New back pain clinical trial

PharmaLinea's >Your< Back Pain Capsules clinically shown to substantially improve standard physical therapy's effect on back pain severity and mobility

PharmaLinea has announced the publication of another clinical study on their finished products, addressing a leading cause of disability worldwide – low back pain. Analgesics, the most common treatment, can often cause side effects and dependency, which is why many consumers seek natural alternatives. These, however, often fail to provide effective relief. In the newly published study on 247 patients with chronic back pain, the addition of >Your< Back Capsules to conventional physical therapy resulted in a significantly higher reduction of pain severity and significantly higher improvement in mobility when compared to physical therapy alone. The study and the product have thus provided consumers with an effective, side-effect-free solution for a highly prevalent condition that can severely impact quality of life.

The issue

Up to 80% of people suffer from low back pain at some point in their lives and it’s the second most frequent symptom-related reason for physician visits after the common cold. Around 5-10% of patients develop persistent back pain. This complex condition involving various pain mechanisms, can arise from physical damage to the musculoskeletal system (nociceptive pain) or nerve damage or dysfunction (neuropathic pain). The latter may be present without obvious physical findings. Neuropathic pain is a chronic condition that leads to persistent pain symptoms and usually develops when peripheral nerves are damaged as a result of injury, inflammation, or disease like diabetes.

Pain in the lower back area can significantly reduce quality of life. Consequences include significant work-related disability and medical expenses. As the population ages, the number of individuals with this issue is likely to increase substantially. The two most common ways to treat lower back pain are with physical therapy or analgesics. However, they both come with limitations. The issue with physical therapy is, that it can help relieve the pain and improve mobility to a certain point, but it does not address its source – neuronal damage. And the issue with analgesics is, that they should not be taken over long periods due to side effects and the possibility of leading to dependence.

These drawbacks are what we addressed when developing >Your< Back Pain Capsules. The product targets neuronal damage, the underlying cause of neuropathic pain, and not only symptom relief and is now clinically confirmed to achieve significantly better results when treating back pain than physical therapy alone. It is based on PharmaLinea’s own proprietary complex, Qspine®, which is a result of extensive R&D. Unlike analgesics, it causes no side effects or addiction.

“Low back pain is the leading cause of disability worldwide. The affected typically seek analgesic drugs to alleviate their symptoms. But for neuropathic pain, which is very common in low back pain, analgesics are often unable to provide the side effects-free, effective relief that consumers seek. This is the goal we aimed to support with our product and the presented clinical study. We are very impressed with the robustness of the results and the product’s efficacy. The results stand out due to the high values of the shown differences, such as 51% higher improvement. These differences were statistically significant across a number of different questionnaires and tests, such as the VAS scale, SF-MPQ, Schober test, and so forth. Importantly, the product was compared against physical therapy and not just placebo capsules, which makes effects more difficult to show, and results even more solid, “ stated Maja Orešnik, Science and Research Director at PharmaLinea.

“Consumers are increasingly searching for natural alternatives to address their pain in the lower back area and many industry experts agree that pain is the next big white space in supplements. However, among available solutions, clinically supported ones, suitable for medical detailing, are still rare. They mostly target symptom relief, not the cause of the issue. This market gap led us to develop >Your< Back Pain Capsules, which target neuronal damage, the underlying cause of neuropathic pain, and to clinically confirm their efficacy,“ commented PharmaLinea's Marketing Director Matevž Ambrožič.

The trial

The clinical trial aimed to confirm the efficacy of >Your< Back Pain Capsules and rehabilitation program (physical exercise) in regaining functional status and pain control in patients with chronic lumbosacral radicular syndrome (LRS). The study included 247 participants over the age of 18, diagnosed with LRS persisting for more than 3 months confirmed by MRI within the last 6 months. The participants were randomized into 2 groups in the ratio 2 (study group):1 (control group). The study group received >Your< Back Pain Capsules in combination with the rehabilitation program (physical therapy) and the control group received a placebo in combination with the rehabilitation program. The trial lasted 3 months.

The study was performed on ProHumano+ SpineDinamic (a commercial brand name of >Your< Back Pain Capsules, launched by our clients) by researchers from Filantropia Clinical Municipal Hospital Craiova and the University of Medicine and Pharmacy of Craiova in Romania.

Results

The combination of >Your< Back Pain Capsules and the rehabilitation program resulted in a significant reduction of radicular pain severity according to multiple standardized questionnaires and significant improvement in mobility according to multiple standardized mobility tests compared to placebo in combination with the rehabilitation program.

For example, key results, when compared to control, include:

● 51% improvement in the pain-relieving effect of physical therapy (according to the SF-MPQ scale)

● 52% increase in physical therapy's improvement of mobility (according to the Finger-to-floor distance test)

Your< Back Pain Capsules combined with physical therapy resulted in a 43% reduction in pain severity after 3 months, while physical therapy alone resulted only in a 29% reduction. The effect of physical therapy was thus improved by 51%. >Your< Back Pain Capsules combined with physical therapy also resulted in a 17% improvement in finger-to-floor distance mobility after 3 months, while physical therapy alone resulted in an 11% improvement. The effect of physical therapy was thus improved by 52%. The study did not report any adverse effects related to the administration of >Your< Back pain Capsules. The product was thus found to be safe and well-tolerated.

Aside from the above-mentioned results, the test group also showed a statistically significant improvement compared to the control group in:

- pain severity according to the VAS scale

- independent living index according to the ADL scale

- Radicular syndrome test, Schober test, and Myofascial syndrome test

Trial implications

In the past, healthcare professionals could choose between prescribing physical therapy, which offered limited pain relief and mobility improvement, or analgesics, which often came with side effects. The outcome of the trial means they now finally have a safe solution, which significantly improves the effects of physical therapy, they can confidently prescribe. Patients with chronic issues have gained a natural solution without side effects targeting the cause of the issue instead of only providing symptom relief. Brand owners, in turn, are presented with a proven product they can efficiently promote through healthcare professionals, distinguishing them from competitors.

“Already a commercial success, the product has been launched in multiple markets across Europe, the Middle East, CIS, and Asia. The product line has grown at a CAGR of 54% between 2018 and 2023. The new clinical data is bound to only increase the opportunity, “ said Jernej Klopčič, PharmaLinea's Business Development Director.