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CompletedNCT06548633HypoLumbarUpdated Aug 12, 2024

The Immediate Extent of the Hypoalgesic Effect Following Central Mobilisations to L3, L4 and L5

An interventional study of Lumbar Vertebral Mobilisation in Low Back Pain, sponsored by Darren Cooper. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-12.

Sponsored by Darren Cooper · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 9 months after the study started (first participant enrolled Oct 2018, registered Aug 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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 21.9 years (±2.67, 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 train/exercise 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 participant's 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 participant's finger breadth to establish dermatome testing sites the dermatome testing sites were based on Keegan and Garrett's 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 participant's left leg, a demonstration of the Neuropen® (Owen Mumford, Oxfordshire, UK) was performed on the participant's 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 Maitland's 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.

02

Conditions studied

  • Low Back Pain

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Keywords

  • Vertebral Lumbar Mobilisations
  • Hypoalgesia
  • Pinprick sensitivity (PPS)
  • Neuropen®
03

In context

Low Back Pain

2,875 studies on the registry are indexed under Low Back Pain; 484 are open to participants now.

This study's enrollment of 20 is below the median of 60 across 2,315 interventional studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

This is the only study on the registry with Darren Cooper as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy and consent.

Exclusion criteria

Exclusion Criteria:

  • Yes to any Vertebral Mobilisation Contraindication.
  • Consulted a doctor within the last 6 months?
  • Presently taking any form of medication?
  • Suffered from a bacterial or viral infection in the last 2 weeks?
  • Ever suffered from any form of heart complaint?
  • Family history of heart disease?
  • Ever suffered from: Asthma, Diabetes, Bronchitis, Epilepsy, High blood pressure or Low blood pressure?
  • Currently have any form of muscle or joint injury?
  • Had to suspend training in the last two weeks for a physical reason?
  • Is there anything that may prevent the successful completion of the tests that have been outlined?

Any "yes" answers to any of the questions above will require further detail, then the answers will be assessed to establish the potential risks to the participant and established if it is safe to participate in the study.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Vertebral Lumbar Mobilisations

    Participants received the intervention.

    Other: Lumbar Vertebral Mobilisation

Interventions

  • OtherLumbar Vertebral Mobilisation

    The participants received Vertebral Lumbar Mobilisations, these were posterior-anterior central vertebral pressures (PACVPs) for four sets of 30 seconds, with up to 30s between each, at a grade III amplitude.

06

What researchers measure

Primary outcomes

  1. Pinprick sensitivity (PPS)

    Using a Neuropen® (Owen Mumford, Oxfordshire, UK) a standardised force of 40g was applied to one of the dermatome 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.

    Time frame: Up to 15 minutes

07

Study locations

1 site
  • University of Worcester
    Worcester, Worcestershire WR5 3WP, United Kingdom
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Oct 27, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — IPD used in the results publication will be available upon request.

Supporting information: Study protocol, Clinical study report

Time frame: December 2024 onwards

Access criteria: Emailing the study contact.

Data sharing details ↗ · www.worcester.ac.uk

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06548633
Lead sponsor
Darren Cooper
Responsible party
Darren Cooper (Principal Lecturer in Sports Therapy, University of Worcester) — Sponsor-investigator
First posted
Aug 12, 2024
Start date
Oct 4, 2018
Primary completion
Feb 1, 2019
Completion
May 28, 2019
Last update
Aug 12, 2024

Study contacts

Darren Cooper, Dr
study director · University of Worcester

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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