The effect of the spinal mobilization in subjects with acute low back pain

ISRCTN	ISRCTN16069685
DOI	https://doi.org/10.1186/ISRCTN16069685
Protocol serial number	N/A
Sponsors	Haute École Louvain en Hainaut, GEPTO A.S.B.L, Siemens s.a. - Healthcare, GHdC a.s.b.l.
Funder	Investigator initiated and funded

Submission date: 11/03/2015
Registration date: 23/03/2015
Last edited: 15/10/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Plain English summary under review

Contact information

Mr François Reumont
Scientific

Rue du camp, 48
Marbais
1495
Belgium

ORCID ID	0000-0001-6950-3595

Dr Frédéric Dierick
Scientific

134, Rue Trieu Kaisin
Montignies-sur-Sambre
6061
Belgium

Mr Paul Thiry
Scientific

Avenue Gambetta, 51
La Louvière
7100
Belgium

Study information

Primary study design	Interventional
Study design	Non randomized single-center trial
Secondary study design	Non randomised study
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
Study objectives	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(s)	Saint-Luc Hospital and Departmental Ethics Committee (2014/07AOU/419), 06/10/2014, ref: B403201421675.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	30/08/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	20
Total final enrolment	16
Key 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
Key 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
Date of first enrolment	07/10/2014
Date of final enrolment	30/08/2015

Locations

Countries of recruitment

Belgium

Study participating centre

HELHa (Haute Ecole Louvain en Hainaut)

134, rue Trieu Kaisin
Montignies -sur-Sambre
6061
Belgium

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	29/05/2018	15/10/2020	Yes	No

Editorial Notes

15/10/2020: Publication reference and total final enrolment number added.