Condition category
Musculoskeletal Diseases
Date applied
11/03/2015
Date assigned
23/03/2015
Last edited
23/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Plain English summary under review

Trial website

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

Publication citations

Additional files

Editorial Notes