Cervical Spinal Manipulation and Visteral Osteopathy for Mechanical Neck Pain

Comparison of Cervical Spinal Manipulation and Visceral Osteopathy Techniques in People with Mechanical Neck Pain

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.

Study Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Behavioral: Chiropractic; Behavioral: Osteopathy

Detailed Description

The purpose of this study is to compare the acute effects of cervical spinal manipulation (CSM) treatment and visceral osteopathy (VO) techniques on pain, cervical range of motion (ROM), muscle strength, and grip strength in individuals with mechanical neck pain (MNP).

The study is going to include a total of 30 subjects aged 18-60 diagnosed with MNP. The subjects are randomly divided into two groups. The CSM group received high-velocity, low-amplitude (HVLA) spinal manipulation, while the other group underwent VO techniques. Each treatment technique is going to be applied in only one session. Pain intensity is assessed using the Visual Analog Scale (VAS). Cervical ROM and the craniovertebral angle (CVA) are evaluated using a goniometer. Neck and elbow muscle strength are measured with a hand-held dynamometer, and grip strength is assessed using a hand-grip dynamometer.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kagıthane
    • İstanbul, Kagıthane, Turkey, 34408, 34403
      • Istanbul Atlas University
  • Kağıthane
    • İstanbul, Kağıthane, Turkey, 34413
      • Atlas University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Exclusion criteria included individuals with rheumatic diseases, a history of spinal surgery, neck fractures, tumors in the neck region, vertebrobasilar artery insufficiency, blood clotting disorders, or inadequate mental capacity.

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: Cervical Spinal Manipulation (CSM); 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; high speed low amplitude neck manipulation
Experimental: Visceral Osteopathy; 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; the stomach and liver technique was applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand Dynamometer	A hand dynamometer is a electronic device used to measure grip strength, which is an important indicator of overall muscle strength and function. The hand dynamometer is widely used in clinical, rehabilitation, and research settings to assess the strength of the hand and forearm muscles. This measurement can provide valuable information regarding a patient's recovery progress, functional capacity, and overall health status. Consistent use of the hand dynamometer can help establish baselines, track changes in muscle strength over time, and guide treatment interventions for various conditions affecting hand function.	At baseline and immediately following the intervention session.

Collaborators and Investigators

• Sponsor: Atlas University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): December 22, 2023
• Study Completion (Actual): October 25, 2024

Study Registration Dates

• First Submitted: October 17, 2024
• First Submitted That Met QC Criteria: October 17, 2024
• First Posted (Actual): October 21, 2024

Study Record Updates

• Last Update Posted (Estimated): November 4, 2024
• Last Update Submitted That Met QC Criteria: November 1, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: osteopathy; visceral osteopathy; neck pain treatment; servical spinal manupilation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: Cihat Seyrek

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No