NCT06649903

Brief Summary

This study compares two treatment techniques, cervical spinal manipulation (CSM) and visceral osteopathy (VO), in patients with mechanical neck pain (MNP). The aim of the study was to evaluate the effects of these treatments on pain levels, neck mobility, and muscle strength in both the neck and upper extremities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2024

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2024

Completed
Last Updated

November 4, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

October 17, 2024

Last Update Submit

November 1, 2024

Conditions

Keywords

neck pain treatmentvisceral osteopathyservical spinal manupilationosteopathy

Outcome Measures

Primary Outcomes (2)

  • VAS pain scale

    The Visual Analog Scale (VAS) for pain is a subjective measurement tool used to assess an individual\'s pain intensity. It consists of a straight line, typically 10 centimeters in length, with endpoints that represent the extremes of pain: one end signifies \"no pain\" (0) and the other indicates \"worst pain imaginable\" (10). Participants mark a point on the line that corresponds to their pain level at the moment of assessment. The distance from the \"no pain\" end to the marked point is then measured in centimeters, providing a numerical value that quantifies the intensity of the pain experienced. This scale is commonly used in clinical settings for its simplicity and effectiveness in capturing the subjective experience of pain.

    At baseline and immediately following the intervention session.

  • Microfet 2 Dynamometer

    The Microfet 2 Dynamometer is a handheld device used to objectively measure muscle strength in clinical and research settings. It employs a digital force transducer that provides accurate and reliable assessments of isometric muscle strength across various muscle groups. It is commonly used in physical therapy and rehabilitation to evaluate muscle function, track progress over time, and inform treatment decisions. Its compact size and versatility make it suitable for various assessments, including grip strength, limb strength, and specific muscle testing. The device is particularly valuable for ensuring standardized measurements in strength evaluation protocols.

    At baseline and immediately following the intervention session.

Secondary Outcomes (1)

  • Hand Dynamometer

    At baseline and immediately following the intervention session.

Study Arms (2)

Cervical Spinal Manipulation (CSM)

EXPERIMENTAL

This arm includes participants who receive a single session of high-velocity, low-amplitude spinal manipulation aimed at reducing pain and improving cervical range of motion and muscle strength in individuals with mechanical neck pain. The intervention is administered by a qualified physiotherapist, following established protocols for cervical spinal manipulation.

Behavioral: Chiropractic

Visceral Osteopathy

EXPERIMENTAL

Participants in this arm undergo a single session of visceral osteopathy techniques focused on improving pain and functional outcomes in individuals with mechanical neck pain. The VO techniques are designed to enhance mobility and alleviate discomfort through manipulation of the viscera and associated structures, performed by a trained osteopath.

Behavioral: Osteopathy

Interventions

ChiropracticBEHAVIORAL

high speed low amplitude neck manipulation

Cervical Spinal Manipulation (CSM)
OsteopathyBEHAVIORAL

the stomach and liver technique was applied

Visceral Osteopathy

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Participants is included if they had neck pain present for at least one week, reduced cervical ROM, a manual muscle test score of 4 or higher for the neck muscles, and no neurological pain in the neck.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Istanbul Atlas University

Istanbul, Kagıthane, 34408, 34403, Turkey (Türkiye)

Location

Atlas University

Istanbul, Kağıthane, 34413, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Manipulation, ChiropracticOsteopathic Physicians

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysiciansHealth PersonnelHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: It is a randomized controlled study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

October 17, 2024

First Posted

October 21, 2024

Study Start

November 1, 2023

Primary Completion

December 22, 2023

Study Completion

October 25, 2024

Last Updated

November 4, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

At this time, we are undecided about sharing individual participant data (IPD) with other researchers. We will evaluate the feasibility and ethical considerations of data sharing upon study completion. Factors influencing this decision may include participant confidentiality, data integrity, and potential research collaborations. A final determination will be made based on these considerations to ensure compliance with ethical guidelines and the responsible use of participant data.

Locations