About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

LASER
Device
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.
Ultrasound
Device
1 MHz therapeutic ultrasound for 5 min at a frequency of 4-6 times two week at the painful upper trapezius muscle.
Prolotherapy
Drug
Hypertonic prolotherapy at perimysium of upper trapezius muscle. The injectant is 5ml 5% dextrose solution.

Treatment groups

160 Participants

are divided into 3 treatment groups

Group A: Cohort A-A.therapeutic ultrasound groupActive comparator 3 interventions

Group B: Cohort A-B.prolotherapy groupActive comparator 3 interventions

Group C: Cohort BNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

2

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.

3

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)

Secondary outcomes

1

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

2

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

3

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

4

SF-36

Quality of life (36-Item Short Form Survey)

Time frame

Cohort A: Baseline, week 2, week 4 (if crossover); Cohort B: Baseline

Precision Medicine for Nociception, Sngception and Proprioception.

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts