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

T

Thibaut Guiraud

Status

Enrolling

Conditions

Chronic Low-back Pain

Treatments

Behavioral: HUBER exercises
Behavioral: Standard exercises

Study type

Interventional

Funder types

Other

Identifiers

NCT05437016
2022-A00885-38

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

20 to 55 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

70 participants in 2 patient groups

HUBER rehabilitation group
Experimental group
Description:
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 on the HUBER platform to perform exercises
Treatment:
Behavioral: HUBER exercises
Standard rehabilitation group
Active Comparator group
Description:
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.
Treatment:
Behavioral: Standard exercises

Trial contacts and locations

1

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Central trial contact

Thibaut Guiraud, PhD

Data sourced from clinicaltrials.gov

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