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

Sponsor
Atılım University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05937503
Collaborator
(none)
40
Enrollment
2
Locations
2
Arms
1.1
Anticipated Duration (Months)
20
Patients Per Site
19
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: manual therapy
  • Other: conventional physiotherapy
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
prospective randomized controlled studyprospective randomized controlled study
Masking:
Single (Participant)
Masking Description:
Participant will not informed about the intervention
Primary Purpose:
Treatment
Official Title:
Efficiency of Manual Therapy on Central Sensitization in Patients With Nonspecific Chronic Back Pain.A Randomized Controlled Study.
Anticipated Study Start Date :
Jun 30, 2023
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Manual therapy

Manual therapy group

Other: manual therapy
The manual therapy group will receive a 4-week manual therapy plus conventionel physiotherapy.
Other Names:
  • conventional physiotherapy

    • Other: conventional physiotherapy
    Control group will only receive conventionel physiotherapy intervention.
    Other: Conventional physiotherapy

    Conventional physiotherapy group

    Other: manual therapy
    The manual therapy group will receive a 4-week manual therapy plus conventionel physiotherapy.
    Other Names:
  • conventional physiotherapy

    • Other: conventional physiotherapy
    Control group will only receive conventionel physiotherapy intervention.

    Outcome Measures

    Primary Outcome Measures

    1. 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)

    2. 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

    1. Oswestry Disability Index [Up to one month]

      Oswestry Disability Index (ODI) will be used to measure disability level

    2. Health Survey [Up to one month]

      36-item Short Form Health Survey Questionnaire (SF-36) will be used

    3. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Naime Ulug Ankara Select State Turkey 06830
    2 Atılım University Ankara Turkey

    Sponsors and Collaborators

    • Atılım University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NAİME ULUG, PhD., Atılım University
    ClinicalTrials.gov Identifier:
    NCT05937503
    Other Study ID Numbers:
    • E-59394181-604.01.02-33380
    First Posted:
    Jul 10, 2023
    Last Update Posted:
    Jul 10, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by NAİME ULUG, PhD., Atılım University
    central sensitization
    manual therapy
    non-specific low back pain
    Additional relevant MeSH terms:
    Back Pain

    Study Results

    No Results Posted as of Jul 10, 2023