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Efficacy and safety of microemulsion gel containing Nam-Mun-Wan remedy in patients with myofascial pain syndrome in upper trapezius muscle (Clinical trial phase II)

Efficacy and safety of microemulsion gel containing Nam-Mun-Wan remedy in patients with myofascial pain syndrome in upper trapezius muscle (Clinical trial phase II)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260723013
Enrollment
105
Registered
2026-07-23
Start date
2026-08-10
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients were diagnosed with myofascial pain syndrome in the upper trapezius muscle, with at least one tender point in the upper trapezius muscle, accompanied by tenderness, a palpable taut band, a jump sign, and referred pain, with symptoms persisting for at least one week. MPS, Myofascial Pain Syndrome, upper trapezius

Interventions

The placebo group consisted of 1.5% gelling agent, water, and water-soluble synthetic coloring. The color of the formulation was carefully adjusted to closely resemble that of the 2% Nam-Mun-Wan remed
Placebo Comparator No treatment,Experimental Drug,Active Comparator Drug
Placebo group,Experimental group,Active control group

Sponsors

Faculty of Medicine, Thammasat University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged between 18 and 60 years who were diagnosed with myofascial pain syndrome. Presence of myofascial pain in the upper trapezius muscle, with at least one tender point in the upper trapezius muscle, accompanied by tenderness, a palpable taut band, a jump sign, and referred pain, with symptoms persisting for at least one week. 2. Pain intensity ranging from 4 to 7, as assessed by the Visual Analog Scale (VAS). 3. Ability and willingness to comply with the study protocol, including attendance at all scheduled study visits. Voluntary participation in the study, following a clear explanation of the research procedures, with provision of written informed consent, and no concurrent participation in other research studies.

Exclusion criteria

Exclusion criteria: 1. History of hypersensitivity or allergic reactions to 1% diclofenac gel. 2. History of allergy to herbal components, extracts used in the NMW formulation, or any constituents of the microemulsion or microemulsion gel. 3. History of trauma, injury, or structural abnormalities of the cervical spine, thoracic spine, or shoulder, including but not limited to cervical spondylosis, muscle tears involving the neck or shoulder, or pathological conditions of the shoulder joint. 4. History of neurological disorders, such as peripheral neuropathy, multiple sclerosis, hemiparesis, or myelopathy, or neurological symptoms (e.g., upper limb numbness) attributable to cervical spine disorders or cervical disc herniation (entrapment neuropathy). 5. Presence of open wounds, skin lesions, or infections at the shoulder, neck, or upper back areas. 6. Use of non-steroidal anti-inflammatory drugs (NSAIDs) or topical analgesic medications within two weeks prior to study enrollment. 7. Receipt of other therapeutic interventions for myofascial pain, including acupuncture or dry needling, physical therapy modalities (e.g., heat therapy, massage, stretching), trigger point injections, or steroid injections within one week prior to study initiation. 8. Pregnant or breastfeeding women.

Design outcomes

Primary

MeasureTime frame
Pain assessment 5 times, on Days 0, 3, 7, 14, and 28 following the start of the intervention. Visual Analog Scale (VAS)

Secondary

MeasureTime frame
Cervical range of motion 5 times, on Days 0, 3, 7, 14, and 28 following the start of the intervention. Cervical Range of Motion (CROM) instrument,Pressure Pain Threshold assessment 5 times, on Days 0, 3, 7, 14, and 28 following the start of the intervention. Algometer,Assess disability due to neck pain 4 times, on Days 0, 7, 14, and 28 following the start of the intervention. Neck Disability Index,Product satisfaction 1 times, on Days 28 following the start of the intervention. product satisfaction questions

Countries

Thailand

Contacts

Public ContactChanoknach Buakhlee

Faculty of Medicine, Thammasat University

Chanoknach.buak@dome.tu.ac.th029269749

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026