Lower Back Pain
Conditions
Keywords
Proprioception
Brief summary
The main objective of this study is to evaluate in patients with chronic low back pain (lasting for more than 3 months and not postoperative) the effect of an instrumental rehabilitation using the I-Moove ® device compared to a conventional physiotherapy rehabilitation for ambulatory postural stability (mean and standard deviation of excursions from the center of gravity) without visual control, 6 weeks after the start of the rehabilitation protocol. We focus on the relative variation between the values obtained on day 0 versus 6 weeks, via measures performed on a force platform. The results will be stratified into 3 age groups (18-39 years, 40-60 years and over 60 years).
Detailed description
The secondary objectives of this study are to evaluate and compare the two physical therapy techniques at 6 weeks and 6 months after the start of the rehabilitation protocol in terms of: A - improving postural stability and visual control on an unstable surface (with and without visual control) B - improving levels of abdominal strength (Ito test) and erector spinae (Sørensen test) C - the impact of back pain on daily life using questionnaires (Dallas, Québec, FABQ and Tampa questionnaires/scores) D - Improvement of pain (Visual Analog Scale),
Interventions
OTHERRoutine Physical Therapy
Patients randomized to this arm will participate in a classic physical therapy program (15 weeks, a total of 15 sessions).
DEVICEI-Moove Physical Therapy
Patients randomized to this arm will participate in a physical therapy program using the I-Moove device (15 weeks, a total of 15 sessions).
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* The patient must have given his/her informed and signed consent * The patient must be insured or beneficiary of a health insurance plan * The patient is available for 6 months of follow-up * Patients with pain in the lumbar spine (low back pain) for at least 3 months, not in connection with an operation
Exclusion criteria
* The patient is participating in another study * The patient is in an exclusion period determined by a previous study * The patient will have difficulties with follow-up (the patient is about to move, or isn't motivated) * The patient is under judicial protection, under tutorship or curatorship * The patient refuses to sign the consent * It is impossible to correctly inform the patient * The patient is pregnant, parturient, or breastfeeding * The patient has already participated in a dynamic physical therapy program * The patient has a contraindication for a treatment used in this study * The patient has had surgery in the past year * The patient has a pathology that can interfere with the physical therapy regimen (heart failure, respiratory failure, major orthopedic problems)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in postural stability on the platform, eyes closed | Baseline to 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in postural stability on the platform, eyes open | Baseline to 6 weeks | — |
| Change in postural stability on the platform, eyes open and with an unstable surface | Baseline to 6 weeks | — |
| Change in postural stability on the platform, eyes closed and with an unstable surface | Baseline to 6 weeks | — |
| Abdominal endurance: Ito test | Baseline (day 0) | — |
| Sorensen test | Baseline (day 0) | — |
| Change in postural stability on the platform, eyes closed | Baseline to 6 months | — |
| Quebec questionnaire | Baseline (day 0) | — |
| FABQ questionnaire | Baseline (day 0) | — |
| Tampa Score | Baseline (day 0) | — |
| Visual analog scale for pain | Baseline (day 0) | ranging from 0 to 10 |
| Dallas questionnaire | Baseline (day 0) | — |
Countries
France
Outcome results
None listed