NCT05937503

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

July 17, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

July 18, 2023

Status Verified

July 1, 2023

Enrollment Period

1 month

First QC Date

June 27, 2023

Last Update Submit

July 15, 2023

Conditions

Central SensitizationManual Therapy

Keywords

central sensitizationmanual therapynon-specific low back pain

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Oswestry Disability Index

    Up to one month

  • Health Survey

    Up to one month

  • Hospital Anxeity and depresssion

    Up to one month

Study Arms (2)

Manual therapy

EXPERIMENTAL

Manual therapy group

Other: manual therapyOther: conventional physiotherapy

Conventional physiotherapy

OTHER

Conventional physiotherapy group

Other: manual therapyOther: conventional physiotherapy

Interventions

manual therapyOTHER

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

Also known as: conventional physiotherapy
Conventional physiotherapyManual therapy
conventional physiotherapyOTHER

Control group will only receive conventionel physiotherapy intervention.

Conventional physiotherapyManual therapy

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • non-spesific low back pain patients with pain longer than 12 weeks
  • aged between 20-64 years male and female participants

You may not qualify if:

  • concomitant disease that would interfere with treatment
  • pregnancy
  • have had any spinal surgery or fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Naime Ulug

Ankara, Select State, 06830, Turkey (Türkiye)

Location

Atılım University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Musculoskeletal Manipulations

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participant will not informed about the intervention
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: prospective randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD.

Study Record Dates

First Submitted

June 27, 2023

First Posted

July 10, 2023

Study Start

July 17, 2023

Primary Completion

August 30, 2023

Study Completion

August 30, 2023

Last Updated

July 18, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)