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

Primary Purpose

Chronic Low-back Pain

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
HUBER exercises
Standard exercises
Sponsored by
Thibaut Guiraud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Low-back Pain focused on measuring isokinetic, physical activity, rehabilitation, HUBER platform

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • CLINEA - Centre de Rééducation fonctionnelle de TreboulRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HUBER rehabilitation group

Standard rehabilitation group

Arm 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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in the flexor to extensor ratio measured by Cybex at 120°/s.
change at 6 weeks from baseline in the flexor to extensor ratio measured by Cybex at 60°/s
Change in the peak torque of the extensor muscles of the spine measured by Cybex at 60 and 120°/s.
change at 6 weeks from baseline in the strength of the extensor muscles of the spine (peak torque at 60°/s and 120°/s concentric)
Change in the peak torque of the flexor muscles of the spine measured by Cybex at 60 and 120°/s.
change at 6 weeks from baseline in the strength of the flexor muscles of the spine (peak torque at 60°/s and 120°/s concentric)
Change in the hamstring extensibility (Right/Left) (in degrees)
The patient was lying in the supine position with the contralateral lower limb extended on the table. The therapist then flexed the hip at 90°, brought the knee to extension until their limit (according to the sensations of the patient). An inclinometer was placed on the anterior tibial tuberosity to measure the angle (in degrees) of the popliteal between the tibia and the femur on both legs.
Change in Extensibility of the Psoas (Right/Left) (in degrees)
the modified Thomas' test was used to measure flexibility of the hip flexors, which included the iliopsoas muscle group. The patient laid on their back, with both legs hanging freely at the edge of the table. First, they achieved a maximum flexion of both knees using both arms to ensure that the lumbar spine is flexed and flat on the table to avoid an anterior tilt of the pelvis. The patient then lowered the tested limb toward the table, whilst the contralateral hip and knee was held in maximal flexion to stabilize the pelvis and flatten out the lumbar lordosis. Once the final position was reached, the inclinometer was placed along the midline of the femur, between the greater trochanter and the lateral femoral condyles (in degrees). The length of the iliopsoas was measured by the angle of the hip flexion.
Change in Extensibility of the Quadriceps (Right/Left) (in cm)
Ely's test heal-buttock distance was used to measure the flexibility of the quadriceps. The patient laid in prone position. The therapist stood next to the patient, at the side of the leg that is tested. The patient's knee was flexed to bring their heel as close as possible to their buttock. One hand was on the lower back, the other holding the leg at the heel. The closest distance between the heel and the buttock (in cm) was measured. The test is done on both sides for comparison.
Change in the double-lumbar inclinometry in flexion (in degrees)
Dual inclinometer technique was used to assess spinal. Lumbar range of motion in flexion, extension, right and left lateral flexion.
Change in the double-lumbar inclinometry in extension (in degrees)
Dual inclinometer technique was used to assess spinal. Lumbar range of motion in flexion, extension, right and left lateral flexion.
Change in the double-lumbar inclinometry in inclination (Right/Left) (in degrees)
Dual inclinometer technique was used to assess spinal. Lumbar range of motion in flexion, extension, right and left lateral flexion.
Change in the muscular endurance of the trunk and of the lower limbs (in secondes)
Shirado-Ito test (spinal flexors), Sorensen test (Extensors of the spine), Killy test.
Change in the Score of Pain (Scale from 0 to 10)
A visual analogue pain scale graded from 0 to 10 was used to quantify the amount of pain that a patient feels from none (0) to an extreme amount of pain (10)
Change in Fear and Avoidance Belief Questionnaire (FABQ) score
is a self-reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability. Sixteen questions scaled from 0 to 6 (higher the score indicates fear avoidance behaviors). The Physical Activity subscale (FABQ-PA) range from 0 to 24 and the Work subscale (FABQ-W) range from 0 to 42.
Change in Oswestry Disability Index questionnaire score
is a self-completed questionnaire containing ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category was followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient checked the statement which most closely resembled their situation. Each question was scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.

Full Information

First Posted
June 23, 2022
Last Updated
September 26, 2022
Sponsor
Thibaut Guiraud
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1. Study Identification

Unique Protocol Identification Number
NCT05437016
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thibaut Guiraud

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
isokinetic, physical activity, rehabilitation, HUBER platform

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
monocentric, prospective, randomised, simple blind study (evaluators) with 2 intervention arms (1:1 ratio)
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HUBER rehabilitation group
Arm Type
Experimental
Arm 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
Arm Title
Standard rehabilitation group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
HUBER exercises
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the flexor to extensor ratio measured by Cybex at 60°/s.
Description
change at 6 weeks from baseline in the flexor to extensor ratio measured by Cybex at 60°/s
Time Frame
Baseline and post-intervention at 6 weeks
Secondary Outcome Measure Information:
Title
Change in the flexor to extensor ratio measured by Cybex at 120°/s.
Description
change at 6 weeks from baseline in the flexor to extensor ratio measured by Cybex at 60°/s
Time Frame
Baseline and post-intervention at 6 weeks
Title
Change in the peak torque of the extensor muscles of the spine measured by Cybex at 60 and 120°/s.
Description
change at 6 weeks from baseline in the strength of the extensor muscles of the spine (peak torque at 60°/s and 120°/s concentric)
Time Frame
Baseline and post-intervention at 6 weeks
Title
Change in the peak torque of the flexor muscles of the spine measured by Cybex at 60 and 120°/s.
Description
change at 6 weeks from baseline in the strength of the flexor muscles of the spine (peak torque at 60°/s and 120°/s concentric)
Time Frame
Baseline and post-intervention at 6 weeks
Title
Change in the hamstring extensibility (Right/Left) (in degrees)
Description
The patient was lying in the supine position with the contralateral lower limb extended on the table. The therapist then flexed the hip at 90°, brought the knee to extension until their limit (according to the sensations of the patient). An inclinometer was placed on the anterior tibial tuberosity to measure the angle (in degrees) of the popliteal between the tibia and the femur on both legs.
Time Frame
Baseline and post-intervention at 6 weeks
Title
Change in Extensibility of the Psoas (Right/Left) (in degrees)
Description
the modified Thomas' test was used to measure flexibility of the hip flexors, which included the iliopsoas muscle group. The patient laid on their back, with both legs hanging freely at the edge of the table. First, they achieved a maximum flexion of both knees using both arms to ensure that the lumbar spine is flexed and flat on the table to avoid an anterior tilt of the pelvis. The patient then lowered the tested limb toward the table, whilst the contralateral hip and knee was held in maximal flexion to stabilize the pelvis and flatten out the lumbar lordosis. Once the final position was reached, the inclinometer was placed along the midline of the femur, between the greater trochanter and the lateral femoral condyles (in degrees). The length of the iliopsoas was measured by the angle of the hip flexion.
Time Frame
Baseline and post-intervention at 6 weeks
Title
Change in Extensibility of the Quadriceps (Right/Left) (in cm)
Description
Ely's test heal-buttock distance was used to measure the flexibility of the quadriceps. The patient laid in prone position. The therapist stood next to the patient, at the side of the leg that is tested. The patient's knee was flexed to bring their heel as close as possible to their buttock. One hand was on the lower back, the other holding the leg at the heel. The closest distance between the heel and the buttock (in cm) was measured. The test is done on both sides for comparison.
Time Frame
Baseline and post-intervention at 6 weeks
Title
Change in the double-lumbar inclinometry in flexion (in degrees)
Description
Dual inclinometer technique was used to assess spinal. Lumbar range of motion in flexion, extension, right and left lateral flexion.
Time Frame
Baseline and post-intervention at 6 weeks
Title
Change in the double-lumbar inclinometry in extension (in degrees)
Description
Dual inclinometer technique was used to assess spinal. Lumbar range of motion in flexion, extension, right and left lateral flexion.
Time Frame
Baseline and post-intervention at 6 weeks
Title
Change in the double-lumbar inclinometry in inclination (Right/Left) (in degrees)
Description
Dual inclinometer technique was used to assess spinal. Lumbar range of motion in flexion, extension, right and left lateral flexion.
Time Frame
Baseline and post-intervention at 6 weeks
Title
Change in the muscular endurance of the trunk and of the lower limbs (in secondes)
Description
Shirado-Ito test (spinal flexors), Sorensen test (Extensors of the spine), Killy test.
Time Frame
Baseline and post-intervention at 6 weeks
Title
Change in the Score of Pain (Scale from 0 to 10)
Description
A visual analogue pain scale graded from 0 to 10 was used to quantify the amount of pain that a patient feels from none (0) to an extreme amount of pain (10)
Time Frame
Baseline and post-intervention at 6 weeks
Title
Change in Fear and Avoidance Belief Questionnaire (FABQ) score
Description
is a self-reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability. Sixteen questions scaled from 0 to 6 (higher the score indicates fear avoidance behaviors). The Physical Activity subscale (FABQ-PA) range from 0 to 24 and the Work subscale (FABQ-W) range from 0 to 42.
Time Frame
Baseline and post-intervention at 6 weeks
Title
Change in Oswestry Disability Index questionnaire score
Description
is a self-completed questionnaire containing ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category was followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient checked the statement which most closely resembled their situation. Each question was scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Time Frame
Baseline and post-intervention at 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thibaut Guiraud, PhD
Phone
+33 5 46 68 00 77
Email
t.guiraud@orpea.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thibaut Guiraud, PhD
Organizational Affiliation
ORPEA/CLINEA Group
Official's Role
Study Director
Facility Information:
Facility Name
CLINEA - Centre de Rééducation fonctionnelle de Treboul
City
Douarnenez
ZIP/Postal Code
29100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thibaut Guiraud, PhD
Phone
+33 5 46 68 00 77

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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