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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Central Sensitization; Manual Therapy
• Intervention / Treatment: Other: manual therapy; Other: conventional physiotherapy

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Atılım University
  • Select State
    • Ankara, Select State, Turkey, 06830
      • Naime Ulug

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	Up to one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index	Oswestry Disability Index (ODI) will be used to measure disability level	Up to one month
Health Survey	36-item Short Form Health Survey Questionnaire (SF-36) will be used	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)	Up to one month

Collaborators and Investigators

• Sponsor: Atılım University

Study record dates

Study Major Dates

• Study Start (Estimated): July 17, 2023
• Primary Completion (Estimated): August 30, 2023
• Study Completion (Estimated): August 30, 2023

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: July 6, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 15, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: manual therapy; central sensitization; non-specific low back pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: E-59394181-604.01.02-33380

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No