NCT05437016

Functional Rehabilitation With HUBER Platform in the Treatment of Non-specific Chronic Low Back Pain.

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Thibaut Guiraud · Academic / Other
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Low-back Pain

Interventions

Type	Name	Description
BEHAVIORAL	HUBER exercises	All the exercises involve mobility, flexibility and muscle strengthening exercises. Specifically, these exercises included self-awareness of the lumbo-pelvic-femoral complex and multidirectional mobility of the lumbar spine. We gradually integrated aerobic exercises and muscle strengthening of the lower limbs, trunk and spine extensors with bodyweight exercises. HUBER exercises require the synergistic activation of various muscle groups of the lower limbs, trunk and upper limbs to develop low-high force levels against the handles.
BEHAVIORAL	Standard exercises	All the exercises involve mobility, flexibility and muscle strengthening exercises. Specifically, these exercises included self-awareness of the lumbo-pelvic-femoral complex and multidirectional mobility of the lumbar spine. We gradually integrated aerobic exercises and muscle strengthening of the lower limbs, trunk and spine extensors with bodyweight exercises.

Timeline

• Start date: 2022-06-23
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2022-06-29
• Last updated: 2022-09-28

Locations

1 site across 1 country: France