An interventional study of LASER and Ultrasound in Rehabilitation, Pain, Shoulder and Pain, Chronic, sponsored by National Taiwan University Hospital. Active, not recruiting at 1 site in Taiwan. Open to participants aged 13 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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.
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.
Pain is defined as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage" by the International Association for the Study of Pain (IASP).Traditionally, soreness, or sng, is also included as one of the pain sensation. Recently, the investigators defined sngception as acid and/or soreness sensation in the somatosensory system, and revealed that analgesia in muscle is through substance P and Tac1.
According to the clinical outcome, some patients responded to physical agents well, and some preferred injections. The genetic variants of the above-mentioned genes might be the determining factors of differential therapeutic effects. However, it took about 4-8 weeks for a patient to switch from one treatment option to another one. If the investigators can determine the optimal treatment modality by genetic biomarkers, the treatment course and total expanse will decrease a lot.
The investigators hypothesize that the genetic variants of the proposed genes (TRPV1, ASIC1a, ASIC3, Tac1, COMT, TCL1A, POMC, RGS4, ASIC2, ASIC4, TRPA1, NK1R, G2A, GPR4, OGR1, TDAG8, TASK1, TASK2, TASK3, TREK1, P2X2, P2X3, P2X5, TRPV4, KCNK1, NTSR1, NTSR2, CaV3.2, Nav1.1, Piezo1, and Piezo2, Runx3 or Egr3, endothelin converting enzyme-like 1 (ECEL1), myosin heavy chain genes MYH3 and MYH8, myosin-binding protein C gene, MYBPC1, and TNNI2, TNNT3 and TPM2 that encode the muscle regulatory proteins troponin I, troponin T and beta-tropomyosin) could be the prognostic biomarkers of sng/pain treatments or proprioceptive function.
1.Specific Aims
2.In the past years, our team had some achievements to justify the search of genetic variants for development of a new sore/pain treatment algorithm.
3.Study design
(1) Participants from cohort A-Myofascial pain syndrome: The investigators will recruit 80 participant from National Taiwan University Hospital and its Branch hospital.
B. Clinical trail design:
(2) Participants from cohort B-idiopathic scoliosis: The investigators will recruit 80 participant from National Taiwan University Hospital and its Branch hospital, and Taichung Veteran Hospital.
B. Clinical Trail design:
Data analyses will be performed as previously described. Briefly, the raw sequencing data will be aligned to the reference human genome (Feb. 2009, GRCh37/hg19) using BWA-MEM. The investigators will use Picard to perform necessary data conversion, sorting and indexing. The main variant calling process, for both single nucleotide variants and indels, will be operated with the GATK software package. Structural variants will also be identified. The investigators will apply ANNOVAR to appropriately annotate the genetic variants; this include at least gene annotation, amino acid change annotation, SIFT scores, PolyPhen2 score, dbSNP identifiers, 1000 Genome Project allele frequencies, gnomAD allele frequencies and ClinVar database with variant clinical significance. The investigators will then use IGV to view the mapping and annotation of sequences on a graphic interface.
The allele frequencies of variants of interest will be compared between different groups of participants. The investigators will look for possible rare variants with very strong effects (the single-gene model) as well as relatively common variants with moderate to strong effects (the complex phenotype model).
707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.
This study's planned enrollment of 160 is above the median of 60 across 561 interventional studies indexed under Shoulder Pain.
Browse Shoulder Pain studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 568 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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1.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:
Exclusion Criteria:
1.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.
2.Cohort B:
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.
Device: LASER · Device: Ultrasound · Drug: Prolotherapy
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.
Device: LASER · Device: Ultrasound · Drug: Prolotherapy
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
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.
1 MHz therapeutic ultrasound for 5 min at a frequency of 4-6 times two week at the painful upper trapezius muscle.
Also known as: Therapeutic ultrasound
Hypertonic prolotherapy at perimysium of upper trapezius muscle. The injectant is 5ml 5% dextrose solution.
Also known as: Hypertonic prolotherapy
Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) anchor the patient's mark, providing a range of scores from 0-100. score 0 means 'no pain' and score 100 means 'pain worst'. VAS have been recommended: no pain (0 point), mild pain(10-40 point), moderate pain (50-70 point ), and severe pain (80-100 point).
Time frame: Baseline Visual Analogue Scale.
Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) anchor the patient's mark, providing a range of scores from 0-100. score 0 means 'no pain' and score 100 means 'pain worst'. VAS have been recommended: no pain (0 point), mild pain(10-40 point), moderate pain (50-70 point ), and severe pain (80-100 point).
Time frame: Only cohort A: Change from Baseline Visual Analogue Scale at 2 weeks.
Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) anchor the patient's mark, providing a range of scores from 0-100. score 0 means 'no pain' and score 100 means 'pain worst'. VAS have been recommended: no pain (0 point), mild pain(10-40 point), moderate pain (50-70 point ), and severe pain (80-100 point).
Time frame: Only cohort A: Change from Baseline Visual Analogue Scale at 4 weeks (if crossover)
Myoton-Muscle tone
Muscle tone means state of muscle tension, which unit is Natural oscillation frequency \[Hz\]. This higher or lower value meaning is uncertainty. The range was from 10 to 30 Hz.
Time frame: Cohort A: Baseline, week 2, week 4 (if crossover); Cohort B: Baseline
Myoton- Dynamic stiffness
Muscle tone means muscle biomechanical properties, which unit is N/m. This higher or lower value meaning is uncertainty. The range was from 100 to 600 Hz.
Time frame: Cohort A: Baseline, week 2, week 4 (if crossover); Cohort B: Baseline
Pain thresholds
The item evaluate by SBMEDIC Algometer. The investigators used a device to press the participant's upper trapezius muscle until the subject call "uncomfortable" and then recorded the value. The investigators catch mean by three times. Pain thresholds range from 0 to 800 Kpa. Low thresholds means higher pain sensitivity (Pain tolerance) or muscle inflammation.
Time frame: Cohort A: Baseline, week 2, week 4 (if crossover); Cohort B: Baseline
SF-36
Quality of life (36-Item Short Form Survey)
Time frame: Cohort A: Baseline, week 2, week 4 (if crossover); Cohort B: Baseline
Plan to share: No — The data doesn't shared with other researchers.
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National Taiwan University Hospital