NCT06098131

Brief Summary

In accordance with an independently matched group design methodology, 90 healthy volunteers (aged 18 to 40) were enlisted and randomly assigned to one of three experimental groups (sliding, tension, or control groups). The participants' group assignment was concealed from them. Using the Biopac MP36 electrodermal amplifier, constant skin conductors (SC) levels were captured for 20 minutes. A blind data collector used the Biopac software to gather the data. A pre and post-treatment measurement was taken with the thermal-camera and an ambulatory blood pressure monitor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

September 10, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 11, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

2 years

First QC Date

October 11, 2023

Last Update Submit

August 20, 2024

Conditions

Keywords

NeurodynamicNeuromobilisationTensioner Neurodynamic TechniqueSlider Neurodynamic TechniqueSlump Test

Outcome Measures

Primary Outcomes (3)

  • Biopac Galvanic skin response 100B electrodermal activity amplifier (MP36 Biopac Systems Incorporation)

    The skin electrodes were placed on the 2nd and 3rd toes on both legs of each participant. Aiming to be sure of the maximum contact of the pads sticking on the skin, the ventral surfaces on the 2nd and 3rd toes were initially cleaned with an isopropyl alcohol tissue before the pads were placed. They remained for a few seconds to dry, aiming to remove any sweat residue or unwanted skin that might influence the data reading process.

    7 min continuously monitoring will take place during the intervention (7 min following the start of the experiment).

  • Thermo-Camera

    Skin temperature will be measured using a thermo-camera (ThermaCam SC2000©, FLIR, Danderyd, Sweden) pre-post intervention. The thermo-camera will be positioned, pointing at the participant's entire body and monitoring the body temperature in degrees Celsius.

    Monitoring will start when participants will take the final sympathetic slump position on the plinth before the intervention (4 min following the starting of the experiment) and following the intervention (20 min following the start of the experiment).

  • Ambulatory blood pressure monitoring

    Therapist placed the cuff of an ambulatory blood pressure monitor (Omron© HEM-9210T Healthcare, Co, Ltd, Kyoto, Japan) on the left arm of the participant. The monitor was used to monitor pre and post-intervention systolic and diastolic blood pressure.

    Monitoring will start when participants will take the final sympathetic slump position on the plinth before the intervension (3 min following the starting of the experiment) and following the intevension (18 min following the start of the experiment).

Study Arms (3)

Sliding Technique Group

EXPERIMENTAL

Participants in the sliding technique group first adopted the SSP. The therapist main-tained the head in a less flexed and closer to neutral position. During this process, they performed full dorsiflexion of the foot, ensuring that the movements allowed the nerve to glide through its pathway rather than creating significant tension

Other: Neurodynamic

Tension Technique Group

EXPERIMENTAL

Participants in the tensioner technique group first adopted the SSP, then proceeded to enhance neural tension by simultaneously fully dorsiflexing the foot and fully flexing the cervical spine forward, thereby increasing tension throughout the nerve pathway. The technique is applied dynamically with relaxation intervals to prevent any potential negative effects on neural vasculature

Other: Neurodynamic

Control Group

NO INTERVENTION

In this group the participants will be requested to position themselves on the plinth in supine line position. All participants in this group will not receive any intervention and they will be instructed to remain in this position for 20 minutes.

Interventions

Neurodynamic Slider and Tensioner Technique

Sliding Technique GroupTension Technique Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 18 and 40 years
  • Body Mass Index less than 30

You may not qualify if:

  • Previous History of Lower Back Pain
  • Skin Disorders
  • Previous Experience of Spinal Manual Therapy Treatment
  • Previous Lower Limb Injuries or Trauma
  • Food, Caffeine, Nicotine, or Alcohol consumed 3 hours before the experiment strenuous Activity done 3 hours before the experiment
  • Chronic Systemic Health Conditions (for example, diabetes)
  • Psychiatric Illnesses or Anxiety Disorders
  • Medication that may have an affect on the SNS (for example, anti-depressants, anti-nausea medication, beta-blockers, muscle relaxants)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European University Cyprus

Nicosia, 1516, Cyprus

Location

MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 11, 2023

First Posted

October 24, 2023

Study Start

September 10, 2021

Primary Completion

September 10, 2023

Study Completion

October 10, 2023

Last Updated

August 22, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations