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

Manual Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05937503
• Other study ID #: E-59394181-604.01.02-33380
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 17, 2023
• Est. completion date: August 30, 2023

Study information

• Verified date: July 2023
• Source: Atilim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Central Sensitization
• Manual Therapy

Intervention

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

Locations

Country	Name	City	State
Turkey	Atilim University	Ankara
Turkey	Naime Ulug	Ankara	Select State

Sponsors (1)

Lead Sponsor	Collaborator
Atilim University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Oswestry Disability Index	Oswestry Disability Index (ODI) will be used to measure disability level	Up to one month
Secondary	Health Survey	36-item Short Form Health Survey Questionnaire (SF-36) will be used	Up to one month
Secondary	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