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

NCT ID: NCT05937503

Last Updated: 2023-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-17

Study Completion Date

2023-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Central Sensitization Manual Therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective randomized controlled study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participant will not informed about the intervention

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Manual therapy

Manual therapy group

Group Type EXPERIMENTAL

manual therapy

Intervention Type OTHER

The manual therapy group will receive a 4-week manual therapy plus conventionel physiotherapy.

conventional physiotherapy

Intervention Type OTHER

Control group will only receive conventionel physiotherapy intervention.

Conventional physiotherapy

Conventional physiotherapy group

Group Type OTHER

manual therapy

Intervention Type OTHER

The manual therapy group will receive a 4-week manual therapy plus conventionel physiotherapy.

conventional physiotherapy

Intervention Type OTHER

Control group will only receive conventionel physiotherapy intervention.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

manual therapy

The manual therapy group will receive a 4-week manual therapy plus conventionel physiotherapy.

Intervention Type OTHER

conventional physiotherapy

Control group will only receive conventionel physiotherapy intervention.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

conventional physiotherapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Atılım University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

NAİME ULUG

PhD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Naime Ulug

Ankara, Select State, Turkey (Türkiye)

Site Status

Atılım University

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

E-59394181-604.01.02-33380

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.