RecruitingNot ApplicableNCT06161038

Precision Medicine for Nociception, Sngception and Proprioception.


Sponsor

National Taiwan University Hospital

Enrollment

160 participants

Start Date

Oct 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Precision medicine is defined as "an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person" by the Precision Medicine Initiative. Patients have different response to different treatment modalities, and sore/pain medicine is no exception. In our experience, low-level laser (LLL), ultrasound, and prolotherapy can reduce sore /pain through different genetic pathway. Whether the therapeutic effect is controlled by the genetic variants of those sore /pain related genes or not, is still in debate. The aims of this study are (1) To set up next generation sequencing (NGS)-based approach to find genetic variants which can determine the response of sng/pain treatment modalities and the phenotype of idiopathic scoliosis. (2) To find possible metabolomics and proteomic markers of sng/pain. (3) To determine the algorithm of precision medicine for sng/pain control via the genetic markers. Investigators will recruit 80 myofascial pain participant and 80 idiopathic scoliosis participant from Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital Bei-Hu Branch in 2023 and 2025. The myofascial pain participant participants will receive LLL, ultrasound, and prolotherapy, and the therapeutic effect will be recorded. The clinical trial will evaluate the Sng / pain (VAS) and muscle tone of the idiopathic scoliosis participant. The blood and urine samples from the first, the second, and the third visits will be analyzed by next generation sequencing, and mass spectrometry to find the possible biomarker in 2024 and 2025. Investigators expect to develop the individualized treatment plan by means of these biomarkers. Hopefully, the results will be widely applied in the field of sore /pain medicine.


Eligibility

Min Age: 13 YearsMax Age: 100 Years

Inclusion Criteria4

  • Cohort A:
  • (1) Age between 20-100 years old. (2) VAS>=30 or VAS>=30 at 4 kg pressure (3) Diagnosed as myofascial pain syndrome patients and willing to receive treatment (including LLLT, therapeutic ultrasound, and local dextrose injection therapy) 2. Cohort B:
  • Age between 13-65 years old.
  • Diagnosed as idiopathic scoliosis The diagnosis of scoliosis was confirmed by antero-posterior plain Xray with Cobbs angle larger than 10 degrees.

Exclusion Criteria5

  • Cohort A: Those having active infection, malignancy, and hematological diseases were excluded. The patients had received local injection at upper trapezius within 6 months are also excluded.
  • Cohort B:
  • Those having active infection, malignancy, and hematological diseases were excluded.
  • Those having specific etiologies of scoliosis, including congenital scoliosis due to malformation or faulty segmentation of the vertebrae and neuromuscular scoliosis due to muscular imbalance, syndromic scoliosis or degenerative scoliosis.
  • Pregnancy.

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Interventions

DEVICELASER

LLLT with a 685-nm wavelength and an output of 30 mW (BTL-5000 Laser, BTL, Stevenage, UK) at energy densities of 8 J/cm2 at trigger point of upper trapezius muscle.

DEVICEUltrasound

1 MHz therapeutic ultrasound for 5 min at a frequency of 4-6 times two week at the painful upper trapezius muscle.

DRUGProlotherapy

Hypertonic prolotherapy at perimysium of upper trapezius muscle. The injectant is 5ml 5% dextrose solution.


Locations(1)

National Taiwan University Hospital Bei-Hu Branch

Taipei, Taiwan

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NCT06161038


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