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Completed

NCT Number: NCT05429827

The Therapeutic Effects of Dextrose Injection for Myofascial Pain Syndrome

Patients with an myofascial trigger point (MTrP) in their upper trapezius will be divided into three groups: Group A receiving MTrP injection with normal saline (control group), Group B with hypo-osmolar dextrose (5% dextrose), and Group C with hyper-osmolar dextrose (15% dextrose). Clinical outcomes and morphological changes will be measured before the injection, one hour after, one week after, two weeks after, and one month after the injection to delineate the therapeutic effects of dextrose injection for an MTrP.

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Key information

Conditions

Myofascial Trigger Point Pain Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of physical Medicine and Rehabilitation, National Cheng Kung University Hospital

Tainan, 704, Taiwan

About this study

This experiment is designed to evaluate the therapeutic effects of dextrose injection on an myofascial trigger point (MTrP). Patients with an MTrP in their upper trapezius will be recruited and be divided into three groups: Group A receiving MTrP injection with normal saline (control group), Group B with hypo-osmolar dextrose (5% dextrose), and Group C with hyper-osmolar dextrose (15% dextrose). Clinical outcomes (visual analog scale, pressure pain threshold, range of motion, neck disability index) will be measured before the injection, one hour after, one week after, two weeks after, and one month after the injection. Morphological changes of an MTrP before, and after the injection will also be evaluated by sonography. Through this study, the definite therapeutic effects, and the better osmolality of dextrose injection for the treatment of an MTrP will be delineated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1). Patients should be 20 years of age or older;
  • 2). They are able to communicate freely;
  • 3). Patients have the diagnosis of myofascial pain syndrome (MPS) with a definite myofascial trigger point (MTrP) in the neck base and upper back regions (the upper trapezius muscle). The MTrP is identified based on the following criteria, as recommended by Simons [Simons et al., 1999]:
  • (a). a localized tender spot in a palpable taut band of muscle fibers,
  • (b). recognized pain (as the usual clinical complaint) when the tender spot is compressed,
  • (c). characteristic and consistent referred pain.
  • 4). Symptoms of MPS should be more than 3 weeks.

Exclusion criteria

  • (1). acute or serious medical problems;
  • (2). cognitive impairment or psychiatric disorder;
  • (3). coagulopathy or any other bleeding disorder;
  • (4). taking medication of anticoagulation or antithrombolytics;
  • (5). sensory deficiency over the body part where MTrPs located;
  • (6). serum hepatitis B or acquired immunodeficiency syndrome;
  • (7). malignancy;
  • (8). pregnant or likely to be pregnant.
  • (9). diabetes mellitus

Treatment and study plan

Normal Saline

Other

Inject 2 ml normal saline into a myofascial trigger point and evaluate the clinical effects before and after the injection.

Dextrose 5% in water

Drug

Inject 2 ml 5% dextrose into a myofascial trigger point and evaluate the clinical effects before and after the injection.

Dextrose 15% in water

Drug

Inject 2 ml 15% dextrose into a myofascial trigger point and evaluate the clinical effects before and after the injection.

Primary outcomes

  1. visual analog scale (VAS)

    Time frame: Change from Baseline visual analog scale at one hour after intervention.

    To measure the pain intensity of a myofascial trigger point. The minimum value is 0, and the maximum value is 10, and higher scores mean worse outcome (more painful).

  2. visual analog scale (VAS)

    Time frame: Change from Baseline visual analog scale at one week after intervention.

    To measure the pain intensity of a myofascial trigger point. The minimum value is 0, and the maximum value is 10, and higher scores mean worse outcome (more painful).

  3. visual analog scale (VAS)

    Time frame: Change from Baseline visual analog scale at two weeks after intervention.

    To measure the pain intensity of a myofascial trigger point. The minimum value is 0, and the maximum value is 10, and higher scores mean worse outcome (more painful).

  4. visual analog scale (VAS)

    Time frame: Change from Baseline visual analog scale at one month after intervention.

    To measure the pain intensity of a myofascial trigger point. The minimum value is 0, and the maximum value is 10, and higher scores mean worse outcome (more painful).

Secondary outcomes

  1. pressure pain threshold (PPT)

    Time frame: Change from Baseline pressure pain threshold at one hour after intervention.

    To measure the change of pressure pain threshold of a myofascial trigger point. The minimum value is 0 Kg/cm2, the maximum value is 5 Kg/cm2, and higher scores mean better outcome (less painful).

  2. pressure pain threshold (PPT)

    Time frame: Change from Baseline pressure pain threshold at one week after intervention.

    To measure the change of pressure pain threshold of a myofascial trigger point. The minimum value is 0 Kg/cm2, the maximum value is 5 Kg/cm2, and higher scores mean better outcome (less painful).

  3. pressure pain threshold (PPT)

    Time frame: Change from Baseline pressure pain threshold at two weeks after intervention.

    To measure the change of pressure pain threshold of a myofascial trigger point. The minimum value is 0 Kg/cm2, the maximum value is 5 Kg/cm2, and higher scores mean better outcome (less painful).

  4. pressure pain threshold (PPT)

    Time frame: Change from Baseline pressure pain threshold at one month after intervention.

    To measure the change of pressure pain threshold of a myofascial trigger point. The minimum value is 0 Kg/cm2, the maximum value is 5 Kg/cm2, and higher scores mean better outcome (less painful).

  5. Range of motion (ROM) of the neck

    Time frame: Change from Baseline range of motion (ROM) of the neck at one hour after intervention.

    To measure the change of the range of motion of cervical spine. The minimum value is 0 degree, the maximum value is 90 degree, and higher scores mean better outcome.

  6. Range of motion (ROM) of the neck

    Time frame: Change from Baseline range of motion (ROM) of the neck at one week after intervention.

    To measure the change of the range of motion of cervical spine. The minimum value is 0 degree, the maximum value is 90 degree, and higher scores mean better outcome.

  7. Range of motion (ROM) of the neck

    Time frame: Change from Baseline range of motion (ROM) of the neck at two weeks after intervention.

    To measure the change of the range of motion of cervical spine. The minimum value is 0 degree, the maximum value is 90 degree, and higher scores mean better outcome.

  8. Range of motion (ROM) of the neck

    Time frame: Change from Baseline range of motion (ROM) of the neck at one month after intervention.

    To measure the change of the range of motion of cervical spine. The minimum value is 0 degree, the maximum value is 90 degree, and higher scores mean better outcome.

  9. neck disability index (NDI)

    Time frame: Change from Baseline neck disability index (NDI) at one hour after intervention.

    To measure the change of neck disability index (NDI) related to the myofascial trigger point. The minimum value is 0, the maximum value is 50, and higher scores mean worse outcome (increased functional disability).

  10. neck disability index (NDI)

    Time frame: Change from Baseline neck disability index (NDI) at one week after intervention.

    To measure the change of neck disability index (NDI) related to the myofascial trigger point. The minimum value is 0, the maximum value is 50, and higher scores mean worse outcome (increased functional disability).

  11. neck disability index (NDI)

    Time frame: Change from Baseline neck disability index (NDI) at two weeks after intervention.

    To measure the change of neck disability index (NDI) related to the myofascial trigger point. The minimum value is 0, the maximum value is 50, and higher scores mean worse outcome (increased functional disability).

  12. neck disability index (NDI)

    Time frame: Change from Baseline neck disability index (NDI) at one month after intervention.

    To measure the change of neck disability index (NDI) related to the myofascial trigger point. The minimum value is 0, the maximum value is 50, and higher scores mean worse outcome (increased functional disability).

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jun 23, 2022
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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