15, 2023
Sponsor
Atılım University
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1. Study Identification

Unique Protocol Identification Number
NCT05937503
Brief Title
Efficiency of Manual Therapy on Central Sensitization in Patients With Nonspecific Chronic Back Pain
Official Title
Efficiency of Manual Therapy on Central Sensitization in Patients With Nonspecific Chronic Back Pain.A Randomized Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 17, 2023 (Anticipated)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Atılım University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Sensitization, Manual Therapy
Keywords
central sensitization, manual therapy, non-specific low back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective randomized controlled study
Masking
Participant
Masking Description
Participant will not informed about the intervention
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Manual therapy
Arm Type
Experimental
Arm Description
Manual therapy group
Arm Title
Conventional physiotherapy
Arm Type
Other
Arm Description
Conventional physiotherapy group
Intervention Type
Other
Intervention Name(s)
manual therapy
Other Intervention Name(s)
conventional physiotherapy
Intervention Description
The manual therapy group will receive a 4-week manual therapy plus conventionel physiotherapy.
Intervention Type
Other
Intervention Name(s)
conventional physiotherapy
Intervention Description
Control group will only receive conventionel physiotherapy intervention.
Primary Outcome Measure Information:
Title
Pain intensity
Description
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
Title
Central Sensitization
Description
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
Secondary Outcome Measure Information:
Title
Oswestry Disability Index
Description
Oswestry Disability Index (ODI) will be used to measure disability level
Time Frame
Up to one month
Title
Health Survey
Description
36-item Short Form Health Survey Questionnaire (SF-36) will be used
Time Frame
Up to one month
Title
Hospital Anxeity and depresssion
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Naime Ulug
City
Ankara
State/Province
Select State
ZIP/Postal Code
06830
Country
Turkey
Facility Name
Atılım University
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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