09.27.24
A finished product marketed by private label manufacturer PharmaLinea as >Your< Back Pain Capsules appeared to improve back pain and certain quality of life measures compared to placebo, among a population of patients who were all undergoing physical therapy. These findings were published in Family Medicine and Primary Care: Open Access.
According to PharmaLinea, the new supplement may serve as a complement or alternative to analgesics, a more common treatment which can cause unwanted side effects or dependency.
Back pain can arise due to physical damage, or can be of neuropathic origin, the latter of which is a chronic condition caused by damage to peripheral nerves from injury, inflammation, or diseases such as diabetes, PharmaLinea noted. “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 ot side effects and the possibility of leading to dependence,” the company reported.
>Your< Back Pain Capsules, a proprietary combination of B vitamins, vitamin D, and two nucleotides called uridine and cytidine marketed as Qspine, is designed to target neuronal damage, the underlying cause of neuronal pain, the company noted.
“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,” said Maja Orešnik, science and research director at PharmaLinea. “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.”
“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,” said Matevž Ambrožič, marketing director at PharmaLinea. “However, among available solutions, clinically supported ones suitable for medical detailing are still rare.”
Study Details
In the clinical study, researchers recruited 247 participants with chronic lumbosacral radicular syndrome, who were randomized to either receive a daily treatment of the supplement or a placebo in combination with a physical rehabilitation program over a period of three months.
The study was performed by researchers from Filantropia Clinical Municipal Hospital Craiova and the University of Medicine and Pharmacy of Craiova in Romania.
Patients were evaluated using multiple standardized questionnaires, and, compared to placebo, those taking >Your< Back Pain Capsules experienced a significant self-reported improvement in pain severity, as well as a significant improvement in mobility using standardized mobility tests.
Specifically, the treatment group saw a 51% greater improvement in pain severity as measured by SF-MPQ Scale scores compared to physical therapy alone. There was also a 52% increase in mobility as measured by the Finger-to-floor distance test, compared to physical therapy alone.
Across the panel of tests, the treatment group experienced statistically significant improvements in pain severity as measured by the VAS scale, independent living index according to the ADL scale, and scores on the radicular syndrome test, Schober test, and Myofascial syndrome test.
“Already a commercial success, the product has been launched in multiple markest across Europe, the Middle East, CIS, and Asia. The product line has grown at a CAGR fo 54% between 2018 and 2023. The new clinical data is bound to only increase the opportunity,” said Jernej Klopčič, business development director at PharmaLinea.
According to PharmaLinea, the new supplement may serve as a complement or alternative to analgesics, a more common treatment which can cause unwanted side effects or dependency.
Back pain can arise due to physical damage, or can be of neuropathic origin, the latter of which is a chronic condition caused by damage to peripheral nerves from injury, inflammation, or diseases such as diabetes, PharmaLinea noted. “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 ot side effects and the possibility of leading to dependence,” the company reported.
>Your< Back Pain Capsules, a proprietary combination of B vitamins, vitamin D, and two nucleotides called uridine and cytidine marketed as Qspine, is designed to target neuronal damage, the underlying cause of neuronal pain, the company noted.
“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,” said Maja Orešnik, science and research director at PharmaLinea. “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.”
“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,” said Matevž Ambrožič, marketing director at PharmaLinea. “However, among available solutions, clinically supported ones suitable for medical detailing are still rare.”
Study Details
In the clinical study, researchers recruited 247 participants with chronic lumbosacral radicular syndrome, who were randomized to either receive a daily treatment of the supplement or a placebo in combination with a physical rehabilitation program over a period of three months.
The study was performed by researchers from Filantropia Clinical Municipal Hospital Craiova and the University of Medicine and Pharmacy of Craiova in Romania.
Patients were evaluated using multiple standardized questionnaires, and, compared to placebo, those taking >Your< Back Pain Capsules experienced a significant self-reported improvement in pain severity, as well as a significant improvement in mobility using standardized mobility tests.
Specifically, the treatment group saw a 51% greater improvement in pain severity as measured by SF-MPQ Scale scores compared to physical therapy alone. There was also a 52% increase in mobility as measured by the Finger-to-floor distance test, compared to physical therapy alone.
Across the panel of tests, the treatment group experienced statistically significant improvements in pain severity as measured by the VAS scale, independent living index according to the ADL scale, and scores on the radicular syndrome test, Schober test, and Myofascial syndrome test.
“Already a commercial success, the product has been launched in multiple markest across Europe, the Middle East, CIS, and Asia. The product line has grown at a CAGR fo 54% between 2018 and 2023. The new clinical data is bound to only increase the opportunity,” said Jernej Klopčič, business development director at PharmaLinea.
