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

NCT05437016 | Unknown

• 1 other identifier: 2022-A00885-38
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Keywords

isokinetic; physical activity; rehabilitation; HUBER platform

Outcome Measures

Primary Outcomes (1)

• Change in the flexor to extensor ratio measured by Cybex at 60°/s.

  change at 6 weeks from baseline in the flexor to extensor ratio measured by Cybex at 60°/s

  Baseline and post-intervention at 6 weeks

Secondary Outcomes (13)

• Change in the flexor to extensor ratio measured by Cybex at 120°/s.

  Baseline and post-intervention at 6 weeks

• Change in the peak torque of the extensor muscles of the spine measured by Cybex at 60 and 120°/s.

  Baseline and post-intervention at 6 weeks

• Change in the peak torque of the flexor muscles of the spine measured by Cybex at 60 and 120°/s.

  Baseline and post-intervention at 6 weeks

• Change in the hamstring extensibility (Right/Left) (in degrees)

  Baseline and post-intervention at 6 weeks

• Change in Extensibility of the Psoas (Right/Left) (in degrees)

  Baseline and post-intervention at 6 weeks

Study Arms (2)

HUBER rehabilitation group

EXPERIMENTAL

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

Behavioral: HUBER exercises

Standard rehabilitation group

ACTIVE COMPARATOR

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.

Behavioral: Standard exercises

Interventions

HUBER exercises BEHAVIORAL

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.

HUBER rehabilitation group

Standard exercises BEHAVIORAL

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.

Standard rehabilitation group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thibaut Guiraud: lead

Study Sites (1)

CLINEA - Centre de Rééducation fonctionnelle de Treboul

Douarnenez, 29100, France

RECRUITING

Related Publications (1)

• LE Moal V, Tantot M, Mevellec E, Nouy-Trolle I, Lemoine-Josse E, Besnier F, Guiraud T. Rehabilitation therapy using the HUBER platform in chronic non-specific low back pain: a randomized controlled trial. Eur J Phys Rehabil Med. 2023 Oct;59(5):576-585. doi: 10.23736/S1973-9087.23.07998-4. Epub 2023 Sep 22.

  PMID: 37737050 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Thibaut Guiraud, PhD

  ORPEA/CLINEA Group

  STUDY DIRECTOR

Central Study Contacts

Thibaut Guiraud, PhD

CONTACT

+33 5 46 68 00 77; t.guiraud@orpea.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Thibaut Guiraud, PhD

Model Details: monocentric, prospective, randomised, simple blind study (evaluators) with 2 intervention arms (1:1 ratio)

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 29, 2022
• Study Start: June 23, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)