Low Back PainHypoLumbarNCT06548633
The Immediate Extent of the Hypoalgesic Effect Following Central Mobilisations to L3, L4 and L5
A study testing Lumbar Vertebral Mobilisation in people with Low Back Pain, run by Darren Cooper at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Lumbar Vertebral Mobilisation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Oct 2018to 28 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy and consent.
Who cannot join
- 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?
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Worcester
Worcester, Worcestershire, WR5 3WP
About this study
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.
- Conditions
- Low Back Pain
- Being tested
- Lumbar Vertebral Mobilisation
- Keywords
- Vertebral Lumbar Mobilisations, Hypoalgesia, Pinprick sensitivity (PPS), Neuropen®
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Vertebral MobilisationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Vertebral Lumbar Mobilisations | Experimental | Participants received the intervention. Receives: Other: Lumbar Vertebral Mobilisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start4 Oct 2018
- Primary completion1 Feb 2019
- Study completion28 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The design of the study was a randomised, single-blind, repeated measures, cross-over design, performed in a single-centre environment.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Darren Cooper
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Darren Cooper, University of Worcester
- Investigators
- Darren Cooper, Dr, Study director, University of Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548633
- Sponsor's protocol ID
- TIEHEFCML345
- Acronym
- HypoLumbar
- Status last verified
- Aug 2024
- First submitted
- 2 Aug 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD used in the results publication will be available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immediate Extent of the Hypoalgesic Effect Following Central Mobilisations to L3, L4 and L5
- ClinicalTrials.gov ID
- NCT06548633
- Acronym / sponsor ID
- HypoLumbar / TIEHEFCML345
- Conditions
- Low Back Pain
- Keywords
- Vertebral Lumbar Mobilisations, Hypoalgesia, Pinprick sensitivity (PPS), Neuropen®
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Darren CooperUniversity, hospital or other
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 28 May 2019 (actual)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The design of the study was a randomised, single-blind, repeated measures, cross-over design, performed in a single-centre environment.
| Arm | Type | Receives |
|---|---|---|
| Vertebral Lumbar Mobilisations | Experimental | Other: Lumbar Vertebral MobilisationParticipants received the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy and consent.
Key exclusion criteria (11 listed)
- 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?
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar Vertebral MobilisationThe 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. | Other | Vertebral Lumbar Mobilisations |
Primary outcome
Pinprick sensitivity (PPS)
Time frame: Up to 15 minutes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: Yes. IPD used in the results publication will be available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darren Cooper, Dr study director
University of Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar Vertebral Mobilisation in people with Low Back Pain, run by Darren Cooper at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pinprick sensitivity (PPS) (time frame: Up to 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.