Ignite Creation Date:
2024-10-25 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548633
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
The Immediate Extent of the Hypoalgesic Effect Following Central Mobilisations to L3 L4 and L5
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Immediate Extent of the Hypoalgesic Effect Following Central Mobilisations to L3 L4 and L5
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HypoLumbar
Brief Summary:
The aim of this study was to establish the efficacy of spinal mobilisations a controlled application of a specific amount of force to a targeted spinal level for reducing pain across different areas of the lower back Pain was assessed using a pin prick sensation device and recorded in specific locations by the participant using a 10 cm line with one end indicating no pain and the other the worst pain possible
Detailed Description:
Study Design The design of the study was a randomised single-blind repeated measures cross-over design performed in a single-centre environment Ethical approval was gained from the School of Sport and Exercise Science ethics committee at the University of Worcester ISES2018RF1 Informed consent was gained from each participant before testing
Sample and Inclusion Criteria The study included twenty asymptomatic participants 11 females and 9 males the mean age of the participants was 219 years 267 range 20- 30 A health questionnaire based on the PARQ was completed by each participant to establish any contraindications they may have to the experimental procedures namely the application of vertebral mobilisations No participants were required to be excluded as none of them had consulted their doctor in the last six months were taking any medication had an infection in the past two weeks had no heart asthma diabetes bronchitis epilepsy or blood pressure issues had any current muscle or joint injury were able to trainexercise normally or knew of any other reason that would preclude them from participating
Data Collection Each participant was randomly assigned using a random number generator to the order in which their lumbar vertebral levels were mobilised and to the order of each dermatome level tested for the baseline and all three mobilisation interventions
Before initiating the experimental procedure the participants age height and weight were recorded The participant was instructed to lay on their back on the plinth and had the five locations for dermatome testing marked with a water-soluble pen The researchers utilised the method of using participants finger breadth to establish dermatome testing sites the dermatome testing sites were based on Keegan and Garretts dermatome map From this point forth the spinal levels will be referred to as L2 or L3 respectively and the corresponding dermatome of the vertebral level will be referred to as DL2 or DL3
Once these locations were marked on the participants left leg a demonstration of the Neuropen Owen Mumford Oxfordshire UK was performed on the participants hand opposite to the side being tested Once all this had been completed baseline measures were taken Using the Neuropen a standardised force of 40g was applied to one of the locations The participant then received a small piece of card with a vertical 10cm visual analogue scale VAS line on it and a pen and was asked to draw a horizontal line on the scale to indicate how much sensation you feel 0 being can-not feel anything and 10 being an extremely strong sensation Following this explanation the participant was asked if they understood and whether they needed further instruction to complete the VAS card Once the participant marked the card the card and pen were collected and stored this process was repeated with the remaining four locations these five cards provided the baseline data A new tip was used for each participant and a decrease in PPS represents a reduction in pain
Once baseline measurements were collected by the lead researcher the participant was asked to turn onto their front the first pre-determined lumbar vertebra was found using the iliac crest as an anatomical landmark for the differentiation test When the correct vertebra was located the experimenter pressed record on the laptop connected to the PGD plinth to record the force applied and calculate the frequency
The lumbar vertebra was mobilised using Maitlands vertebral mobilisation method for posterior-anterior central vertebral pressures PACVPs for four sets of 30 seconds with up to 30s between each at a grade III amplitude and a target rate of 3Hz to ensure the total time for testing was less than fifteen minutes in duration before the opioid system is activated Once the fourth 30-second mobilisation had been completed the researcher pressed stop on the laptop and asked the participant to roll onto their back Then the next five sets of data were collected following the same procedure implemented for the baseline measures collected in a different pre-determined order each time This process was repeated for the remaining two vertebrae
Sample and Inclusion Criteria The study included twenty asymptomatic participants 11 females and 9 males the mean age of the participants was 219 years 267 range 20- 30 A health questionnaire based on the PARQ was completed by each participant to establish any contraindications they may have to the experimental procedures namely the application of vertebral mobilisations No participants were required to be excluded as none of them had consulted their doctor in the last six months were taking any medication had an infection in the past two weeks had no heart asthma diabetes bronchitis epilepsy or blood pressure issues had any current muscle or joint injury were able to trainexercise normally or knew of any other reason that would preclude them from participating
Data Collection Each participant was randomly assigned using a random number generator to the order in which their lumbar vertebral levels were mobilised and to the order of each dermatome level tested for the baseline and all three mobilisation interventions
Before initiating the experimental procedure the participants age height and weight were recorded The participant was instructed to lay on their back on the plinth and had the five locations for dermatome testing marked with a water-soluble pen The researchers utilised the method of using participants finger breadth to establish dermatome testing sites the dermatome testing sites were based on Keegan and Garretts dermatome map From this point forth the spinal levels will be referred to as L2 or L3 respectively and the corresponding dermatome of the vertebral level will be referred to as DL2 or DL3
Once these locations were marked on the participants left leg a demonstration of the Neuropen Owen Mumford Oxfordshire UK was performed on the participants hand opposite to the side being tested Once all this had been completed baseline measures were taken Using the Neuropen a standardised force of 40g was applied to one of the locations The participant then received a small piece of card with a vertical 10cm visual analogue scale VAS line on it and a pen and was asked to draw a horizontal line on the scale to indicate how much sensation you feel 0 being can-not feel anything and 10 being an extremely strong sensation Following this explanation the participant was asked if they understood and whether they needed further instruction to complete the VAS card Once the participant marked the card the card and pen were collected and stored this process was repeated with the remaining four locations these five cards provided the baseline data A new tip was used for each participant and a decrease in PPS represents a reduction in pain
Once baseline measurements were collected by the lead researcher the participant was asked to turn onto their front the first pre-determined lumbar vertebra was found using the iliac crest as an anatomical landmark for the differentiation test When the correct vertebra was located the experimenter pressed record on the laptop connected to the PGD plinth to record the force applied and calculate the frequency
The lumbar vertebra was mobilised using Maitlands vertebral mobilisation method for posterior-anterior central vertebral pressures PACVPs for four sets of 30 seconds with up to 30s between each at a grade III amplitude and a target rate of 3Hz to ensure the total time for testing was less than fifteen minutes in duration before the opioid system is activated Once the fourth 30-second mobilisation had been completed the researcher pressed stop on the laptop and asked the participant to roll onto their back Then the next five sets of data were collected following the same procedure implemented for the baseline measures collected in a different pre-determined order each time This process was repeated for the remaining two vertebrae
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None