Topical AnalgesiaPhase 3mirtapatchNCT07713771
Effectiveness of Mitragynine Topical Patch for Pain Reduction in Myofascial Pain Syndrome
A Phase 3 study testing mitragynine topical patch from kratom in people with Topical Analgesia and Myofascial Pain Syndrome - Neck, run by Prince of Songkla University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Topical Analgesia, Myofascial Pain Syndrome - Neck
- What is being tested?
- mitragynine topical patch from kratom
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteThailand
- Study dates
- 1 Oct 2026to 31 Oct 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- - 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).
Who cannot join
- - 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Prince of Songkla university
Songkhla, Changwat Songkhla, 90110
sumairao toateng, B.Sc., +6674451601, sumairao.t@psu.ac.th
About this study
Official title: 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.
Read more
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.
Read the detailed description
- Study Design Double-blinded, placebo-controlled randomized controlled trial
- Study Setting Rehabilitation Clinic, hospital
- Target Population Individuals with pain in the shoulder and neck region.
- Study Population Patients with subacute myofascial pain syndrome involving the upper trapezius muscle.
- 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.
- 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.
- 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.
- 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.
- Conditions
- Topical Analgesia, Myofascial Pain Syndrome - Neck
- Being tested
- mitragynine topical patch from kratom, Placebo
- Keywords
- mirtagynine, kratom patch, topical patch, pain reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mitragynine topical patch from kratomDrug
mirtagynine topical patch contains of 10 mg
PlaceboDrug
topical patch similar to active patch but no mirtagynine
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | topical patch contains of mirtagynine 10 mg Receives: Drug: mitragynine topical patch from kratom |
| control group | Placebo comparator | topical patch similar to treatment group except mirtagynine extract Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 days after used
Secondary outcomes (1)
satisfaction score
Satisfaction score: Measured using a 5-point Likert scale with five levels of rating.
Measured: 3 days after used
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Topical AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded, placebo-controlled randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SUTTIPONG TIPCHATYOTIN, Prince of Songkla University
- Investigators
- suttipong tipchatyotin, m.d., Principal investigator, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713771
- Sponsor's protocol ID
- REC.68-226-41-1
- Acronym
- mirtapatch
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study is an intellectual property of out team. We have plan to develop product in the future.
Publications
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.
PubMed 27192616Goodwin 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.
PubMed 39589498Hsieh 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.
PubMed 19822404Takayama 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.
PubMed 15304982Cerezo-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.
PubMed 28025371Borg-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.
PubMed 11973695
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mitragynine Topical Patch From Kratom for Pain Reduction in Myofascial Pain Syndrome of Upper Trapezius Muscle: Double Blinded Placebo, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07713771
- Acronym / sponsor ID
- mirtapatch / REC.68-226-41-1
- Conditions
- Topical Analgesia, Myofascial Pain Syndrome - Neck
- Keywords
- mirtagynine, kratom patch, topical patch, pain reduction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Study Design Double-blinded, placebo-controlled randomized controlled trial
- Study Setting Rehabilitation Clinic, hospital
- Target Population Individuals with pain in the shoulder and neck region.
- Study Population Patients with subacute myofascial pain syndrome involving the upper trapezius muscle.
- 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.
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded, placebo-controlled randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: mitragynine topical patch from kratomtopical patch contains of mirtagynine 10 mg |
| control group | Placebo comparator | Drug: Placebotopical patch similar to treatment group except mirtagynine extract |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- - 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).
Key exclusion criteria (8 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mitragynine topical patch from kratommirtagynine topical patch contains of 10 mg | Drug | treatment group |
| Placebotopical patch similar to active patch but no mirtagynine | Drug | control group |
Primary outcome
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
1 secondary outcome
satisfaction score
Time frame: 3 days after used
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Results publication: PubMed 27192616Kruegel 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.
- Results publication: PubMed 39589498Goodwin 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.
- Results publication: PubMed 19822404Hsieh 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.
- Results publication: PubMed 15304982Takayama 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.
- Results publication: PubMed 28025371Cerezo-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.
- Results publication: PubMed 11973695Borg-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.
- Individual participant dataSharing planned: No. This study is an intellectual property of out team. We have plan to develop product in the future.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
suttipong tipchatyotin, m.d. principal investigator
Prince of Songkla University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing mitragynine topical patch from kratom in people with Topical Analgesia and Myofascial Pain Syndrome - Neck, run by Prince of Songkla University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact suttipong tipchatyotin, m.d. (+66848559898, tsuttipo@medicine.psu.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score (time frame: 3 days after used). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07713771, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.