The effect of the spinal mobilization in subjects with acute low back pain
| ISRCTN | ISRCTN16069685 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16069685 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Rue du camp, 48
Marbais
1495
Belgium
 ORCID ID |
0000-0001-6950-3595 |
|---|
Dr Frédéric Dierick
Scientific
Scientific
134, Rue Trieu Kaisin
Montignies-sur-Sambre
6061
Belgium
Mr Paul Thiry
Scientific
Scientific
Avenue Gambetta, 51
La Louvière
7100
Belgium
Study information
| Study design | Non randomized single-center trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 06/10/2014 |
| Completion date | 30/08/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | n=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
Montignies -sur-Sambre
6061
Belgium
Sponsor information
Haute École Louvain en Hainaut
University/education
University/education
134, rue Trieu Kaisin
Montignies-sur-Sambre
6061
Belgium
| Website | http://www.helha.be/#1 |
|---|---|
"ROR" |
https://ror.org/03sfp2d76 |
GEPTO A.S.B.L
Other
Other
51, Avenue Gambetta
La Louvière
7100
Belgium
Siemens s.a. - Healthcare
Industry
Industry
123, Guido Gezellestraat
Huizingen
1654
Belgium
GHdC a.s.b.l.
Hospital/treatment centre
Hospital/treatment centre
3, Grand'Rue
Charleroi
6000
Belgium
Funders
Funder type
Other
Investigator initiated and funded
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | |
| 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.
