The Therapeutic Effects of Dextrose Injection for Myofascial Pain Syndrome

July 13, 2026 updated by: Ta-Shen Kuan, MD, National Cheng-Kung University Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Taiwan
      • Tainan, Taiwan, 704
        • Department of physical Medicine and Rehabilitation, National Cheng Kung University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Normal saline
Injection of 2 ml normal saline into a myofascial trigger point.
Other: normal saline
Inject 2 ml normal saline into a myofascial trigger point and evaluate the clinical effects before and after the injection.
Experimental: hypo-osmolar dextrose solution
Injection of 2 ml 5% dextrose into a myofascial trigger point.
Drug: Dextrose 5% in water
Inject 2 ml 5% dextrose into a myofascial trigger point and evaluate the clinical effects before and after the injection.
Experimental: hyper-osmolar dextrose solution
Injection of 2 ml 15% dextrose into a myofascial trigger point.
Drug: Dextrose 15% in water
Inject 2 ml 15% dextrose into a myofascial trigger point and evaluate the clinical effects before and after the injection.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Change from Baseline visual analog scale at one hour after intervention.
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).
Change from Baseline visual analog scale at one week after intervention.
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).
Change from Baseline visual analog scale at two weeks after intervention.
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).
Change from Baseline visual analog scale at one month after intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Change from Baseline pressure pain threshold at one hour after intervention.
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).
Change from Baseline pressure pain threshold at one week after intervention.
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).
Change from Baseline pressure pain threshold at two weeks after intervention.
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).
Change from Baseline pressure pain threshold at one month after intervention.
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.
Change from Baseline range of motion (ROM) of the neck at one hour after intervention.
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.
Change from Baseline range of motion (ROM) of the neck at one week after intervention.
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.
Change from Baseline range of motion (ROM) of the neck at two weeks after intervention.
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.
Change from Baseline range of motion (ROM) of the neck at one month after intervention.
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).
Change from Baseline neck disability index (NDI) at one hour after intervention.
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).
Change from Baseline neck disability index (NDI) at one week after intervention.
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).
Change from Baseline neck disability index (NDI) at two weeks after intervention.
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).
Change from Baseline neck disability index (NDI) at one month after intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cheng-Kung University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ta-Shen Kuan, M.D., M.S., National Cheng-Kung University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 18, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 21, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B-BR-110-078

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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