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

NCT07713771 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: REC.68-226-41-1
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Topical Analgesia; Myofascial Pain Syndrome - Neck

Keywords

mirtagynine; kratom patch; topical patch; pain reduction

Outcome Measures

Primary Outcomes (1)

• pain score

  * Pain intensity: Used to indicate the level of pain on a scale ranging from 0-100 mm. * compared mean VAS score between group

  3 days after used

Secondary Outcomes (1)

• satisfaction score

  3 days after used

Study Arms (2)

treatment group

EXPERIMENTAL

topical patch contains of mirtagynine 10 mg

Drug: mitragynine topical patch from kratom

control group

PLACEBO COMPARATOR

topical patch similar to treatment group except mirtagynine extract

Drug: Placebo

Interventions

mitragynine topical patch from kratom DRUG

mirtagynine topical patch contains of 10 mg

treatment group

Placebo DRUG

topical patch similar to active patch but no mirtagynine

control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- Patients aged 18-50 years.
• Experiencing neck or shoulder pain for more than 3 months.
• Diagnosed with myofascial pain syndrome, with the most tender trigger point located in the upper trapezius muscle and a pain score between 30-60 mm measured using the Visual Analogue Scale (VAS).

You may not qualify if:

• \- History of other neck-related conditions (e.g., whiplash injury, cervical radiculopathy, fibromyalgia syndrome, cervical spine surgery and/or fracture).
• History of systemic diseases (e.g., rheumatism, multiple sclerosis, cervical myelopathy), hepatitis, liver failure, or kidney disease (serum creatinine \> 2.0 mg/dL).
• Symptoms or conditions contraindicating the use of patches, such as wounds or infections at the painful site.
• History of allergy to paracetamol or kratom.
• History of allergy to adhesive patches/plasters.
• Pregnant or breastfeeding women.
• Receipt of treatment with analgesics other than paracetamol, physical therapy, dry needling/acupuncture, massage, or topical medications within the previous week.
• Individuals who are unable to read or write.

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

Prince of Songkla university

Songkhla, Changwat Songkhla, 90110, Thailand

Location

Related Publications (6)

• Kruegel AC, Gassaway MM, Kapoor A, Varadi A, Majumdar S, Filizola M, Javitch JA, Sames D. Synthetic and Receptor Signaling Explorations of the Mitragyna Alkaloids: Mitragynine as an Atypical Molecular Framework for Opioid Receptor Modulators. J Am Chem Soc. 2016 Jun 1;138(21):6754-64. doi: 10.1021/jacs.6b00360. Epub 2016 May 18.

  PMID: 27192616 RESULT

• Goodwin B, Mitchell J, Major E, Podwojniak A, Brancaccio H, Rusinak K, King M, Tahir H. The efficacy of topical 8% capsaicin patches for the treatment of postsurgical neuropathic pain: a systematic review. Pain Manag. 2024 Oct-Nov;14(10-11):591-598. doi: 10.1080/17581869.2024.2433931. Epub 2024 Nov 26.

  PMID: 39589498 RESULT

• Hsieh LF, Hong CZ, Chern SH, Chen CC. Efficacy and side effects of diclofenac patch in treatment of patients with myofascial pain syndrome of the upper trapezius. J Pain Symptom Manage. 2010 Jan;39(1):116-25. doi: 10.1016/j.jpainsymman.2009.05.016. Epub 2009 Oct 12.

  PMID: 19822404 RESULT

• Takayama H. Chemistry and pharmacology of analgesic indole alkaloids from the rubiaceous plant, Mitragyna speciosa. Chem Pharm Bull (Tokyo). 2004 Aug;52(8):916-28. doi: 10.1248/cpb.52.916.

  PMID: 15304982 RESULT

• Cerezo-Tellez E, Torres-Lacomba M, Mayoral-Del Moral O, Sanchez-Sanchez B, Dommerholt J, Gutierrez-Ortega C. Prevalence of Myofascial Pain Syndrome in Chronic Non-Specific Neck Pain: A Population-Based Cross-Sectional Descriptive Study. Pain Med. 2016 Dec;17(12):2369-2377. doi: 10.1093/pm/pnw114. Epub 2016 Jun 20.

  PMID: 28025371 RESULT

• Borg-Stein J, Simons DG. Focused review: myofascial pain. Arch Phys Med Rehabil. 2002 Mar;83(3 Suppl 1):S40-7, S48-9. doi: 10.1053/apmr.2002.32155.

  PMID: 11973695 RESULT

Study Officials

• suttipong tipchatyotin, m.d.

  Prince of Songkla University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

suttipong tipchatyotin, m.d.

CONTACT

+66848559898; tsuttipo@medicine.psu.ac.th

sumairao toateng, B.Sc.

CONTACT

+6674451601; sumairao.t@psu.ac.th

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: Double-blinded, placebo-controlled randomized controlled trial

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: July 20, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)