Bournemouth University
Bournemouth, Dorset, BH12 5BB, United Kingdom
NCT Number: NCT04155970
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. In patients with acute NSLBP, does lumbar intervertebral movement change following a course of manual therapy? 2. 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?
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Bournemouth, Dorset, BH12 5BB, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Manual therapy, which includes spinal manipulation; spinal mobilisation; light massage; and trigger point therapy.
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.
Other names: Low back pain self help booklet
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)
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.
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)
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)
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)
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)
Time frame: 1 year
Ratio of total number of participants (in both groups) vs. serious adverse events, as well as adverse events.
Time frame: 2 weeks
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.
Time frame: 2 weeks
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.
Time frame: 2 weeks
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.
Time frame: 2 weeks
Baseline and follow up measurement taken from Quantitative Fluoroscopy (QF). Sagittal translation is scale data measured in millimetres.
Time frame: 2 weeks
Baseline and follow up measurement taken from Quantitative Fluoroscopy (QF). Laxity is scale data and represents initial attainment rate.
Time frame: 2 weeks
Baseline and follow up measurement taken from Quantitative Fluoroscopy (QF). Anterior disc height is scale data measured in millimetres.
Time frame: 2 weeks
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.
Time frame: 2 weeks
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.
Bournemouth University
Other
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
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