Lower Back Pain Clinical Trial
— IMOOVE ITOfficial title:
Traditional Rehabilitation Versus Rehabilitation With the Imoove® Device for Spinal Musculoskeletal Disorders: a Randomised Controlled Trial
Verified date | January 2019 |
Source | Centre Hospitalier Universitaire de Nimes |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 60 |
Est. completion date | June 28, 2018 |
Est. primary completion date | June 28, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
France | CHRU de Montpellier - Hôpital Lapeyronie | Montpellier | |
France | CHRU de Nîmes - Hôpital Universitaire Carémeau | Nîmes Cedex 9 |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nimes |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in postural stability on the platform, eyes closed | Baseline to 6 weeks | ||
Secondary | Change in postural stability on the platform, eyes closed | Baseline to 6 months | ||
Secondary | Change in postural stability on the platform, eyes open | Baseline to 6 weeks | ||
Secondary | Change in postural stability on the platform, eyes open | Baseline to 6 months | ||
Secondary | Change in postural stability on the platform, eyes open and with an unstable surface | Baseline to 6 weeks | ||
Secondary | Change in postural stability on the platform, eyes open and with an unstable surface | Baseline to 6 months | ||
Secondary | Change in postural stability on the platform, eyes closed and with an unstable surface | Baseline to 6 weeks | ||
Secondary | Change in postural stability on the platform, eyes closed and with an unstable surface | Baseline to 6 months | ||
Secondary | Abdominal endurance: Ito test | Baseline (day 0) | ||
Secondary | Abdominal endurance: Ito test | 6 weeks | ||
Secondary | Abdominal endurance: Ito test | 6 months | ||
Secondary | Sorensen test | Baseline (day 0) | ||
Secondary | Sorensen test | 6 weeks | ||
Secondary | Sorensen test | 6 months | ||
Secondary | Dallas questionnaire | Baseline (day 0) | ||
Secondary | Dallas questionnaire | 6 weeks | ||
Secondary | Dallas questionnaire | 6 months | ||
Secondary | Quebec questionnaire | Baseline (day 0) | ||
Secondary | Quebec questionnaire | 6 weeks | ||
Secondary | Quebec questionnaire | 6 months | ||
Secondary | FABQ questionnaire | Baseline (day 0) | ||
Secondary | FABQ questionnaire | 6 weeks | ||
Secondary | FABQ questionnaire | 6 months | ||
Secondary | Tampa Score | Baseline (day 0) | ||
Secondary | Tampa Score | 6 weeks | ||
Secondary | Tampa Score | 6 months | ||
Secondary | Visual analog scale for pain | ranging from 0 to 10 | Baseline (day 0) | |
Secondary | Visual analog scale for pain | ranging from 0 to 10 | 6 weeks | |
Secondary | Visual analog scale for pain | ranging from 0 to 10 | 6 months |
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