Clinical trial NCT02116387: Traditional Rehabilitation Versus Rehabilitation With the Imoove® Device for Spinal Musculoskeletal Disorders
Official title: Traditional Rehabilitation Versus Rehabilitation With the Imoove® Device for Spinal Musculoskeletal Disorders: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Back Pain
Keywords: Proprioception
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2014-04-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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),

Eligibility criteria: 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)

Primary outcomes:
measure: Change in postural stability on the platform, eyes closed
timeFrame: Baseline to 6 weeks
Secondary outcomes:
measure: Change in postural stability on the platform, eyes closed
timeFrame: Baseline to 6 months
measure: Change in postural stability on the platform, eyes open
timeFrame: Baseline to 6 weeks
measure: Change in postural stability on the platform, eyes open
timeFrame: Baseline to 6 months
measure: Change in postural stability on the platform, eyes open and with an unstable surface
timeFrame: Baseline to 6 weeks
measure: Change in postural stability on the platform, eyes open and with an unstable surface
timeFrame: Baseline to 6 months
measure: Change in postural stability on the platform, eyes closed and with an unstable surface
timeFrame: Baseline to 6 weeks
measure: Change in postural stability on the platform, eyes closed and with an unstable surface
timeFrame: Baseline to 6 months
measure: Abdominal endurance: Ito test
timeFrame: Baseline (day 0)
measure: Abdominal endurance: Ito test
timeFrame: 6 weeks
measure: Abdominal endurance: Ito test
timeFrame: 6 months
measure: Sorensen test
timeFrame: Baseline (day 0)
measure: Sorensen test
timeFrame: 6 weeks
measure: Sorensen test
timeFrame: 6 months
measure: Dallas questionnaire
timeFrame: Baseline (day 0)
measure: Dallas questionnaire
timeFrame: 6 weeks
measure: Dallas questionnaire
timeFrame: 6 months
measure: Quebec questionnaire
timeFrame: Baseline (day 0)
measure: Quebec questionnaire
timeFrame: 6 weeks
measure: Quebec questionnaire
timeFrame: 6 months
measure: FABQ questionnaire
timeFrame: Baseline (day 0)
measure: FABQ questionnaire
timeFrame: 6 weeks
measure: FABQ questionnaire
timeFrame: 6 months
measure: Tampa Score
timeFrame: Baseline (day 0)
measure: Tampa Score
timeFrame: 6 weeks
measure: Tampa Score
timeFrame: 6 months
measure: Visual analog scale for pain
timeFrame: Baseline (day 0)
measure: Visual analog scale for pain
timeFrame: 6 weeks
measure: Visual analog scale for pain
timeFrame: 6 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHRU de Montpellier - Hôpital Lapeyronie
city: Nîmes Cedex 9
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Arnaud Dupeyron, MD, PhD
role: STUDY_DIRECTOR
References: