Precision Medicine for Nociception, Sngception and Proprioception.

Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 13
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Taiwan
National Taiwan University Hospital Bei-Hu Branch
RECRUITING
Taipei
Contact Information
Primary
Der-Sheng Han, Physician
dshan1121@yahoo.com.tw
0972-653-916
Backup
Der-Sheng Han, Physician
dshan1121@yahoo.com.tw
02-23717101
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 160
Treatments
Active_comparator: Cohort A-A.therapeutic ultrasound group
1. Participants: Age between 20-100 years old who diagnosed as myofascial pain syndrome patients and willing to receive treatment.~2. Intervention: Group A (A) receives 1 MHz therapeutic ultrasound for 5 min at a frequency of 2-3 times per week at the painful upper trapezius muscle.
Active_comparator: Cohort A-B.prolotherapy group
1. Participants: Age between 20-100 years old who diagnosed as myofascial pain syndrome patients and willing to receive treatment.~2. Intervention: Group B receives hypertonic prolotherapy at perimysium of upper trapezius muscle. The injectant is 5ml 5% dextrose solution.
No_intervention: Cohort B
1. Participants: Age between 13-65 years old who diagnosed as idiopathic scoliosis The diagnosis of scoliosis was confirmed by antero-posterior plain Xray with Cobbs angle larger than 10 degrees.~2. Intervention: None
Related Therapeutic Areas
Sponsors
Collaborators: National Science and Technology Council, National Health Research Institutes, Taiwan
Leads: National Taiwan University Hospital

This content was sourced from clinicaltrials.gov