Precision Medicine for Nociception, Sngception and Proprioception.

NCT06161038 | Recruiting

• 1 other identifier: 202302118RINA
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rehabilitation; Pain, Shoulder; Pain, Chronic; Idiopathic Scoliosis

Keywords

Sng / Pain; Precision medicine; Next generation sequencing; Proprioception; Prolotherapy

Outcome Measures

Primary Outcomes (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).

  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).

  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).

  Only cohort A: Change from Baseline Visual Analogue Scale at 4 weeks (if crossover)

Secondary Outcomes (4)

• Myoton-Muscle tone

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

• Myoton- Dynamic stiffness

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

• Pain thresholds

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

• SF-36

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

Study Arms (3)

Cohort A-A.therapeutic ultrasound group

ACTIVE COMPARATOR

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

Cohort A-B.prolotherapy group

ACTIVE COMPARATOR

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

Cohort B

NO INTERVENTION

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

Interventions

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.

Cohort A-A.therapeutic ultrasound group; Cohort A-B.prolotherapy group

Ultrasound DEVICE

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

Cohort A-A.therapeutic ultrasound group; Cohort A-B.prolotherapy group

Prolotherapy DRUG

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

Also known as: Hypertonic prolotherapy

Cohort A-A.therapeutic ultrasound group; Cohort A-B.prolotherapy group

Eligibility Criteria

• Age: 13 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Science and Technology Council: collaborator
• National Health Research Institutes, Taiwan: collaborator

Study Sites (1)

National Taiwan University Hospital Bei-Hu Branch

Taipei, 802, Taiwan

RECRUITING

Related Publications (21)

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MeSH Terms

Conditions

Shoulder Pain; Chronic Pain; Pain

Interventions

Lasers; Ultrasonography; Ultrasonic Therapy; Prolotherapy

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diathermy; Hyperthermia, Induced; Therapeutics; Complementary Therapies

Central Study Contacts

Der-Sheng Han, Physician

CONTACT

0972-653-916; dshan1121@yahoo.com.tw

Der-Sheng Han, Physician

CONTACT

02-23717101; dshan1121@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. Cohort A-Myofascial pain syndrome The eligible patients first received LLLT with a 685-nm wavelength and an output of 30 mW at energy densities of 8 J/cm2 at trigger point of upper trapezius muscle. Then, they are conveniently assigned into two groups (40 subjects in each group): A. therapeutic ultrasound group; B. prolotherapy group. The same physician (the principal investigator) injects all patients to avoid inter-physician variability. Rescue therapy (cross-over treatment): If the participant does not satisfy with their first round treatment and the improvement of VAS is less than 10, then they are eligible to receive the rescue therapy-the treatment in the other group. 2. Cohort B-idiopathic scoliosis: The recruited patients receive evaluation for once only. The collected parameters include Cobb's angle, spine rotational angle, VAS-pain and VAS-sng (visual analogue scale), pain threshold, strength and tone of paraspinal muscle, and SF-36.

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 7, 2023
• Study Start: October 1, 2023
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)