Clinical Research Directory

Effectiveness of Mitragynine Topical Patch for Pain Reduction in Myofascial Pain Syndrome

Myofascial Pain Syndrome (MPS) is one of the leading causes of both acute and chronic musculoskeletal pain encountered in clinical practice.¹ The most common presentation is low back pain, followed by pain in the neck and scapular regions.² These symptoms significantly affect quality of life and work performance. A common site involved in neck pain syndrome is the trapezius muscle, which may cause pain in the shoulder, neck, and occipital region. In some patients, neurological symptoms such as goosebumps or dizziness may also occur.³ Pain can occur in individuals of all age groups and may be either acute or chronic. It can arise from injuries or various diseases. Pain may result from different pathologies, including nociceptive pain, neuropathic pain, or a combination of both. Current medical treatment guidelines include both conventional medications and herbal extract-based therapies. In the 2022 National List of Essential Herbal Medicines of Thailand, several herbal formulations are indicated for pain relief. Oral preparations include Khasai Sen, Thorani Sandhakhat, and Ya Phasom Thao Wan Priang, while topical preparations include chili-based formulations, plai preparations, and plai oil. These remedies are indicated for the relief of body aches and muscle pain.⁶ Kratom, or \*Mitragyna speciosa\* (Korth.) Havil., is a plant belonging to the Rubiaceae family. In southern Thailand, it is commonly known as "Thom." Kratom leaves contain a variety of chemical constituents, including alkaloids, flavonoids, triterpenes, and phenolic compounds. Among these, indole alkaloids represent the major group. The principal active compound is mitragynine, which accounts for approximately two-thirds of the total alkaloid content, or about 66% by weight.⁷ Pharmacologically, orally administered mitragynine affects both the autonomic and central nervous systems. It possesses analgesic properties through binding to opioid receptors. Additionally, it reduces pain signal transmission to the brain via the noradrenergic and serotonergic systems.⁸ The mitragynine pain-relief patch used in this study is a product containing kratom extract formulated to deliver 10 milligrams of mitragynine per patch. It is designed as a topical patch, allowing the active ingredient to be absorbed into the outer layers of the skin without entering the bloodstream.¹¹ The patch consists of sodium alginate, pectin, and agar, which are naturally derived polymers commonly used as pharmaceutical excipients. The hypothesis of this study is that this locally acting "mitragynine pain-relief patch" can reduce pain and inflammation through the TRPV1 receptor mechanism described above. Neck, shoulder, and upper back pain are among the most common reasons patients attend general practice, orthopedic, and rehabilitation clinics. Patients with chronic myofascial pain syndrome (defined as pain persisting for more than three months) may be treated using various approaches depending on symptom severity, accessibility of services, and individual suitability. These approaches include oral medications, topical agents, local injections, acupuncture, physical therapy, and muscle stretching exercises. Many patients may have contraindications to oral medications, acupuncture, or regular attendance at physical therapy sessions, which can negatively affect their overall quality of life. Currently, topical medications are commonly prescribed for these patients at Hospital; however, treatment outcomes are often suboptimal. Moreover, most topical preparations produce a warming effect and may easily cause skin irritation, particularly in elderly patients with fragile skin. If the mitragynine pain-relief patch demonstrates effective pain reduction, it may be further developed as an alternative treatment option for these patients. The objective of this study is to evaluate the efficacy of a mitragynine-containing kratom pain-relief patch in patients with myofascial pain syndrome, compared with a placebo patch (a patch containing only the base formulation without kratom extract), and to determine whether there is a difference in pain-relief response between the two groups and, if so, how that difference manifests.

Combined Therapy and Jones Technique for Upper Trapezius Myofascial Trigger Points

Myofascial trigger points in the upper trapezius muscle are a common cause of neck pain and may negatively affect pressure pain threshold, upper limb function, sleep quality, and quality of life. This randomized, sham-controlled clinical trial aimed to compare the effects of the Jones Technique, combined therapy (therapeutic ultrasound plus transcutaneous electrical nerve stimulation \[TENS\]), their combination, and a sham intervention in women with active upper trapezius myofascial trigger points. The primary outcome was pressure pain threshold. Secondary outcomes included pain intensity, upper limb disability, sleep quality, quality of life, physical activity level, and participant satisfaction.

Effects of Different Myofascial Release Techniques on Function in Chronic Non-Specific Neck Pain

This single-center, three-arm randomized controlled trial compares the effects of different myofascial release techniques, combined with a structured exercise program, on functional outcomes in individuals with chronic non-specific neck pain (CNNP). Eligible participants (aged 18 to 45 years, neck pain for at least 3 months, pain intensity VAS at least 3, and myofascial trigger points in the upper-quarter muscles) are allocated by simple randomization into three groups: * Conventional Therapy Group: hot pack, conventional TENS, and a structured exercise program. * Manual Myofascial Release Group: conventional therapy plus therapist-applied manual myofascial release. * Self-Myofascial Release Group: conventional therapy plus supervised self-applied myofascial release using a duo-ball, balls, and a massage stick/cane. All interventions are delivered 3 days per week for 6 weeks. The primary outcome is pain intensity. Secondary outcomes include pressure pain threshold and tolerance, cervical range of motion, muscle stiffness, craniovertebral angle, cervical proprioception, muscle strength and endurance, disability, neck awareness, multidimensional biopsychosocial status, sleep quality, quality of life, and kinesiophobia. The aim is to determine whether manual or self-applied myofascial release, added to exercise, produces greater functional improvement in people with chronic non-specific neck pain.

rESWT vs LLLT for Cervical Myofascial Pain

Background and Aim: Myofascial pain syndrome (MPS) in the cervical region is one of the most common musculoskeletal disorders associated with myofascial trigger points that cause muscle pain, stiffness, and reduced range of motion, precipitated by forward head posture. Many non-invasive modalities, including low-level laser therapy (LLLT) and extracorporeal shockwave therapy (ESWT), have been reported to reduce symptoms. However, comparative effectiveness of these interventions remains unclear. This study aimed to compare the effectiveness of radial ESWT and LLLT in reducing pain and improving functional outcomes in patients with cervical MPS among the working-age adults. Methods: A randomized controlled study was conducted in a working-age adults with MPS. Fifty subjects, divided in two groups received either ESWT or LLLT. Numeric rating scale (NRS), cervical range of motion (ROM), and craniovertebral angle (CVA) were assessed before and throughout three weeks post intervention. Results: Both LLLT and ESWT showed significant (p \< 0.001) changes in NRS, cervical ROM, and CVA. LLLT showed a difference in pain reduction at week three (p \< 0.001) and flexion and extension ROM at week two and three (p \< 0.05). Conclusion: LLLT demonstrated superior results in pain reduction at the three-week mark and produced greater increases in cervical flexion and extension ROM during the two- and three-week periods when compared with ESWT.

Low-Energy Ultrasound, Electrical and Magnetic Field Stimulation in Therapy-Resistant Myofascial Pain Syndrome

Sonodyn is an investigational device that within this clinical investigation is intended for use in patients suffering from low back pain, tension headache or neck pain, originating from therapy-resistant myofascial pain syndrome. Myofascial pain syndrome is a prevalent pain condition in the adult population and a common cause of pain and dysfunction in the musculoskeletal system. It is a trigger point-induced regional musculoskeletal pain disorder affecting one or more muscles or groups of muscles. Sonodyn is a handheld medical device that combines low-energy ultrasound, electrical and magnetic field stimulation for non-invasive transcutaneous treatment of chronic myofascial pain syndrome. Sonodyn is a battery-operated, rechargeable stimulation device to be placed over specific trigger points for associated pain patterns in the human body. It emits ultrasound, electrical and magnetic stimulation signals with a pre-defined set of parameters for each of the independently operated power sources. The study will follow a prospective, randomized, sham-controlled, double-blind parallel group design. It will be conducted as a multi-center investigation at 6 sites in Austria and Switzerland. Patients are randomized in a 2:1 ratio into Treatment and Control. * Active Sonodyn therapy (Treatment) * No therapy (Sham Control) Two types of Sonodyn devices will be used: a fully functional one for Therapy arm patients that can deliver stimulation, and a non-functional one for Control arm patients that cannot convey any energy signals to the device output. The devices will look fully identical. Randomization will be stratified by study site, pain diagnosis and sex of the patient. For each subject, after a screening phase of 1 week, patients will be treated for 3 weeks with a follow-up of additional 8 weeks, adding up to 12 weeks. During treatment patients will activate their device 3 times a day for 10 minutes each. During screening, treatment and follow-up period, all patients will twice per day report the average and maximum intensity of their pain Numeric Rating Scale (NRS). Patients will also enter the date, amount, and time of intake of rescue medication, if applicable. The primary objective of this study is to assess the impact on pain. Secondary objectives are to compare the performance between active therapy and sham, as well as to correlate changes in pain intensity with other pain related scales.

Can Blood Biomarkers of Inflammation and BDNF be Used to Assess the Effectiveness of Collagen Mesotherapy in Chronic CMPS?

The aim of the study is to assess the concentration of anti-inflammatory markers after the use of cervical spine mesotherapy in the course of pain syndrome. The study is randomized. Patients will be divided into two groups: A - mesotherapy using injectable type I collagen, B - mesotherapy using 1% lignocaine. The mesotherapy procedure will be performed five times, at weekly intervals. Blood will be collected before the start of mesotherapy, a week after its completion and after 3 months of follow-up. In addition, the effectiveness and safety of mesotherapy of the cervical spine will be assessed.

Comparing Physical Therapy Interventions on Craniovertebral Angle (CVA) in Cervical Myofascial Pain Syndrome (MPS)

Myofascial pain syndrome (MPS) and radiculopathy are prevalent musculoskeletal conditions that afflict a substantial portion of the population, causing significant discomfort and impairments in daily functioning. MPS is characterized by localized muscle pain, trigger points, and referred pain, often accompanied by stiffness and restricted range of motion. A common feature shared by individuals with MPS and radiculopathy is the presence of postural abnormalities and balance impairments . The craniovertebral angle, which reflects the relationship between the head and neck, is often compromised in these individuals due to muscle imbalances, pain-related guarding, and structural changes in the spine. Various physiotherapy modalities, including dry needling, manual mobilization and soft tissue release, trigger point therapy, stretching, cupping therapy, and electrotherapy, have been utilized in clinical practice, but their relative efficacy in improving the craniovertebral angle and alleviating symptoms in individuals with MPS and radiculopathy has not been comprehensively compared. Understanding the underlying mechanisms and comparative effectiveness of various physiotherapy interventions is essential for guiding evidence-based clinical decision-making and optimizing treatment outcomes for individuals with MPS and radiculopathy. By elucidating the effects of different treatment modalities on the craniovertebral angle and associated outcomes, this research endeavor aims to contribute to the development of more tailored and effective physiotherapy approaches for improving the well-being of individuals affected by these debilitating musculoskeletal conditions.