Low Back Pain, MechanicalNCT04155970
The Biomechanical Effects of Manual Therapy - A Feasibility Study
A study testing Manual therapy and Evidence-informed home management booklet in people with Low Back Pain, Mechanical, run by Bournemouth University at 1 site in United Kingdom.
Trial summary
The aim of this study is to determine the feasibility of conducting a full-scale trial to explore if there is a change in intervertebral movement following a course of manual therapy in patients with acute non-specific low back pain (NSLBP). Research Questions: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- Manual therapy and Evidence-informed home management booklet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Feb 2020to 19 Mar 2021
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with acute non-specific low back pain (NSLBP), without leg pain, of at least 2 weeks duration, but no more than 4 weeks duration
- Patients between the ages of 18 and 65
Who cannot join
- Patients who cannot understand written English and unable to provide full informed consent.
- Patients who are currently involved in another research study
- Patients with a BMI over 30 (less likely to obtain the required information from the images)
- Pregnancy or potentially pregnant
- Previous ionising radiation exposure within the last 6 months greater than 8mSv.
- Previous lumbar spine surgery, as well as recent abdominal or pelvic surgery (within the last 12 months).
Show all 12Show fewer
- Scoliosis or positive Adams forward Bending Test for Scoliosis.
- Diagnosed Osteoporosis (Bone Density Scan)
- Patients with a numeric pain scale of 8 or more, or 2 or less, taken at the New Patient Examination Appointment.
- Manual therapy already received for this episode of NSLBP
- Litigation or compensation pending
- Diagnosis of depression (by a medical doctor) within the last 12 months.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Bournemouth University
Bournemouth, Dorset, BH12 5BB
About this study
Official title: In Patients With Acute Non-specific Low Back Pain, do Lumbar Inter-vertebral Motion Variables Change Following a Course of Manual Therapy: A Feasibility Study
The aim of this study is to determine the feasibility of conducting a full-scale trial to explore if there is a change in intervertebral movement following a course of manual therapy in patients with acute non-specific low back pain (NSLBP).
Research Questions:
- In patients with acute NSLBP, does lumbar intervertebral movement change following a course of manual therapy?
- In patients with acute NSLBP, do those who respond to manual therapy (established by patient reported outcomes measures) have different intervertebral movement to those who do not?
Read the detailed description
Non-specific low back pain (NSLBP) is a leading cause of disability and work-days lost worldwide. Yet, in most cases we do not know the specific cause. It is thought to be due to abnormal movement between the spinal bones (vertebrae). The investigators can now measure movement between vertebrae using low-dose quantitative fluoroscopy (QF), or motion x-ray videos. QF is a reliable method of measuring spinal movement which is non-invasive and does not expose the patient to a lot of radiation. In this study, QF will be used as a measuring tool to measure spinal movement in patients with acute NSLBP before manual therapy versus after manual therapy to explore if there is a change in spinal movement. Research suggests that some patients respond to manual therapy and some do not, a secondary question in this study is to explore if there are differences in spinal movement between those who respond to manual therapy (measured using pain and disability questionnaires) and those who do not.
This study is a feasibility study to determine whether the study can be carried out as a full-scale trial. Participants will be recruited from the AECC University College (AECC UC) Clinic. Following an examination, patients with acute low back pain, and who are eligible for the study will be invited to join. Participants will proceed with initial measurements which include validated questionnaires and QF. Following these measurements participants will be randomised into two groups, each containing 15 participants. Both groups will receive an evidence-informed home management booklet, the manual therapy group will receive five manual therapy treatments in two weeks. Participants will return for follow-up measurements two weeks after baseline measurements.
- Conditions
- Low Back Pain, Mechanical
- Being tested
- Manual therapy, Evidence-informed home management booklet
- Keywords
- Manual Therapy, Fluoroscope, Mechanics, Kinematics
- 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.
Manual therapyOther
Manual therapy, which includes spinal manipulation; spinal mobilisation; light massage; and trigger point therapy.
Evidence-informed home management bookletOther
Also called Low back pain self help booklet
The home management booklet includes advice on posture, over the counter pain medication, cold and heat packs. The booklet also includes a section on patient reassurance and where to seek help from a medical professional in an emergency.
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy Arm | Experimental | The group will receive manual therapy, as well as an evidence-informed home management booklet. Receives: Other: Manual therapy; Other: Evidence-informed home management booklet |
| Non-Manual Therapy Arm | Experimental | The group will receive an evidence-informed home management booklet only. Receives: Other: Evidence-informed home management booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of presenting patients and eligible patients
Ratio of the number of patients seeking care for acute non-specific low back pain vs. number of eligible patients (according to eligibility criteria)
Measured: 1 year
Ratio of patients approached vs. number of participants who consent to trial
Rate of conversion from number of patients approached (who are eligible for the trial) to number of participants who consent to be a part of the trial.
Measured: 1 year
Incidence of participant withdrawal
Total participant number in the trial vs. number of participants who withdraw from the trial (where the participant withdraws from the trial)
Measured: 1 year
Incidence of participant being withdrawn
Total participant number in the trial vs. number of participants who have been withdraw from the trial (where the practitioner withdraws the participant from the trial)
Measured: 1 year
Participant compliance in arm one
Ratio of total participants in arm one vs. number of participants who were non-compliant with the intervention (in arm one)
Measured: 1 year
Participant compliance in arm two
Ratio of total participants in arm two vs. number of participants who were non-compliant with the intervention (in arm two)
Measured: 1 year
Number of participants who experienced adverse or serious adverse events
Ratio of total number of participants (in both groups) vs. serious adverse events, as well as adverse events.
Measured: 1 year
Secondary outcomes (8)
Bournemouth Questionnaire
Baseline and follow up Bournemouth Questionnaire scores. Scale data from 0 - 70, where 0 is the best outcome and 70 is the worst outcome. Minimally Important Change = 26.
Measured: 2 weeks
Roland Morris Disability Questionnaire - 24
Baseline and follow up Roland Morris Disability Questionnaire - 24. Scale data from 0 - 24, where 0 is the best outcome and 24 is the worst outcome. Minimally Important Change = 5.
Measured: 2 weeks
Inter-vertebral range of angular motion
Baseline and follow up measurement taken from Quantitative Fluoroscopy (QF). QF systems combines fluoroscopy, with a computer-based process which tracks the vertebrae motion and calculates inter-vertebral movement variables.
Inter-vertebral range of angular motion is scale data measured in degrees.
Measured: 2 weeks
Sagittal translation
Baseline and follow up measurement taken from Quantitative Fluoroscopy (QF). Sagittal translation is scale data measured in millimetres.
Measured: 2 weeks
Laxity
Baseline and follow up measurement taken from Quantitative Fluoroscopy (QF). Laxity is scale data and represents initial attainment rate.
Measured: 2 weeks
Anterior disc height
Baseline and follow up measurement taken from Quantitative Fluoroscopy (QF). Anterior disc height is scale data measured in millimetres.
Measured: 2 weeks
Motion Sharing Inequality (MSI)
Baseline and follow up measurement taken from Quantitative Fluoroscopy (QF). MSI is scale data and calculated as the average of the maximum distances between levels (L2-L5) at all data points.
Measured: 2 weeks
Motion Sharing Variability (MSV)
Baseline and follow up measurement taken from Quantitative Fluoroscopy (QF). MSV is scale data and calculated as the square root of the variance between levels (L2-L5) at all data points.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start6 Feb 2020
- Primary completion19 Mar 2021
- Study completion19 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bournemouth University
- Sponsor type
- University, hospital or other
- Collaborators
- AECC University College
- Responsible party
- Sponsor
- Investigators
- Philip Sewell, Study chair, Head of Department - Design & Engineering
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155970
- Sponsor's protocol ID
- Version 1.0
- Status last verified
- Mar 2021
- First submitted
- 1 Nov 2019
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the project is complete, the final anonymised dataset captured during the study will be uploaded to BORDaR (Bournemouth Online Research Data Repository). This is in the interest of open data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Patients With Acute Non-specific Low Back Pain, do Lumbar Inter-vertebral Motion Variables Change Following a Course of Manual Therapy: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04155970
- Acronym / sponsor ID
- Version 1.0
- Conditions
- Low Back Pain, Mechanical
- Keywords
- Manual Therapy, Fluoroscope, Mechanics, Kinematics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Bournemouth UniversityUniversity, hospital or other
- Collaborators
- AECC University College
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 19 Mar 2021 (actual)
- Study completion
- 19 Mar 2021 (actual)
- First posted
- 7 Nov 2019 (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 is to determine the feasibility of conducting a full-scale trial to explore if there is a change in intervertebral movement following a course of manual therapy in patients with acute non-specific low back pain (NSLBP).
Research Questions:
- In patients with acute NSLBP, does lumbar intervertebral movement change following a course of manual therapy?
- In patients with acute NSLBP, do those who respond to manual therapy (established by patient reported outcomes measures) have different intervertebral movement to those who do not?
Detailed description
Non-specific low back pain (NSLBP) is a leading cause of disability and work-days lost worldwide. Yet, in most cases we do not know the specific cause. It is thought to be due to abnormal movement between the spinal bones (vertebrae). The investigators can now measure movement between vertebrae using low-dose quantitative fluoroscopy (QF), or motion x-ray videos. QF is a reliable method of measuring spinal movement which is non-invasive and does not expose the patient to a lot of radiation. In this study, QF will be used as a measuring tool to measure spinal movement in patients with acute NSLBP before manual therapy versus after manual therapy to explore if there is a change in spinal movement. Research suggests that some patients respond to manual therapy and some do not, a secondary question in this study is to explore if there are differences in spinal movement between those who respond to manual therapy (measured using pain and disability questionnaires) and those who do not.
This study is a feasibility study to determine whether the study can be carried out as a full-scale trial. Participants will be recruited from the AECC University College (AECC UC) Clinic. Following an examination, patients with acute low back pain, and who are eligible for the study will be invited to join. Participants will proceed with initial measurements which include validated questionnaires and QF. Following these measurements participants will be randomised into two groups, each containing 15 participants. Both groups will receive an evidence-informed home management booklet, the manual therapy group will receive five manual therapy treatments in two weeks. Participants will return for follow-up measurements two weeks after baseline measurements.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two groups in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy Arm | Experimental | Other: Manual therapy, Other: Evidence-informed home management bookletThe group will receive manual therapy, as well as an evidence-informed home management booklet. |
| Non-Manual Therapy Arm | Experimental | Other: Evidence-informed home management bookletThe group will receive an evidence-informed home management booklet only. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with acute non-specific low back pain (NSLBP), without leg pain, of at least 2 weeks duration, but no more than 4 weeks duration
- Patients between the ages of 18 and 65
Key exclusion criteria (12 listed)
- Patients who cannot understand written English and unable to provide full informed consent.
- Patients who are currently involved in another research study
- Patients with a BMI over 30 (less likely to obtain the required information from the images)
- Pregnancy or potentially pregnant
- Previous ionising radiation exposure within the last 6 months greater than 8mSv.
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 |
|---|---|---|
| Manual therapyManual therapy, which includes spinal manipulation; spinal mobilisation; light massage; and trigger point therapy. | Other | Manual Therapy Arm |
| Evidence-informed home management bookletAlso: Low back pain self help bookletThe home management booklet includes advice on posture, over the counter pain medication, cold and heat packs. The booklet also includes a section on patient reassurance and where to seek help from a medical professional in an emergency. | Other | Manual Therapy Arm, Non-Manual Therapy Arm |
Primary outcome
Ratio of presenting patients and eligible patients
Time frame: 1 year
Ratio of the number of patients seeking care for acute non-specific low back pain vs. number of eligible patients (according to eligibility criteria)
Ratio of patients approached vs. number of participants who consent to trial
Time frame: 1 year
Rate of conversion from number of patients approached (who are eligible for the trial) to number of participants who consent to be a part of the trial.
Incidence of participant withdrawal
Time frame: 1 year
Total participant number in the trial vs. number of participants who withdraw from the trial (where the participant withdraws from the trial)
Incidence of participant being withdrawn
Time frame: 1 year
Total participant number in the trial vs. number of participants who have been withdraw from the trial (where the practitioner withdraws the participant from the trial)
Participant compliance in arm one
Time frame: 1 year
Ratio of total participants in arm one vs. number of participants who were non-compliant with the intervention (in arm one)
Participant compliance in arm two
Time frame: 1 year
Ratio of total participants in arm two vs. number of participants who were non-compliant with the intervention (in arm two)
Number of participants who experienced adverse or serious adverse events
Time frame: 1 year
Ratio of total number of participants (in both groups) vs. serious adverse events, as well as adverse events.
8 secondary outcomes
Bournemouth Questionnaire
Time frame: 2 weeks
Roland Morris Disability Questionnaire - 24
Time frame: 2 weeks
Inter-vertebral range of angular motion
Time frame: 2 weeks
Sagittal translation
Time frame: 2 weeks
Laxity
Time frame: 2 weeks
Anterior disc height
Time frame: 2 weeks
Motion Sharing Inequality (MSI)
Time frame: 2 weeks
Motion Sharing Variability (MSV)
Time frame: 2 weeks
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 25 Mar 2021.
- Individual participant dataSharing planned: Yes. Once the project is complete, the final anonymised dataset captured during the study will be uploaded to BORDaR (Bournemouth Online Research Data Repository). This is in the interest of open data sharing.
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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.
Philip Sewell study chair
Head of Department - Design & Engineering
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy and Evidence-informed home management booklet in people with Low Back Pain, Mechanical, run by Bournemouth University 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 2 inclusion and 12 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 25 Mar 2021. 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?
Ratio of presenting patients and eligible patients (time frame: 1 year). The study lists 7 primary outcomes in all. 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 25 Mar 2021.