Clinical trial NCT04155970: The Biomechanical Effects of Manual Therapy - A Feasibility 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain, Mechanical
Keywords: Manual Therapy
Fluoroscope
Mechanics
Kinematics
Lead sponsor: Bournemouth University
Sponsor class: OTHER
Collaborators: name: AECC University College
First posted: 2019-11-07
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two groups in parallel for the duration of the study.
Primary purpose: BASIC_SCIENCE

Brief 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. 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?

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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).
* 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.

Primary outcomes:
measure: Ratio of presenting patients and eligible patients
timeFrame: 1 year
measure: Ratio of patients approached vs. number of participants who consent to trial
timeFrame: 1 year
measure: Incidence of participant withdrawal
timeFrame: 1 year
measure: Incidence of participant being withdrawn
timeFrame: 1 year
measure: Participant compliance in arm one
timeFrame: 1 year
measure: Participant compliance in arm two
timeFrame: 1 year
measure: Number of participants who experienced adverse or serious adverse events
timeFrame: 1 year
Secondary outcomes:
measure: Bournemouth Questionnaire
timeFrame: 2 weeks
measure: Roland Morris Disability Questionnaire - 24
timeFrame: 2 weeks
measure: Inter-vertebral range of angular motion
timeFrame: 2 weeks
measure: Sagittal translation
timeFrame: 2 weeks
measure: Laxity
timeFrame: 2 weeks
measure: Anterior disc height
timeFrame: 2 weeks
measure: Motion Sharing Inequality (MSI)
timeFrame: 2 weeks
measure: Motion Sharing Variability (MSV)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
facility: Bournemouth University
state: Dorset
Study officials:
affiliation: Head of Department - Design & Engineering
name: Philip Sewell
role: STUDY_CHAIR
References: