Contact information
Type
Scientific
Primary contact
Mr François Reumont
ORCID ID
http://orcid.org/0000-0001-6950-3595
Contact details
Rue du camp
48
Marbais
1495
Belgium
Type
Scientific
Additional contact
Professor Frédéric Dierick
ORCID ID
Contact details
134
Rue Trieu Kaisin
Montignies-sur-Sambre
6061
Belgium
Type
Scientific
Additional contact
Mr Paul Thiry
ORCID ID
Contact details
Avenue Gambetta
51
La Louvière
7100
Belgium
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Diffusion of water within lumbar intervertebral discs after a single session of postero-anterior spinal mobilization in subjects with acute low back pain
Acronym
Study hypothesis
The objective of our research project is to study the effectiveness of a single session of postero-anterior (PA) spinal mobilization of lumbar vertebrae in patients suffering from acute low back pain. The evaluation of the effectiveness of the PA will be mainly based on the analysis of MRI diffusion-weighted images and the computation of the apparent diffusion coefficient (ADC). Our main hypothesis is that in vivo diffusion of water within lumbar intervertebral discs will be increased at least at the level of the PA pressure.
Ethics approval
Saint-Luc Hospital and Departmental Ethics Committee (2014/07AOU/419), 06/10/2014, ref: B403201421675.
Study design
Non randomized single-center trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Low back pain (LBP). By definition, LBP is a lumbar pain localization, between the twelfth thoracic vertebra (Th12) and lumbosacral junction, with radiating pain in the gluteal area or towards the knee.
Intervention
During data collection, each subject was assessed by two therapists. The first therapist filled in the Visual Analogue Scale for pain and 2 questionnaires with the subject (Saint-Antoine and DN4). The second therapist, carried out various musculoskeletal clinical tests (flexion, extension and lateral flexion of the trunk in standing) and a neuro-dynamic test (SLUMP test). Then, a first MRI scan of the lumbar region of the subject was carried out. After this first MRI, a spinal mobilization type PA (Maitland) was carried by the second therapist. To complete the data collection, a second MRI scanner, identical to the first, was carried out on the subject within an hour after the spinal manipulation. During this time, all questionnaires (except DN4) and clinical tests are again carried out by the two therapists.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
We used the diffusion-weighted sequences to quantify the “micro” movements of water molecules within the intervertebral discs (IVDs) of the lumbar spine. The apparent diffusion coefficient (ADC) provides the image of the mobility of water molecules.
Secondary outcome measures
1. VAS: The visual analogue scale is a slider that allows the subject to self-evaluate the pain using a cursor. The patient moves the cursor to the end of "no pain" to the end "worst pain imaginable ". On the back of the slider, the therapist can evaluate the pain felt by the subject, using a scale in millimeters.
2. Trunk flexion before onset of pain: Positioning the patient standing with knees extended. Asked to flex the trunk while specifying it to properly wrap one by one the vertebrae trying to go touch her toes until the onset of pain. Finally, the therapist noted measuring the distance between the fingertips and the ground.
3. Trunk extension before onset of pain: Positioning the patient standing knees, in strict extension. It then requests extension of the column leaving the arms hang vertically. The therapist must be careful to secure the patient's pelvis to look only at the extension of the column. Finally, the therapist noted measuring the distance between the fingertips and the ground.
4. Lateral flexion of the trunk before onset of pain: Measuring the distance over which the hand moves along the lower member in a lateral flexion of the trunk
Overall trial start date
06/10/2014
Overall trial end date
30/08/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. Acute low back pain
2. A period of less than 6 consecutive weeks of pain
3. More than 1 month without pain between the current and previous episodes of low back pain
4. The patient must have had more days without pain than days with pain in the past year
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
n=20
Participant exclusion criteria
1. Aversion to spinal manipulation
2. Patients with chronic low back pain (pain for more than 3 months)
3. Radiating pain below the knees
4. Spine fracture
5. Spine Surgery
6. Osteoporosis
7. Pregnancy
8. Implanted devices that could interact with the magnetic field of the MRI
9. Intolerance using MRI (claustrophobia)
10. Safety issue related to the equipment's weight capacity (obesity)
11. Alcohol or drug abuse, mental illness or lack of cognitive ability
Recruitment start date
07/10/2014
Recruitment end date
30/08/2015
Locations
Countries of recruitment
Belgium
Trial participating centre
HELHa (Haute Ecole Louvain en Hainaut)
134, rue Trieu Kaisin
Montignies -sur-Sambre
6061
Belgium
Sponsor information
Organisation
HELHa (Haute Ecole Louvain en Hainaut)
Sponsor details
134
rue Trieu Kaisin
Montignies-sur-Sambre
6061
Belgium
Sponsor type
University/education
Website
Organisation
GEPTO A.S.B.L
Sponsor details
51
Avenue Gambetta
La Louvière
7100
Belgium
Sponsor type
Other
Website
Organisation
Siemens s.a. - Healthcare
Sponsor details
123
Guido Gezellestraat
Huizingen
1654
Belgium
Sponsor type
Industry
Website
Organisation
GHdC a.s.b.l.
Sponsor details
3
Grand'Rue
Charleroi
6000
Belgium
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Not defined
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish date
Participant level data
Available on request
Results - basic reporting
Publication summary