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Comparative Effects of the Neurodynamic Slider and Tensioner Mobilisation Techniques on Sympathetic Nervous System Function: A Randomised Controlled Trial

E

European University Cyprus

Status

Completed

Conditions

Health Care Acceptor

Treatments

Other: Neurodynamic

Study type

Interventional

Funder types

Other

Identifiers

NCT06098131
EEBK/EΠ/2021/58

Details and patient eligibility

About

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.

Full description

Ninety healthy volunteer participants were randomly allocated to three groups (sliding neurodynamic techniques (NDT), tension NDT, and control) using the hypothetico-deductive method of theory testing that allows the comparison within the variables. Additionally, a double-blind experimental research strategy was used in this study. The study's participants were not informed on their allocation to the groups in an effort to reduce the likelihood of expectation bias. It is crucial to note that the researcher maintained his or her blindness throughout the data selection process in order to safeguard the study's internal validity. Two people carried out the experiment in order to accomplish this: the "therapist" who applied the NDT and the "data collector" in charge of documenting the outcomes of the intervention.

Any changes in the Sympathetic Nervous System (SNS) were noted and recorded using three valuable outcome measure tools: the Biopac Galvanic skin response 100B electrodermal activity amplifier (MP36 Biopac Systems Incorporation), a thermo-camera © and an ambulatory blood pressure monitor.

The practical room was set up during the experiment so that neither the therapist nor the subjects came in contact with the apparatus. In order to ensure blinding from the results as the experiment was running, the plinth (treatment area) was separated from the data collection table with the computer and equipment (Biopac, blood pressure monitor, environmental thermometer, and thermo-camera) by a screen. Only the data collector has access to the Biopac software, blood pressure monitor, environmental thermometer, and thermo-camera in order to blind the therapist to the results of the experiment completely. Throughout the whole experiment, the therapist stayed hidden behind the screen.

The therapist begins standardising the equipment when the subjects are seated on the plinth. The thermo-camera has to be positioned correctly, pointing at the participant's hold body in the first stage. Second, the therapist placed the blood pressure monitor's cuff on the participant's left arm. The ideal placement of the skin electrodes was the next step. Each participant's second and third toes on both legs received skin electrodes. When the participant finally assumed their position, the therapist asked the data collector to quickly verify SC activity using the thermo-camera, ambulatory blood pressure monitor, and graph readings from the Biopac acquisition programme.

The experiment comprised three phases: (1) Pre-Intervention Phase, (2) Intervention Phase, and (3) Post-Intervention Phase. The experiment started with an 8-minute stabilisation phase aiming to achieve a physiological resting state, followed by the baseline recording period, which lasted 2 minutes. During this phase, the therapist took the body temperature and the blood pressure of each participant, using the blood pressure monitor and the thermo-camera ©. Following, three phases of 1-minute interventions were applied on the 'intervention leg', each separated by a 1-minute rest period. Finally, the experiment concluded with a 5-minute resting period. The SC was recorded through the Biopac software the whole time, and the whole experiment lasted 20 minutes. Throughout the experiment, the data collector indicated the time frame for each phase with the verbal cue 'Intervention Phase 1 or 2 or 3'.

Moreover, the data collector placed markers on the Biopac graph to demonstrate the start and end of each intervention phase. Finally, when the experiment passed into the Post-Intervention Phase, the therapist took the body temperature and the blood pressure from each participant. It must be noted that NDT manoeuvres during the experiment were performed on the participants as described by Shacklock (2005).

Enrollment

90 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Aged between 18 and 40 years
  2. Body Mass Index less than 30

Exclusion criteria

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

90 participants in 3 patient groups

Sliding Technique Group
Experimental group
Description:
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
Treatment:
Other: Neurodynamic
Tension Technique Group
Experimental group
Description:
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
Treatment:
Other: Neurodynamic
Control Group
No Intervention group
Description:
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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