Precision Medicine for Sng/Pain Control

NCT05154695 | Completed

• 1 other identifier: 202011007RIND
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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 find genetic SNPs which can determine the response of sore /pain treatment modalities. (2) To find possible metabolomics and proteomic markers of sore /pain. (3) To determine the algorithm of precision medicine for sore /pain control via the genetic markers. Investigators will recruit 80 myofascial pain patients from Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital Bei-Hu Branch in 2021 and 2022. The participants will receive LLL, ultrasound, and prolotherapy, and the therapeutic effect will be recorded. 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 2023 and 2024. 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

Keywords

sng/pain; Low-level Laser Therapy; ultrasound; prolotherapy; next generation sequencing

Outcome Measures

Primary Outcomes (3)

• Visual Analogue Scale (VAS) - first

  Visual Analogue Scale (VAS) anchor the patient's mark, providing a range of scores from 0-10. score 0 means 'no pain' and score 10 means 'pain worst'. VAS have been recommended: no pain (0 point), mild pain(1-4 point), moderate pain (5-7 point ), and severe pain (8-10 point).

  Baseline Visual Analogue Scale

• Visual Analogue Scale (VAS) - second

  Visual Analogue Scale (VAS) anchor the patient's mark, providing a range of scores from 0-10. score 0 means 'no pain' and score 10 means 'pain worst'. VAS have been recommended: no pain (0 point), mild pain(1-4 point), moderate pain (5-7 point ), and severe pain (8-10 point).

  Change from Baseline Visual Analogue Scale at 2 weeks.

• Visual Analogue Scale (VAS) - third

  Visual Analogue Scale (VAS) anchor the patient's mark, providing a range of scores from 0-10. score 0 means 'no pain' and score 10 means 'pain worst'. VAS have been recommended: no pain (0 point), mild pain(1-4 point), moderate pain (5-7 point ), and severe pain (8-10 point).

  Change from Baseline Visual Analogue Scale at 4 weeks (if crossover).

Secondary Outcomes (4)

• SF-36

  Baseline, week 2, week 4 (if crossover)

• Pain thresholds

  Baseline, week 2, week 4 (if crossover)

• Myoton-Muscle tone

  Baseline, week 2, week 4 (if crossover)

• Myoton- Dynamic stiffness

  Baseline, week 2, week 4 (if crossover)

Study Arms (2)

A.therapeutic ultrasound group

ACTIVE COMPARATOR

Group 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: A.therapeutic ultrasound group; Drug: B.prolotherapy group

B.prolotherapy group

ACTIVE COMPARATOR

Group B receives hypertonic prolotherapy at perimysium of upper trapezius muscle. The injectant is 5ml 5% dextrose solution.

Device: LASER; Device: A.therapeutic ultrasound group; Drug: B.prolotherapy group

Interventions

LASER DEVICE

The eligible participants 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.

A.therapeutic ultrasound group; B.prolotherapy group

A.therapeutic ultrasound group DEVICE

Group A receives 1 MHz therapeutic ultrasound for 5 min at a frequency of 2-3 times per week at the painful upper trapezius muscle.

Also known as: Group A

A.therapeutic ultrasound group; B.prolotherapy group

B.prolotherapy group DRUG

Group B receives hypertonic prolotherapy at perimysium of upper trapezius muscle. The injectant is 5ml 5% dextrose solution.

Also known as: Group B

A.therapeutic ultrasound group; B.prolotherapy group

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) Age between 20-100 years old.
• (2) Diagnosed as myofascial pain syndrome patients and willing to receive treatment (including LLLT, therapeutic ultrasound, and local dextrose injection therapy).

You may not qualify if:

• Those having active infection, malignancy, and hematological diseases were excluded. The patients had received local injection at upper trapezius within 3 months are also excluded.

Sponsors & Collaborators

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

Study Sites (1)

National Taiwan University Hospital Bei-Hu Branch

Taipei, Taiwan, 802, Taiwan

Location

Related Publications (17)

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MeSH Terms

Conditions

Shoulder Pain; Chronic Pain

Interventions

Lasers

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Der-Sheng Han, Physician

  International Committee of Medical Journal Editors

  STUDY DIRECTOR

Study Design

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

Model Details: The eligible participants 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. They are randomly assigned into two groups (40 subjects in each group): A. therapeutic ultrasound group; B. prolotherapy group. The same physician (the principal investigator) injects all participants to avoid inter-physician variability. No other medication or physical modality was given to avoid efficacy interference in both groups. Rescue therapy (cross-over treatment): If the participant does not satisfy with their first round treatment and the improvement of VAS is less than 1.0, then they are eligible to receive the rescue therapy-the treatment in the other group

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: December 13, 2021
• Study Start: August 28, 2021
• Primary Completion: October 31, 2023
• Study Completion: November 30, 2023
• Last Updated: November 21, 2025

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)