Chronic Low-back PainNCT05437016
Functional Rehabilitation With HUBER Platform in the Treatment of Non-specific Chronic Low Back Pain.
A study testing HUBER exercises and Standard exercises in people with Chronic Low-back Pain, run by Thibaut Guiraud at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- HUBER exercises and Standard exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jun 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- people aged between 20 - 55 years old
- with non-specific chronic low back pain (over 3 months)
- with clinical and radiological assessment.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CLINEA - Centre de Rééducation fonctionnelle de Treboul
Douarnenez, 29100
Thibaut Guiraud, PhD, +33 5 46 68 00 77
About this study
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
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.
Read the 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
- Being tested
- HUBER exercises, Standard exercises
- Keywords
- isokinetic, physical activity, rehabilitation, HUBER platform
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HUBER exercisesBehavioural
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.
Standard exercisesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Standard exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and post-intervention at 6 weeks
Secondary outcomes (13)
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
Measured: 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.
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)
Measured: 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.
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)
Measured: Baseline and post-intervention at 6 weeks
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.
Measured: Baseline and post-intervention at 6 weeks
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.
Measured: Baseline and post-intervention at 6 weeks
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.
Measured: Baseline and post-intervention at 6 weeks
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.
Measured: Baseline and post-intervention at 6 weeks
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.
Measured: Baseline and post-intervention at 6 weeks
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.
Measured: Baseline and post-intervention at 6 weeks
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.
Measured: Baseline and post-intervention at 6 weeks
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)
Measured: Baseline and post-intervention at 6 weeks
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.
Measured: Baseline and post-intervention at 6 weeks
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.
Measured: Baseline and post-intervention at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start23 Jun 2022
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- monocentric, prospective, randomised, simple blind study (evaluators) with 2 intervention arms (1:1 ratio)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thibaut Guiraud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thibaut Guiraud, Orpea Group
- Investigators
- Thibaut Guiraud, PhD, Study director, ORPEA/CLINEA Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437016
- Sponsor's protocol ID
- 2022-A00885-38
- Status last verified
- Sep 2022
- First submitted
- 23 Jun 2022
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37737050
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05437016
- Acronym / sponsor ID
- 2022-A00885-38
- Conditions
- Chronic Low-back Pain
- Keywords
- isokinetic, physical activity, rehabilitation, HUBER platform
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Thibaut GuiraudUniversity, hospital or other
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- monocentric, prospective, randomised, simple blind study (evaluators) with 2 intervention arms (1:1 ratio)
| Arm | Type | Receives |
|---|---|---|
| HUBER rehabilitation group | Experimental | Behavioral: HUBER exercisescentre-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 |
| Standard rehabilitation group | Active comparator | Behavioral: Standard exercisescentre-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. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- people aged between 20 - 55 years old
- with non-specific chronic low back pain (over 3 months)
- with clinical and radiological assessment.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HUBER exercisesAll 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. | Behavioural | HUBER rehabilitation group |
| Standard exercisesAll 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. | Behavioural | Standard rehabilitation group |
Primary outcome
Change in the flexor to extensor ratio measured by Cybex at 60°/s.
Time frame: Baseline and post-intervention at 6 weeks
change at 6 weeks from baseline in the flexor to extensor ratio measured by Cybex at 60°/s
13 secondary outcomes
Change in the flexor to extensor ratio measured by Cybex at 120°/s.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and post-intervention at 6 weeks
Change in the hamstring extensibility (Right/Left) (in degrees)
Time frame: Baseline and post-intervention at 6 weeks
Change in Extensibility of the Psoas (Right/Left) (in degrees)
Time frame: Baseline and post-intervention at 6 weeks
Change in Extensibility of the Quadriceps (Right/Left) (in cm)
Time frame: Baseline and post-intervention at 6 weeks
Change in the double-lumbar inclinometry in flexion (in degrees)
Time frame: Baseline and post-intervention at 6 weeks
Change in the double-lumbar inclinometry in extension (in degrees)
Time frame: Baseline and post-intervention at 6 weeks
Change in the double-lumbar inclinometry in inclination (Right/Left) (in degrees)
Time frame: Baseline and post-intervention at 6 weeks
Change in the muscular endurance of the trunk and of the lower limbs (in secondes)
Time frame: Baseline and post-intervention at 6 weeks
Change in the Score of Pain (Scale from 0 to 10)
Time frame: Baseline and post-intervention at 6 weeks
Change in Fear and Avoidance Belief Questionnaire (FABQ) score
Time frame: Baseline and post-intervention at 6 weeks
Change in Oswestry Disability Index questionnaire score
Time frame: Baseline and post-intervention at 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Derived from this study: PubMed 37737050LE 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.
- Individual participant dataSharing planned: No
Related trials for Chronic Low-back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thibaut Guiraud, PhD study director
ORPEA/CLINEA Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HUBER exercises and Standard exercises in people with Chronic Low-back Pain, run by Thibaut Guiraud at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thibaut Guiraud, PhD (+33 5 46 68 00 77, t.guiraud@orpea.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the flexor to extensor ratio measured by Cybex at 60°/s. (time frame: Baseline and post-intervention at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05437016, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.