Low Back PainREACTIVENCT05213845
Spine Rehabilitation Using Spine Flexion / Extension Full Active Range of Motion for Patients With Chronic Low Back Pain
A study testing Spine flexion/extension active range of motion exercises in people with Low Back Pain, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.
Trial summary
The main objective of this study is to assess efficacy of a spine rehabilitation program, using spine flexion and extension full active range of motion, on physical disability of patients with chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Spine flexion/extension active range of motion exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 17 Feb 2022to 13 Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical prescription for chronic low back pain rehabilitation
- Evolution of low back pain for at least 3 months
- No treatment or rehabilitation for low back pain performed within 12 months before enrollment
- Written informed consent given
Who cannot join
- Spinal fracture or previous spinal surgery
- Cognitive impairments that prevent from understanding the rehabilitation exercises
- Patient with insufficient understanding or expression in French
- Non-mechanical pain : gradually worsening pain, present at rest and especially at night
- Neurological symptom : deficit in the control of bladder and anal sphincters, motor weakness of lower limbs, Cauda equina syndrome
- Pubis paresthesia (or perineum)
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- Severe trauma (such as fall from height, traffic accident)
- Unexplained weight loss
- History of cancer
- Drug use or long-term use of corticosteroid
- Spinal deformity
- Altered general condition
- Patient with signs of neurological impairment : positive Lasegue test (Straight Leg Raise Test) or positive Slump test, or DN4 questionnaire greater than or equal to 4
- Patient suffering from a central or peripheral neurological pathology
- Patient taking a level II (weak opiates) or III (morphine and related substances) analgesic treatment
- Patient under guardianship, curatorship or legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Spine Rehabilitation Program Using Spine Flexion and Extension Full Active Range of Motion for Patients With Chronic Low Back Pain : a Monocentric Prospective Cohort Study
The main objective of this study is to assess efficacy of a spine rehabilitation program, using spine flexion and extension full active range of motion, on physical disability of patients with chronic low back pain.
Read the detailed description
Secondary objectives
The other objectives of this study are to assess the impact of spine rehabiliation program using spine flexion and extension full active range of motion on :
- pain intensity ;
- kinesiophobia
- active range of motion of lumbar flexion and lumbar extension
Conduct of research
After receiving the written consent of the study, participants will benefit from 5 sessions of spine flexion and extension full active range of motion exercises. The following tests and questionnaires will be performed before (baseline) and after (posttreatment) the 5 sessions :
- Visual Analogue Pain Scale,
- Fear Avoidance Beliefs Questionnaire (FABQ),
- Double-inclinometer to measure active range of motion of lumbar flexion and lumbar extension.
- Conditions
- Low Back Pain
- Being tested
- Spine flexion/extension active range of motion exercises
- Keywords
- rehabilitation, active range of motion, kinesiophobia, physiotherapy
- Medical subject headings
- Low Back Pain, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spine flexion/extension active range of motion exercisesProcedure or surgery
Five full active range of motion rehabilitation sessions will be scheduled. Four or the five following full active range of motion exercises will be performed during one rehabilitation session : spine flexion and extension (quadrupedic position), lumbar flexion and extension (sitting position), posterior and anterior pelvic tilt (sitting and standing position), lumbar flexion and extension (standing position) and Jefferson Curl exercise. All five rehabilitation sessions must be performed within 60 days
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic low back pain | Other | Not described Receives: Procedure: Spine flexion/extension active range of motion exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Roland-Morris disability questionnaire
The Roland-Morris questionnaire is a 24-item self report questionnaire assessing physical disability, ranging from 0 (no disability) to 24 (severe disability).
Measured: Posttreatment (2 months)
Secondary outcomes (3)
Pain intensity
Pain intensity will be measured with a Visual Analog Pain Scale, from 0 (no pain) to 10 (pain of maximum intensity)
Measured: Posttreatment (2 months)
Fear Avoidance Beliefs Questionnaire (FABQ)
The FABQ is a patient reported questionnaire which specifically focuses on how patient's fear-avoidance beliefs about physical activity may affect and contribute to his/her low back pain and resulting disability.
Measured: Posttreatment (2 months)
Active range of motion of lumbar flexion and lumbar extension
Active range of motion of lumbar flexion and lumbar extension will be measured with two inclinometers.
Measured: Posttreatment (2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start17 Feb 2022
- Primary completion13 Jan 2023
- Study completion13 Jan 2023
Why it stopped: insufficient recruitment to meet the objectives in time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213845
- Sponsor's protocol ID
- GHR 1206
- Other IDs
- 2021-A02319-32
- Acronym
- REACTIVE
- Status last verified
- Feb 2022
- First submitted
- 17 Jan 2022
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Spine Rehabilitation Program Using Spine Flexion and Extension Full Active Range of Motion for Patients With Chronic Low Back Pain : a Monocentric Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05213845
- Acronym / sponsor ID
- REACTIVE / GHR 1206
- Conditions
- Low Back Pain
- Keywords
- rehabilitation, active range of motion, kinesiophobia, physiotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment to meet the objectives in time
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud AlsaceUniversity, hospital or other
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 28 Jan 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 main objective of this study is to assess efficacy of a spine rehabilitation program, using spine flexion and extension full active range of motion, on physical disability of patients with chronic low back pain.
Detailed description
Secondary objectives
The other objectives of this study are to assess the impact of spine rehabiliation program using spine flexion and extension full active range of motion on :
- pain intensity ;
- kinesiophobia
- active range of motion of lumbar flexion and lumbar extension
Conduct of research
After receiving the written consent of the study, participants will benefit from 5 sessions of spine flexion and extension full active range of motion exercises. The following tests and questionnaires will be performed before (baseline) and after (posttreatment) the 5 sessions :
- Visual Analogue Pain Scale,
- Fear Avoidance Beliefs Questionnaire (FABQ),
- Double-inclinometer to measure active range of motion of lumbar flexion and lumbar extension.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic low back pain | Other | Procedure: Spine flexion/extension active range of motion exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Medical prescription for chronic low back pain rehabilitation
- Evolution of low back pain for at least 3 months
- No treatment or rehabilitation for low back pain performed within 12 months before enrollment
- Written informed consent given
Key exclusion criteria (16 listed)
- Spinal fracture or previous spinal surgery
- Cognitive impairments that prevent from understanding the rehabilitation exercises
- Patient with insufficient understanding or expression in French
- Non-mechanical pain : gradually worsening pain, present at rest and especially at night
- Neurological symptom : deficit in the control of bladder and anal sphincters, motor weakness of lower limbs, Cauda equina syndrome
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 |
|---|---|---|
| Spine flexion/extension active range of motion exercisesFive full active range of motion rehabilitation sessions will be scheduled. Four or the five following full active range of motion exercises will be performed during one rehabilitation session : spine flexion and extension (quadrupedic position), lumbar flexion and extension (sitting position), posterior and anterior pelvic tilt (sitting and standing position), lumbar flexion and extension (standing position) and Jefferson Curl exercise. All five rehabilitation sessions must be performed within 60 days | Procedure or surgery | Patients with chronic low back pain |
Primary outcome
Roland-Morris disability questionnaire
Time frame: Posttreatment (2 months)
The Roland-Morris questionnaire is a 24-item self report questionnaire assessing physical disability, ranging from 0 (no disability) to 24 (severe disability).
3 secondary outcomes
Pain intensity
Time frame: Posttreatment (2 months)
Fear Avoidance Beliefs Questionnaire (FABQ)
Time frame: Posttreatment (2 months)
Active range of motion of lumbar flexion and lumbar extension
Time frame: Posttreatment (2 months)
Results and safety
The study was stopped early (reason given: insufficient recruitment to meet the objectives in time). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spine flexion/extension active range of motion exercises in people with Low Back Pain, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace 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 4 inclusion and 16 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: stopped early, as of the sponsor's last update on 25 Jan 2023. 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?
The study was stopped early (reason given: insufficient recruitment to meet the objectives in time). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Roland-Morris disability questionnaire (time frame: Posttreatment (2 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2023.