Effectiveness of Mitragynine Topical Patch for Pain Reduction in Myofascial Pain Syndrome (mirtapatch)

August 5, 2026 updated by: SUTTIPONG TIPCHATYOTIN, Prince of Songkla University

Effectiveness of Mitragynine Topical Patch From Kratom for Pain Reduction in Myofascial Pain Syndrome of Upper Trapezius Muscle: Double Blinded Placebo, Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. Study Design Double-blinded, placebo-controlled randomized controlled trial
  2. Study Setting Rehabilitation Clinic, hospital
  3. Target Population Individuals with pain in the shoulder and neck region.
  4. Study Population Patients with subacute myofascial pain syndrome involving the upper trapezius muscle.

  5. Inclusion Criteria - 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).

  6. Exclusion Criteria - 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.

  7. Participant Withdrawal Criteria - Participants experiencing severe allergic reactions (e.g., anaphylaxis, severe rash, or intolerable itching).

    • Receipt of treatments other than paracetamol or any interventions outside those specified in the study during the follow-up period.
    • Participants who wish to withdraw from the study.
  8. Study Termination Criteria The study will be terminated if participants experience significant adverse events, including severe allergic reactions (anaphylaxis) or systemic side effects such as nausea and vomiting, in at least 7 participants, representing 10% of the sample size.
  9. Sample Size 1. Irritation testing group: 10 healthy volunteers aged 18-50 years. 2. Efficacy testing group: 64 participants, calculated using the following formula: Sample size calculation for a randomized controlled trial with a continuous outcome μ_trt = mean VAS change in the treatment group μ_con = mean VAS change in the control group σ_trt = SD in the treatment group σ_con = SD in the control group λ = 1; α = 0.05; β = 0.2 The calculation was based on the study by Hsieh (2009) on the use of a diclofenac patch for reducing pain in the upper trapezius muscle.

Estimated values:

μ_trt = 2.57; μ_con = 3.92 σ_trt = 1.75; σ_con = 1.80 n_trt = 28; n_con = 28

Assuming a 10% dropout rate:

28 / 0.9 ≈ 32 participants per group Therefore, the total sample size ≈ 64 participants. 10 Variables and Operational Definitions Independent Variable

- Pain intensity: Used to indicate the level of pain on a scale ranging from 0-100 mm.

Dependent Variable

- Satisfaction score: Measured using a 5-point Likert scale with five levels of rating.

Confounding Variables

  • Paracetamol consumption: Date and number of tablets taken will be recorded.
  • Neck muscle stretching exercises: Date and frequency of stretching exercises will be recorded.

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
    • Changwat Songkhla
      • Songkhla, Changwat Songkhla, Thailand, 90110
        • Prince of Songkla University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • - 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).

Exclusion Criteria:

  • - 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment group
topical patch contains of mirtagynine 10 mg
Drug: mitragynine topical patch from kratom
mirtagynine topical patch contains of 10 mg
Placebo Comparator: control group
topical patch similar to treatment group except mirtagynine extract
Drug: Placebo
topical patch similar to active patch but no mirtagynine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain score
Time Frame: 3 days after used
  • 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
satisfaction score
Time Frame: 3 days after used
Satisfaction score: Measured using a 5-point Likert scale with five levels of rating.
3 days after used

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prince of Songkla University

Investigators

  • Principal Investigator: suttipong tipchatyotin, m.d., Prince of Songkla University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 31, 2028

Study Completion (Estimated)

October 31, 2029

Study Registration Dates

First Submitted

July 15, 2026

First Submitted That Met QC Criteria

July 15, 2026

First Posted (Actual)

July 20, 2026

Study Record Updates

Last Update Posted (Actual)

August 10, 2026

Last Update Submitted That Met QC Criteria

August 5, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REC.68-226-41-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This study is an intellectual property of out team. We have plan to develop product in the future.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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