Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Evaluation of the benefit and safety of Localized Tissue Hydration (LTH) in the management of chronic common low back pain: Non-randomized single-center phase II study

This research is investigating a treatment called Localized Tissue Hydration (LTH) for people who have been living with common lower back pain for a long time. The study will combine this new treatment with the standard care you would usually receive. We want to see how well it works and if it's safe. Specifically, we'll be checking if people's pain, measured on a simple scale from 0 to 10, improves by at least 30% after six months. This is a small, focused study happening in one location, aimed at understanding more about how LTH could help. Participants will include adults aged 18 and over, both men and women, who experience ongoing lower back pain.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Groupement De Cooperation Sanitaire Ramsay Generale De Sante Pour L'enseignement Et La Recherche

Enrolment target

Start

29 May 2024

chronic common low back pain

What is this study about?

For many people, long-lasting lower back pain can be a real challenge, affecting daily life. This study is exploring a new approach called Localized Tissue Hydration (LTH) as a possible way to help. LTH involves giving a saline solution, which is just sterile salt water, to specific areas in the back. The idea is to see if this treatment, when given alongside the care you'd normally receive for your back pain, can make a difference.

We're aiming to find out how effective and safe this LTH treatment is over a six-month period. We'll be looking closely at whether people experience a noticeable reduction in their pain. To do this, participants will rate their pain on a simple scale, and we'll track these scores over time to see if there's a significant improvement after six months of treatment combined with regular care.

This is an early-stage study, sometimes called a Phase II study, which means we're still learning about this treatment. It's not a large study where different treatments are compared directly against each other. Instead, it's focused on understanding the LTH treatment better and seeing if it shows promise for people with chronic lower back pain. The results will help us decide if further, larger studies are needed.

Key takeaways

Exploring a new treatment (LTH) for long-lasting lower back pain.
Combines LTH with your usual back pain care.
Aims to see if pain reduces significantly after six months.
Open to adults aged 18 and older with common chronic back pain.
Study lasts approximately six months, including follow-up.

Who may be eligible?

This study is looking for adults who have persistent, ongoing lower back pain. If you're 18 years old or older, you might be able to take part. Both men and women are welcome to consider joining this research.

This study is specifically for 'common' lower back pain, which means back pain that doesn't have a clear cause like an injury or a specific medical condition. If your back pain is due to something else, like a recent accident or a diagnosed illness affecting your spine, this study might not be suitable for you.

Quick self-check

Are you 18 years old or older?
Do you have lower back pain that has been ongoing for a while?
Is your back pain 'common' – meaning it's not due to a specific injury or other medical condition?
Are you willing to attend follow-up appointments for six months?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you'll receive the Localized Tissue Hydration (LTH) treatment along with your usual care. The LTH treatment involves receiving a specific saline solution, similar to sterile salt water, as an infusion. You'll have an initial visit where your pain level will be measured using a simple scale.

After you've had the treatment, you'll need to attend follow-up visits. These visits are important for us to track your progress and how you're feeling. There will be follow-up visits at three months and six months after your treatment has finished. At these visits, your pain level will be measured again. The total time you'll be involved in the study, including treatment and follow-up, will be around six months.

Potential risks and benefits

As with any medical treatment, there are potential benefits and potential risks to consider. The potential benefit of this study is that the Localized Tissue Hydration (LTH) treatment, combined with standard care, might help reduce your chronic lower back pain. However, we cannot guarantee any specific outcome or improvement. Potential risks, which your doctor will discuss with you, could include discomfort or reactions where the saline solution is given, or other side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
France

Common questions

What is 'Localized Tissue Hydration' (LTH)?

LTH is a treatment where a special sterile salt water solution is given to specific areas in your lower back to see if it helps with pain.

What kind of back pain is this study for?

This study is for people who have common, ongoing lower back pain that hasn't been caused by a specific injury or another health condition.

How long will I be in the study?

Your involvement in the study, including treatment and follow-up appointments, will last for about six months.

Will I still receive my usual care for back pain?

Yes, the LTH treatment in this study is given in combination with the standard care you would normally receive for your back pain.

Can I leave the study if I change my mind?

Yes, you can decide to stop participating in the study at any point, and it won't affect your future medical care.