Clinical trial NCT05437016: Functional Rehabilitation With HUBER Platform in the Treatment of Non-specific Chronic Low Back Pain.
Official title: Effectiveness of Functional Rehabilitation With HUBER Platform Compared to a Standard Program, on the Flexion/Extension Ratio of the Spine, in Patients With Non-specific Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: isokinetic
physical activity
rehabilitation
HUBER platform
Lead sponsor: Orpea Group
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: monocentric, prospective, randomised, simple blind study (evaluators) with 2 intervention arms (1:1 ratio)
Primary purpose: PREVENTION

Brief summary: The objective of this study is to evaluate the effectiveness of centre-based program of 6 weeks with HUBER platform on the spine flexion-to-extension ratio at 60 and 120˚/s, pain and trunk flexibility in individuals with chronic low back pain (CLBP). A total of 70 individuals with Non-specific Chronic Low Back Pain will be randomised into 2 intervention arms (1:1 ratio) that will be blindly evaluated: 1/ standard rehabilitation group and 2/ HUBER rehabilitation group. Both programs are centre-based and will last 6 weeks, with 4 sessions of 2 hours each per week.

Detailed description: The prevalence of chronic low back pain (CLBP) is increasing with age and the prevalence of sedentary lifestyle. According to guidelines, non-pharmacological approaches such as exercise and physical therapy have been proposed in first line treatments along with psychological follow-up and pain medication if needed. The physiotherapy, used in a comprehensive CLBP rehabilitation program, aims to decrease chronic pain and promotes proprioceptive and postural work, as well as spinal mobility, flexibility and muscle strengthening of the spinal area. Isokinetic concentric strength assessment at 60 and 120˚/s is one of the most commonly used criteria to examine the trunk flexors and extensors muscles strength. The objective of this study is therefore to evaluate the effectiveness of an intensive care program with HUBER platform on the spine flexion-to-extension ratio at 60 and 120˚/s measured by Cybex, pain and trunk flexibility in individuals with non-specific CLBP. A total of 70 individuals with CLBP will be randomised into 2 intervention arms (1:1 ratio) that will be blindly evaluated: 1/ standard rehabilitation group and 2/ HUBER rehabilitation group. Both programs are centre-based and will last 6 weeks, with 4 sessions of 2 hours each per week. All the sessions will be supervised by a physiotherapist and will include 1h of physiotherapy, 30min of balneotherapy and 30min of exercise on cycloergometer for the standard rehabilitation group or 30min of exercise on the HUBER platform for the HUBER group. All patients included will benefit from medical monitoring, evaluations and the rehabilitation program set up at the Clinique de Tréboul, Douarnenez, France.

Eligibility criteria: Inclusion Criteria:

* people aged between 20 - 55 years old
* with non-specific chronic low back pain (over 3 months)
* with clinical and radiological assessment.

Exclusion Criteria:

* chronic low back pain of specific etiology (trauma, tumor, inflammatory or infectious disease, and radicular syndrome)
* spine with major anatomical deformations
* any contraindication for the rehabilitation program
* surgery less than 3 months and/or receiving treatment with corticosteroids.

Primary outcomes:
measure: Change in the flexor to extensor ratio measured by Cybex at 60°/s.
timeFrame: Baseline and post-intervention at 6 weeks
Secondary outcomes:
measure: Change in the flexor to extensor ratio measured by Cybex at 120°/s.
timeFrame: Baseline and post-intervention at 6 weeks
measure: Change in the peak torque of the extensor muscles of the spine measured by Cybex at 60 and 120°/s.
timeFrame: Baseline and post-intervention at 6 weeks
measure: Change in the peak torque of the flexor muscles of the spine measured by Cybex at 60 and 120°/s.
timeFrame: Baseline and post-intervention at 6 weeks
measure: Change in the hamstring extensibility (Right/Left) (in degrees)
timeFrame: Baseline and post-intervention at 6 weeks
measure: Change in Extensibility of the Psoas (Right/Left) (in degrees)
timeFrame: Baseline and post-intervention at 6 weeks
measure: Change in Extensibility of the Quadriceps (Right/Left) (in cm)
timeFrame: Baseline and post-intervention at 6 weeks
measure: Change in the double-lumbar inclinometry in flexion (in degrees)
timeFrame: Baseline and post-intervention at 6 weeks
measure: Change in the double-lumbar inclinometry in extension (in degrees)
timeFrame: Baseline and post-intervention at 6 weeks
measure: Change in the double-lumbar inclinometry in inclination (Right/Left) (in degrees)
timeFrame: Baseline and post-intervention at 6 weeks
measure: Change in the muscular endurance of the trunk and of the lower limbs (in secondes)
timeFrame: Baseline and post-intervention at 6 weeks
measure: Change in the Score of Pain (Scale from 0 to 10)
timeFrame: Baseline and post-intervention at 6 weeks
measure: Change in Fear and Avoidance Belief Questionnaire (FABQ) score
timeFrame: Baseline and post-intervention at 6 weeks
measure: Change in Oswestry Disability Index questionnaire score
timeFrame: Baseline and post-intervention at 6 weeks
Other outcomes:
Locations:
city: Douarnenez
country: France
facility: CLINEA - Centre de Rééducation fonctionnelle de Treboul
Study officials:
affiliation: ORPEA/CLINEA Group
name: Thibaut Guiraud, PhD
role: STUDY_DIRECTOR
References: