Not recruiting

Study of sodium chloride solution injections (Localized Tissue Hydration) for adults with chronic low back pain

Registered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on evaluating a treatment for chronic low back pain, a condition characterized by back pain lasting more than 3 months that does not require surgery. The study investigates a treatment method called Localized Tissue Hydration, which involves injecting sodium chloride solution (a sterile salt water solution) under the skin in the affected area.

The purpose of the study is to determine if this tissue hydration treatment, when combined with standard care, can help reduce back pain. The treatment uses special infusion kits to deliver the salt water solution through small needles placed under the skin, creating what is called a hydration cushion in the tissue to help treat the pain locally.

During the study, participants will receive the treatment and be monitored for 6 months to assess changes in their pain levels. Pain will be measured using a simple numerical scale where patients rate their pain from 0 to 10. The total treatment period lasts 10 weeks, with follow-up visits scheduled at 3 and 6 months after treatment begins to evaluate the long-term effects of the procedure.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial evaluation
A medical assessment will be performed to confirm your eligibility for the study of chronic low back pain treatment
Your current pain level will be measured using a Verbal Numerical Scale (a pain scale from 0 to 10)
Your existing lumbar MRI results will be reviewed
Step 2
Treatment initiation
You will receive Localized Tissue Hydration (LTH) treatment, which involves subcutaneous injections of saline solution
The treatment will be combined with standard care for low back pain
The injectable solution used will be sodium chloride 0.9% administered through subcutaneous injection
Step 3
3-month follow-up
A follow-up visit will take place 3 months after starting treatment
Your pain level will be measured again using the pain scale from 0 to 10
The effectiveness of the treatment will be assessed
Step 4
6-month follow-up
A final evaluation will occur 6 months after starting treatment
Your pain level will be measured for the final time using the pain scale
The success of the treatment will be determined by checking if your pain has decreased by at least 30% compared to the start of the study

Who can join the trial?

7 criteria

You must be 18 years of age or older
You must have chronic low back pain that has lasted for more than 3 months with a pain level of 5 or higher on the pain scale (where 0 means no pain and 10 means worst possible pain)
Your back pain condition must not require surgery
You must have had a lumbar MRI (a detailed image of your lower back using magnetic resonance imaging) before joining the study
You must be enrolled in a National Health Insurance program
You must be willing and able to provide written informed consent (agreement to participate in the study after understanding all the details)
Both men and women may participate in this study

Who cannot join the trial?

14 criteria

Age below 18 or above 65 years
Patients with acute back pain (pain lasting less than 6 weeks)
History of spinal surgery in the past 6 months
Presence of nerve root compression (when a nerve in the spine is squeezed or irritated)
Current malignant condition (cancer) or history of cancer in the past 5 years
Pregnant or breastfeeding women
Patients with inflammatory back conditions (such as rheumatoid arthritis or ankylosing spondylitis)
Severe mental health conditions that could affect participation
Current participation in another clinical trial
Known allergy to any components of the study treatment
Inability to follow study procedures or attend follow-up visits
Severe osteoporosis (significant bone weakness)
Uncontrolled diabetes or high blood pressure
Serious heart, kidney, or liver conditions

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Investigated drugs

Localized Tissue Hydration (LTH) is a therapeutic treatment that involves the injection of sterile water into specific tissue areas of the lower back. This treatment is designed to help manage chronic low back pain by hydrating the affected tissues. It is used alongside standard treatment methods for back pain. The procedure aims to reduce pain intensity and improve patient comfort by targeting specific areas of discomfort in the lower back region. Standard back pain management techniques are also used in conjunction with LTH therapy. These may include conventional pain management approaches that are typically prescribed for chronic low back pain, though specific details are not provided in the source data.

Sodium Chloride

What is already known about the treatment

Localized Tissue Hydration (LTH) – A therapeutic treatment method being investigated for chronic low back pain management, which involves the targeted delivery of hydration to specific tissue areas in the lower back. This non-pharmacological intervention is currently undergoing Phase II clinical trials to evaluate its effectiveness and safety profile when used alongside standard treatment protocols. The treatment works by improving tissue hydration levels in affected areas, potentially reducing inflammation and promoting better tissue function, though its exact molecular mechanism is still being studied. LTH represents an innovative approach in physical medicine and rehabilitation, being evaluated as a complementary therapy to existing pain management strategies.

Investigated diseases

Chronic Common Low Back Pain - A persistent condition characterized by pain in the lower region of the back that lasts for more than 12 weeks. The pain typically occurs between the bottom of the rib cage and the buttock creases, often developing gradually over time. It can vary in intensity from mild to severe, and may be accompanied by stiffness in the lower back area. The condition can affect daily activities and movement patterns, potentially leading to reduced physical activity. The pain may worsen with prolonged sitting, heavy lifting, or certain movements.