Chronic Low-back PainPhase 2HTL-LOMBNCT06471998
Evaluation of the Benefit and Safety of Localized Tissue Hydration in the Management of Chronic Low Back Pain
A Phase 2 study testing Sodium Chloride injection in people with Chronic Low-back Pain, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The purpose of this study is to evaluate the benefit of Localized Tissue Hydration associated with standard management of chronic common low back pain, in terms of improvement in the numerical verbal scale score at 6 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Sodium Chloride injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2025to 31 Mar 2026
- Phase
- Phase 2
- 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
- Patient 18 years of age or older ;
- Patient with chronic, non-operated low-back pain operated for more than 3 months (verbal numerical scale ≥ 5);
- Chronic common lumbago not requiring surgical management surgical ;
- Lumbar MRI performed as part of routine care and available available for the inclusion visit;
- For women of childbearing age, use of a highly effective contraceptive method;
- Patient affiliated to a French health insurance scheme;
- Patient has signed an informed consent form.
Who cannot join
- Pregnant or breast-feeding woman;
- Patient in accident at work ;
- Patient with radicular syndrome;
- Contraindication to magnetic resonance imaging or CT scan;
- Severe cases of hydric inflation and hydrosodic retention, particularly in cases of :
- Decompensated heart failure;
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- Acute renal failure with oliguria or anuria;
- Decompensated liver failure;
- Pre-eclampsia/eclampsia.
- Hypochloremia ;
- Hypernatremia ;
- Patients of legal age subject to legal protection, guardianship, curatorship or deprived of liberty by judicial or administrative decision;
- Patient hospitalized without consent;
- Patient unable to answer a questionnaire;
- Patients who do not understand or speak French.
- Included patients will not be allowed to participate in another interventional study during the entire follow-up period. The exclusion period is 8.5 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Benefit and Safety of Localized Tissue Hydration (HTL) in the Management of Chronic Common Low Back Pain: Phase II Monocentric Non-randomized Study
The purpose of this study is to evaluate the benefit of Localized Tissue Hydration associated with standard management of chronic common low back pain, in terms of improvement in the numerical verbal scale score at 6 months.
Read the detailed description
This is a proof-of-concept, single-center, prospective, interventional, non-randomized Phase II study designed to evaluate the benefit of 0.9% sodium chloride Localized Tissue Hydration in patients with chronic common low back pain.
The study corresponds to a clinical trial of a medicinal product in compliance with Regulation (EU) n°536/2014.
The study population is composed of patients suffering from chronic common low back pain for more than 3 months with a numerical verbal scale ≥ 5.
Patients will receive a localized subcutaneous injection of 0.9% sodium chloride over 10 sessions (1 session per week), combined with standard management including stage I and II analgesics and physiotherapy in accordance with the recommendations of the French National Authority for Health.
- Conditions
- Chronic Low-back Pain
- Being tested
- Sodium Chloride injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Chloride injectionDrug
Patients will receive a localized subcutaneous injection of 0.9% sodium chloride over 10 sessions (1 session per week), combined with standard treatment including stage I and II analgesics and physiotherapy in line with the recommendations of the French National Authority for Health.
At each session, 250ml to 500ml of physiological serum will be injected subcutaneously using a Meso-Kit-Perfuser* or "injection octopus" positioned by the nurse according to the injection points defined by the investigating physician during the inclusion visit, with a dermographic tracer for surgical use.
| Study group | Role | What they receive |
|---|---|---|
| Localized Tissue Hydration with standard care | Experimental | Localized tissue injections of saline in the routine management of pain and functional disability in patients with chronic common low back pain. Receives: Drug: Sodium Chloride injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
Success rate after treatment with Localized Tissue Moisturization combined with standard management, defined by a reduction in the Verbal Numerical Scale score of at least 30%.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start28 Feb 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- proof-of-concept, single-center, prospective, interventional, non-randomized Phase II study
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471998
- Sponsor's protocol ID
- 2024-510625-25-00
- Acronym
- HTL-LOMB
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2024
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Benefit and Safety of Localized Tissue Hydration (HTL) in the Management of Chronic Common Low Back Pain: Phase II Monocentric Non-randomized Study
- ClinicalTrials.gov ID
- NCT06471998
- Acronym / sponsor ID
- HTL-LOMB / 2024-510625-25-00
- Conditions
- Chronic Low-back Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Euraxi Pharma
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 24 Jun 2024 (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 purpose of this study is to evaluate the benefit of Localized Tissue Hydration associated with standard management of chronic common low back pain, in terms of improvement in the numerical verbal scale score at 6 months.
Detailed description
This is a proof-of-concept, single-center, prospective, interventional, non-randomized Phase II study designed to evaluate the benefit of 0.9% sodium chloride Localized Tissue Hydration in patients with chronic common low back pain.
The study corresponds to a clinical trial of a medicinal product in compliance with Regulation (EU) n°536/2014.
The study population is composed of patients suffering from chronic common low back pain for more than 3 months with a numerical verbal scale ≥ 5.
Patients will receive a localized subcutaneous injection of 0.9% sodium chloride over 10 sessions (1 session per week), combined with standard management including stage I and II analgesics and physiotherapy in accordance with the recommendations of the French National Authority for Health.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- proof-of-concept, single-center, prospective, interventional, non-randomized Phase II study
| Arm | Type | Receives |
|---|---|---|
| Localized Tissue Hydration with standard care | Experimental | Drug: Sodium Chloride injectionLocalized tissue injections of saline in the routine management of pain and functional disability in patients with chronic common low back pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient 18 years of age or older ;
- Patient with chronic, non-operated low-back pain operated for more than 3 months (verbal numerical scale ≥ 5);
- Chronic common lumbago not requiring surgical management surgical ;
- Lumbar MRI performed as part of routine care and available available for the inclusion visit;
- For women of childbearing age, use of a highly effective contraceptive method;
Key exclusion criteria (16 listed)
- Pregnant or breast-feeding woman;
- Patient in accident at work ;
- Patient with radicular syndrome;
- Contraindication to magnetic resonance imaging or CT scan;
- Severe cases of hydric inflation and hydrosodic retention, particularly in cases of :
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 |
|---|---|---|
| Sodium Chloride injectionPatients will receive a localized subcutaneous injection of 0.9% sodium chloride over 10 sessions (1 session per week), combined with standard treatment including stage I and II analgesics and physiotherapy in line with the recommendations of the French National Authority for Health. At each session, 250ml to 500ml of physiological serum will be injected subcutaneously using a Meso-Kit-Perfuser* or "injection octopus" positioned by the nurse according to the injection points defined by the investigating physician during the inclusion visit, with a dermographic tracer for surgical use. | Drug | Localized Tissue Hydration with standard care |
Primary outcome
Success rate
Time frame: 6 months
Success rate after treatment with Localized Tissue Moisturization combined with standard management, defined by a reduction in the Verbal Numerical Scale score of at least 30%.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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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 Phase 2 study testing Sodium Chloride injection in people with Chronic Low-back Pain, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 7 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: finished, as of the sponsor's last update on 15 Jun 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Success rate (time frame: 6 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 15 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.